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TEXAS DEPARTMENT OF CORRECTIONS
Huntsville, Texas

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AGENDA FOR REGULAR MEETING

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OF THE
TEXAS BOARD OF CORRECTIONS

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McAllen, Texas

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:TEXAS BOARD OF ,CORRECTIONS

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May 16, 1977
ORDER OF' B~S r'N°ESS

Call to Order
Invocation
Approval of Minutes
I.

INMATE AFFAIRS - Mr. Windham

A.

Activity Summary
1.
2.
3.

4.
5.

Educational Programs
Agency ,Reports
Chaplaincy Program
MedicaL Reports
Release Programs

B. 'Deaths

)

C.

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Statistical Reports
1.
2.
3.

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Escapes

E.

Interviews with Inmates

F.

MUlti-Purp~se Buiiding at Retrieve

G.

Expenditure from E & R Funds for
Folding Chairs at: Coffield

H.

Medical Research and Experimentation and
Pharmaceutical Te~ting·protocols from
Baylor College of Medicine

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Disciplinary
Inmate Strength
Received-Released

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Comparison of Resistance to Wildtype Influenza A/Victoria Virus
Following Vaccination with a LiveAttenuated Vaccine Candidate

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Development of Rhinovirus Type 3
Chal1~ng~System for Normal Volunteers

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Amendment to Inmate Rules and Regulations

PERSONNEL - Mr. Boyd

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B'.

C.

Training Academy

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BUSINESS AND BUDGET - Mr. Montemayor

A.

Selected Budget Records

B.' Industrial Budget Report

IV.

v;.

c.

Food Service

D.

Inmate Cost Per Day Report

E.

Livestock Report

~EGISLATION

VII.

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Re~ort

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CONSTRUCTION - Mr. Shield
Progress Report

B.

Authorization for Construction
Renovation

INDUSTRIES -

Mr~

Austin

Progress Report

VIII.

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. Mr. McLaughlin

A.

LEGAL - Mr. MtLaughlin

A.

Tanya Tucker

B.

Phillips Petroleum Company

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Rcpo~ts

AGRICULTURE - Mr. LaMantia
Agricultural

VI..

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Out-of-State Travel
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Promotion Board

A.

III.

(Cold-Adapted Recombinant) and
That Following Natural Infection

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TEXAS
DEPARTMENT OF CORRECTIONS

w. J.

E~tdle,

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Director
Huntsville, Texas 77340
A. P. MANNING
ASSISTANT DlI\I;CTOR
III CHAttC& OF TRl::A.T.ld.ENT

Apr i.l 25, 1977

TEXAS BOARD OF

lJiREC'l'lONS

Ja~es M. Windham
Texas Board of Corrections
P. ,0. Box 1272
Livingston, Texas 77351

-Mr.

H. H. Co!tield

ti,,,,.a -

JI&4&I•. Tuao

Dear Mr. Windha.m:
r, Louis

Austin, Jr,

."'tall'

~Iu. Tex.u

Board approval is requested for the following i ~eIll.s :

ter Boyd

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Enclosed is the Activity Summary for Inmate
Affairs for the months of February and March,
1977~ Would you please present this report
at the next Board of Corrections meeting?

•

rk McLaughlin
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BacoD, H. D.

Funds rema1nlng from the Retrieve
MUlti-Purpose Building to be diverted as follows:
$17,500

Enlarge visiting room area
at Retrieve Unit

$5,000

Wynne Unit Band BUilding
(additional $14,'000 required is donated funds)

.\Utoa, Tau

l~d W. Shield
[ber
"' Ant.GDlo. 'JIu u

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Expenditure of $6,000 out of E & R
Funds to be used for folding chairs
on the Coffield Unit.

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Mr. James M. Windham
Boa'rd Agenda
April 25, 1977
Page 2

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Medical Research and Experimentatlo~'~hd Pharmaceutical Testing Protocols from Baylor College
of Medicine:
1.

2.

Comparison of Resistance to Wild-Type
Influenza A/Victoria Virus Following
Vaccination with a Live-Attenuated
Vaccine Candidate (Cold-Adapted Recombinant) and That Following Natural Infection.
Development of Rhinovirus Type 3 Challenge System for Normal Volunteers.
Very truly yours,

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Enclosures

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Activity Summary for
Inmate Affairs
April 25, 1977
Page 8

State Commission for the Blind
Inmates Receiving Services
Monies Expended
Local Funds (Non-client Services)

366
$583.30
$595.40

Social Security Administration
Inmates Receiving Services

109

Texas Veterans Affairs Commission
Inmates ReceiVing Services

141

CHAPLAINCY
Number of Church Services
Inmate Attendance-Church Services
Counseling Interviews .
Death Messages Delivered
Inmate Letters Written

653
"43,020
11,224
230
1,402

MEDICAL REPORTS
General Hospital Report
Patients Admitted
Patients Discharged
Out-Patients Treated
Current Census

409
404
2,067
102

Unit Hospital Report
(All Units)
Medication Line
Sick Call with Physician
Sick Call with Medical Assistant
Routin~ Transfers for Medical Attention
Emergency Transfers for Medical Attention
Emergency Transfers to Civilian Hospital
~ew Tnmates Processed

413,560
4,776
80,968

1,547
138

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Activity Summary for
Inmate Affairs
April 25, 1977
Page 9

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Treatment Center

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Treatment in First Aid
Sick Call with Medical Assistant
Sick Call with physician
Interviews with Psychiatrist
Current Census
:

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3

281
293

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Operating Room Census
General Surgery
Local Surgery
Oral Surgery
Ophthalmolic Surgery
ENT Clinic
Plastic Procedures
Podiatry Clinic
Anesthetics
Procedures - John Sealy Hospital
Blood Transfusions
Procedures - Huntsville Unit Hospital

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0

21
30
32
0
49
0

141

Laboratory Reports
Hemotology
Blood Chemistry
Bacteriology
Parasitology
'Urinalysis
Serology
Blood Bank
Cerebrospinal Fluids
Total Laboratory Reports (All Units)

2,430

3,604
426
12
2,602
810
8
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9,892

Roentgenologist Reports
General
Head

Extremities
Electrocardiograms
Electroencephalographs
Total Reports

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1,154
199

518
166
22
6,803

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Activity Summary for
Inmate Affairs
April 2~, 1977
Page 10

Special Clinics Report
Ophthalmology Out-Patients
Optometrist-Refractions Completed
Total Reports

\

607
2,699

Oral Surgery Reports
Total

136

Dental Procedures
(All Uni ts)
Total

10,964

Medical Reprieves
Total

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2,092

98

RELEASE PROGRAMS
Pre-Release Programs'
Inmates Completing Programs
General Sessions
Group Counseling Sessions
Individual Counseling Sessions
Outside Activities
Speakers Participating
Present Enrollment

345
136
8

SO
10
126
161

Work Release Programs
(See Exhibit A)
Inmates Employed
Inmates Removed
Inmates Currently Employed

38
8
30

Post-Release Program
Inmates Enrolled

Job Resources Developed
~nrolled Inmat~s Released
Positive Termin3tions

1)2
17~

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Comparison 'of· Resistance to Wild-Tipe Influenza A/Victo~ia
Virus Following Vaccination with alive-Attenuated VaCClne
Candidate (Cold-Adapted Recornbinant) and That Following
Natural Infection

1.

