Status:
COMPLETED
A Phase I Study of the Safety and Immunogenicity of rgp120/HIV-1IIIB Vaccine in Healthy Adult Subjects (NOTE: Study Extended ONLY for Subjects Who Have Previously Received rgp120/HIV-1IIIB or rgp120/HIV-1MN on VEU 006 or VEU 006 Rollover Study)
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Genentech, Inc.
Conditions:
HIV Infections
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
AMENDED 11/17/93: To determine whether the pattern of response to MN rgp120 vaccine is altered by pre-exposure to IIIB rgp120. ORIGINAL DESIGN: To evaluate the safety (clinical and immunologic) of rg...
Detailed Description
Recent evidence suggests that gp120 is the HIV-1 protein with the greatest potential as a vaccine against HIV-1 infection. The gp120 envelope protein may be produced by recombinant DNA technology, and...
Eligibility Criteria
Inclusion Criteria
Patients must have:
- Documented HIV seronegativity.
- Good general health.
- No high-risk behavior for HIV infection.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
- Postive PPD (unless a chest x-ray is negative and there is no suggestion of active or old pulmonary tuberculosis).
- Positive VDRL or HBsAG.
- No febrile illness within 1 week of study.
Concurrent Medication:
Excluded:
- Concomitant corticosteroids or other known immunosuppressive drugs.
- Other experimental agents.
Patients with the following prior conditions are excluded:
- History of clinically significant cardiac, pulmonary, hepatic, renal, neurologic, or autoimmune disease.
Prior Medication:
Excluded:
- Other immunization within 4 weeks prior to study entry.
Identifiable high-risk behavior for HIV infection.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
February 1 1995
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00001020
End Date
February 1 1995
Last Update
May 18 2012
Active Locations (3)
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1
St Louis Univ School of Medicine
St Louis, Missouri, United States, 63104
2
Univ of Pennsylvania at Philadelphia
Philadelphia, Pennsylvania, United States, 19104
3
Children's Hospital & Medical Center / Seattle ACTU
Seattle, Washington, United States, 981050371