- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00001044
A Phase I, Multicenter, Randomized, Double-Blind, Placebo-Controlled HIV-1 Vaccine Trial to Evaluate the Safety and Immunogenicity of rgp120/HIV-1MN (Genentech) in Combination With QS21 Adjuvant and/or Alum in Healthy Adults.
PRIMARY: To examine the safety and potential improvement in immune responses elicited by combining rsgp120/HIV-1MN with the adjuvant QS-21. SECONDARY: To examine the role of alum in the vaccine/adjuvant formulation; to determine the optimal dose ratio of vaccine to adjuvant; and to obtain initial information on the optimal schedule of administration. AS PER AMENDMENT 07/02/97: To determine the ability of immunization with rsgp120/HV-1MN in combination with QS21 with or without alum to induce an HIV-1 envelope-specific delayed-type hypersensitivity (DTH) response in volunteers who undergo rsgp120/MN skin testing.
Immune responses in HIV-uninfected individuals receiving subunit envelope vaccines formulated with alum adjuvant suggest that functional antibodies capable of neutralizing HIV-1 in vitro may be induced, but the titers are relatively low in comparison to those measured in individuals with natural HIV-1 infection. These limitations might be overcome by the addition or substitution of a more suitable adjuvant such as QS-21.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Immune responses in HIV-uninfected individuals receiving subunit envelope vaccines formulated with alum adjuvant suggest that functional antibodies capable of neutralizing HIV-1 in vitro may be induced, but the titers are relatively low in comparison to those measured in individuals with natural HIV-1 infection. These limitations might be overcome by the addition or substitution of a more suitable adjuvant such as QS-21.
Volunteers are randomized to 20 treatment arms containing four patients each. rsgp120/HIV-1MN is administered at four dose levels: 0, 100, 300, and 600 mcg, and QS-21 adjuvant is administered at three dose levels: 0, 50, and 100 mcg. Some subject cohorts receive alum in the vaccine formulation. Sixty volunteers receive injections at months 0, 1, and 10, and 20 volunteers receive injections at months 0, 1, and 6. AS PER AMENDMENT 07/02/97: All consenting volunteers who have received three immunizations will be tested for DTH response to HIV-1 envelope with use of intradermal MN rsgp120. Follow-up is extended to 56 days after administration of the intradermal injections.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Missouri
-
Saint Louis, Missouri, United States, 63104-1004
- St. Louis Univ. School of Medicine AVEG
-
-
New York
-
Rochester, New York, United States, 14642
- Univ. of Rochester AVEG
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15261
- JHU AVEG
-
-
Washington
-
Seattle, Washington, United States, 98144
- UW - Seattle AVEG
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria
Subjects must have:
- Normal history and physical exam.
- HIV negativity by ELISA within 6 weeks of immunization.
- CD4 count >= 400 cells/mm3.
- Normal urine dipstick with esterase and nitrite.
Exclusion Criteria
Co-existing Condition:
Subjects with the following symptoms or conditions are excluded:
- Hepatitis B surface antigen.
- Medical or psychiatric condition or occupational responsibilities that preclude compliance.
- Active syphilis. NOTE: Subjects with serology documented to be false positive or due to a remote (> 6 months) treated infection are eligible.
- Active tuberculosis. NOTE: Subjects with a positive PPD and normal chest x-ray showing no evidence of TB and not requiring isoniazid therapy are eligible.
Subjects with the following prior conditions are excluded:
- History of immunodeficiency, autoimmune disease, or use of immunosuppressive medications.
- History of anaphylaxis or other serious adverse reactions to vaccines.
- History of allergy to thimerosal.
- AS PER AMENDMENT 07/02/97: History of eczema or allergic-type reactions to rsgp120/HIV-1MN vaccine (for volunteers undergoing DTH testing).
Prior Medication:
Excluded:
- Live attenuated vaccines within 60 days prior to study entry. (NOTE: Medically indicated subunit or killed vaccines, such as influenza or pneumococcal, are allowed but should be given at least 2 weeks prior to HIV immunizations.)
