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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: | NCT00000630 |
To determine if priming (giving the first vaccination) with a vaccinia recombinant (HIVAC-1e) provides a significant advantage in immunogenicity (production of antibodies) compared to priming with a soluble recombinant protein (gp160); to learn more about the safety of the combination use of the two HIV envelope vaccines utilized in the study.
Recent studies at the AIDS vaccine units have shown the safety of two candidate HIV vaccines, HIVAC-1e and gp160. Specific questions to be addressed in this part of the study include: Does combination vaccination result in a synergistic (added) response not predicted by just the addition of a second vaccination, and does this synergism depend on the unique priming effect of a vaccinia recombinant, or will any combination do?
Condition | Intervention | Phase |
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HIV Infections |
Biological: HIVAC-1e Biological: gp160 Vaccine (MicroGeneSys) |
Phase I |
Study Type: | Interventional |
Study Design: | Prevention, Randomized |
Official Title: | Phase I Safety and Immunogenicity Trial of Vaccinia-HIV Envelope Recombinant Vaccine (HIVAC-1e) in Combination With Soluble Recombinant Envelope Vaccine (gp160; VaxSyn) |
Estimated Enrollment: | 35 |
Recent studies at the AIDS vaccine units have shown the safety of two candidate HIV vaccines, HIVAC-1e and gp160. Specific questions to be addressed in this part of the study include: Does combination vaccination result in a synergistic (added) response not predicted by just the addition of a second vaccination, and does this synergism depend on the unique priming effect of a vaccinia recombinant, or will any combination do?
Volunteers will be randomized to one of four groups. Group A (20 volunteers) will receive gp160 (VaxSyn) followed two months later by a repeat dose. Group B (20 volunteers) will receive VaxSyn followed two months later by HIVAC-1e. Group C (20 volunteers) will receive HIVAC-1e followed two months later by VaxSyn. Group D (10 volunteers) will receive HIVAC-1e followed two months later by HIVAC-1e. For volunteers in Groups A, B, and C who do not react to the initial vaccination, a second attempt to obtain a reaction may be made 7 or more days following the initial inoculation. Per addendum, two additional booster inoculations are given: one at 6 months or later post initial inoculation (Groups A, C, and D receive VaxSyn and Group B receives HIVAC-1e) and another at 12 months or later (all Groups receive VaxSyn).
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms and conditions are excluded:
Patients with the following prior conditions are excluded:
Prior Treatment:
Excluded within 6 months prior to study entry:
Risk Behavior:
Excluded:
United States, Maryland | |
Johns Hopkins Univ / Ctr for Immunological Research | |
Baltimore, Maryland, United States, 21205 | |
United States, Missouri | |
St Louis Univ School of Medicine | |
St. Louis, Missouri, United States, 63104 | |
United States, New York | |
Univ of Rochester Med Ctr | |
Rochester, New York, United States, 14642 | |
United States, Tennessee | |
Vanderbilt Univ Hosp | |
Nashville, Tennessee, United States, 37232 | |
United States, Washington | |
Children's Hospital & Medical Center / Seattle ACTU | |
Seattle, Washington, United States, 981050371 |
Study Chair: | Koff W |
Study ID Numbers: | AVEG 002A |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00000630 |
Health Authority: | United States: Federal Government |
Vaccines, Synthetic Vaccinia Virus Viral Envelope Proteins Acquired Immunodeficiency Syndrome |
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 |