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Sponsors and Collaborators: |
International AIDS Vaccine Initiative Aaron Diamond AIDS Research Center University of Rochester |
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Information provided by: | International AIDS Vaccine Initiative |
ClinicalTrials.gov Identifier: | NCT00252148 |
The purpose of this study is to determine the safety of an immune response to an investigational HIV vaccine, ADMVA, at three different dosage levels, in adults who are not infected with HIV
Condition | Intervention | Phase |
---|---|---|
HIV Infection |
Biological: ADMVA |
Phase I |
Study Type: | Interventional |
Study Design: | Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety Study |
Official Title: | A Randomized, Placebo-Controlled, Dose-Escalating, Double-Blinded Phase 1 Study to Evaluate the Safety and Immunogenicity of a Modified Vaccinia Ankara (MVA) Expressing HIV-1 Clade C Env/Gag-Pol and Nef-Tat Fusion Genes (ADMVA) Vaccine Administered Intramuscularly to HIV-Uninfected, Healthy Volunteers |
Estimated Enrollment: | 48 |
Study Start Date: | January 2005 |
Estimated Study Completion Date: | November 2005 |
This is a dose escalation trial. Study site staff and volunteers will be blinded. Blinding will not apply to the assignment of dose levels (low, middle or high).
Volunteers will be screened up to 42 days before enrolment and will be followed for 18 months after the first vaccination.
16 volunteers will be randomized in a 3:1 ratio of active vaccine to placebo. Safety and tolerability of the ADMVA vaccine/placebo will be evaluated at least 14 days after the 12th volunteer in the low dose group receives the second injection before proceeding to the middle dose group.
Ages Eligible for Study: | 18 Years to 40 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Within 6 months before vaccination, the volunteer has:
History of, or known active cardiac disease including:
Have 3 or more of the following risk factors:
United States, New York | |
Rockefeller University Hospital | Recruiting |
New York, New York, United States, 10021 | |
Contact: Elizabeth London 212-327-7260 elondon@adarc.org | |
Principal Investigator: David Ho, MD | |
University of Rochester Medical Center | Recruiting |
Rochester, New York, United States, 14642 | |
Contact: Catherine Bunce Bunce 585-275-5744 Catherine_Bunce@urmc.rochester.edu | |
Principal Investigator: Michael Keefer, MD |
Principal Investigator: | David Ho, MD | ADARC |
Principal Investigator: | Michael Keefer, MD | University of Rochester |
Study Director: | Soe Than, MD | International AIDS Vaccine Initiative |
Study ID Numbers: | IAVI C002 |
Study First Received: | November 9, 2005 |
Last Updated: | December 16, 2005 |
ClinicalTrials.gov Identifier: | NCT00252148 |
Health Authority: | United States: Food and Drug Administration |
HIV Preventive Vaccine |
Virus Diseases Sexually Transmitted Diseases, Viral Vaccinia HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Healthy Retroviridae Infections Immunologic Deficiency Syndromes |
RNA Virus Infections Slow Virus Diseases Immune System Diseases Lentivirus Infections Infection |