Completed
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
Eligibility Criteria
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.
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
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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