Status:

COMPLETED

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

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Conditions:

HIV Infections

HIV Seronegativity

Eligibility:

All Genders

18-60 years

Phase:

PHASE1

Brief Summary

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 va...

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...

Eligibility Criteria

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.

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

May 1 2001

Estimated Enrollment :

60 Patients enrolled

Trial Details

Trial ID

NCT00001136

End Date

May 1 2001

Last Update

November 1 2021

Active Locations (6)

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Page 1 of 2 (6 locations)

1

UAB AVEG

Birmingham, Alabama, United States, 35294

2

JHU AVEG

Baltimore, Maryland, United States, 21205

3

St. Louis Univ. School of Medicine AVEG

St Louis, Missouri, United States, 63110

4

Univ. of Rochester AVEG

Rochester, New York, United States, 14642