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| Sponsor: | Bristol-Myers Squibb |
|---|---|
| Information provided by: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT00002261 |
Purpose
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:
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Biological: Smallpox Vaccine Biological: HIVAC-1e Biological: gp160 Vaccine (MicroGeneSys) |
Phase I |
| Study Type: | Interventional |
| 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 |
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria
Concurrent Medication:
Allowed:
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
Concurrent Medication:
Excluded:
Patients with the following are excluded:
Risk Behavior:
Patients who do not agree to behave sexually in a manner that will minimize the risk of HIV infection for the duration of the study are excluded.
Patients must:
Patients must agree to behave sexually in a manner that will minimize the risk of HIV infection for the duration of the study.
Contacts and Locations| United States, Connecticut | |
| Bristol - Myers Squibb Co | |
| Wallingford, Connecticut, United States, 064927600 | |
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
More Information
| ClinicalTrials.gov Identifier: | NCT00002261 History of Changes |
| Other Study ID Numbers: | 063A, AI452-003001 |
| Study First Received: | November 2, 1999 |
| Last Updated: | September 24, 2007 |
| Health Authority: | United States: Food and Drug Administration |
|
Vaccines, Synthetic Vaccinia Virus Viral Vaccines Smallpox Vaccine |
HIV-1 AIDS Vaccines HIV Seronegativity |
|
HIV Infections Acquired Immunodeficiency Syndrome Smallpox Vaccinia Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Poxviridae Infections DNA Virus Infections |