An Investigational Combination Vaccine Given to People Who Are Not Infected With HIV

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
HIV Infections	Biological: Combination Vaccine (NefTat and gp120W61D) Formulated with AS02A; Biological: NefTat; Drug: AS02A Adjuvant; Biological: gp120W61D	Phase 1

Detailed Description:

Despite recent advances in the treatment and prevention of HIV disease, the epidemic is worsening throughout most of the world. HIV/AIDS is the leading cause of death in sub-Saharan Africa and the leading infectious cause of death in the world. An effective and inexpensive vaccine to prevent HIV disease remains as the best option to try to deal with this expanding epidemic. A number of vaccine products have been tested; however, only 2 have progressed to a Phase III trial, underscoring the need for new vaccine strategies.

Prior to study entry, participants have their risk status for HIV infection determined by a series of questions. Further eligibility is determined by results of physical exam, laboratory tests, and further questions. Blood is drawn on each study visit. Participants are assigned randomly to 1 of 4 study groups:

Group I: NefTat or placebo. Groups II, III, and IV: NefTat and gp120 or placebo. Each group receives a different concentration of gp120.

All immunizations are admixed with AS02A adjuvant. Vaccinations are administered intramuscularly at 3 time points (entry, 1 month, and 3 months). Product safety and immunogenicity are performed at designated time points; participants have about 11 clinic visits.

Study Design

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Study Type :	Interventional (Clinical Trial)
Enrollment :	84 participants
Masking:	Double
Primary Purpose:	Prevention
Official Title:	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
Actual Study Completion Date :	June 2003

Arms and Interventions

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Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 60 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria

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.

Exclusion Criteria

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.
• Have seizures.
• Have a bleeding disorder.
• Have had their spleen removed.
• Have angioedema (a certain type of body tissue swelling).
• Have active syphilis.
• Have high blood pressure (unless controlled by medication).
• Have mental or emotional problems that make them unsuitable for the study.
• Have any medical, mental, or social condition; job responsibilities; or other responsibility that, in the opinion of the doctor, would interfere with the study.
• Have reactions to components of the vaccines.
• Are at high risk for contracting HIV.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Alabama
Alabama Vaccine CRS
Birmingham, Alabama, United States, 35294
United States, California
San Francisco Vaccine and Prevention CRS
San Francisco, California, United States, 94102
United States, Maryland
Johns Hopkins Bloomberg School of Public Health,Ctr for Immunization Research, Project SAVE-Baltimore
Baltimore, Maryland, United States, 21205
Project Brave HIV Vaccine CRS
Baltimore, Maryland, United States
United States, Massachusetts
Brigham and Women's Hosp. CRS
Boston, Massachusetts, United States, 02115
Fenway Community Health Clinical Research Site (FCHCRS)
Boston, Massachusetts, United States, 02115
United States, Missouri
Saint Louis Univ. School of Medicine, HVTU
Saint Louis, Missouri, United States, 63110
United States, New York
NY Blood Ctr./Bronx CRS
Bronx, New York, United States, 10456
NY Blood Ctr./Union Square CRS
New York, New York, United States, 10021
HIV Prevention & Treatment CRS
New York, New York, United States
Univ. of Rochester HVTN CRS
Rochester, New York, United States, 14642
United States, Rhode Island
Miriam Hospital's HVTU
Providence, Rhode Island, United States, 02906
United States, Tennessee
Vanderbilt Vaccine CRS
Nashville, Tennessee, United States, 37232
United States, Virginia
Infectious Diseases Physicians, Inc.
Annandale, Virginia, United States
United States, Washington
FHCRC/UW Vaccine CRS
Seattle, Washington, United States

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

Study Chair:	Tom Evans

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

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.

Responsible Party:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00027365 History of Changes
Other Study ID Numbers:	HVTN 041; 10196 ( Registry Identifier: DAIDS ES Registry Number )
First Posted:	December 5, 2001
Last Update Posted:	May 4, 2012
Last Verified:	May 2012

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):

HIV Seronegativity; HIV Preventive Vaccine; Injections, Intramuscular; HIV Antibodies; HIV-1; HIV Envelope Protein gp120	Gene Products, tat; AIDS Vaccines; Neutralization Tests; Vaccines, Combined; AIDS Seronegativity; Gene Products, nef

Additional relevant MeSH terms:

HIV Infections; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Sexually Transmitted Diseases, Viral	Sexually Transmitted Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Vaccines; Immunologic Factors; Physiological Effects of Drugs