Title:

2.

Principal Investigator and Associates:

3.

Department Involved:

4.

Granting Agency:

5.

Period of Grant: June 26, 1974 - June 25, 1979

6.

Location of Study:·· Baylor College of Medicine
Ramsey Unit of the Texas Department of

7.

,.

Thomas R. Cate, M. O.
Robert B. Couch, M. O.
Julius A. Kasel, Ph. o.
Howard R. Six~ Ph. O.
W. Paul Glezen, M. D.
Vernon Knight, M. D.

Hicrobiology and Immunology

NIH Contract AI 42528

Correclion~

Outline of Study:

Background Information. Parenteral vaccination ''lith currently available
inactivated influenza A virus vaccines provides 50-90% protection against
infection with homologous virus (1). Estimates of the duration of protection
against closely related influenza viruses have ranged from 3 years to more
than 15 but less than 27 months (2). An additional problem is frequent
antigenic variation of influenza A viruses necessitating yearly review and
frequent updating of the vaccines. As a consequence, annual revaccination
is recommended i~ order to obtain the greatest possible protection with
inactivated influenza vaccines.
.
Occasionally troublesome but rarely serious reactions to inactivated
influenza vaccines, such as headache, malaise and fever, have been reduced
to an apparent minimum consistent \'/i·th retention of antigenicity by cu",-ent
methods of manufacture. However, a much 1ess frequent but inore set-ious
concomitant to vaccination \'1 it h ; nacti va ted i nfl uenza vacci nes came to 1i ght
during the 1976 National Influenza Immunization Pl-o~ram, namely, the.GuillainBarre syndrome (3). ·This syndrome of uncertain pathogenesis is charactel';zcd
by ascending paralysis and frequently follows mild respiratory illnesses by
2-3 \'/eeks. It normally Occurs at a monthly incidence of about-O.6 per millioll
persons and carries a 5-10% mortality. Recipients of influenza vaccine in
the fall of 1976 had a definitely increased incidence of Guillain-Barre
sY~drpme, ~ppr?ximately 12-fold, 'i,ith the incre.3se being greatest 2-3 \'!<?ek<;
af~er vacClnatlon and not persisting longer than 2 months after vaccination (4).

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Because of the association of inactivated influenza vaccine administration
with Guillain-Barre syndrome, all .human stud.ie·s· involVing ,·influenza vaccination
were suspended~ This suspension in~ludes trials that we and others (Drs.
Brian ~1urp.hy, Myron Levine, and Gordon Dougla's) have been performing with
live-attenuated influenza virus vaccine candidate strains administered
intranasally. No complications have occurred during the latter trials, but
the number of participants is low enough that it· is still possible
that an attenuated influenza virus infection co~ld be associated with GuillainBarre syndrome if the monthly incidence is as low as the approximately one
case per 140,000 observed following receipt of inactivated influenza vaccine.
However, when one examines the question of whether Guillain-Barre syndrome
occurs following natural influenza virus infection, the seasonal patterns of
occurrence of the two do not over,lap, suggesting that there is no association
(5, 6). A study comparing serological evidence of recent influenza infection
in patients with Guillain-Barre syndrome and control subjects failed to find
any difference in the two populations (7), and there is no ,correlation of deaths
fro~ Guillain-Barre syndrome with influenza-pneumonia deaths over the past
10 years (see attached figure and reference 8). Jherefore~ if attenuated
influenza virus infections behave like natural infe~tions appear to do in
causing little predisposition to Guill~in-Barre syndrome, it could be argued
that the increased incidence of the syndrome after receipt of inactivated
influenza vaccines should provide added impetus to the development of live
attenuated vaccines. Moreover, it is hoped that respiratory infection \"ith
the latter vaccines will induce a more effective and durable immunity than
that. foll,owing receipt of inactivated vaccine. '.
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.
.
The protocol under which we were performing trials· wlth live attenuated
influenza viruses, IIEvaluation of Recombinant ts.;.mutant·..Vaccines for Influenzii
A/Victoria Virus ," was approved by Baylor College of Medicine {6/22/76}.
the Texas Board of Corrections (7/12/76). and the National Institutes of
Health (6/22/76) committees for review of human research; Studies performed
under this protocol prior to the suspension involved a total of 55 volunteers
and are summarized below.
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Thirty-two men were inoculated intranasally with 8 x 10 4 TeIO SO of
influenza vaccine candidate, A/V;ctoria/7S-ts-l[E), on 7/25/76. Two of those
32 men had high titers of naturally acquired antibody 'and have been excluded
from further analysis. Of the remaining 30 men with both hemagglutination
inhibiting (HAl) and antineuraminidase serum antibody titers of ~1:20 before
inoculation, 15 shed ts-virus in their nasal secreti~ns, 18 developed an
).A-fold·rise in serum antibody titer (HAl and/or neutralizing) against influenza
A/Victoria, and a total of 23 were infected based on one ~r both of these
criteria. However, 10 of 30 men inoculated with the candidate vaccine virus
also developed a respiratory illness, 4 with fever (~.lOOOF).
On 9/19/76, 14 of the men who had rec~ived influenza A/Vic~oria-ts-l[Ej
eight weeks preViously were challenged in~r&nasally with 8 x 10 TCrO So of
wild-type influenza A/Victoria virus. Two of these men had had no eVl~ence
of infection with the ts-virus~ botil \'J~re infected by the Wild-type virus

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(no virus shedding. but.~4-fold rises i~ serum neutralizing antib~d~ titer)
and both developed febrile ,respiratory lllnesses. Of the 12 remalnlng men
who had'all sho\in evidence of infection with the ts-virus, 7 also developed
infection with wild-type virus based on virus shedding (1 man) and/or an
>4-fold rise in serum HAl or neutralizing antibody titer (7 men) ,and 3
developed respiratory 'illness, 2 with fever. Among 5 contro~ subjects for
the wild-type virus challenge. 1 man was excluded from analysls because of
high titers of naturally acquired antibody; the remaining 4 all shed virus
and developed ~4-fold rises in HAl or neutralizing antibody. and 3 of the 4
developed respiratory illnesses, 2 with fever.

