ALVAC-HIV vCP1452 Alone and Combined With MN rgp120
Condition: HIV Infections; HIV Seronegativity
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to test how the body's immune system responds to the vaccine
      ALVAC-HIV vCP1452 and to determine if the vaccine is safe when given alone and with MN
      rgp120.

      HIV infection and AIDS have no cure, in spite of recent advances in anti-HIV drugs. Many
      worldwide populations cannot afford the antiviral treatments for infected people. HIV
      vaccines offer hope for disease prevention. In this trial, 2 experimental HIV vaccines called
      ALVAC vCP1452 and MN rgp120 will be given to volunteers in Haiti, Brazil, Peru, and Trinidad
      and Tobago. The study will determine how volunteers' immune systems respond to the vaccines.
      (This protocol has been changed by adding new international sites.)
    

Detailed description: 
      There is no cure for HIV infection or AIDS in spite of recent advances in antiviral therapy.
      Furthermore, drug therapy is too expensive for most affected populations. For this reason,
      there is a commitment to the development of safe, effective vaccines to prevent HIV infection
      and AIDS worldwide. This study evaluates the immunogenicity and safety of candidate HIV-1
      vaccines, based on the canarypox vector termed ALVAC, alone and combined with an MN rgp120
      product, at 3 [AS PER AMENDMENT 7/19/01: 5] international sites.

      [AS PER AMENDMENT 7/19/01: Volunteers in Rio de Janeiro, Haiti, and Trinidad and Tobago
      comprise Part I; volunteers in Sao Paulo and Peru comprise Part II.] Volunteers from Haiti,
      Brazil, [AS PER AMENDMENT 7/19/01: Peru] and Trinidad and Tobago are enrolled into 1 of 3
      arms and followed for 18 months. Arm 1 volunteers receive ALVAC-HIV vCP1452 at 0, 1, 3, and 6
      months. Arm 2 volunteers receive ALVAC-HIV vCP1452 on the same schedule as Arm 1 and receive
      HIV-1 MN rgp120 subunit simultaneously with the 3-month and 6-month vaccine doses. Arm 3
      volunteers receive a placebo. Blood and urine samples are collected for immunologic assays,
      virologic determinations, pregnancy testing, and safety assessments. Risk behavior and social
      harms are assessed every 6 months during follow-up [AS PER AMENDMENT 7/19/01: Social harms
      are assessed every 3 months during follow-up and risk behavior every 6 months]. At all clinic
      visits volunteers receive counseling on avoidance of HIV infection and pregnancy.
      Participants are tested for HIV-1 every 3 [AS PER AMENDMENT 7/19/01: the following text has
      been deleted: to 6] months. Counseling and follow-up for any needed medical care are
      provided.
    

Intervention name(s): ALVAC(2)120(B,MN)GNP (vCP1452); MN rgp120/HIV-1; ALVAC(2)120(B,MN)GNP (vCP1452) placebo; MN rgp120/HIV-1 placebo
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): 1 x 10^ 7 TCID50 administered intramuscularly; 0.6 mg administered intramuscularly; ALVAC placebo administered intramuscularly; Alum placebo administered intramuscularly
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Keywords: HIV Antibodies; HIV Antigens; HIV Envelope Protein gp120; AIDS Vaccines; CD4-Positive T-Lymphocytes; CD8-Positive T-Lymphocytes; Neutralization Tests; Haiti; Brazil; Cytotoxicity, Immunologic; Epitopes; Viral Proteins; Trinidad and Tobago; Peru; HIV Preventive Vaccine; HIV Seronegativity