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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000631 |
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.
Condition | Intervention | Phase |
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HIV Infections |
Biological: HIVAC-1e Biological: gp160 Vaccine (MicroGeneSys) |
Phase I |
Study Type: | Interventional |
Study Design: | Prevention, Open Label, Safety Study |
Official Title: | 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) |
Estimated Enrollment: | 13 |
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.
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria
Patients must have:
Prior Medication: Required:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms and conditions are excluded:
Patients with the following prior conditions are excluded:
Prior Medication:
Excluded:
Prior Treatment:
Excluded:
Risk Behavior: Excluded:
Study ID Numbers: | AVEG 002B |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00000631 |
Health Authority: | United States: Federal Government |
Vaccines, Synthetic Vaccinia Virus Viral Envelope Proteins Viral Vaccines |
AIDS Vaccines HIV Seronegativity HIV Preventive Vaccine |
Virus Diseases Sexually Transmitted Diseases, Viral Poxviridae Infections Vaccinia HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome DNA Virus Infections Retroviridae Infections Immunologic Deficiency Syndromes |
RNA Virus Infections Slow Virus Diseases Immune System Diseases Lentivirus Infections Infection |