A Phase I Multicenter Study of the Safety and Immunogenicity of MN rgp120/HIV-1 Vaccine Given Either Alone or in Combination With IIIB rgp120/HIV-1 Vaccine in Healthy Adult Subjects (NOTE: Original Study Extended ONLY for Patients Previously Enrolled on VEU 009)
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      AMENDED 10/1/93: To evaluate the influence of prior immunization with an rgp120 vaccine on
      immune response to a subsequent immunization with a different strain of rgp120 (VEU 009X
      extension - in patients previously enrolled on VEU 009).

      ORIGINAL DESIGN: To evaluate the clinical and immunologic safety of MN rgp120/HIV-1 vaccine
      (MN rgp120 vaccine) given alone or concurrently with the IIIB rgp120/HIV-1 vaccine (IIIB
      rgp120 vaccine) in healthy HIV-1 seronegative adult subjects. To compare the immune response
      to MN rgp120 vaccine given at 100, 300, or 600 mcg. To determine the immune response to 300
      mcg MN rgp120 vaccine and 300 mcg IIIB rgp120 vaccine given concurrently.

      Recent studies suggest that immunity to the HIV-1 rgp120 protein may prevent primary
      infection. MN rgp120 vaccine and IIIB rgp120 vaccine are both prepared by recombinant DNA
      technology. Because the two vaccines are derived from distinct HIV-1 strains, they may elicit
      some immunologic responses that differ. Unlike IIIB rgp120 vaccine, the MN rgp120 vaccine has
      not yet been evaluated in humans, although it is expected that the MN type will result in
      similar safety and immunogenicity as the IIIB type.
    

Detailed description: 
      Recent studies suggest that immunity to the HIV-1 rgp120 protein may prevent primary
      infection. MN rgp120 vaccine and IIIB rgp120 vaccine are both prepared by recombinant DNA
      technology. Because the two vaccines are derived from distinct HIV-1 strains, they may elicit
      some immunologic responses that differ. Unlike IIIB rgp120 vaccine, the MN rgp120 vaccine has
      not yet been evaluated in humans, although it is expected that the MN type will result in
      similar safety and immunogenicity as the IIIB type.

      AMENDED 10/1/93: Selected patients on VEU 009 who received four previous injections will
      receive three additional injections on the study extension (VEU 009X), administered at weeks
      72, 76, and 104. Patients who received 300 or 600 mcg MN rgp120 vaccine (eight patients per
      dosage) in the original portion of the study will be randomized to receive either 300 mcg MN
      rgp120 or 300 mcg IIIB rgp120 vaccine. Eight patients who previously received the MN/IIIB
      combination will again receive 300 mcg of both vaccines. Additionally, six patients who
      received placebo in the original portion will receive 300 mcg IIIB rgp120 vaccine. There will
      be nine clinic visits required for the study extension.

      ORIGINAL DESIGN: Fifty-seven adult subjects will be randomized to receive MN rgp120 vaccine
      at one of three dosages (100, 300, or 600 mcg), or 300 mcg MN rgp120 vaccine given
      concurrently with 300 mcg IIIB rgp120 vaccine, or placebo. Twelve subjects will be entered
      onto each of the four vaccine arms, and nine subjects will be entered on the placebo arm.
      Immunizations (or placebo injections) are given intramuscularly at 0, 4, 24, and 48 weeks.
      Subjects are followed for 15 months after the first immunization.
    

Intervention name(s): rgp120/HIV-1IIIB; rgp120/HIV-1MN
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