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)

June 23, 2005 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

AMENDED 10/1/93: To evaluate the influence of prior immunization with an rgp120 vaccine on immune response to a subsequent immunization with a different strain of rgp120 (VEU 009X extension - in patients previously enrolled on VEU 009).

ORIGINAL DESIGN: To evaluate the clinical and immunologic safety of MN rgp120/HIV-1 vaccine (MN rgp120 vaccine) given alone or concurrently with the IIIB rgp120/HIV-1 vaccine (IIIB rgp120 vaccine) in healthy HIV-1 seronegative adult subjects. To compare the immune response to MN rgp120 vaccine given at 100, 300, or 600 mcg. To determine the immune response to 300 mcg MN rgp120 vaccine and 300 mcg IIIB rgp120 vaccine given concurrently.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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 receive three additional injections on the study extension (VEU 009X), administered at weeks 72, 76, and 104. Patients who received 300 or 600 mcg MN rgp120 vaccine (eight patients per dosage) in the original portion of the study will be randomized to receive either 300 mcg MN rgp120 or 300 mcg IIIB rgp120 vaccine. Eight patients who previously received the MN/IIIB combination will again receive 300 mcg of both vaccines. Additionally, six patients who received placebo in the original portion will receive 300 mcg IIIB rgp120 vaccine. There will be nine clinic visits required for the study extension.

ORIGINAL DESIGN: Fifty-seven adult subjects will be randomized to receive MN rgp120 vaccine at one of three dosages (100, 300, or 600 mcg), or 300 mcg MN rgp120 vaccine given concurrently with 300 mcg IIIB rgp120 vaccine, or placebo. Twelve subjects will be entered onto each of the four vaccine arms, and nine subjects will be entered on the placebo arm. Immunizations (or placebo injections) are given intramuscularly at 0, 4, 24, and 48 weeks. Subjects are followed for 15 months after the first immunization.

Study Type

Interventional

Enrollment

57

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
    • New York
      • Rochester, New York, United States, 14642
        • Univ of Rochester Med Ctr
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt Univ Hosp

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

Yes

Genders Eligible for Study

All

Description

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.

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.

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 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)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

October 1, 2002

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AVEG 009
  • V0385g

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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