A Comparative Phase I Clinical Study of HIVAC-1e and Smallpox (Vaccinia) Vaccines in Previously (Vaccinia) Vaccinated and Unvaccinated Volunteers
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:
- 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.
- The appearance, identity, quantity, and duration of humoral antibodies against HIV and vaccinia virus.
- The appearance, identity, quantity, and duration of cell-mediated immunity against HIV and vaccinia virus.
- The adequacy of a procedure using a special dressing to contain viral shedding from the vaccination site.
- The safety, humoral and cellular immune responses of a booster injection of the recombinant subunit gp160 vaccine (MicroGeneSys) in HIVAC-1e recipients.
Biological: Smallpox Vaccine
Biological: gp160 Vaccine (MicroGeneSys)
|Study Design:||Primary Purpose: Prevention|
|Official Title:||A Comparative Phase I Clinical Study of HIVAC-1e and Smallpox (Vaccinia) Vaccines in Previously (Vaccinia) Vaccinated and Unvaccinated Volunteers|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002261
|United States, Connecticut|
|Bristol - Myers Squibb Co|
|Wallingford, Connecticut, United States, 064927600|
|Study Director:||Bristol-Myers Squibb||Bristol-Myers Squibb|