HIV Vaccine Trial in Thai Adults
Condition: HIV Infection
MeSH terms: HIV Infections
Intervention: ALVAC-HIV vCP1521 + AIDSVAX; ALVAC Placebo + AIDSVAX Placebo
Intervention description: Combined dose of 600 μg (300 μg of each antigen), co-formulated and administered in alumi-um hydroxide gel at a dose of 600 μg/mL; ALVAC carrier, supplied as a lyophilized product, without virus and Aluminum hydroxide adjuvant, 1.2 mL per vial, given as a 1 mL injection
Intervention MeSH terms: Aluminum Hydroxide
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 16402.0
Sex: All
Minimum age: 18 Years
Maximum age: 30 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: HIV Seronegativity

Summary:

      The purpose of this study is to determine whether immunizations with an integrated
      combination of ALVAC-HIV (vCP1521) boosted by AIDSVAX gp120 B/E prevent HIV infection in
      healthy Thai volunteers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Possession of the 13-digit Thai National ID card

          -  18-30 years of age (inclusive), male or female

          -  For women, a negative urine pregnancy test on the day of enrollment, as well as
             assurance that adequate birth control measures would be applied during the course of
             the injections and the 3 months after the last injection.

          -  Absence of systemic disease or immunodeficiency as determined by medical history and
             directed physical examination.

          -  Negative serology for HIV-1 infection within 45 days prior to enrollment.

          -  Availability and commitment for 3.5 years of participation.

          -  Able to understand the study (shown by receiving a passing score on the Test of
             Understanding administered under the screening protocol) and gave written informed
             consent.

          -  Enrollment in and referral from screening protocol, RV148

        Exclusion Criteria:

          -  Previous participation in any HIV vaccine trial (unless the volunteer could provide
             documentation that he/she received placebo).

          -  Active tuberculosis, other systemic disease process, or immunodeficiency as detected
             by medical history and directed physical examination that would, in the opinion of the
             investigator, impede compliance with study requirements or complicate the
             interpretation of adverse events.

          -  Any significant finding that in the opinion of the investigator would increase the
             risk of having an adverse outcome from participating in this study or might interfere
             with the volunteer's ability to successfully complete the study.

          -  Occupational or other responsibilities that would prevent completion of 3.5 years of
             participation in the study.

          -  History of anaphylaxis or other serious adverse reactions to vaccines, or allergies or
             reactions likely to be exacerbated by any component of the vaccine or placebo,
             including egg products and neomycin.

          -  Women breast-feeding or pregnant (positive pregnancy test) or planning to become
             pregnant during the 9-month window between study enrollment and 3-months after the
             last vaccination visit.

          -  Study site employees who were involved in the protocol and may have had direct access
             to trial-related data.

          -  Chronic use of therapies which may modify immune response, such as IV immune globulin
             and systemic corticosteroids (in doses of > 20 mg prednisone equivalent for periods
             exceeding 10 days), and use of experimental drugs or vaccines.

          -  Receipt of a non-HIV vaccine or immune globulins within 14 days.