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| 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 |
| Estimated Enrollment: | 84 |
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 |
Inclusion Criteria
Participants may be eligible for this study if they:
Exclusion Criteria
Participants may not be eligible for this study if they:
Contacts and 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 | |
| Study Chair: | Tom Evans |
More Information
| 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 |
|
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 |
|
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 |
|
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 |