A Study to Evaluate the Safety and Effectiveness of HIV-1 LAI gp120 (an HIV Vaccine) Given With or Without HIV-1 MN rgp120 (Another HIV Vaccine) to HIV-Negative Volunteers
Condition: HIV Infections; HIV Seronegativity
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and effectiveness of giving healthy
      volunteers a new oral HIV vaccine which has been incorporated into a bacterial cell. This
      oral vaccine (HIV-1 LAI gp120) will be given with or without a different injected HIV vaccine
      (HIV-1 MN rgp120).

      Vaccines are preparations that are introduced into the body to try to prevent infection or
      create resistance to infection. This study examines a new oral vaccine to see if it can
      improve the immune system's ability to fight the HIV virus when given alone or with another
      injected vaccine.
    

Detailed description: 
      Although recent advances have been made in antiviral therapy for AIDS, there is no cure for
      HIV-1 infection or AIDS, and drug therapy is too expensive for most affected populations. The
      development of safe, effective vaccines to prevent HIV-1 infection and AIDS worldwide is a
      global priority. One promising approach in the development of HIV-1 vaccines utilizes live
      vaccines as vectors to express HIV-1 antigens. The potential advantages of the live vector
      approach include the ability of live vector recombinants to induce long-lasting humoral and
      cell-mediated immunity (particularly neutralizing antibody and CD8+ cytotoxic T-cell
      activity) and the relatively low cost of production. Moreover, live vector recombinant
      vaccines administered orally might be able to stimulate the production of secretory IgA
      vaccine-specific antibodies locally at relevant mucosal sites.

      Part I of this study is conducted as an open-label, dose-escalation trial. The first 5
      volunteers (Group A) receive a single oral dose of Salmonella typhi CVD 908-HIV-1 LAI gp 120
      (VVG203). If no typhoid fever-like illness is seen in these volunteers during at least 14
      days of follow-up, the next 5 patients (Group B) receive a single dose of VVG203. If this
      higher dose is well-tolerated, Phase II of the study is initiated once all Phase I volunteers
      have been assessed for safety for at least 21 days. [AS PER AMENDMENT 11/07/97: Groups A and
      B are expanded to 10 patients each.] Part II of this study is a randomized,
      placebo-controlled, double-blind trial. Nine volunteers are randomized to each of treatment
      groups, with oral VVG203 given alone or sequentially with HIV-1 SF-2 rgp 120 in MF59 (SF)
      given intramuscularly. [AS PER AMENDMENT 11/07/97: Randomization is to VVG 203 alone or
      sequentially with HIV-1 MN rgp120 in alum (MN).] A total of 3 vaccinations are administered
      within each 9-person cohort, 1 volunteer serves as a control and receives a sodium
      bicarbonate buffer rather than VVG203 or a vaccine placebo rather than SF. Group C receives
      VVG at Month 0 and SF at Months 2 and 6. Group D receives VVG at Months 0, 2, and 6. Group E
      receives SF at Months 0 and 2 and VVG at Month 6. [AS PER AMENDMENT 11/07/97: MN is given in
      place of SF in all Groups C, D, and E.]
    

Intervention name(s): Salmonella typhi CVD 908-HIV-1 LAI gp 120 (VVG 203); Aluminum hydroxide; MF59; rgp120/HIV-1MN
Intervention type(s): Biological; Biological; Biological; Biological
Intervention MeSH terms: Aluminum Hydroxide
Masking: Double
Primary purpose: Prevention
Keywords: Vaccines, Synthetic; HIV-1; Administration, Oral; AIDS Vaccines; HIV Seronegativity; HIV Envelope Protein gp120; Recombination, Genetic; Salmonella typhi; HIV Preventive Vaccine