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On 1/6/77, 18 additional men were inoculated intranasa1ly with
8 x 105 TC10SO of another live a~tenuate~ vaccine.candidate, an influenza
A/Victoria/75-cold-adapted recombinant V1rus straln. Of, these men. 14 had
initial serum neutralizing antibody titers of Sl:4 and 13 of them became
infected as manifested by an ~4-fold rise in serum neutralizing antibody
titer; two of the latter 13 men also shed virus and three developed mild,
afebdle rhinitis. Of 4 'men who initially had serum neutralizing antibody
titers of 1: 8 or 1: 16, none shed virus nor became i1 J. but one developed a
rise in antibody tHel:" from '1: 16 to 1: 128.
In sunmary, the data obtained in these studies suggests that the influenza
A/Victoria/75-ts-l{E] vaccine can'didate strain retains the capacity to
cause ill ness in about a thi rd of persons ,·,ith 10\'/ ti ters of both HAl and
antineuraminidase antibody, and the resistance imparted by this vaccine
candidate strain against challenqe with wild-type virus was less complete
,than anticipated. In contrast, illness caused by the A/Victoria/75-co1dadapted vaccine candidate strain was negligible and serum neutralizing
antibody responses occurred with greater frequency than was observed with the
ts-virus. Data,concerning th~ resistance of recipients of the cold~adapted
recombinant to challenge ",lith wild-type virus and the resistance of men
with natura lly-acqui red anti'body to a s imil ar cha 11 enge are needed to complete
an evaluation of the efficacy of these t\'IO types of vaccine candidate strains.
Purpose. To evaluate the protection against ",Ii'ld,,:,type influenz-a A/Victoria
challenge afforded by previous intranasal infection with A/Victoria/75-cold
adapted-recombinant vaccine candidate virus, and to compare 'these results
with the protection afforded by previous naturally-acquired A/Victoria infection.
Description of Study. Volunteers \'/ho \'tere previously vaccinated by means
of intranasal inoculation with the influenza A/Victoria-cold-adapted~recombin­
ant virus and 25 additional men who are 18-40 years old and selected to have
a range of naturally acquired serum neutl"alizing antibody to influenza A/Victoria~virus (up to 10 men having little or no detectable antibody) will
be housed in the ll-Wing of Ramsey Unit I of the Texas Department of Corrections.
,Hter an initial history, physical examination, and laboratory evaluation
(C8C, ~rinalysis, chest x-ray and electrocardiogram) to insure their good
health, the men will be challenged intranasally \'Iith a <;imilar dllt;tion of

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the same wild type influenza A/Victoria virus used in previous. components
of this· study. This virus pool, supplied through 'NIAID, was gro\·m in embryonated
eggs and has. satisfied safety requirements of the Bureau' of Biologics.
Federal Drug Administration. Volunteers will remain isolated in the II-Wing
and will be examined at least daily by a physician for respiratory. illness
for 8-14 days after inoculation. depending on the duration of any respiratory
illnesses observed. Studies outlined on the attached protocol (appendix #1)
will be performed to detect evidence of virus infection.
Discomfort to Subjects. The discomforts associate~ with this project
are those of venipunctures, nasal wash collections. and possible influenza
illness. Experience with several hundred such intranasal influenza virus
challenges indicates that any illness which occurs will generally be mild
and last only 3-4 days; no pneumonia or serious complications of these
artificially-induced infections have occurred. The possibility that a
volunteer may develop Guillain-Barre syndrome is considered remote.

8.

HUMAN SUBJECTS

a) Subject population. Volunteers will be 18 to 40 year old male
inmates of the Ramsey Unit, Texas Department of Corrections. Details of the
selection process have been previously submitted. Volunteers must have no
known allergy to chicken eggs or feathers. since the challenge virus was grown
in embryonated eggs. Volunteers who complete the protocol will be offered
$35. This level of remuneration is approximately equivalent to $4 for each
blood specimen and $1 for each nasal wash specimen, the rate at which any
volunteer who chooses to withdraw will be remunerated for specimens ~ollected
prior to his withdrawal.
"

b) Discomfort and Potential Hazards. Some discomfort will be associated
with obtaining blood and nasal wash specimens for virus isolation. Acute
allergic reactions to the intranasal virus inocula are remotely pO$sible
and all will be administered in the presence of a physician with ~mergency
medications on hand if needed. Influenza illness may occur "in some volunteel's
(see consent form). Volunteers will be seen at least daily by a physician.
and all volunteers will have immediate access 24 hours a day to a medical
aide who'will notify the responsible physician so that care can be given as
indicated. If illness should be severe enough to warrant care beyond facilities
in~ediately available, arrangements have be~n made for hospitalizing individuals
for more definitive care.
of virus to persons not par~ici -t:ir,g in the studies is a possibilbut minimal for several reasons. A! I subjects will be isolated during
the period whrin they might be infectir~" Furthermore, the virus to be
used in this study belongs to the Hon~ K0ng (H3M2) era which began in 1968;
Spread

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infection with a member of this subtype of influenza A virus has been almost
universal among adults, and a large proportion have been infected with the
particular strain to be used, influenza A/Victoria. : The level of immunity
in the general population is sufficiently high to minimize any spread of the
virus with which we will be working. Sick calls will be monitored, nevertheless, to make sure that there is no evidence of increased respiratory disease
during the period of study, and appropriate diagnostic studies \'Ii11 be
undertaken for any illnesses which do occur.

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The hazard of one of the volunteers developing Guill~in-[3arre syndrolile
is considered remote. The volunteers and medical officers and dides at the
Ramsey Uni t ",Ii 11 all be informed about the syndrome and they wi 11 a11 be
a~ked to contact us if any suspicious signs or symptoms appear.
In addition,
the volunteers win be questioned ,about any suspicicus signs or symptoms
at the time of the collection of the blood sample 1 month after inoculation
and again 3 months after ihoculation. Any suspicious findings will be further
evaluated and the volunteer will be aided in obtaining appropriate care.

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c) Method of Obt~ining Informed Consent. A general description of the
study and the procedures to be performed will be given the volunteers verbally.
Then, while they have the consent form (Appendix #2) in hand, the volunteers
will be given a detailed explanation of what is to be done, including all
known hazards, and they wi 11 be gi ven an opportunity to ask any questi ons
they desire. It will be made clear that the volunteer can remove himself
from" the study at any time, but that he may have to remain in isolation a
few days' if he is potentially infectious for others. Volunteers will then
be asked to sign the consent form for the study.

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d) Protection against Hazards. Pr'otection against physical hazards
has been outlined under section 8b above. Records concerning each volunteer's
participation in this project will be maintained in a secure place in the
Influenza Research Center. Any publication of results will not contain
individual volunteers' identities.

.
e) Benefits to the Subjec~. Those subjects. who have sufficient" immunity
to resist infection will obtain no direct benefit from these studies. 'Those
volunteers who do become infected with the challenge virus should have long
lasting protection against closely related viruses, a protection acquired
with much less risk of serious illness than occurs ~Iith natural influenza
virus infection. The major benefit of this study, hm·,ever, is a societal
one of helping in the attempt to develop more efficacious means of orp"~,,,·:'·
influenza disease.

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f) Risk-Benefit Ratio. The major risk of this study consists of having
influenza illness, but an illness generally much less severe than the ndtural
influenza illness to which these men would have otherwise also been susceptible.
The incidence of Guillain-Barre syndrome does not appear to be significantly
increased by natural influenza illness and there is no reaso,n-to believe
that it would be by artificial infection with wild-type virus. Thus, the
relative risks of this study seem acceptable when plac~d against the
possibil ity of furthering the development of more effective means for reducing
the morbidity and mortality caused by naturally occurring influenza virus
infection.

