Safety and Effectiveness of Anti-HIV Vaccines in HIV-Negative Adults
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to find out whether three different anti-HIV vaccines are safe
      and whether they help prevent HIV infection. These vaccines are called vCP205, vCP1433, and
      vCP1452. Some patients also receive another anti-HIV vaccine, gp160. The vaccines are made up
      of small pieces of HIV, which help the body learn to recognize and destroy HIV. You cannot
      get HIV from these vaccines.

      There are two different ways a vaccine can protect the body from infection. First, a vaccine
      may help the immune system make antibodies, which are proteins that recognize invading
      viruses or bacteria. Second, a vaccine may help the body make immune cells that destroy
      infected cells. The second type of vaccine is more powerful against HIV. In this study,
      doctors will see whether vCP205, vCP1433, vCP1452, and gp160 are good vaccines by seeing
      whether they help the body make immune cells.
    

Detailed description: 
      Previous studies in humans have shown that immunization with certain vaccine combinations
      (that is, ALVAC-HIV construct and an envelope subunit vaccine) can elicit CTL activity,
      antibody-dependent cellular toxicity (ADCC), neutralizing antibodies, and other antibody
      responses more often and at higher levels than either vaccine alone. This study examines
      improved vaccine candidates that can elicit broader, longer-lasting CTL activity in the
      majority of vaccine recipients.

      Volunteers are randomized to one of four groups. Group I receives vCP205. Group II receives
      vCP1433. Group III receives vCP1452. Group IV receives an ALVAC rabies vaccine, as a control.
      Immunizations are administered at Months 0, 1, 3, and 6. At Months 3 and 6, patients in
      Groups I, II, and III also receive gp160 MN/LAI-2, the subunit boost vaccine. Group IV
      receives another placebo vaccine. Participants have regular clinic visits and blood is drawn
      to determine humoral and cellular immune responses to the vaccines. [AS PER AMENDMENT
      10/23/98: A cell-mediated immunity substudy has been added at selected institutions following
      the fourth vaccination at 6 months; this study will assess the newer assays of CD8+ T cells
      and the kinetic response following immunization. The 6-month immunization may be rescheduled
      by up to 14 days to accommodate clinical, laboratory, or volunteer scheduling issues.] [AS
      PER AMENDMENT 6/17/99: Three study arms are added. Group V receives vCP1452 at Months 0,1,3,
      and 6. Group VI receives vCP205 at Months 0,1,3, and 6. Group VII receives placebo at Months
      0,1,3, and 6. Patients in Groups V, VI, and VII do not receive the subunit boost, gp160
      MN/LAI-2. Consenting volunteers enrolled in the three new groups at Johns Hopkins University
      undergo PET scanning as part of an ancillary study.]
    

Intervention name(s): ALVAC(2)120(B,MN)GNP (vCP1452); gp160 MN/LAI-2; ALVAC(1)120(B,MN)GNP (vCP1433); ALVAC-HIV MN120TMG (vCP205); ALVAC-RG Rabies Glycoprotein (vCP65)
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention MeSH terms: polysaccharide-K
Masking: Double
Primary purpose: Prevention
Keywords: Vaccines, Synthetic; Viral Vaccines; HIV Antibodies; HIV Envelope Protein gp160; AIDS Vaccines; T-Lymphocytes, Cytotoxic; HIV Seronegativity; Antibody Formation; Risk-Taking; Avipoxvirus; Genetic Vectors; Immunization; HIV Preventive Vaccine