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)

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Keywords

ClinConnect Summary

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 studies have shown that the vaccine is capable of eliciting neutralizing antibody activity in both rodents and nonhuman primate species.

AMENDED 11/17/93: Selected subjects from VEU 006 or VEU 006 Rollover study will receive two injections of MN rgp120 vaccine, administered 28 days apart beginning 10-16 months after their last injection. Eight additional clinic visits will be required. Subjec...

Gender

ALL

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.

Trial Officials