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| Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT00031304 |
Purpose
Healthy volunteers will be screened under this protocol for possible participation in a study testing a vaccine against HIV, the virus that causes AIDS.
Healthy adults 18 to 60 years of age may be eligible for this study. Participants must be in good general health with no history of significant medical problems or abnormal laboratory test results. Pregnant or breast-feeding women and people infected with HIV will not be enrolled.
Participants enrolled in this protocol will undergo the following tests and procedures within 8 weeks before the start of the experimental vaccine study:
Individuals who are identified through this screening protocol as possible candidates for an HIV vaccine trial will be provided additional information about study options.
| Condition |
|---|
|
HIV Seronegativity HIV Infections |
| Study Type: | Observational |
| Official Title: | Screening Subjects for HIV Vaccine Research Studies |
| Estimated Enrollment: | 1000 |
| Study Start Date: | February 2002 |
The purpose of this study is to screen subjects to determine if they are suitable candidates for Phase I HIV vaccine trials. All work will be conducted at the National Institutes of Health.
Healthy, HIV-negative subjects will be recruited and screened. The results of this study will be used to determine if the subject meets all of the eligibility requirements for participation in Phase I HIV trials of preventative vaccines. Educational materials on vaccines will be reviewed with and provided to subjects before enrollment into the study.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Age: 18-60 years of age.
Available to participate for the planned duration of the investigational vaccine study for which the screening is being done (vaccine studies may require 6 months to 18 months of clinic visits).
Able and willing to complete the informed consent process.
Agree to have blood stored for future studies of the vaccine, the immune system, and/or other medical conditions.
EXCLUSION CRITERIA:
Known to be HIV-1 positive (seropositive).
Women who are known to be pregnant and/or breast feeding.
A condition in which repeated blood draws or injections pose more than minimal risk for the subject such as hemophilia, other severe coagulation disorders or significantly impaired venous access.
A condition that requires active medical intervention or monitoring to avert serious danger to the participant's health or well-being.
A condition in which signs or symptoms could be confused with reactions to vaccine.
Contacts and Locations| Contact: Patient Recruitment and Public Liaison Office | (800) 411-1222 | prpl@mail.cc.nih.gov |
| Contact: TTY | 1-866-411-1010 |
| United States, Maryland | |
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
| Bethesda, Maryland, United States, 20892 | |
More Information
| Study ID Numbers: | 020127, 02-I-0127 |
| Study First Received: | February 28, 2002 |
| Last Updated: | December 6, 2008 |
| ClinicalTrials.gov Identifier: | NCT00031304 |
| Health Authority: | United States: Federal Government |
|
HIV AIDS Vaccine Screening Prevention HIV |
Vaccine HV Healthy Volunteer Volunteer HIV Seronegativity HIV Preventive Vaccine |
|
Virus Diseases Sexually Transmitted Diseases, Viral 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 |
