A Randomized, Placebo-Controlled, Double-Blinded Phase I Safety and Immunogenicity Trial of Recombinant Envelope Protein, HIV-1 SF-2 rgp120 (BIOCINE), Combined With MF59 in HIV-1 Uninfected Adult Volunteers

October 27, 2021 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

To determine the safety and immunogenicity of rgp120/HIV-1SF2 combined with MF59 adjuvant emulsion versus MF59 alone in HIV-negative volunteers.

One approach to improve the immunogenicity of an HIV-1 subunit protein vaccine is to combine the immunogen with an adjuvant.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

One approach to improve the immunogenicity of an HIV-1 subunit protein vaccine is to combine the immunogen with an adjuvant.

Healthy volunteers receive intramuscular injections of rgp120/HIV-1SF2 with MF59 adjuvant emulsion or MF59 alone at months 0, 1, 6, 9, 10 and 12 (was months 0, 1, 6 and 10, amended 12/19/96).

Study Type

Interventional

Enrollment (Actual)

30

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
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • UAB AVEG
    • Missouri
      • Saint Louis, Missouri, United States, 63104
        • St. Louis Univ. School of Medicine AVEG
    • New York
      • Rochester, New York, United States, 14642
        • Univ. of Rochester AVEG
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States
        • JHU AVEG

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

Volunteers must have:

  • Normal history and physical exam.
  • HIV negativity.
  • Absolute CD4 count >= 400 cells/mm3.
  • Normal urine dipstick with esterase and nitrite.
  • Lower risk sexual behavior.

Exclusion Criteria

Co-existing Condition:

Subjects with the following symptoms or conditions are excluded:

  • Positive hepatitis B surface antigen.
  • Medical or psychiatric condition (such as recent suicidal ideation or present psychosis) that precludes compliance.
  • Active syphilis. NOTE: Subjects with serology documented to be a false positive or due to a remote (> 6 months) treated infection are eligible.
  • Active tuberculosis. NOTE: Subjects with a positive PPD and a normal chest x-ray showing no evidence of TB and not requiring isoniazid therapy are eligible.

Subjects with the following prior conditions are excluded:

  • History of immunodeficiency, chronic illness, autoimmune disease, or use of immunosuppressive medications.
  • History of anaphylaxis or other serious adverse reactions to vaccines.
  • History of serious allergic reaction to any substance, requiring hospitalization or emergent medical care (e.g., Stevens-Johnson syndrome, bronchospasm, or hypotension).
  • Prior psychiatric condition (such as history of suicide attempts or past psychosis) that precludes compliance.
  • History of cancer unless there has been surgical excision that is considered to have achieved cure.

Prior Medication:

Excluded:

  • Live attenuated vaccines within 60 days prior to study entry. NOTE: Medically indicated killed or subunit vaccines (e.g., influenza, pneumococcal) do not exclude if administered at least 2 weeks from HIV immunizations.
  • Experimental agents within 30 days prior to study entry.
  • Prior HIV vaccines.

Prior Treatment:

Excluded:

  • Blood products or immunoglobulin within the past 6 months.

Identifiable high-risk behavior for HIV infection, including:

  • History of injection drug use within past 12 months.
  • Higher risk sexual behavior.

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)

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)

January 1, 1998

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 (Actual)

November 4, 2021

Last Update Submitted That Met QC Criteria

October 27, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AVEG 024
  • 10575 (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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