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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00001096 |
To assess the safety and immune response to two experimental vaccines when formulated with QS-21 or QS-21 plus alum. To determine whether the new preparation of QS-21 in polysorbate 80 is less reactogenic than the QS-21 formulation used in AVEG Protocols 016, 016A, and 016B. To examine whether QS-21 is immunologically equivalent to that used in 16B. To determine if QS-21, when given with low doses of antigen, induces measurable HIV-1-specific CTL activity. To evaluate if the QS-21 dose-sparing effect extends to an antigen dose of 0.5 micrograms. To determine if the bivalent vaccine gives responses equivalent to the monovalent product or if a broadening of the HIV-1-specific binding and neutralizing antibody responses occurs.
An effective vaccine to prevent HIV-1 infection may need to generate diverse and multifaceted immunologic responses. Required parts of the immune response may include: humoral antibodies, which broadly neutralize non-syncytium-inducing strains of HIV-1; T cell help provided by both CD4 and CD8 positive subsets; and a class I-restricted cytotoxic lymphocyte response. Other effector responses, such as the generation of antibody-dependent cellular cytotoxicity, cytokines, chemokines, or other antiviral factors may also be critical in mounting protective immunity. Given the lack of a surrogate immunologic marker, the most practical approach for possible efficacy trials would be to evaluate a candidate vaccine that elicits as many of these responses as possible.
Condition | Intervention | Phase |
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HIV Infections |
Biological: MN rgp120/HIV-1 and A244 rgp120/HIV-1 Biological: QS-21 Biological: rgp120/HIV-1MN |
Phase I |
Study Type: | Interventional |
Study Design: | Prevention, Double-Blind, Safety Study |
Official Title: | A Phase I, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Immunogenicity of HIV-1 MN rsgp120 and Bivalent AIDSVAX B/E (HIV-1 MN rgp120/A244 rgp120) in Combination With QS-21 With or Without Alum in Healthy HIV-1 Uninfected Adults |
Estimated Enrollment: | 60 |
Study Start Date: | December 1998 |
Primary Completion Date: | March 2000 (Final data collection date for primary outcome measure) |
An effective vaccine to prevent HIV-1 infection may need to generate diverse and multifaceted immunologic responses. Required parts of the immune response may include: humoral antibodies, which broadly neutralize non-syncytium-inducing strains of HIV-1; T cell help provided by both CD4 and CD8 positive subsets; and a class I-restricted cytotoxic lymphocyte response. Other effector responses, such as the generation of antibody-dependent cellular cytotoxicity, cytokines, chemokines, or other antiviral factors may also be critical in mounting protective immunity. Given the lack of a surrogate immunologic marker, the most practical approach for possible efficacy trials would be to evaluate a candidate vaccine that elicits as many of these responses as possible.
Volunteers in each of 5 groups receive vaccine or placebo by intramuscular injection at Months 0, 1, and 6. All patients receive one of two doses of QS-21 along with vaccine or placebo and some groups receive alum as follows:
Group 1: low-dose MN rsgp120/HIV-1 plus QS-21 (13 volunteers). Group 2: high-dose MN rsgp120/HIV-1 plus QS-21 (13 volunteers). Group 3: AIDSVAX B/E (injection contains each of the two vaccine components, HIV-1 MN rgp120 and A244 rgp120/HIV-1) plus QS-21 plus alum (13 volunteers).
Group 4: high-dose MN rgp120/HIV-1 plus QS-21 plus alum (13 volunteers). Group 5: placebo plus QS-21 (8 volunteers). Volunteers will be closely monitored after each immunization and followed for a minimum of 12 months after the initial immunization.
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria
Volunteers must have:
Exclusion Criteria
Co-existing Condition:
Volunteers with the following conditions or symptoms are excluded:
Volunteers with the following prior conditions are excluded:
Prior Medication:
Excluded:
Prior Treatment:
Excluded:
Risk Behavior:
Excluded:
United States, Alabama | |
Univ of Alabama at Birmingham | |
Birmingham, Alabama, United States, 35294 | |
Univ of Alabama at Birmingham / 1917 Rsch Cln | |
Birmingham, Alabama, United States, 35294 | |
United States, Maryland | |
Johns Hopkins Bloomberg School of Public Health | |
Baltimore, Maryland, United States, 21205 | |
Johns Hopkins Univ School / Sch of Hygiene & Pub Hlth | |
Baltimore, Maryland, United States, 212051901 | |
United States, Missouri | |
Saint Louis Univ Health Sciences Ctr | |
Saint Louis, Missouri, United States, 63110 | |
United States, New York | |
Univ of Rochester Med Ctr | |
Rochester, New York, United States, 14642 | |
United States, North Carolina | |
Central Immunology Laboratory / Duke Univ Med Ctr | |
Durham, North Carolina, United States, 27710 | |
United States, Tennessee | |
Vanderbilt Univ / Med Ctr North | |
Nashville, Tennessee, United States, 37232 | |
United States, Washington | |
Univ of Washington / Fred Hutchinson Cancer Research | |
Seattle, Washington, United States, 98104 |
Study Chair: | Tom Evans |
Study ID Numbers: | AVEG 036 |
Study First Received: | November 2, 1999 |
Last Updated: | September 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00001096 |
Health Authority: | United States: Federal Government |
Vaccines, Synthetic HIV Antibodies HIV Antigens HIV-1 Adjuvants, Immunologic AIDS Vaccines |
T-Lymphocytes, Cytotoxic HIV Seronegativity HIV Envelope Protein gp120 Alum Compounds HIV Preventive Vaccine |
Sexually Transmitted Diseases, Viral HIV Antibodies Acquired Immunodeficiency Syndrome Healthy Immunologic Deficiency Syndromes Virus Diseases Antibodies |
Aluminum sulfate HIV Infections Sexually Transmitted Diseases QS 21 Retroviridae Infections Immunoglobulins |
RNA Virus Infections Slow Virus Diseases Immunologic Factors Immune System Diseases Physiological Effects of Drugs |
Adjuvants, Immunologic Lentivirus Infections Infection Pharmacologic Actions |