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| Sponsor: | Wyeth-Lederle Vaccines |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002232 |
Purpose
The purpose of this study is to see if it is safe to give GENEVAX-HIV, a potential HIV vaccine, to HIV-negative volunteers. The study also compares the effects of GENEVAX-HIV injected into the muscle to the effects of the drug when injected into the skin.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections HIV Seronegativity |
Biological: APL 400-003 |
Phase I |
| Study Type: | Interventional |
| Study Design: | Prevention, Double-Blind, Safety Study |
| Official Title: | GENEVAX-HIV (APL 400-003), a Candidate DNA Vaccine: A Pilot Study of GENEVAX-HIV Given by Intramuscular or Intradermal Administration in HIV Seronegative Volunteers |
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Any medication which may affect immune function with the exception of low doses of nonprescription-strength NSAIDS, aspirin, or acetaminophen for acute conditions such as headache or trauma.
Patients with the following prior conditions are excluded:
Prior Medication:
Excluded:
Cytotoxic chemotherapy that may affect immune function.
Prior Treatment:
Excluded:
Risk Behavior:
Excluded:
Contacts and Locations| United States, District of Columbia | |
| Walter Reed Army Institute of Research | |
| Washington, District of Columbia, United States, 20307 | |
| Study Chair: | Merlin Robb |
More Information
| Study ID Numbers: | 005, 400-003-05 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002232 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Injections, Intradermal Injections, Intramuscular HIV Antibodies Immunity, Cellular AIDS Vaccines |
HIV Seronegativity Dose-Response Relationship, Immunologic Vaccines, DNA Immunity, Mucosal |
|
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 |