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| Descriptive Information Fields | |||||
| Brief Title † | A Comparative Phase I Clinical Study of HIVAC-1e and Smallpox (Vaccinia) Vaccines in Previously (Vaccinia) Vaccinated and Unvaccinated Volunteers | ||||
| Official Title † | A Comparative Phase I Clinical Study of HIVAC-1e and Smallpox (Vaccinia) Vaccines in Previously (Vaccinia) Vaccinated and Unvaccinated Volunteers | ||||
| Brief Summary | 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:
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| Detailed Description | |||||
| Study Phase | Phase I | ||||
| Study Type † | Interventional | ||||
| Study Design † | Prevention | ||||
| Primary Outcome Measure † | |||||
| Secondary Outcome Measure † | |||||
| Condition † | HIV Infections | ||||
| Intervention † | Biological: Smallpox Vaccine Biological: HIVAC-1e Biological: gp160 Vaccine (MicroGeneSys) |
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| MEDLINE PMIDs | |||||
| Links | BMS Clinical Trials Disclosure ![]() For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm  ![]() |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Completed | ||||
| Enrollment † | |||||
| Start Date † | |||||
| Completion Date | |||||
| Eligibility Criteria † | 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. |
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| Gender | Both | ||||
| Ages | 18 Years to 60 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00002261 | ||||
| Organization ID | 063A | ||||
| Secondary IDs †† | AI452-003001 | ||||
| Study Sponsor † | Bristol-Myers Squibb | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | Bristol-Myers Squibb | ||||
| Verification Date | September 2007 | ||||
| First Received Date † | November 2, 1999 | ||||
| Last Updated Date | September 24, 2007 | ||||