- Experimental agents within 30 days prior to study entry.
- Prior HIV vaccines.
- AS PER AMENDMENT 07/02/97: Use of systemic steroids in the past month (for volunteers undergoing DTH testing).
Prior Treatment:
Excluded:
- Receipt of blood products or immunoglobulin within the past 6 months.
Identifiable high-risk behavior for HIV infection as determined by screening questionnaire, including history of injection drug use within the past year and higher or intermediate risk sexual behavior.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Masking: DOUBLE
Collaborators and Investigators
Publications and helpful links
General Publications
- Evans TG, McElrath MJ, Matthews T, Montefiori D, Weinhold K, Wolff M, Keefer MC, Kallas EG, Corey L, Gorse GJ, Belshe R, Graham BS, Spearman PW, Schwartz D, Mulligan MJ, Goepfert P, Fast P, Berman P, Powell M, Francis D; NIAID AIDS Vaccine Evaluation Group. QS-21 promotes an adjuvant effect allowing for reduced antigen dose during HIV-1 envelope subunit immunization in humans. Vaccine. 2001 Feb 28;19(15-16):2080-91. doi: 10.1016/s0264-410x(00)00415-1.
- Zolla-Pazner S, Alving C, Belshe R, Berman P, Burda S, Chigurupati P, Clements ML, Duliege AM, Excler JL, Hioe C, Kahn J, McElrath MJ, Sharpe S, Sinangil F, Steimer K, Walker MC, Wassef N, Xu S. Neutralization of a clade B primary isolate by sera from human immunodeficiency virus-uninfected recipients of candidate AIDS vaccines. J Infect Dis. 1997 Apr;175(4):764-74. doi: 10.1086/513969.
Study record dates
Study Major Dates
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- HIV Infections
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Immunologic Factors
- Gastrointestinal Agents
- Adjuvants, Immunologic
- Antacids
- Aluminum Hydroxide
Other Study ID Numbers
- AVEG 016
- 10564 (REGISTRY: DAIDS ES Registry Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on HIV Infections
-
University of MinnesotaWithdrawnHIV Infections | HIV/AIDS | Hiv | AIDS | Aids/Hiv Problem | AIDS and InfectionsUnited States
-
University of California, San DiegoUniversity of California, Los Angeles; University of Southern California; California... and other collaboratorsCompleted
-
Gérond'ifRecruiting
-
University of California, DavisCompleted
-
University of California, San DiegoNational Center for Complementary and Integrative Health (NCCIH)CompletedHIV PositiveUnited States
-
University of ChicagoUniversity of Athens; National Development and Research Institutes, Inc.Completed
-
HIV Prevention Trials NetworkNational Institute on Drug Abuse (NIDA); National Institute of Allergy and...CompletedHIV PositiveIndonesia, Ukraine, Vietnam
-
University of ZimbabweCompleted
-
Florida International UniversityCompleted
-
Boston Children's HospitalNational Institute on Minority Health and Health Disparities (NIMHD)Completed
Clinical Trials on Aluminum hydroxide
-
National Institute of Diabetes and Digestive and...National Institute of Allergy and Infectious Diseases (NIAID); Eunice Kennedy... and other collaboratorsCompletedType 1 Diabetes MellitusUnited States, Canada
-
Spero TherapeuticsCompleted
-
National Institute of Allergy and Infectious Diseases...Completed
-
National Institute of Allergy and Infectious Diseases...Completed
-
H. Lundbeck A/SCompletedHealthyUnited Kingdom
-
Shanghai Institute Of Biological ProductsUnknown
-
National Institute of Allergy and Infectious Diseases...Completed
-
MedImmune LLCGlaxoSmithKlineCompleted
-
National Institute of Allergy and Infectious Diseases...Completed
-
National Institute of Allergy and Infectious Diseases...CompletedHIV InfectionsUnited States