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
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.
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
Principal Investigator: Barney S. Graham, M.D., Ph.D., VRC/NIAID/NIH
- INCLUSION CRITERIA:
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
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.
Known to be HIV infected.
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
A condition that requires active medical intervention or monitoring to avert serious danger
to the participant's health or well-being.