OUTLINE OF PROTOCOL
014A
A MULTICENTER, RANDOMIZED,
PLACEBO-CONTROLLED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY AND
IMMUNOGENICITY OF A RECOMBINANT VACCINIA-HIV-1 IIIB ENV/GAG/POL
VACCINE (TBC-3B) [THERION]
Subjects: Healthy, HIV-1
uninfected adult volunteers who have no identifiable high-risk
behavior for HIV-1 infection, and who have received smallpox
(vaccinia) vaccination at least 5 years prior to
enrollment.
Schema:
|
Group
|
Accrual
|
Day 0
|
Day 56
|
|
A
|
14
|
T
|
T
|
|
B
|
4
|
D
|
D
|
|
T = Therion TBC-3B (109
pfu/ml)
|
D = DryVax (control
vaccine)
|
Notes: The original protocol included a third
immunization at Day 392, which was canceled. Protocol 014B,
originally planned as a companion trial to Protocol 014A, in
vaccinia-naive individuals, was never opened for enrollment and was
replaced in concept by Protocol 014C.
ACCRUAL, IMMUNIZATIONS AND FOLLOW-UP
COMPLETED
Product Description: TBC-3B:
Recombinant vaccinia-HIV-1 IIIB expressing the env and
gag/pol genes of HIV-1 strain IIIB, grown in RK13 (rabbit
kidney) cells [Therion Biologics]
Time Period: First volunteer
enrolled on 04/13/94 and the last on 07/08/94; follow-up of
24 months.
Clinical Sites: Saint Louis
University, University of Rochester, University of Washington,
Vanderbilt University
Study Chair: Michael Keefer,
University of Rochester
INCLUSION CRITERIA
Standard inclusion criteria, with the addition
of:
- History of smallpox vaccination at least 5
years prior to enrollment
- Negative HIV-1 Western Blot (No envelope
bands on any pre-entry assay) within 8 weeks of
immunization
EXCLUSION CRITERIA
Standard exclusion criteria, with the addition
of:
- Eczema within the past year
- Household contacts with persons who are
pregnant, <12 months of age, have eczema or who have
immunodeficiency disease or use immunosuppressive
medications
STUDY GOALS
- To evaluate the safety and immunogenicity of
the prime-boost immunization approach in vaccinia-naive and
vaccinia-immune individuals using a novel priming immunogen
including HIV-1 envelope, core and polymerase antigens, and
subsequently address questions pertaining to the optimal boosting
strategy raised by the previous HIVAC-1e trials.
- To evaluate the overall duration of the immune
response in all groups.
- To evaluate the safety and immunogenicity of
TBC-3B in humans with prior vaccinia exposure and compare two
different priming regimens in the vaccinia-naive
group.