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To determine the physiological and immunological responses in healthy HIV seronegative adult volunteers vaccinated with a) the HIVAC-1e (vaccinia-HIV) vaccine expressing the envelope glycoproteins of HIV and b) the Wyeth smallpox vaccine. The parameters to be studied will include:
1. The course of physiological responses to vaccination, including (a) lesion development, progression, and resolution; (b) physiological changes such as temperature, malaise, itching at the site, etc. and (c) any observable AE.
2. The appearance, identity, quantity, and duration of humoral antibodies against HIV and vaccinia virus.
3. The appearance, identity, quantity, and duration of cell-mediated immunity against HIV and vaccinia virus.
4. The adequacy of a procedure using a special dressing to contain viral shedding from the vaccination site.
5. The safety, humoral and cellular immune responses of a booster injection of the recombinant subunit gp160 vaccine (MicroGeneSys) in HIVAC-1e recipients.
Primary Purpose: Prevention
Smallpox Vaccine, HIVAC-1e, gp160 Vaccine (MicroGeneSys)
Bristol - Myers Squibb Co
Published on BioPortfolio: 2014-08-27T03:59:13-0400
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 prim...
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 a...
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
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 recombinan...
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
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 ...
To evaluate the safety and immune response to 160 mcg HIV-1 recombinant envelope glycoprotein gp160. To evaluate the duration of antibody response and its relationship to dose and frequenc...
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