This protocol will screen healthy normal volunteers for participation in studies of vaccines under development at NIAID's Vaccine Research Center. Of interest are vaccines for:

- Newly identified infectious diseases such as SARS.

- Infectious diseases of concern as possible bioweapons, such as smallpox and Ebola virus

- Emerging infectious diseases that are more widespread geographically than in the past, such as West Nile virus

- For preventing diseases such as tuberculosis and malaria.

Healthy normal volunteers between 18 and 60 years of age may be eligible for this protocol. Screening begins about 1 to 6 months before the start of the vaccine study. Participants will have a physical examination and health history, including questions about sexual activity and drug use. Over the course of the screening visits, participants will be asked to give urine and blood samples to test for various infections and other medical problems. Women capable of getting pregnant will be given a pregnancy test. Women who are pregnant or breastfeeding will not be enrolled in the study.

At the end of the screening, participants will be informed about which vaccines are currently being tested in clinical trials for which they may be eligible. Once participants enroll in a vaccine study, their participation in the screening protocol ends.

Condition
Healthy

Further Study Details: 

Expected Total Enrollment:  1000

The purpose of the study is to screen potential study volunteers to determine if they are eligible for Phase I infectious disease vaccine clinical trials being sponsored by the Vaccine Research Center at the NIH Clinical Center. All work will be conducted at the National Institutes of Health. Educational materials on vaccines will be reviewed with and provided to subjects before enrollment into the study.

Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

INCLUSION CRITERIA:
Age: 18 to 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 infected with HIV, syphilis, tuberculosis, hepatitis B or hepatitis C.
A condition requiring medication that affects the immune response to a vaccine such as corticosteroids, hydroxyurea, interleukin-2 or other immune modulators.
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.
Active participation in other experimental treatment studies.
Pregnancy or breast-feeding.

Maryland
      National Institute of Allergy and Infectious Diseases (NIAID), 9000 Rockville Pike,  Bethesda,  Maryland,  20892,  United States; Recruiting

Study ID Numbers:  030285; 03-I-0285
Record last reviewed:  May 28, 2004
Last Updated:  November 23, 2004
Record first received:  September 11, 2003
ClinicalTrials.gov Identifier:  NCT00068926
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08