A Phase I Randomized Trial to Evaluate the Safety and Immunogenicity of Vaccinia-HIV Envelope Recombinant Vaccine (HIVAC-1e) in Combination With Soluble Recombinant Envelope Vaccine (VaxSyn)

Study Overview
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Brief Summary
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Primary: To determine whether additional boosting with soluble recombinant gp160 vaccine (VaxSyn) after priming with a vaccinia-HIV envelope recombinant (HIVAC-1e) provides a significant advantage in the degree and duration of immunogenicity. Secondary: To learn more about the safety of the combination use of the two HIV envelope vaccines in the study (VaxSyn and HIVAC-1e). Recent Phase I trials conducted at the AIDS Vaccine Units have shown that antibodies have persisted in most recipients for 6 months after boosting, and responses seem significantly higher and more persistent than responses achieved by just two doses of soluble protein vaccine alone or two doses of HIVAC-1e alone. This study tests in a previously recruited cohort of volunteers whether additional boosting with soluble recombinant gp160 results in increased immunogenicity of longer duration.

Detailed Description
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Recent Phase I trials conducted at the AIDS Vaccine Units have shown that antibodies have persisted in most recipients for 6 months after boosting, and responses seem significantly higher and more persistent than responses achieved by just two doses of soluble protein vaccine alone or two doses of HIVAC-1e alone. This study tests in a previously recruited cohort of volunteers whether additional boosting with soluble recombinant gp160 results in increased immunogenicity of longer duration. Twelve volunteers who have previously received two doses of HIVAC-1e (or DryVax) and two doses of gp160 receive an additional boost of gp160 at 12-20 months after the last boost and an additional dose of HIVAC-1e at least 9 months after the final gp160 boost.

Official Title
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A Phase I Randomized Trial to Evaluate the Safety and Immunogenicity of Vaccinia-HIV Envelope Recombinant Vaccine (HIVAC-1e) in Combination With Soluble Recombinant Envelope Vaccine (VaxSyn)

Conditions
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HIV Infections

Intervention / Treatment
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* Biological: HIVAC-1e
* Biological: gp160 Vaccine (MicroGeneSys)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Patients must have: Normal history and physical exam. Negative ELISA for HIV. Negative HIV p24 antigen test. Normal urinalysis. Prior Medication: Required: Two prior doses of HIVAC-1e (or DryVax) and two prior doses of gp160 vaccine. Exclusion Criteria Co-existing Condition: Patients with the following symptoms and conditions are excluded: Risk factors for HIV infection including active intravenous drug use and more than 2 sexual partners. History of immunodeficiency or chronic illness. Hypersensitivity to insects. Medical or psychiatric condition that makes it unlikely the patient will comply with the protocol. Patients with the following prior conditions are excluded: History of immunodeficiency or chronic illness. Prior Medication: Excluded: Immunosuppressive medications. Prior Treatment: Excluded: Blood or blood product transfusion within the past 6 months. Risk Behavior: Excluded: Intravenous drug use. More than 2 sexual partners.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: HIVAC-1e|nan|
|Biological: gp160 Vaccine (MicroGeneSys)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vaccines, Synthetic, Vaccinia Virus, Viral Envelope Proteins, Viral Vaccines, AIDS Vaccines, HIV Seronegativity, HIV Preventive Vaccine