Completed

Phase 1
Age: 18Years - 60Years
All Genders
Healthy Volunteers
ID00001136

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

Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2021-11-01

60

Participants Needed

6

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 60Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

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.
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

Trial Site Locations

Total: 6 locations

1

UAB AVEG

Birmingham, Alabama, United States, 35294

Status Unknown

2

JHU AVEG

Baltimore, Maryland, United States, 21205

Status Unknown

3

St. Louis Univ. School of Medicine AVEG

St Louis, Missouri, United States, 63110

Status Unknown

4

Univ. of Rochester AVEG

Rochester, New York, United States, 14642

Status Unknown

5

Vanderbilt Univ. Hosp. AVEG

Nashville, Tennessee, United States, 37232

Status Unknown

6

UW - Seattle AVEG

Seattle, Washington, United States, 98104

Status Unknown

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

PREVENTION

Number of Arms

0

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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 | DecenTrialz