A Phase II Clinical Trial to Evaluate the Immunogenicity and Reactogenicity of the Recombinant HIV-1 Envelope Vaccines SF-2 rgp120 (CHO) [Chiron Vaccines] in MF59 Adjuvant and MN rgp120/HIV-1 [VaxGen] in Alum Adjuvant in Healthy Adults
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the safety and immunogenicity of SF-2 rgp120 vaccine in MF59 versus MN rgp120
      vaccine in alum in volunteers who are seronegative for HIV-1. AS PER AMENDMENT 07/02/97: To
      determine the ability of immunization with MN rgp120/HIV-1 in combination with alum or SF-2
      rgp120 in combination with MF59 to induce an HIV-1 envelope-specific delayed-type
      hypersensitivity (DTH) response in volunteers who receive rsgp120/MN skin testing.

      The amino acid sequence of HIV-1 gp120 can vary as much as 40 percent from isolate to
      isolate. Thus, the identification of an immunogen that can elicit broadly neutralizing
      antibodies to HIV-1 is a major challenge in AIDS vaccine development. Two candidate vaccines,
      recombinant envelope subunit proteins from the SF-2 and MN isolates of HIV-1, have shown
      immunogenicity and good tolerance in healthy immunocompetent adults. This study will expand
      testing into a larger population base, particularly targeting individuals at high risk for
      HIV infection.
    

Detailed description: 
      The amino acid sequence of HIV-1 gp120 can vary as much as 40 percent from isolate to
      isolate. Thus, the identification of an immunogen that can elicit broadly neutralizing
      antibodies to HIV-1 is a major challenge in AIDS vaccine development. Two candidate vaccines,
      recombinant envelope subunit proteins from the SF-2 and MN isolates of HIV-1, have shown
      immunogenicity and good tolerance in healthy immunocompetent adults. This study will expand
      testing into a larger population base, particularly targeting individuals at high risk for
      HIV infection.

      HIV-seronegative volunteers (including four populations at higher risk for HIV infection and
      two populations at lower risk) receive one of four regimens. Two treatment groups receive 50
      mcg SF-2 rgp 120 (BIOCINE) in MF59 adjuvant or 600 mcg MN rgp120 (Genentech) in alum. Two
      control groups receive vehicle (placebo) in MF59 adjuvant alone or alum adjuvant alone.
      Immunizations are given at months 0, 1, and 6. AS PER AMENDMENT 10/93: patients enrolled by
      June 15, 1993, receive a fourth immunization at month 12 or 18 (50 percent of patients for
      each schedule). Patients are followed until 2 years after the first injection. AS PER
      AMENDMENT 05/10/94: a special study of vaccine acceptability and HIV-related risk behavior
      will be conducted at some time between months 12 and 18. AS PER AMENDMENT 07/02/97: a special
      DTH study will be conducted in consenting volunteers who have received three or four
      immunizations. The injections will be given at the end of the study (on or after day 1, &
      56). Followup is extended to 56 days after administration of the intradermal injection.
    

Intervention name(s): rgp120/HIV-1MN; rgp120/HIV-1 SF-2
Intervention type(s): Biological; Biological
Masking: Double
Primary purpose: Prevention
Keywords: Vaccines, Synthetic; HIV-1; HIV Envelope Protein gp120; AIDS Vaccines; HIV Seronegativity; HIV Preventive Vaccine