A Comparative Phase I Clinical Study of HIVAC-1e and Smallpox (Vaccinia) Vaccines in Previously (Vaccinia) Vaccinated and Unvaccinated Volunteers
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|ClinicalTrials.gov Identifier: NCT00002261|
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : September 26, 2007
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.
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Biological: Smallpox Vaccine Biological: HIVAC-1e Biological: gp160 Vaccine (MicroGeneSys)||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||A Comparative Phase I Clinical Study of HIVAC-1e and Smallpox (Vaccinia) Vaccines in Previously (Vaccinia) Vaccinated and Unvaccinated Volunteers|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002261
|United States, Connecticut|
|Bristol - Myers Squibb Co|
|Wallingford, Connecticut, United States, 064927600|
|Study Director:||Bristol-Myers Squibb||Bristol-Myers Squibb|