An Investigational Combination Vaccine Given to People Who Are Not Infected With HIV
A Phase I Safety and Immunogenicity Trial of a Combination Vaccine (NefTat and gp120w61d) Formulated With AS02A (GlaxoSmithKline Biologicals) Given Intramuscularly in HIV-1 Uninfected Adult Participants
2 other identifiers
interventional
84
1 country
15
Brief Summary
The purpose of this study is to see if the investigational vaccines NefTat and gp120w61d are safe and tolerable in humans and to see how the immune system responds to the vaccines. There have been advances in the treatment and prevention of HIV, but the spread of HIV/AIDS is getting worse. HIV/AIDS is the main infectious cause of death in the world. A vaccine to prevent HIV disease is the best way to try to deal with this situation. Several vaccine products have been tested, but only 2 are still in trial. There is a need for a new product.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 hiv-infections
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 4, 2001
CompletedFirst Posted
Study publicly available on registry
December 5, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2003
CompletedOctober 14, 2021
October 1, 2021
December 4, 2001
October 13, 2021
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Participants may be eligible for this study if they:
- Are between 18 and 60 years of age.
- Are in good general health and meet laboratory test requirements.
- Have a CD4 count of 400 or more cells/mm3.
- Agree to use at least 1 of the following methods of contraception for at least 21 days before enrollment until the last protocol visit: condoms (male or female) with or without a spermicide, diaphragm or cervical cap with spermicide, IUD, or hormonal-based therapy (applies to women who are able to have children).
- Have access to a participating site and are willing to have follow-up for the entire study (12 months).
- Answer questions about their understanding of the study.
- Do not have hepatitis B or C.
- Are HIV-uninfected.
You may not qualify if:
- Participants may not be eligible for this study if they:
- Are pregnant or breast-feeding.
- Have recently received a vaccine.
- Have used experimental agents within 30 days before enrollment.
- Have received HIV vaccines or placebo in a previous HIV vaccine study.
- Have received blood products 120 days before HIV screening.
- Have received immunoglobulin (antibodies) 60 days before HIV screening.
- Have serious reactions to vaccines.
- Have problems with their immune system.
- Have cancer.
- Have used drugs that affect the immune system within the past 6 months.
- Have diabetes.
- Have a thyroid disease.
- Have unstable asthma.
- Are taking anti-tuberculosis drugs.
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Alabama Vaccine CRS
Birmingham, Alabama, 35294, United States
San Francisco Vaccine and Prevention CRS
San Francisco, California, 94102, United States
Johns Hopkins Bloomberg School of Public Health,Ctr for Immunization Research, Project SAVE-Baltimore
Baltimore, Maryland, 21205, United States
Project Brave HIV Vaccine CRS
Baltimore, Maryland, United States
Brigham and Women's Hosp. CRS
Boston, Massachusetts, 02115, United States
Fenway Community Health Clinical Research Site (FCHCRS)
Boston, Massachusetts, 02115, United States
Saint Louis Univ. School of Medicine, HVTU
St Louis, Missouri, 63110, United States
NY Blood Ctr./Union Square CRS
New York, New York, 10021, United States
HIV Prevention & Treatment CRS
New York, New York, United States
Univ. of Rochester HVTN CRS
Rochester, New York, 14642, United States
NY Blood Ctr./Bronx CRS
The Bronx, New York, 10456, United States
Miriam Hospital's HVTU
Providence, Rhode Island, 02906, United States
Vanderbilt Vaccine CRS
Nashville, Tennessee, 37232, United States
Infectious Diseases Physicians, Inc.
Annandale, Virginia, United States
FHCRC/UW Vaccine CRS
Seattle, Washington, United States
Related Publications (1)
Vaine M, Wang S, Liu Q, Arthos J, Montefiori D, Goepfert P, McElrath MJ, Lu S. Profiles of human serum antibody responses elicited by three leading HIV vaccines focusing on the induction of Env-specific antibodies. PLoS One. 2010 Nov 9;5(11):e13916. doi: 10.1371/journal.pone.0013916.
PMID: 21085486RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Tom Evans
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Masking
- DOUBLE
- Purpose
- PREVENTION
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 4, 2001
First Posted
December 5, 2001
Study Completion
June 1, 2003
Last Updated
October 14, 2021
Record last verified: 2021-10