Thomas R. Cate, 1'1. D.:
Principal Investigator

Robert B. Couch, N. D.
Director, Influenza Research Center

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--..:/:..-._-----Vernon Knight, M. D.
Chairman. Dept. of Microbiology and Immunology

6

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REFERENCES
1.

f

Leibovitz, A., Coultrip, R. L., Kilbourne. E. D., 'et al: Correlated
studies of a recombinant influenza virus vaccine. IV. Protection
against naturally occurring influenza in military trainees. J. Inf. Dis.

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124:481-487, 1971.

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2.

From the National Institutes of Health. Influenza Vaccines--Summary of
Influenza Workshop V. J. Inf.:Dis. 129:750-77L 1974.

3.

Gui1lain-Barre Syndrome--United States.
Weekly Report£§.:401, 1976.

4.

Center for Diseasc Control. Handout #4, January 7, 1977. (Note
that components' of the handout are dated February 3-4, 1977.)

,

5.

McFarland, H. R., and Heller, G. L.: Guillain-Barre disease complex:
A statement,of diagnostic criteria and analysis of 100 cases.
Arch. Neural. ji:196, 1966.

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6.

Wiederholt. \~. C.• l1ulder, D. '~., and Lambert, E. H.: The landry. Guillain-Barre-Strohl syndrome or polyradiculoneuropathy: Historical
review, report an 97 patients, and present concepts. Mayo Clinic
Proceedings 39:427, 1964.

rlorbidity and

r~ortality

7.

Melnick, S. C., and Flewett, T.H.: Role of infection in the GuillainBarre syndrome. J. Neural. NCUl·osurg. Psychiat. 1l:395, 1964.

8.

Data of Drs. L. Schonberger and Mathew lack. CDC.
by Dr. Robert 11. Chanocl<.

Kindly provided

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DOy'Of lOllege or Medicine
DEPARTMENT OF MICROBIOLOGY AND IMMUNOLOGY. 113 100-4412
Inlluenla Resea,ch Cellie' • 113 190-4469

VOLUNTEER'S CONSENT FORM
Influenza A/Victoria Virus Challenge

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I understand that I am consenting to have dropped into my nose a fluid which
contains a live influenza virus. I understand that the virus was grown in chicken
eggs and that 1 should not participate if I am allergic to chicken feathers or eggs.
1 understand that the virus in the nose drops may give me the flu. Though
the flu caused by nose drops in studie$ like these is usually very mild. I understand
that J may have such symptoms as a runny nose, headache. muscle aches. joint a::hes.
bad feeling, fever and even pneumonia. I understand that no currently available
medicines can cure the flu and that recovery depends primarily on my body's defenses
and usually takes a few days to a week. I understand that I will be confined to
the ll-Wing 'for the period of time when [ may be infectious for other persons (up
to 2 weeks after the nosp. drops) and that I may not have visitors during this period.

I

I understand that blood samples of 15 ml (1 tablespoon) will be collected prior
to the nose drops and Z times over the following month. I understand that nasal wash
specimens will be collected daily over approximately a 2-week period and 3 times
over the following 2 weeks.

I.

I und~rstand tha~ an illness consisting of progressive muscle weatnoss with
pain or .funny sensations (Guf1lain-Barre syndrome) sometimes occurs one or two months
following mild respiratory illnesses; the incidence of this illness is less than
1 case per month for every million people but about 1 person in 20 who develop it
die of complications. I understand that there is no evidence .that influenza virus
infection causes any increase in the frequency of this type of illness. HO\'lever.
I understand that I should report to the doctor. the medical officers or the w~dical
aides if J develop any unusual weakness. pains. numbness or tingling so that the
cause can be investigated.

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I understand that these studies may help my body develop increased resistanc~
to a type of flu virus l'ihich may spread next fall and \',inter.

I understand that I wil I receive $35 for comflleting these studies. I unde"stand
that 1 may \':ithdraw from the stUdy at any time without affecting my right to be in
future studies or my care. I understand that if I \.,i thdraw, I may have to rentain in
isolation until r am no longer infectious for other persons, and that I will be paid
$4 for each blood sample and $1 for each nasal wash sample collected up to the point
1 \1i thd ra",.

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(-:ontinued on next page)

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I understand that the Influenza Research Center at Baylor will retain a copy
of this consefl't form \.,.ith my name and identifying number, as well as other records
concerning' such things as any illness J may ~ave and laboratory evidence of virus

infection. I understand that I may obtain copies of all
my participation in thi~ study by writing to the address
giving my name and the approximate date of the study. I
publication of results of these studies will not give my

information concerning
on the head of this form,
understand that any
identity.

The proposed study has been clearly explained to me and I understand the
hazards involved. I have been given' the opportunity to ask any questions I may
desire.

I

5i gnature.

_

Date

Witness

_

Identifying No.

-------------------

I have carefully explained. the nature, demands, and foreseeable risks of the
above study to the normal volunteer.
Signature

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Date

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OEPAATMHIT OF MlCMOOIOLOGV AND ;:/,I.IUNOLOGY· 713 ;UO·.\oH2
Influenza Research Cenle' • 71 J 790·44G~

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April 11; 1977

Dr. Robert Chanock
Lab. of Infectious Disease, NIAID
National Institutes of Health
Building 7. Room 301
Bethesda, Mary1and 20014
Dear Bob:
Thanks for sendi ng me a copy of the proposed addC!ndum concern i 119 Guill a i nBarre syndrome \':hi ch you prepared for attacl)J;lent to protoeo 1s concerni ng study
of £ recombinant vaccine candidates of the H3N2 subtype of influenza A virus.
The suspension of studies concerning influen~a in hum~ns because of the
increased incidence of Guillain-Barre syndrome following inactivated influenza
vaccines caught us at a time \'IhC!n \'Ie had completed all of OUI· plannetl administrations of ts-recombinant viruses. The only component of the studies remaining
to be donefrom the previ ous ly approved protocol slloioti tted from Baylol· \'Ias a
\l/ild-type virus challenge of ·volunteers \'/ho recei\"f:~d the cOld-adapted recombinant. In addition, \ole \-Iould like to add a \'lild-type virus chiJllenge of men with
natura.1ly acqui red anti body for compari son purposes.
Enclosed is a copy of a protocol descl';bing \·/h ..: t i'le hope to do. I have
incorporated some of your thoughts and infonlliltion cOllcer'ning Gui1lain-Barre
syndrome. Even if your "generic" addendulII ;s approved and thel"eby reactivates
all previously approved protocols concerning .t5..-viru~cs. \'Ie \',i11 still need
approval of the enclosed protocol because it adds a further' wild-type
virus challenge group (previous natural infection) for which we do not have
previous approval.
Best wishes.
Sincerely yours,'
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Thomas R. Catc, 14. D.
Associate Professor·of
'r'\icl'obiology Clnd :·ledicine

TRC: 1 fs ,
cc: Or. John La Montagne
Enclosure

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. April 11. 1977

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Dr. John La Montagne
Development and Applications Branch
NIAID, National Institutes of Health
Westwood Building
Bethesda, Maryland 20014

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Dear John:
Enclosed is the protocol which I spoke to you about on the phone.
Also enclosed is a copy of a letter which I have mailed to Bob Chanock
whjch explains why we need approval of this protocol even if Bobls
"generic" addendum for ts-virus protocols is approved.",

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let me know if there are any questions I can help to clear up.
Sincerely yours.

