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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Biocine |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000632 |
To evaluate the safety and immune response of 100 mcg Env 2-3 antigen administered on days 0, 30, 180, and 365.
Preliminary immunologic data from protocol VEU 005B show evidence of the development of functional antibodies in the form of increased peptide binding and development of neutralizing antibodies. Evaluation of an antigen dose having potentially greater immunogenicity is therefore of particular interest.
Condition | Intervention | Phase |
---|---|---|
HIV Infections HIV Seronegativity |
Biological: Env 2-3 |
Phase I |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Safety Study |
Official Title: | A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of 100 Mcg of Env 2-3 in MF59 |
Estimated Enrollment: | 14 |
Preliminary immunologic data from protocol VEU 005B show evidence of the development of functional antibodies in the form of increased peptide binding and development of neutralizing antibodies. Evaluation of an antigen dose having potentially greater immunogenicity is therefore of particular interest.
Twelve healthy volunteers receive injections of 100 mcg Env 2-3 in MF59 emulsion and two volunteers receive MF59 only on days 0, 30, 180, and 365. Follow-up continues for 6 months after the last injection.
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria
Subjects are:
Exclusion Criteria
Co-existing Condition:
Subjects with the following conditions or symptoms are excluded:
Subjects with the following prior conditions are excluded:
Prior Medication:
Excluded:
Prior Treatment:
Excluded:
Identifiable high-risk behavior for HIV infection, including:
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 | |
Children's Hospital & Medical Center / Seattle ACTU | |
Seattle, Washington, United States, 981050371 |
Study Chair: | Dolin R |
Study ID Numbers: | AVEG 005C |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00000632 |
Health Authority: | United States: Federal Government |
Vaccines, Synthetic Drug Evaluation Adjuvants, Immunologic AIDS Vaccines HIV Preventive Vaccine |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
RNA Virus Infections Slow Virus Diseases Immune System Diseases Lentivirus Infections Infection |