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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: | NCT00001043 |
Purpose
AMENDED 8/94: To expand the safety and immunogenicity profile of MN rgp160 vaccine (Immuno-AG) by administering a higher dose (800 mcg) at 0, 1, 6, and 12 months and 0, 2, 8 and 14 months (these two schedules were compared in VEU 013A using a dose of 200 mcg). To obtain plasma following the fourth immunization. To evaluate skin test reactivity.
ORIGINAL (replaced): To determine in healthy volunteers the safety and immunogenicity of two immunizations of MN rgp160 vaccine (Immuno-AG) in combination with a live recombinant vaccinia virus LAV HIV-1 gp160 vaccine (HIVAC-1e) versus DryVax (the standard smallpox vaccine that was used for many years) control in combination with placebo.
ORIGINAL (replaced): A gp160 vaccine derived from the MN strain, the most prevalent strain of HIV-1 in the United States, has been developed. A previous study showed that a combination vaccine strategy, consisting of priming with HIVAC-1e followed by boosting with a gp160 subunit vaccine, resulted in humoral and cellular immune responses of greater and longer duration than either vaccine alone. Thus, a live vector/subunit boost approach using the MN rgp160 vaccine merits investigation.
| Condition | Intervention | Phase |
|
HIV Infections HIV Seronegativity |
Biological: gp160 Vaccine (Immuno-AG) |
Phase I |
| MedlinePlus related topics: | AIDS Smallpox |
| Drug Information available for: | Krestin 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 Vaccinia-Derived MN HIV-1 Recombinant Envelope Glycoprotein (rgp160) of Human Immunodeficiency Virus at Two Different Vaccination Schedules |
| Estimated Enrollment: | 16 |
ORIGINAL (replaced): A gp160 vaccine derived from the MN strain, the most prevalent strain of HIV-1 in the United States, has been developed. A previous study showed that a combination vaccine strategy, consisting of priming with HIVAC-1e followed by boosting with a gp160 subunit vaccine, resulted in humoral and cellular immune responses of greater and longer duration than either vaccine alone. Thus, a live vector/subunit boost approach using the MN rgp160 vaccine merits investigation.
AMENDED 8/94: Volunteers are randomized to receive 800 mcg MN rgp160 vaccine (Immuno-AG) or adjuvant control (placebo) on one of two dosing schedules. Sixteen volunteers receive candidate vaccine and four volunteers receive placebo.
ORIGINAL (replaced): Volunteers are randomized to receive either HIVAC-1e on days 0 and 56 followed by immunization with MN rgp160 vaccine on days 224 and 364, or DryVax control on days 0 and 56 followed by placebo on days 224 and 364. Ten volunteers are entered on the MN rgp160 vaccine arm and two volunteers on the placebo arm.
PER AMENDMENT 7/96: Two additional booster immunizations of 600 mcg of MN rgp 120/HIV-1 vaccine given at study months 22 and 24 to consenting St. Louis University volunteers.
Eligibility
| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria
Subjects must have:
Exclusion Criteria
Co-existing Condition:
Subjects with the following conditions are excluded:
Household contact with persons meeting any of the following criteria:
Subjects with the following prior conditions are excluded:
Prior Medication:
Excluded:
Prior Treatment:
Excluded:
Higher risk behavior for HIV infection as determined by screening questionnaire, including:
Contacts and Locations| United States, Missouri | |||||
| St Louis Univ School of Medicine | |||||
| St. Louis, Missouri, United States, 63104 | |||||
| United States, Washington | |||||
| Univ of Washington / Pacific Med Ctr | |||||
| Seattle, Washington, United States, 98144 | |||||
| Study Chair: | Gorse G |
More Information
|
Gorse GJ, Corey L, Patel GB, Mandava M, Hsieh RH, Matthews TJ, Walker MC, McElrath MJ, Berman PW, Eibl MM, Belshe RB. HIV-1MN recombinant glycoprotein 160 vaccine-induced cellular and humoral immunity boosted by HIV-1MN recombinant glycoprotein 120 vaccine. National Institute of Allergy and Infectious Diseases AIDS Vaccine Evaluation Group. AIDS Res Hum Retroviruses. 1999 Jan 20;15(2):115-32.
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Gorse GJ, McElrath MJ, Belshe RB, Corey L, Matthews T, Eibl M, Kennedy D, Frey S, Hsieh R, Walker MC. High dose HIV-1 MN recombinant gp160 (rgp160) vaccine induces anti-v3 MN, and IgG1-4 and IgA anti-rgp160 antibodies. Int Conf AIDS. 1996 Jul 7-12;11(1):7 (abstract no MoA153)
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| Study ID Numbers: | AVEG 013B |
| First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00001043 |
| Health Authority: | United States: Federal Government |
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