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Associate Professor of
Microbiology and Medicine

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Enclosures

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2. - Principal Investigator and Associates:

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-Title:

Development of Rhinovirus Type 3 Challenge System for Normal
Vo.l unteers

3.

Department:

Microbiology

4.

Granting Agency:

5.

Period of Grant:

6.

Location of Study:

Immunology

NIH-NIAIO Contract No. AI-32506

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and

Robert B. Couch, M. D.
Stephen B. Greenberg, ~\. D.
Thomas R. Cate, M. D.
Maurice W. Harmon, Ph. D.

The Methodist Hospital Gener~l Clinical Research Center
Baylor College of Medicine

Additional Information for Methodist GCRC:
Duration of Study:

1 year

Number of Subjects to be Hasp; ta 1i zed:

]

12-24 va l.unteers

Duration of OcctJE.!I:.I_~f GCRC Bed by Each Subject:
10 days for students

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4 \veeks for p";sonel~s;

Maximum Number of Patients to be Hospitalized at One Time:

12

I
7.

Outline:

Background Inforl~~tion: Rhinoviruses C\!lpear to be the cause of a significant
proportion of acute resj1il~atory d·i~ease (ARD) in all age groups (1). l3ecau~of the reduced over~ll occurrence of ARD in adults, rhinoviruses assume a 9: .u~~·
significance in this ag.e group. Although lO\1l~r re:;p"iriltory 'disease is ~cen
in infants and children, these virll~e~ primarily pl'odllce a corn::lon cold syndrc::~,:.
The major problems regarding prevention of rhinovirus i~fection5 ~rc the
numerous serotypes carab 1e of produci n9 thr~ di se()~e, the llICK of a pl'ev~ 1ence
of Pill~ticulal' serotype~) and the lack of a s'ignifi(~ant frequ:~ncy of hetl~rot'ypi\.
antibody responses following infection. The latter two beli~fs have ~~~n
recently chanenged by Fox (2). The5c beliefs, in cOll1bi!1i1tiun ,,"ith the rn;n1;;v:l
protective effect produced when inactivated v\lccines \"!ere given by a pal'C:::lterCll
route, provided the bu5is fJ:~ the prcvali:nt concept thut conLrol of t1~e c"
cold is most likely to

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thl'ough the

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of l'.l1tivil'als l"c1thl?r thiln

If an antiviral is to be u~ed fOl~ pre'.,renti::lI1 (;1' t,'ealmmt of
common colds, 'it \,'ou:d h<1'!t' to he very c:ol1v(,n;ent ClI1(; very st":fe.
compouad specific Tat" rhi:.ovirus infection has

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a natural body'substance produced in the course of virus infection and
effective against a variety of viruses, is reasonable for consideration.
Jackson and Douglas demonstrated that a small molecular weight interferon
inducer when given topically ~ms capaJle of modifying artificially induced
common colds (3, 4). Similarly, Merigan has indicated that exogenous interferon
is effective against a rhinovirus challenge in adult volunteers (5). However,
notable in the latter studies is that very large doses (14,000,000 units) were
used and yet only a partial protective effect was obtained.
In an attempt to ascertain the reasons for the apparent large dose
required for prevention of rhinovirus common colds by interferon, Greenberg
and Harmon have been systematically studying the effects of interferon in
human nasal epithelial cell cultures and in adult volunteers (6, 7, 8). The
tentative conclusions from those studies are that the difficulties with topical
administration of interferon are a result of incomplete saturation of the
nasopharyngeal mucosa with interferon and/or rapid mucociliary clearance.
Studies are presently being conducted to attempt reduction of mucocil iary
clearance as well as to improve delivery to the nasopharynx. Studies thus far
on the interaction of interferon with nasal epithelial cell cultures have
involved vesicular stomatitis virus as a challenge virus for the .culture systenl.
Recently, rhinovirus type 3 has been shm'/Il to replicate .in the nasal epithelial
cell culture~ and stud{es are ~nderway to ascertain the kinetics of interaction
of interferon and this rhinovirus with nasal epithelial cells in culture. The
eventual goal of these studies is to use the information being obtained on
opt i ma 1 methods for de 11 very 0 fill tel"feron to th~ na scpha rynx of man \'1ith tha t
on required dosage for d~veloprr.ent of and maintenance of an antiviral effect
in specific numbers of nasal epithelial cells for design of experiments
involving challenge of adult volunteers \·,ith rhinovirus type 3. For that
purpose, a rhinovirus type 3 challenge system is re1~ired and the current
proposal is for development of that challenge system.
In earlier studies by us \·lith adult voluntee,·s challenged \·,ith l"hinoviruses, we have shown th~t intranasal and small pal·ticle aerosol inoculation
produces a cornman cold syndrome in about 2/3 of individuals and lasts i.bout
2 to 3 days (g, 10, 11, 12). About lO:~ of indiv'icuals \-:ill d~vclop fevel· of
1 to 3 days dut·ation. The duration of virus shedding vilries bet'..,cen 9 l\nd 20
days although the n.ax;r.n:r.1 pel"iod of virus shedding is 3 to 4 dCty~ in associat.ion
with the acute illness episode. \':chiwe expel"ienee "/ith rhinovit"us typC:!s 113, 14, 15, 16, and 17 and all hove proouced si;:iilar results in adult \'oltlllteer:i,
Approximately 500 health.'! adult \'0llJ"lu~c:;rs hc:'.'e ~:,t'!~n studied bv us; no c<tscs of
pneu'l:lon·ia occul·red and no unJ:ltiC.'ipu~.cd·C:(Jil:lJlicc:L.iOIl$ \':Ci'i;! nofcd. SiuIl'Jar
studies hay!! been conduct(?rl by TYIT~ll) J~;d::;on, C\·:aHnc:·, ilnd Douglns \·:'ith
similar re~.ults.

