A Comparative Phase I Clinical Study of HIVAC-1e and Smallpox (Vaccinia) Vaccines in Previously (Vaccinia) Vaccinated and Unvaccinated Volunteers
Launched by BRISTOL-MYERS SQUIBB · Aug 30, 2001
Trial Information
Current as of December 06, 2024
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- • Inclusion Criteria
- Concurrent Medication:
- Allowed:
- • All drugs, medications, and therapy which, by virtue of direct pharmacologic action or possible drug interaction, could influence the intended effects of the study vaccine or mask its side effects may be concomitantly administered only by prescription by the Principal Investigator and must be documented on the case report form (CRF).
- • Any drug, even aspirin, which is administered after vaccination and during the follow up periods must be documented on the patient's CRF.
- • Exclusion Criteria
- Co-existing Condition:
- Patients with the following conditions or symptoms are excluded:
- • Failure to meet any criteria listed under Inclusion Criteria.
- • Development of active eczema or other skin condition which would increase the risk of secondary vaccinia lesions.
- • Appearance of serologic or clinical evidence of HIV infection prior to vaccination.
- • Current evidence of clinically active viral infections such as Mononucleosis, Epstein-Barr Virus, or cytomegalovirus which may affect immunocompetence.
- • Active and overt parasitic, mycobacterial, or pyogenic infections that affect tests designated in Inclusion Criteria.
- Concurrent Medication:
- Excluded:
- • All drugs, medications and therapy not prescribed by the Principal Investigator, and not documented on the case report form (CRF).
- • Any drug, even aspirin, which is administered after vaccination and during the follow up periods which is not documented on the patient's CRF.
- Patients with the following are excluded:
- • Failure to meet any criteria listed under Inclusion Criteria.
- • Appearance of serologic or clinical evidence of HIV infection prior to vaccination.
- • Current evidence of clinically active viral infections.
- • Active and overt parasitic, mycobacterial, or pyogenic infections that affect tests designated in Inclusion Criteria.
- 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:
- • Be HIV seronegative.
- • Have excellent general health.
- • Be unable to bear children.
- • Have no immediate household contacts, sex partners, intimate contacts.
- • Be free of clinical skin diseases.
- • Have signed an informed consent.
- • Control subjects receiving Smallpox vaccine will also be selected under the same inclusion criteria. They may be recruited from low risk behavior populations; from laboratory and hospital employees providing service to the study who would normally require Smallpox vaccination; and may be heterosexual, homosexual, or bisexual.
- • Patients must agree to behave sexually in a manner that will minimize the risk of HIV infection for the duration of the study.
Trial Officials
Bristol-Myers Squibb
Study Director
Bristol-Myers Squibb
About Bristol Myers Squibb
Bristol-Myers Squibb (BMS) is a global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases. With a robust portfolio of products across multiple therapeutic areas, including oncology, immunology, cardiovascular, and fibrotic diseases, BMS emphasizes cutting-edge research and a commitment to advancing medical science through clinical trials. The company is driven by a mission to provide transformative therapies, leveraging collaboration and scientific expertise to address unmet medical needs and improve patient outcomes worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Wallingford, Connecticut, United States
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0
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