Safety and Immune Response Study of the Vaccine ALVAC vCP1452 Alone or in Combination With AIDSVAX B/B

October 13, 2021 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

A Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of a Combined Regimen Using ALVAC vCP1452 and AIDSVAX B/B

The purpose of this study is to see if the vaccines tested are safe when given alone and when given together, and how the immune system responds to the vaccines.

Vaccines are given to people to try to prevent an infection or disease. Early testing in a few people has shown that the HIV vaccines ALVAC vCP1452 and AIDSVAX B/B seem to be safe to use.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

There is no cure for HIV infection or AIDS, and drug therapy is too expensive for most affected populations. For this reason, the development of safe, effective vaccines to prevent HIV infections worldwide is needed. ALVAC vCP1452 and MN rgp120/HIV-1 have been shown to be well tolerated in Phase I and II studies. ALVAC vCP1452 given alone or in combination with subunit antigens [AS PER AMENDMENT 10/12/00: antigen] is a candidate vaccine to be evaluated for the ability to produce and express vaccine antigen in greater quantity for a longer time and with improved immunogenicity.

Volunteers are randomized to 1 of 7 [AS PER AMENDMENT 10/12/00: 1 of 4] groups and stratified by risk status. Prior to immunization, evaluations and blood draws are done to monitor hematological, chemical, and immunologic parameters. Volunteers receive 2 injections of the following vaccines at Months 0, 1, 3, and 6:

Group A: ALVAC vCP1452 and alum placebo [AS PER AMENDMENT 10/12/00: AIDSVAX placebo (aluminum hydroxide adjuvant)] at Months 0, 1, 3, and 6.

Group B: ALVAC vCP1452 and alum placebo [AS PER AMENDMENT 10/12/00: AIDSVAX placebo] at Months 0 and 1 and ALVAC vCP1452 and AIDSVAX B/B at Months 3 and 6.

Group C: ALVAC placebo and alum placebo. [AS PER AMENDMENT 10/12/00: ALVAC vCP1452 and AIDSVAX B/B at Months 0, 1, and 6 and ALVAC vCP1452 and AIDSVAX placebo at Month 3.] Group D: ALVAC vCP1452 and alum placebo at Months 0 and 1 and ALVAC vCP1452 and MN rgp120 at Months 3 and 6. [AS PER AMENDMENT 10/12/00: ALVAC placebo and AIDSVAX placebo at Months 0, 1, 3, and 6.] Group E: ALVAC vCP1452 and AIDSVAX B/B at Months 0, 1, and 6; ALVAC vCP1452 and alum placebo at Month 3. [AS PER AMENDMENT 10/12/00: Group E has been discontinued.] Group F: ALVAC vCP1452 and AIDSVAX B/B. [AS PER AMENDMENT 10/12/00: Group F has been discontinued.] Group G: ALVAC vCP1452 and alum placebo at Months 0 and 1; ALVAC vCP1452 and AIDSVAX B/E at Months 3 and 6. [AS PER AMENDMENT 10/12/00: Group G has been discontinued.] Following each pair of injections, volunteers are observed in the clinic for 30 minutes. Volunteers keep a record of body temperature and any other symptoms and report results to their AIDS Vaccine Evaluation Unit. Evaluations are performed by telephone or clinic visit on Days 1 and 2 after each vaccination. [AS PER AMENDMENT 10/12/00: Volunteers record all relevant signs and symptoms occurring 48 hours after each vaccination and provide that information at each clinic visit.] HIV testing is conducted every 3 to 6 months and volunteers are asked to complete social harms questionnaires once at Day 168 and once at the end of the study. Volunteers are followed on the study for a minimum of 18 months after the first immunization. Safety is evaluated by closely monitoring for local and systemic adverse reactions during the course of the trial.

Study Type

Interventional

Enrollment

330

Phase

  • Phase 2

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
        • Alabama Vaccine CRS
    • California
      • San Francisco, California, United States
        • San Francisco Vaccine and Prevention CRS
      • San Francisco, California, United States, 94102
        • San Francisco Dept. of Public Health, San Francisco Gen. Hosp.
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Project Brave HIV Vaccine CRS
      • Baltimore, Maryland, United States
        • Johns Hopkins Bloomberg School of Public Health,Ctr for Immunization Research,Project SAVE-Baltimore
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins Bloomberg School of Public Health, Ctr. for Immunization Research, Project SAVE-DC
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hosp. CRS
      • Boston, Massachusetts, United States, 02215
        • Fenway Community Health Clinical Research Site (FCHCRS)
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Saint Louis Univ. School of Medicine, HVTU
    • New York
      • Bronx, New York, United States, 10456
        • NY Blood Ctr./Bronx CRS
      • New York, New York, United States, 10032
        • HIV Prevention & Treatment CRS
      • New York, New York, United States
        • NY Blood Ctr./Union Square CRS
      • Rochester, New York, United States, 14642
        • Univ. of Rochester HVTN CRS
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • Miriam Hospital's HVTU
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt Vaccine CRS
    • Virginia
      • Annandale, Virginia, United States, 22003
        • Infectious Diseases Physicians, Inc.
    • Washington
      • Seattle, Washington, United States, 98104
        • FHCRC/UW Vaccine CRS

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 may be eligible for this study if they:

  • Are HIV-negative.
  • Are 18 to 60 years old.
  • Have a CD4 cell count of 400 cells/mm3 or more.
  • Agree to use adequate birth control for 1 month before study entry and during the study (female participants).
  • Have a normal history and physical examination.
  • Are available for 12 months of follow-up for the planned duration of the study.
  • Have a negative pregnancy test within 3 days prior to injections.

Exclusion Criteria

Volunteers will not be eligible for this study if they:

  • Are pregnant or breast-feeding.
  • Have chronic hepatitis B.
  • Are taking medications that affect the immune system.
  • Have an immune system problem, any long-term illness, or any autoimmune disease.
  • Have cancer, except if it has been removed with surgery and cure is likely.
  • Have a physical condition, mental condition, or job or work that may interfere with the study.
  • Have been suicidal, or have ever needed medicines for a serious mental condition.
  • Have received certain vaccines within 60 days of study entry.
  • Have used experimental drugs within 30 days prior to study entry.
  • Have received any blood products, such as immunoglobulin, in the last 6 months.
  • Have active syphilis.
  • Have active tuberculosis.
  • Have history of severe allergy or any serious reactions to vaccines.
  • Have had HIV-1 vaccines in a clinical study.

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)

Investigators

  • Study Chair: Barney Graham

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)

April 1, 2003

Study Registration Dates

First Submitted

December 16, 2000

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Actual)

October 15, 2021

Last Update Submitted That Met QC Criteria

October 13, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HVTN 203
  • AVEG 203
  • 10596 (Other Identifier: CTEP)

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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