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PurDflc;e of PI'('iect: To dEvrlop a 1·~I.'I'llci~IC;b1~ chcdlcl1r.(: system fOI" .;dult
'ml"nteel·s \·;ith I'hinovin:o; lype?'. The (;,;:11,,:,::;' :.:,,,t-';i:: \"ill 00. s:':)~('<:ll'~!1Uy
uc;ed to evah 3te trc eHc:.:th·(Ii!:::·. 0' l"l!:;(;(iil", .:.::.:illl~u;rr:~ iJ1t~rr(:njll
(,"PP1-ol/i:l1 '!lot rcqllc~L\?ci ill this p,-utocoi j for ·pl't. . . ::::lUU:1 of I-hino\'ir:;s C~J:.·:·01}
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Description of Study: Studies will invo'lvE?" no'rmal adult prisoner volunteers
from the Texas Department of Corrections and students r~cruited from colleges
in the Houston area. A volunteer inoculum has been prep~red from a naturally
occurring isolate of rhinovirus type 3 (kindly supplied by Dr. J. Gwaltney)
in Wl-38 human embryonic fibroblast tissue cultures and is currently being
safety tested accord; ng to the attached protoco " for adventiti a 1 agents.

m
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Prisoner volunteers will be recruited by previously approved methods.
Students \~ill be recruited from groups responding to campus newspaper and
posted notices. In both cases the volunte~r groups will be met and a full
explanation of the study will be given. After this, a candidate must indicate
a desire to participate in the study before any further plans are made. A
blood specimen will be obtained and only volunteers free of detectable serum
antibody to rhinovirus type 3 will be eligible. Volunteers \'1;11 be brought
to the General Clinical Research Center of The Methodist Hospital in groups
of 6 to 12, depending upon available beds. All person's wjll receive a
complete history and physical examination and d variety of, other tests designed
to assess their state of normality. All IIhealthy ll volunteers will be given
a full explanation of the study again and will ha've an'opportunity to withdraw.
Those choosing to rem~;n must sign a written consent form (see attached).

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, The initial study \'Iill consist of 6 voluntee'4s; two",'/jll be given
,
100 50% tissue culture infectious doses (TCIO SO )' twd will 'be given 10 1C1050,
and two will be given 1 TC1DSO by nasal drops. Sub'sequent studies, involving
6 to 12 volunteers, will be designed to determine the 50% human infectious dose
for this virus pool. After inoculation t volunteers will be placed in isolation
and -wi 11 remai n there for 5 to 7 days and each wi 11 be seen once or b'li ce
daily by a physician. Specimens for virus cu1tures and nasal secretion and
serum antibody assays will be obtained according to the attached protocol.
Follow-up sera ",ill be obtai ned as necessat·y for those persons discharged
from the GCRC before 1 month ~ost-inocu~ation.

I

Discomfort to Subjects: Some discomfort is associated with drawings
of blood and nasal wasliTngs, although both of these procedures are commonly
performed by us and the discomfOl'ts ill'e minimal. The only other discomfort
associated \'Iith the investigation \";ould be respiratory illness if it occurs.
Rhinovirus illness is always accompanied by nasal obstruction and/ol- nasal
discharge. Other symptpms fre.quently present include SOt'e.thI4oat, he"adachc t
and malaise. If fever occurs (10% of persons), some mya,lgias anc rlecrease in
appetite" may be noted. An occasional individual develop!' nor.pl·o::' .:tive cough
and the findings of tracheobronch'itis. Clouding of maxillarj' sinuses has
been noted on follow-up sinus films in the past hut without the clinical
findings of acute sinusitis. This clouding has always cleared after antihistamine and vasoconstrictor therapy,
8. d.
~ubj~_s..Lp'opul~.U.o~: The subject n:quirem.;nt is for nOl'IIlJl hettlU",j
adults. ages lS-IW. 1';~lthods fOl' n:cl'witing p:-'isonel- volunteers tlnd ()bLi~ip~;'r
infOI";'led consent have bcp.n previously l'E~vi.;'\';;'(; flnn 0rpl'oved,
I:1 i:dcJ]~:u~ ."
Drisc!lcrs, a number of studies ...,illin-;olvp. stucl.:nts,

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b. Potential risks: The only known risks of the study are the development
of a convnon cold and the possibility of a complication. In our experience.
artificially induced rhinovirus convnon colds 'have been mild, short term,
self-limited nlnesses .. ~Ie have never encountered acute otitis media, clinical
acute sin.usitis, or a primary viral or secondary bacterial pneumonia although
each is possible.
c. Consent procedures: Methods leading up to the obtaining of consent are
described under "Description of Study." The consent form to be utilized is
attached. Subjects wlll be permitted to read the consent form, a full verbal
explanation \"ill be given by one of the investigators. and an questions'
answered before the subjec~ signs the consent form.

d.

Protection against potential risks: An ,awareness of the possible
complications by examining physicians, a complete reevaluatiQn after the illness
episode is completed, and a statement to the subjects regarding the possible
complications will be the methods used for detecting the potential risks.
Treatment of any complication will be by accepted medical procedures. Records
concerning each volunteer's participation in this project.\·,ill be maintained
in a secure place. Any publication of results ,·lil1not contain individual
volunteers' identiti~s~
Potential benefits: Prisoner volunteers will be paid 55 a day for the
duration they al"e hospitaliz~d {a rate previously 'approved by the Texas Department of Corrections} and students will be paid $24 a day (a rate just established
at the University of Houston fo,~ similar studies by others and based upon the
supposition that a student could earn $3 per hour fOI' an 8 hour \'lOrk day ,'/et'e
he not serving as a volunteer subject). An additional benefit is the obtaining
of a cOli1plete assessment of health status. The potential henefit to society
from the series of studies outlined under "Gackr.round" ;s the obtainin9 of a
method for treatment of common colds.

e.

f. Risk-Benefit ratio: Although the risk of ilny hLlrm from rhinovi,"us challenge
is low, tIle risk-benefit ratio of this ~tudy is still 10\'/ for the individuJl
subject because he Qxperienc,es the risk of (;11 illn~ss (Ind poss"il)le cOll;plic;ations,
\'/hereus his tangible benafit is prilililrily financial. The potential be/lcfit to
society improves the risk-benefit ratio.
Further information

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GCRC:

Ql:l_!-'H' :! ne2..LI?!..J!.!..c_lr..q",tect,£D..d .E.:~9,~'~".:; ~I;"~ LP L r_l~~]_i ..!'.hl.~) ).q.!:f..5,',0.t.~_: ThE:.
information ot.taincd fro;ii tilis sp::·r.:ifir. j.~r~lt\lcol i'/ill not be pun'd$h~bl(~ excc·;..t
ill liubliciltions including more inf()rllli~~;(o;'1 (Ill rl",inov;rl:S:S.
Tlr~ planned usc
of the: data obtained in studic:\ \'/ith ill~:,:~d~~.. tJn Iii i1 I>~ plIl>lishi-l!Jle,

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~ignptures

Required:

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Robert B. Couch, M. D.

~ Princi~al In~estigator

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Vernon Kni'ght, M. D·.
Chairman, Department' 'ofI.,. icrobiology
and Immunology

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REFERENCES

{
1.

2.

Gwaltney, J. N., Jr.: Medical Reviews:
Bio1. Med. 48:17-45~ 1975.

Rhinovir'uses.

Fox, John P.:. Is a Rhinovirus Vaccine Possible?

Yale J.

rt

Amer. J. Epid. 103:

345-354, 1976.

3.

