A Phase I Multicenter Study of the Safety and Immunogenicity of MN rgp120/HIV-1 Vaccine Given Either Alone or in Combination With IIIB rgp120/HIV-1 Vaccine in Healthy Adult Subjects (NOTE: Original Study Extended ONLY for Patients Previously Enrolled on VEU 009)

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

Keywords

ClinConnect Summary

Recent studies suggest that immunity to the HIV-1 rgp120 protein may prevent primary infection. MN rgp120 vaccine and IIIB rgp120 vaccine are both prepared by recombinant DNA technology. Because the two vaccines are derived from distinct HIV-1 strains, they may elicit some immunologic responses that differ. Unlike IIIB rgp120 vaccine, the MN rgp120 vaccine has not yet been evaluated in humans, although it is expected that the MN type will result in similar safety and immunogenicity as the IIIB type.

AMENDED 10/1/93: Selected patients on VEU 009 who received four previous injections will re...

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• Patients must have:
• • Documented HIV seronegativity.
• • Negative HIV-1 culture.
• • Normal history and physical exam.
• • No high-risk behavior for HIV infection.
• • Exclusion Criteria
• Co-existing Condition:
• Patients with the following symptoms or conditions are excluded:
• • Clinically significant cardiac, pulmonary, neoplastic, hepatic, renal, neurologic, or autoimmune disease.
• • Serologic evidence of current Hepatitis B or C infection.
• • Positive PPD (unless subject has a clear chest x-ray with no suggestion of active or old pulmonary tuberculosis and is not eligible for tuberculosis prophylaxis.
• • Positive HBsAb (unless positive result is caused by hepatitis vaccination OR infection occurred more than 2 years ago and subjects are HBsAg, HBeAg, and HBcAb negative with no elevation of liver enzymes within the past 2 years).
• • Positive VDRL.
• • Febrile illness within 1 week prior to study entry.
• Concurrent Medication:
• Excluded:
• • Concomitant corticosteroids or other known immunosuppressive drugs.
• • Any experimental agent.
• • Any anti-tuberculosis medication (e.g., isoniazid).
• Patients with the following prior conditions are excluded:
• • History of clinically significant cardiac, pulmonary, neoplastic, hepatic, renal, neurologic, or autoimmune disease.
• • Recent (within past 2 years) evidence of Hepatitis B infection.
• • Past serologic evidence of Hepatitis C infection.
• • Prior history of receiving HIV vaccine.
• Prior Medication:
• Excluded:
• • Other immunization within 4 weeks prior to study entry.
• • Identifiable high-risk behavior for HIV infection.

Trial Officials