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An Investigational Combination Vaccine Given to People Who Are Not Infected With HIV
This study is ongoing, but not recruiting participants.
First Received: December 4, 2001   Last Updated: August 19, 2008   History of Changes
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00027365
  Purpose

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 Intervention Phase
HIV Infections
Biological: Combination Vaccine (NefTat and gp120W61D) Formulated with AS02A
Biological: NefTat
Drug: AS02A Adjuvant
Biological: gp120W61D
Phase I

Study Type: Interventional
Study Design: Prevention, Double-Blind, Safety Study
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

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 84
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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00027365

Locations
United States, Alabama
Univ of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, California
San Francisco Dept of Hlth / AIDS Office
San Francisco, California, United States, 94102
Mt Zion Hospital
San Francisco, California, United States, 94102
United States, District of Columbia
Johns Hopkins Bloomberg School of Public Health
Washington, District of Columbia, United States, 20037
United States, Maryland
Johns Hopkins Bloomberg School of Public Health
Baltimore, Maryland, United States, 21205
Univ of Maryland Institute of Human Virology
Baltimore, Maryland, United States, 212011192
JHU-CIR/DC
Baltimore, Maryland, United States, 21205
United States, Massachusetts
Harvard University / Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Harvard University/Brown University
Boston, Massachusetts, United States, 02115
Fenway Community Health
Boston, Massachusetts, United States, 02115
United States, Missouri
Saint Louis University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, New York
Columbia Univ
New York, New York, United States, 10032
Univ of Rochester Med Ctr
Rochester, New York, United States, 14642
New York Blood Ctr
Bronx, New York, United States, 10456
New York Blood Center
New York, New York, United States, 10021
United States, Rhode Island
Miriam Hosp
Providence, Rhode Island, United States, 02906
United States, Tennessee
Vanderbilt Univ Hosp
Nashville, Tennessee, United States, 37232
Vanderbilt Univ / Med Ctr North
Nashville, Tennessee, United States, 37232
United States, Virginia
Univ of Marlyand / Infectious Diseases Physicians
Fairfax, Virginia, United States
United States, Washington
Fred Hutchinson Cancer Research Ctr
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Investigators
Study Chair: Tom Evans
  More Information

Additional Information:
No publications provided

Study ID Numbers: HVTN 041
Study First Received: December 4, 2001
Last Updated: August 19, 2008
ClinicalTrials.gov Identifier: NCT00027365     History of Changes
Health Authority: United States: Food and Drug Administration

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

Study placed in the following topic categories:
Virus Diseases
Antibodies
Sexually Transmitted Diseases, Viral
HIV Antibodies
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Adjuvants, Immunologic
Retroviridae Infections
Immunologic Deficiency Syndromes
Immunoglobulins

Additional relevant MeSH terms:
Virus Diseases
Sexually Transmitted Diseases, Viral
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Infection
Retroviridae Infections
Immunologic Deficiency Syndromes

ClinicalTrials.gov processed this record on July 02, 2009