Panusarn, C., Stanley, E. Q:', Oirda, V., Rubenis. M., and Jackson, G. G.:
Prevention of "llnes:i' .from rhinovirus infection by a topical interferon
inducer. N. Eng" J.. Med. 291:57-61, 1974.

4.

Douglas, R. G., J~"'Jnd Betts, R. F. Effect of induced interferon
in experimental rhinovirus infections in volunteers. Infect. Immun.
2:506-510, 1974.
.

5.

Merigan, T. C., Reed, S. L, Hall, T. S., and Tyrrell, O. A.· J.:
Inhibition of respiratory virus infection by locally applied. intel·feron.
Lancet 1: 563-567, 1973.•

6.

Johnson, P. L .• Greenbe.rg, .5. B., Harmon, N. H., Alford, B. R., and
. Couch, R. 0.: . Recovery of apP'lied hUnJiin leukocyte intei'feron f"om the
nasal mucosa of chimpanzees and humans. J. Clin. r4ici'o .1:106-107,1976.

7.

Harmon, M. W., Greenberg,S. B., and Couch, R. a.: Effect of human
nasal secretions on the anthiral activity of hum~n fi~roblast and
leukocyte interferon •. Proc. Soc. Exp. B101. r'l~d. 152:598-602, 1976.

B.

Harmon, M. W., Greenberg, S. B., Johnson, P. E., and Couch, R. 0.:
A Human Nasal Epithelial Cell Culture Systel1l: Evaluiltion of Response
to Human Interferons. lnfec. J,,!!!!!!!,. (In Pre.s5)

9.

Cate, 1. R., Couch, R. B., and Johnson, I~. r·L: Studies \'/ith
in volunteers. J .. CHn. Invest. 43:56-67, 1~o4.

rldnoviru$~$

10.

Douglas, R. G., Jr ... Couch, n. B., Cate, T. IL, Genme, P. J., and
Knight, V.: Quantitative rhino·!it~us sll,:..; . ;in~ i't1'~~,;:nl;, in \'ol~:;1t('ers.
Ar.t~R0V...~esp. D15. 2.i:159-167, ]96(.

11.

COllch, R. B., Cate, T. R., DOllgl:ls, fl. ('lo, ,.11'"
G::TO"~':, P. J"
i~nd
Knight, '1.: Effect of route of iIiOClil<,.: inn :)1) e>:rli:!ri;:i'~llt~il rc:-piratory

vi:'1I1 dis(o;1se in vollJl1t':er~ z.1~·j ev;ejc::n,:'..' for rlll"bCii"i1C lrar.$n:i~'.;OIl.
n~£t.

L:.

Rev . .~Q:517-529,

[:O\l91aS,

r..

·:olulltec,~s.

1?6~.

Pat:IO:l0ncsis of !'rl;110villJ;; (:01::::,:", cole',
Ann,
Ot,C,I1., ._r~hir.o\..
lS70.
_ _ _.
.•. _
__
_, _ _ :;IlC
._ •• ..;.~I"/!I:l.
. __ .
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BOtJlor College of Medicine
DEPARTMENT OF MICROBIOLOGY ANO IMMUNOLOGY· 713 79~:l72
Influenza ResearCh Cenler. 713 790·4469

VOLUNTEER'S CONSENT FORM
Rhinovirus Type 3 Challenge
I understand that I am consenting to have dropped into my nose a fluid which
contains a live rhinovirus which came from a person \t/ith a com:non cold. I understand
that I mayor may not II ca tch" the cold. If I "catch it, it mayor may not make me
ill. If I develop an illness it may include nasal obstruction and discharge. sore
throat, hoarseness, cough, and chest pain. I understand that fever may occur and I
may develop headache. weakness, muscle aches and loss of appetite. I have been told
that pneumonia may develop but that it is very unlikely. Fever usually lasts 2 to
4 days and symptoms from 7 to 10 days. I understand that other symptoms may occur
a.nd that it is possible. but un1ikely,:that illhess will last .longer than 10 days.
tl

I understand that no currently available medicines can cure the cold and that
recovery depends primarily on my body's defenses and usually takes a few days to a
week.

J understand that frequent nasal washings. throat swab and cough specimens, and
b10ed drawings will be performed and used for tests. X-rays and oth~r tests will
be performed as needed.
J understand that the information gained from this study \'/il1be of no direct
benefit to me but that the information gained may be of benefit to other peoplE'.
I understand that I will receive $5 per day ($24 per day for .. students ) fOI' the clUI'atioll
of my time in the hasp; tal, at the completion of the study .. Fer blood and nasal
wash specimens obtained after leaving the hospi tal I wil i re'ceive $5 each time this
is done.
I understand the investigators will retain at Baylor.College.of "1edicine a copy
of this consent form \'/ith my name and identifying number. as \'/e"ll ilS othel' records
concerning such things as any illness I may have and labol'atory evidence of virus
infection. I understand that I may obtain copies of all infol-mation concerning
my participation in this study by 'f/riting to the address 011 the hp«d of this form.
giving my name and the approximate date of the study. I understand that ilnV
publication of results of these studies ,\-Ii11 not give -I:iy identity.
.,
The proposed study has been cleal"ly cxplc1inC'd to me a1,~1 I llndel'st\1nd'the
hazat-ds involved. I have been given an opportunity to i)~k 2n)' questiuns I :lIi0ht
dcsil'C and I understand that I have the ,-;ght to \-:1 thdl"ci'! fl"om the st\ liy at ullY
time I may choose without prejudice to PIe.

,

...
I

Si gnuture

_

._-----'-------------

Oa te._---.--.--- --._ ..---- - - 1 d~l1t i Iyi TIS ';0

•

l)l)\·r~

1 have cClreful1y expl.::ined tlll~ nature,
st'.:fj/ to tt,e not-il/ul '1.)luilteer.
:

-.-~-'-_._-

..

(je.:l~n(i~..

_-_._-------_.- .. _--_._. -----_ ..--_..

D.' Ie

SAFETY TEST PROCEDURE

Test Primarily
Designed for

Volume and Method
of Inoculation

T;iiv91J~o;btc i3r~t~

Bacteria I Fungi

1 ml per tube

S,: bo~ :~'~~ljd Li qui d

Fungi

1 mI per tube

Test Units

Observation
Period

3 tubes'

15 days

3 :tubes,

15 days

Number of

",'

l3r~t~: !'/i~dificcJ

T: s :~;e C~l tl~rC:

Cor, ttl mj na li h9
viruses:

Adcnoviruses /
Hcrpf!S ~nd RS
viruses

'•• 1 ..• , . . , _ /
I

L,~

,

... ,...

"~.

I ' t.:. I\.

I-

0.2 m] per tube

I
+ serum
1 tuue, virus alone

4 lubes virus

1 tube I 5 crum a lone

28 days with
subpass as

necessary

2 tubes, lIni nocu ILlted

-

I

Adcnoviruses,
Pi cr~r.(1 viruses

PicCillll Vini!i CS

I terpe 5 vi:'lJSCS
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Sirn~,i:~ virus 40 .

