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)

May 16, 2012 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

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 rgp120/HIV-1IIIB vaccine (gp120 vaccine) immunization in healthy HIV-1 seronegative adult subjects. To compare the immune response to 100 mcg gp120 vaccine versus 300 mcg gp120 vaccine. To determine whether gp120 vaccine immunization causes a significant immune response as defined by specific parameters (e.g., induction of neutralizing antibodies to the IIIB isolate of HIV-1, gp120 antigen-specific lymphocytic proliferation).

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 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. Subjects are followed for at least 6 months.

ORIGINAL DESIGN: Twenty-eight subjects will be randomized to receive 100 or 300 mcg rgp120/HIV-1IIIB vaccine (gp120 vaccine) or matching placebo. For each dose level, 10 subjects will receive vaccine and four subjects will receive matching placebo. Injections are given intramuscularly at 0, 4, and 32 weeks. Each subject receiving treatment at the lower dose level must be monitored for unacceptable toxicity for at least 2 weeks following the initial immunization before his or her second dose is administered and before treatment at the higher dose level begins. Subjects are followed for at least 12 months.

Study Type

Interventional

Enrollment

28

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • St Louis, Missouri, United States, 63104
        • St Louis Univ School of Medicine
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Univ of Pennsylvania at Philadelphia
    • Washington
      • Seattle, Washington, United States, 981050371
        • Children's Hospital & Medical Center / Seattle ACTU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators

Genentech, Inc.

Investigators

  • Study Chair: Clements M

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Completion (Actual)

February 1, 1995

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

May 18, 2012

Last Update Submitted That Met QC Criteria

May 16, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AVEG 006X
  • VEU 006
  • V0199g
  • 11537 (Registry Identifier: DAIDS ES Registry Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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