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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: | NCT00249106 |
The purpose of this study is to determine the safety and immune response to a investigational DNA Plasmid HIV vaccine, ADVAX e/g + ADVAX p/n-t (ADVAX), at three different dosage levels, in adults who are not infected with HIV.
Condition | Intervention | Phase |
---|---|---|
HIV Infection |
Biological: ADVAX e/g Biological: ADVAX p/n-t (ADVAX) |
Phase I |
Study Type: | Interventional |
Study Design: | Prevention, 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 Clade C DNA Vaccine ADVAX e/g + ADVAX p/n-t (ADVAX) Administered Intramuscularly to HIV-Uninfected, Healthy Volunteers. |
Estimated Enrollment: | 45 |
Study Start Date: | December 2003 |
Estimated Study Completion Date: | October 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 vaccination and will be followed for 18 months after the first vaccination.
15 volunteers will be randomized in a 4:1 ratio of active vaccine to placebo. Safety and tolerability of the ADVAX e/g + ADVAX p/n-t investigational product will be evaluated at least 14 days after the tenth volunteer in the lower dosage group receives the second injection before proceeding to the nextdosage group.
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, New York | |
University of Rochester Medical Center | |
Rochester, New York, United States, 14642 | |
Rockefeller University Hospital | |
New York, New York, United States, 10021 |
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 C001 |
Study First Received: | November 3, 2005 |
Last Updated: | November 9, 2005 |
ClinicalTrials.gov Identifier: | NCT00249106 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Healthy Retroviridae Infections Immunologic Deficiency Syndromes |
Virus Diseases Sexually Transmitted Diseases, Viral RNA Virus Infections Slow Virus Diseases Immune System Diseases HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Lentivirus Infections Infection Retroviridae Infections Immunologic Deficiency Syndromes |