OUTLINE OF PROTOCOL
003
A PHASE I MULTICENTER,
RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED TRIAL TO EVALUATE THE
SAFETY AND IMMUNOGENICITY OF HIV-1 RECOMBINANT ENVELOPE GLYCOPROTEIN
GP160
Subjects: Healthy, HIV-1
uninfected adult volunteers without identifiable high-risk behavior
for HIV-1 infection.
Schema:
|
Dose Level
|
Accrual*
|
Immunization Schedule
|
|
Day 0
|
Day 30
|
Day 180
|
Day 545
|
|
VaxSyn 40 µg
|
18
|
X
|
X
|
X
|
X
|
|
VaxSyn 80 µg
|
18
|
X
|
X
|
X
|
X
|
|
Recombivax Hepatitis B
vaccine
|
18
|
X
|
X
|
X
|
X
|
|
Alum Placebo
|
18
|
X
|
X
|
X
|
X
|
|
Total n = 72
|
|
|
|
|
* VaxSyn dose levels filled sequentially with
randomization between VaxSyn, Alum Placebo, or Recombivax at each
dose level; one half of non-antigen groups were entered per VaxSyn
dose level
ACCRUAL, IMMUNIZATIONS, AND
FOLLOW-UP COMPLETED
Product Description: VaxSyn:
Baculovirus/insect cell-derived HIV-1 LAI rgp160 in alum
[MicroGeneSys]
Time Period: First volunteer
entered on 02/28/88 and the last was enrolled on 05/06/88; follow-up
extended to 36 months for volunteers receiving the fourth
immunization.
Clinical Sites: Baylor College of
Medicine, Johns Hopkins University, Saint Louis University (Marshall
University), University of Maryland at Baltimore, University of
Rochester, Vanderbilt University
Study Chair: Raphael Dolin,
University of Rochester
INCLUSION CRITERIA
- Age: >18 and
<50
- Sex: Male or Female
- Normal history and physical
examination
- Normal complete blood count and differential
defined as:
- Hematocrit >35% for women;
>39% for men
- White count >4000
cells/mm3 with normal differential
- Total lymphocyte count >1500
cells/mm3
- T4 cells >800
cells/mm3
- Platelets in the normal range
- Normal chest x-ray
- Normal urinalysis
- Normal ALT and creatinine
- Negative ELISA and Western blot test for
HIV
- Negative HIV p24 antigen test
- Negative surface antibody and core antibody
for Hep B
- Negative for Hep B surface antigen
- For females, negative pregnancy test at time
of entry and assurance that adequate birth control measures are
employed for the next 12 months
- Normal skin reactivity by Merieux multiskin
test kit
- Availability for one year of
follow-up
EXCLUSION CRITERIA
- Subjects with identifiable high-risk behavior
for HIV infection as determined by prescreening questions designed
to identify risk factors for HIV infection
- Previous receipt of blood transfusions or
cryoprecipitates within the past 6 months
- History of immunodeficiency, chronic illness,
or use of immunosuppressive medications
- Positive PPD
- Positive syphilis serology (e.g.,
VDRL)
- Hepatitis B vaccination
STUDY GOALS
- To determine the reactivity and safety of
HIV-1 recombinant envelope glycoprotein gp160
(rgp160).
- To determine the immunogenicity of
rgp160.
REFERENCES
Dolin R, Graham BS, Greenberg SB,
Tacket CO, Belshe RB, Midthun K, Clements ML,
Gorse GJ, Horgan BW, Atmar RL, Karzon DT,
Bonnez W, Fernie BF, Montefiori DC, Stablein DM,
Smith GE, Koff WC, NIAID AIDS Vaccine Clinical Trials
Network. The safety and immunogenicity of a human immunodeficiency
virus type 1 (HIV-1) recombinant gp160 candidate vaccine in
humans. Ann Intern Med. 1991;114:119-127.