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| Sponsor: | Chiron Corporation |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002204 |
Purpose
To evaluate the safety and tolerability of the Chiron vaccine human immunodeficiency virus (HIV) p24(25 or 50 micrograms)/MF59 in healthy HIV-1 seronegative adults. To evaluate the immunogenicity of the HIV p24(50 micrograms)/MF59 vaccine.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections HIV Seronegativity |
Biological: HIV p24/MF59 Vaccine |
Phase I |
| Study Type: | Interventional |
| Study Design: | Prevention, Parallel Assignment, Safety Study |
| Official Title: | A Phase I, Observer-Blind, Placebo-Controlled Study of the Chiron Vaccine HIV p24/MF59 Administered to Healthy HIV-Seronegative Adults |
| Estimated Enrollment: | 40 |
This study evaluates the safety and immunogenicity of the Chiron vaccine HIV p24/MF59. In Part A, 15 volunteers are randomly assigned to receive either HIV p24/MF59 or a placebo at 0, 1, and 6 months. 10 volunteers receive the vaccine and 5 volunteers receive the placebo. If no serious adverse events are observed within 1 week after the first injection in these first 15 patients, Part B is initiated. In Part B, 25 volunteers are randomly assigned to receive HIV p24/MF59 or a placebo at 0, 1, and 6 months. 20 volunteers receive the vaccine and 5 volunteers receive the placebo.
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria
Volunteers must have:
Exclusion Criteria
Co-existing Condition:
Volunteers with the following symptoms or conditions are excluded:
Volunteers with the following prior conditions are excluded:
History of anaphylaxis or other serious adverse reactions to vaccines or vaccine components.
1. Immunosuppressive medications.
NOTE:
Engaging in high-risk behavior within 6 months of study entry, i.e.:
Contacts and Locations
More Information
| Study ID Numbers: | 095, V24P1 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002204 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Reference Values Placebos AIDS Vaccines |
HIV Core Protein p24 HIV Seronegativity MF59 oil emulsion |
|
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 |