A Study of the Effectiveness of an HIV Vaccine (ALVAC vCP205) to Boost Immune Functions in HIV-Negative Volunteers Who Have Already Received an HIV Vaccine

October 28, 2021 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

A Multi-Centered Phase 1 Trial to Evaluate the Memory Responses to a Single Boosting Vaccination With ALVAC-HIV vCP205 in Volunteers Who Have Previously Received Poxvirus-Based Vaccines

The purpose of this study is to see if it is safe to give an HIV vaccine (vCP205) to volunteers who received an HIV vaccine at least 2 years ago, and to study how the immune system responds to this vaccine.

Vaccines are given to people to try to resist infection or prevent disease. There are a number of different HIV vaccines that are currently being tested. The vaccines that seem to be the most promising are canarypox vaccines, known as ALVAC vaccines; the vaccine tested in this study is ALVAC-HIV vCP205. This study will look at the safety of the vaccine and how the immune system responds to it.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Vaccines may provide a route of therapy against HIV-1 infections by boosting the immune system responses. An artificially constructed HIV-1 vaccine (NYCBH), using vaccinia virus as its vector, has the advantage of conferring both cellular and humoral immune responses that are long-lived. Studies have shown that a second artificially constructed vector vaccine, HIV-1 canarypox (vCP205), also increases CD8+ cytotoxic T lymphocyte (CTL) activity, a cell-mediated immune response. Yet, immune responses are not boosted in volunteers previously vaccinated with vaccinia-based HIV-1 vaccines when a second vaccination with the same vaccine is given. One theory for vaccinia vaccine's failure is that immunologic barriers by antibodies to the vector itself may be responsible. This study examines the effectiveness of boosting the immune responses following vCP205 vaccination in the following: 1) volunteers who were previously immunized with vCP205 vaccine who may or may not have shown increased immune responses following the first immunization, and 2) volunteers who were previously immunized with NYCBH vaccine.

Upon study entry volunteers receive one injection of ALVAC-HIV vCP205. Temperature and symptoms should be recorded by the volunteer each day for 2 days and reported to the clinic staff. Volunteers will have seven clinic visits for drawing blood, collecting urine specimens, and performing clinical evaluations. At Month 3 HIV testing will be done. Volunteers will be followed for 3 months, with a passive follow-up call at the end of a year and once or twice a year for the next 5 years. Counseling on avoidance of HIV infection and pregnancy will be done.

Study Type

Interventional

Enrollment (Actual)

60

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
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • JHU AVEG
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • St. Louis Univ. School of Medicine AVEG
    • New York
      • Rochester, New York, United States, 14642
        • Univ. of Rochester AVEG
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt Univ. Hosp. AVEG
    • Washington
      • Seattle, Washington, United States, 98104
        • UW - Seattle 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

You may be eligible for this study if you:

  • Are 18-60 years old.
  • Are willing to use adequate birth control for 1 month before study entry and during the study.
  • Have a CD4 count of at least 400 cells/mm3.
  • Have a normal medical history and physical examination.
  • Are available for 3 months of follow-up.
  • Have participated in AVEG Protocol 014C or 022A and received all the scheduled vaccinations 24 or more months before this study, or have never participated in HIV-vaccine studies.
  • Are HIV-negative within 8 weeks of study entry.
  • Are negative for hepatitis B surface antigen.

Exclusion Criteria

You will not be eligible for this study if you:

  • Are pregnant or breast-feeding.
  • Have a history of an immune system problem, any long-term illness, or any autoimmune disease.
  • Have a history of using medications which affect your immune system.
  • Have a history of cancer, except if it has been removed with surgery and cure is most likely.
  • Have a medical or mental condition which interferes with the study.
  • Have a job or work which interferes with the study.
  • Have ever attempted suicide, thought of attempting suicide, or have a severe mental condition.
  • Have received 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 any history of severe allergic reactions, including reactions to vaccines.
  • Have an allergy to egg products or neomycin.

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

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: Thomas Evans

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)

May 1, 2001

Study Registration Dates

First Submitted

January 25, 2000

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Actual)

November 1, 2021

Last Update Submitted That Met QC Criteria

October 28, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AVEG 038
  • 10586 (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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