Expired Study
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Seattle, Washington 98105


Purpose:

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.


Study summary:

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.


Criteria:

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.


NCT ID:

NCT00000631


Primary Contact:

Study Chair
Corey L


Backup Contact:

N/A


Location Contact:

Seattle, Washington 98105
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: July 27, 2017

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