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Screening Protocol for HIV Vaccine Studies



Screening Protocol for HIV Vaccine Studies

For Condition: HIV Seronegativity,HIV Infections
Status: Recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: 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: - Medical history, including history of sexual activity and drug use - Physical examination - Pregnancy test for women of childbearing age - Blood and urine tests to evaluate possible medical problems such as liver and kidney function; to evaluate immune function; and to test for HIV, hepatitis and syphilis Individuals who are identified through this screening protocol as possible candidates for an HIV vaccine trial will be provided additional information about study options.
Details: 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:
Study Type:  Observational, Screening
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: Age: 18-60 years of age; Good general health without clinically significant medical history, physical examination findings, or clinically significant abnormal laboratory results. A clinically significant condition or process includes: 1. a condition that is chronic or recurring and is life threatening; 2. a process that would affect the immune response, such as an autoimmune disease or HIV infection; 3. a process that would require medication that affects the immune response; 4. a condition for which repeated injections or blood draws may pose additional risk to the participant; 5. a condition that requires active medical intervention or monitoring to avert grave danger to the participant's health or well-being; or 6. a condition or process in which signs or symptoms could be confused with reactions to vaccine; Willingness for follow-up for planned duration of the study (6 months or longer). Able and willing to give informed consent. Agree to have blood stored for future tests. EXCLUSION CRITERIA: Known to be HIV-1 positive (seropositive). Women who are known to be pregnant and/or breast feeding.
Total Enrollment: 1000

Location and Contact Information:

National Institute of Allergy and Infectious Diseases (NIAID) *Recruiting*
Bethesda,  Maryland,  20892
United States
Recruiting Patient  and Public Liaison Office 1-800-411-1222


Additional Information:
Study ID Numbers:  020127;  02-I-0127
Study Start Date: February 27, 2002
Record last reviewed: January 30, 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00031304

Other Hiv Seronegativity Studies:
1. HIV Prevention Preparedness Study

2. HIV Incidence and Participation Retention in Pune, India

3. Safety and Effects of Giving a New HIV Vaccine (GENEVAX-HIV) to HIV-Negative Volunteers

4. An Investigational Combination Vaccine Given to People Who Are Not Infected with HIV

5. HIV Candidate Vaccine, ALVAC-HIV-1, Administration in HIV-Negative Adults

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