HIV Infections
Conditions
Keywords
Vaccines, Synthetic, Vaccinia Virus, Viral Vaccines, HIV-1, HIV Envelope Protein gp160, HIV Envelope Protein gp120, AIDS Vaccines, HIV Seronegativity, HIV Preventive Vaccine
Brief summary
Primary: To determine in healthy volunteers whether priming with a vaccinia HIV-1 gp160 envelope gene recombinant vaccine (HIVAC-1e) followed by boosting with one of two subunit recombinant HIV-1 envelope vaccines (Env 2-3 and gp120) provides enhanced immunogenicity compared to vaccination with the gp120 subunit vaccine alone. (Per 10/01/92 amendment, boosts with VaxSyn (gp160) were eliminated.) To evaluate the immunogenicity of one versus two priming doses of HIVAC-1e prior to a boost with gp120. To compare the relative immunogenicity of the three subunit vaccines when administered as boosters. Secondary: To examine the safety of administering the individual subunit vaccines in combination with HIVAC-1e and the safety of administering the gp120 subunit vaccine alone. In a previous study of candidate HIV vaccines, the evidence suggested that administration of a booster vaccination with a different vaccine preparation may produce a better immune response than administration of HIVAC-1e vaccine alone.
Detailed description
In a previous study of candidate HIV vaccines, the evidence suggested that administration of a booster vaccination with a different vaccine preparation may produce a better immune response than administration of HIVAC-1e vaccine alone. Seventy healthy volunteers are randomized to one of four groups. Groups A and D receive one initial immunization with HIVAC-1e followed by two boosts with subunit gp120 and Env 2-3, respectively, at months 8 and 12. Group B receives two immunizations with HIVAC-1e at months 0 and 8 followed by a single boost with subunit gp120 at month 12. Group C receives three doses of subunit gp120 only at months 0, 8 and 12. (Per 10/01/92 amendment, boosts with VaxSyn (gp160) have been eliminated.) Subjects are followed for 18 months.
Interventions
BIOLOGICALrgp120/HIV-1 SF-2
BIOLOGICALEnv 2-3
BIOLOGICALHIVAC-1e
BIOLOGICALgp160 Vaccine (MicroGeneSys)
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Primary purpose
PREVENTION
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
Subjects must have: * Normal history and physical exam. * Negative HIV screening by ELISA, Western blot, and p24 antigen (PBMC HIV culture or HIV-specific PCR can be substituted for Western blot and p24 antigen). * History of smallpox vaccination more than 5 years prior to enrollment. * Normal urinalysis. * Absolute CD4 count = or \> 500 cells/mm3. Prior Medication: Required: * Vaccinia (smallpox) vaccination more than 5 years prior to study enrollment. Identifiable high-risk behavior for HIV infection as determined by screening questionnaire/interview.
Exclusion criteria
Co-existing Condition: Subjects with the following symptoms or conditions are excluded: * Household contacts who are pregnant, \< 12 months of age, have eczema, or have immunodeficiency disease or who use immunosuppressive medications. * Hepatitis B surface antigenemia. * Medical or psychiatric condition or occupational responsibilities that preclude compliance. Subjects with the following prior conditions are excluded: * History of immunodeficiency or chronic illness. * Eczema within the past year. Prior Medication: Excluded: * Prior experimental HIV vaccine. * Immunoglobulin administration or use of experimental agent within the past 2 months. * History of immunosuppressive medications. Prior Treatment: Excluded: * Blood or blood product transfusion within the previous 6 months.
Countries
United States
Outcome results
None listed