Protocol Number: 02-I-0127

Title:

Screening Subjects for HIV Vaccine Research Studies

Number:

02-I-0127

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.

Sponsoring Institute:

National Institute of Allergy and Infectious Diseases (NIAID)

Recruitment Detail

Type: Active Accrual Of New Subjects

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): Children

Eligibility 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.

Special Instructions: Currently Not Provided

Keywords:

HIV

AIDS

Vaccine

Screening

Prevention

Recruitment Keywords:

HIV

Vaccine

HV

Healthy Volunteer

Volunteer

HIV Seronegativity

HIV Preventive Vaccine

Conditions:

HIV Seronegativity

HIV Infections

Investigational Drug(s):

None

Investigational Device(s):

None

Contacts:

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citations: Not Provided

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Networks and Applications, CC.

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Warren Grant Magnuson Clinical Center (CC)
National Institutes of Health (NIH)
Bethesda, Maryland 20892. Last update: 10/16/2004