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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: | NCT00001052 |
To extend the evaluation of safety and immunogenicity of MN recombinant soluble gp120/HIV-1 (MN rsgp120/HIV-1) in combination with QS21 with or without alum and on two different vaccination schedules.
Recent animal studies indicate that immunizing with MN rsgp120/HIV-1 in combination with QS21 on a 0, 1, 2 month schedule results in a more rapid rise in binding and neutralizing antibody response than on a 0, 1, 6 month schedule. Such an effect may be particularly desirable in vaccine delivery. This study compares these two delivery schedules using the unadjuvanted vaccine formulation rsgp120/HIV-1 with or without addition of alum.
Condition | Intervention | Phase |
---|---|---|
HIV Infections |
Biological: Aluminum hydroxide 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 HIV-1 Vaccine Trial to Evaluate the Safety and Immunogenicity of MN Recombinant Soluble gp120/HIV-1 (rsgp120/HIV-1) (Genentech) in Combination With QS21 Adjuvant and/or Alum in Healthy Adults |
Estimated Enrollment: | 110 |
Recent animal studies indicate that immunizing with MN rsgp120/HIV-1 in combination with QS21 on a 0, 1, 2 month schedule results in a more rapid rise in binding and neutralizing antibody response than on a 0, 1, 6 month schedule. Such an effect may be particularly desirable in vaccine delivery. This study compares these two delivery schedules using the unadjuvanted vaccine formulation rsgp120/HIV-1 with or without addition of alum.
Healthy volunteers (20 per group) receive MN rsgp120/HIV-1 (300 or 0 mcg) in combination with QS21 (100 mcg), either with or without alum, at 0, 1, and 2 months or 0, 1, and 6 months. For both vaccination schedules, an additional five volunteers receive only vehicle with alum. The 0 mcg antigen groups are included primarily as negative controls. Subjects may be contacted for follow-up on health status once or twice yearly for at least 5 years.
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria
Subjects must have:
Exclusion Criteria
Co-existing Condition:
Subjects with the following symptoms or conditions are excluded:
Subjects with the following prior conditions are excluded:
Prior Medication:
Excluded:
Prior Treatment:
Excluded:
Risk Behavior:
United States, Maryland | |
Johns Hopkins Univ / School of Hygiene & Public Health | |
Baltimore, Maryland, United States, 212051901 | |
United States, Missouri | |
St Louis Univ School of Medicine | |
St. Louis, Missouri, United States, 63104 | |
United States, New York | |
Univ of Rochester Med Ctr | |
Rochester, New York, United States, 14642 | |
United States, Tennessee | |
Vanderbilt Univ Hosp | |
Nashville, Tennessee, United States, 37232 | |
United States, Washington | |
Univ of Washington / Pacific Med Ctr | |
Seattle, Washington, United States, 98144 |
Study Chair: | McElrath J |
Study ID Numbers: | AVEG 016A |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00001052 |
Health Authority: | United States: Federal Government |
Vaccines, Synthetic Drug Therapy, Combination Adjuvants, Immunologic HIV Envelope Protein gp120 |
AIDS Vaccines HIV Seronegativity HIV Preventive Vaccine |
Virus Diseases Sexually Transmitted Diseases, Viral Aluminum sulfate HIV Infections Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome |
Healthy QS 21 Retroviridae Infections Immunologic Deficiency Syndromes Aluminum Hydroxide |
RNA Virus Infections Slow Virus Diseases Immunologic Factors Molecular Mechanisms of Pharmacological Action Immune System Diseases Physiological Effects of Drugs |
Adjuvants, Immunologic Lentivirus Infections Antacids Infection Pharmacologic Actions |