Screening Protocol for HIV Vaccine Studies
Condition: HIV Seronegativity; HIV Infections
MeSH terms: HIV Infections
Study type: Observational

Summary: 
      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.
    

Detailed description: 
      Study Design: The purpose of this study is to screen subjects to determine if they are
      suitable candidates for HIV vaccine trials.

      Healthy, HIV-negative subjects will be recruited and screened. The results of this study will
      be used to determine if the subject meets eligibility requirements for participation in H1V
      vaccine trials. Educational materials on vaccines will be reviewed with and provided to
      subjects before enrollment into the study.

      Subjects: Healthy adults

      Number of Subjects: Approximately 3,000

      Outline of Protocol: There are one or more visits to evaluate the subject for their
      eligibility for an HIV vaccine trial. The evaluation will usually include laboratory studies,
      physical assessment, and counseling on avoidance of HIV infection, pregnancy and other
      HIV-related issues. Only those evaluations needed to determine eligibility for a particular
      study will be done. Evaluations of blood and urine samples other than those described in this
      protocol may be done if necessary for eligibility for a study.

      If it is determined that the subject might be eligible for an HIV vaccine trial, the subject
      will receive additional information about trial options by telephone, mail and/or visit with
      study coordinator. Several visits may occur if needed to confirm eligibility for
      participation in a vaccine clinical trial.

      Study Duration: Varies from about 2 weeks to six months for each subject

      Monitoring of Trial: Principal Investigator and designated staff of the Vaccine Research
      Center Regulatory, Affairs and Clinical Trials Core

      Sponsoring Agency: Vaccine Research Center (VRC), National Institute of Allergy and
      Infectious Diseases (NIAID), NIH

      Clinical Sites: NIH Clinical Center [including satellite locations such as the VRC Mobile
      Clinical Trials Unit (MCTU) or the VRC Clinic at Cedar Lane] and IRB-approved extramural
      sites

      Principal Investigator: Barney S. Graham, M.D., Ph.D., VRC/NIAID/NIH
    

Keywords: HIV; AIDS; Vaccine; Screening; Prevention; HV; Healthy Volunteer; Volunteer; HIV Seronegativity; HIV Preventive Vaccine