a phase i, multicenter, randomized trial to evaluate the safety and immunogenicity of a recombinant vaccinia-hiv envelope vaccine (hivac-1e) in combination with a panel of subunit recombinant hiv envelope vaccines

Conditions: HIV Infections

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.

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.

Eligibility criteria:
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.

Keywords: vaccines, synthetic vaccinia virus viral vaccines hiv-1 hiv envelope protein gp160 hiv envelope protein gp120 aids vaccines hiv seronegativity hiv preventive vaccine