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| Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00000746 |
Purpose
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.
| Condition | Intervention | Phase |
|
HIV Infections |
Biological: rgp120/HIV-1 SF-2 Biological: Env 2-3 Biological: HIVAC-1e Biological: gp160 Vaccine (MicroGeneSys) |
Phase I |
| MedlinePlus related topics: | AIDS |
| Drug Information available for: | PANVAC-V |
| Study Type: | Interventional |
| Study Design: | Prevention, Safety Study |
| Official Title: | 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 |
| Estimated Enrollment: | 56 |
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
| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria
Subjects must have:
Prior Medication: Required:
Exclusion Criteria
Co-existing Condition:
Subjects with the following symptoms or conditions are excluded:
Subjects with the following prior conditions are excluded:
Prior Medication:
Excluded:
Prior Treatment:
Excluded:
Contacts and Locations| United States, Maryland | |||||
| Johns Hopkins Univ / School of Hygiene & Public Health | |||||
| Baltimore, Maryland, United States, 212051901 | |||||
| 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 | |||||
| Univ of Washington / Pacific Med Ctr | |||||
| Seattle, Washington, United States, 98144 | |||||
| Study Chair: | Corey L |
More Information
|
Clements ML, Corey L, Weinhold K, Schwartz D, Siliciano R, Matthews T, Hsieh R, Graham B, Keefer M, Gorse G, Zolla-Pazner S, Mascola J, Duliege A, Excler J, Tartaglia J, Paoletti E, Hu SL. HIV immunity induced by priming with canarypox or vaccinia-gp160 recombinants and boosting with rgp120. Inst of Hum Virol Annu Meet. 1996 Sept 7-13
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Graham BS, Belshe RB, Clements ML, Dolin R, Corey L, Wright PF, Gorse GJ, Midthun K, Keefer MC, Roberts NJ Jr, et al. Vaccination of vaccinia-naive adults with human immunodeficiency virus type 1 gp160 recombinant vaccinia virus in a blinded, controlled, randomized clinical trial. The AIDS Vaccine Clinical Trials Network. J Infect Dis. 1992 Aug;166(2):244-52.
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| Study ID Numbers: | AVEG 008, AVEG Protocol 008 |
| First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00000746 |
| Health Authority: | United States: Federal Government |
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