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J

xv
6 tubes, virus ;-serum
1 tube, virus ulone
1 lube, senlin alone
4 tubes / un j nocu fated

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TEXAS

DEPARTMENT OF CORRECTIONS
W.

J. Estelle, Jr.
Director

Huntsville, Texas 77340
~AUL B.

iN
TE:tA~

NEWTON

April 14, 1977

ASSI&'1'ANT DI1\ECT01l

CBAltGIl

BOARD OF

CORRECTIONS

H. H. Coffield
Cbl.......

Roekd:al.. Tau

varnes M. Windham
'V1c.. Cbalnn~"
1.lvlnpto... Teso

T. Louis Austin, Ir.

or AGlUCUL'rtTU

Mr. Joe V. LaMantia, Jr.
115 Houston
McAllen, Texas 78501
Dear Mr. LaMantia:
Since our last meeting, we have made a considerable amount of
progress on the 1977 crop. During the last three or four years,
we have tooled up with larger tractors and equipment. This
factor has enabled us to prepare land more rapidly, and in spite
of the setback we experienced due to four months of wet weather,
we are in relatively good shape. About a week ago, we had some
light rains. Had we have gotten two inches, our planting on
lower units would, with the exception of soybeans, be complete.
OUTSIDE SALES

Le~ter Boyd
),felDbor
VUllO'" TellU

Beets
Dogs
Hogs

Van DeWalle &Sons 20.975 Tons $120/Ton
Baylor College of Medicine 5 ea. $ 50 ea.
Baylor College of Medicine 2 ea. 78.3t lb.

POULTRY PRODUCTION
Composite Poultry Report for February
.5... Annlo. Tau
Ave. No. Hens in Production -------------------------.
B
~1 DAve. No. Eggs per day to Food Service Dept. - --------RohertJ. acon,u .• p 1
ou try Sl aug h tere d - BrOl'1 ers -----------------------

$2,517.00
250.00
92.39

Mark McLaughlin

'Member

'!.l.mb·,
l/""Il~n. Tn...
Fr~d

·N. Shield

Mfm~,

~-;."

Antoft'''.

0

f pauL try slaug h tere d 'ln 1b s. --------

1wo additional broiler houses on Eastham are being completed and
will be 1"eady for delivery of broiler chicks by Hny 2, 1977.

T~a ••

HIIbcn Montemayor
:1f':J\bC'r
0~:l A n~r.fo. °rf' •• '

Jr." V. LaMantIa. Jr.

,·..,,,ber
!#'(AH~a.

0 resse d
' ht
we~g

51,917
33,978
6,471
23,735

TeJ'1S

'!\·/o additional broi ler houses on Coffield are being completed and
will
ready for de 1i very of broiler chicks by May 16, 1977 and
.June 16, 1977.

,e

~

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TEXAS DEPARTMENT OF CORRECTIONS
Authorization for Construction and/or Remodeling
Job No. :_.....Z_4-'-Z-'-ZWlZ.

_

Proposed Project:

John Sealy

Location:

Date

Unit_;.;.".:.,:.a::..;.:.....-

Estimated Cost:
Materials

Issued:~~-~Z7L-

__
_

H~ital Projec~t~

Dept. _ _ Property No.---!n.!.l.~a!-:..
_
(Remodeling Only)
Source of Funds:

_

~Z~-~4~)0~7~0~5~0~B~4~3_ _

Appropriation

Pr0<J:'!:am---__ 03

Other

_

~

$69,000

Total

Justification for Project:

05

Activity

r

T~o~i~n~s~u~r_e~a~d~e~q~u~a~te~m~e~d~i~c~a~l~a~t~t~e~n~t~i~on~~rs~_

received by an increasing inmate population.

[
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Plans by: Construction Div.

Project Proposed By:

Drawing No.:

Construction Superintendent
Assigned:

A-3 t 99
4-19-77

~~~~~~~~

Mr.

Treatment 0 j v.

Paul Guidry

Assistant Director for Construction

Approved:,jIJC~~~~;,c~~C""'.c...~sst. Dirc,::"tor for

another Division: Treatment

Approved :_-"';;;;;.-J~-f-,)t-'"'Y---'
Approved:

____Pg ..

Board of Corrections

Budget Line Item Specifically Authorizes Project?

]yes
Jno

Required Approval:
$1000 or Less - Assi~;tant Director for Construction
$/.500 or Less
Director & Assistant Director for Construction
Ah~ve

$2500

Distribution:

.') (] () 0 8

- Bcnrd vf Corrections or Budget Line Item
1st Copy' Business Divinion
2nd ~0PY Director
J l"d CO~'1 Ccnst r 1lcticn Di viRion
:i til copy Cons t ruction SUr?e rin tendent
:) toll c'o[.l,! ';/arf}house

~C802

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C;::I'::t:minaUng viruses .

.:~nd baclerin:

Adult r·.'1icc

Ncurohopic. viruses

"

·

4

0.03 mile.

,20 nn!ma I 5, yirus alone

{lCM I etc.)

COX'S(1C ki cvirusas

o.01 ml"IC' and
'SC S

.

..-.

28 days

.8 animals, saline

·'O.lmII0 6 xlO

Herpes viruses

16 animals, virus alone

28 days

2 animtlls

28 d"ys

and 2 drops on

seari fi ed cornea
r''':r'c'''
i,,; .1' I '.~

rv1 ycobacterium tuber-

Ir)'lns
:,J

culosis

1 mf IP

7

3.animnls

--

rJ1ycoplilsma S[l.

a .1 ml

.

per plate

.

4 plates (2 anaerobically,
2 aerobically)

,

.l.CI~J!lcr;~~ wjth Echovirus Type 11 elt 28 days

....

L i.J • . , . ' ,." .... ~'r.,
.. ~r.'···'· __ ""lnl:";"

If''l... ....: t..

"'l~

w·.

7 '-'1
, ,1 (\ ..r:,':1 2P
rl
.:J... ays

.~

.' Lt'::::' C:~2 ;: cc;!trcls tl!d 2
.J """'"
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plus serum with Echovirus Type 11 at 14 days

Iy

1r",- .. :- ...... ' t'.•
•

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;

p,!1t~::'?r'Jll1 fo~ rhinovirus type 3 used only in Hep-4, HEK t HI-38, and RhMK tests.

1·

,

....

~~~~~~"~~~"'~c=a.~~~',,,,,

28 days

,>,
\

'

INVESTIGATOR R.B. Couch, M.D.

Date

Day

xx

Prl:.

X

X

X

X

X

X

X

X

Tues.

1

,

Wed.

3

Thurs.

4

Fri.

5

Sal.

6

Sun.

7

Mall.

8

C.~~-+~9-t---t--t--1I-+--f-+-+--4-{--4--+--l--4--:I-.t--J-4--4---l~

Tues.

Wed.

10

~~-+--1--I-4--4--l·-t-t-+--+--t--~-1--+--t--4--4-l'-·1-_l-.-l-1
11

I

Fri.

Sal.

t

!
1
J
)
J

1

1
1
1~ ,.