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Sponsors and Collaborators: |
Marcus Altfeld, M.D., Ph.D. GlaxoSmithKline |
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Information provided by: | Marcus Altfeld, M.D., Ph.D. |
ClinicalTrials.gov Identifier: | NCT00117429 |
This study will test the safety and immunogenicity of the gp120/NefTat/AS02A vaccine candidate in individuals with chronic HIV-1 infection successfully treated with HAART. The rationale for this study is based on previous scientific experiments, including data indicating that this vaccine can elicit strong HIV-1-specific T cell immune responses in humans and monkeys and lead to a retardation of HIV-1 disease progression in animal models of HIV-1 infection.
The HIV vaccine to be administered during this study consists of three recombinant HIV clade B viral antigens: the envelope glycoprotein gp120 and two regulatory proteins, Nef and Tat.The antigens are formulated in a proprietary adjuvant, AS02A, comprised of two immunostimulants in an oil-in-water emulsion (gp120/NefTat/AS02A). The vaccine and the adjuvant are manufactured and provided for the study by GlaxoSmithKline Biologicals, Rixensart, Belgium. The drugs will be given by intramuscular (IM) injection at a standard dose of 20 mg together with 0.5 ml of the AS02A adjuvant.
Twenty HIV-1 infected individuals will be randomly enrolled into three different study groups, receiving either the gp120/NefTat/AS02A vaccine (10 individuals), the AS02A adjuvant alone (5 individuals) or a placebo (5 individuals). After obtaining informed consent, subjects will have a history and physical exam performed and have laboratory tests to confirm they meet all inclusion and exclusion entry criteria. Women of childbearing potential will have a pregnancy test prior to each injection of the investigational product. Injections with vaccine, adjuvant alone, or placebo will then be performed at weeks 0, 4, and 12. Study participants will undergo close monitoring after each vaccination. Blood samples will be obtained for immunological assays at study baseline (2 times) and weeks 2, 4, 6, 12, 14, 24, and 48. All patients will maintain their antiretroviral treatment regimen during the entire study period.
Condition | Intervention | Phase |
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HIV Infections |
Biological: HIV gp120/NefTat/AS02A Vaccine |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase I, Randomized, Double-Blind Clinical Trial of the HIV gp120/NefTat/AS02A Vaccine Candidate in Subjects With Well-Controlled Chronic HIV-1 Infection on Highly Active Antiretroviral Therapy (HAART) |
Estimated Enrollment: | 20 |
Study Start Date: | June 2005 |
DESIGN: This study is a randomized, double blind clinical trial of the gp120/NefTat/AS02A vaccine in individuals with well-controlled chronic HIV-1 infection who have been successfully treated with highly active antiretroviral therapy (HAART). The adjuvanted protein vaccine candidate consists of three recombinant viral antigens: the envelope glycoprotein gp120 and two regulatory proteins, Nef and Tat. The latter are expressed as one recombinant fusion protein, NefTat. The antigens are formulated in the proprietary AS02A adjuvant. The goal of this trial is to assess the safety and immunogenicity of the gp120/NefTat/AS02A vaccine in HIV-1-infected individuals.
DURATION: 48 weeks
SAMPLE SIZE: 20 subjects
POPULATION: Subjects with chronic HIV-1 infection receiving highly active antiretroviral therapy (HAART) with HIV RNA levels <50 copies/mL on at least two measurements in the previous 6 months and a CD4+ T cell count >400 cells/mm3 within 45 days of study entry will be eligible for this study.
REGIMEN: Enrolled patients will be randomized to receive either the vaccine (gp120/NefTat/AS02A) (10 individuals), the AS02A adjuvant only (5 individuals) or a placebo (5 individuals). Injections will be administered IM at weeks 0, 4, and 12.
OBJECTIVES: The two primary objectives of this study are:
ENDPOINTS: The two co-primary study endpoints will be:
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
The study will include subjects who meet all of the following criteria:
Laboratory values within 45 days prior to the first vaccination that meet the following criteria:
Female patient of childbearing potential must:
Agree to use an effective method of birth control during the entire study period. Effective methods of birth control include:
Exclusion Criteria:
Contact: Raj T Gandhi, M. D. | 617-726-3907 | rgandhi@partners.org |
Contact: Theresa Flynn, R. N. | 617-726-3819 | tflynn@partners.org |
United States, Massachusetts | |
Massacusetts General Hospital -Infectious Disease Unit | Recruiting |
Boston, Massachusetts, United States, 02114 | |
Contact: Rajesh T Gandhi, M. D. 617-726-3907 rgandhi@partners.org | |
Contact: Theresa Flynn, R. N. 617-726-3819 tflynn@partners.org |
Principal Investigator: | Marcus Altfeld, MD/PhD | Massachusetts General Hospital |
Principal Investigator: | Mathias Lichterfeld, MD/PhD | Massachusetts Genral Hosptial |
Study ID Numbers: | PARC001, GSK: TH-HIV-007 |
Study First Received: | June 30, 2005 |
Last Updated: | February 1, 2006 |
ClinicalTrials.gov Identifier: | NCT00117429 History of Changes |
Health Authority: | United States: Food and Drug Administration |
HIV-1 therapeutic vaccination cellular immunity humoral immunity |
HAART chronic HIV-1 infection Treatment Experienced HIV Therapeutic Vaccine |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
Communicable Diseases RNA Virus Infections Sexually Transmitted Diseases, Viral Slow Virus Diseases Immune System Diseases Acquired Immunodeficiency Syndrome Infection |
Immunologic Deficiency Syndromes Virus Diseases HIV Infections Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections |