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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Page 1 of 1 (3 locations)

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