NIH Clinical Research Studies

Protocol Number: 03-I-0285

Active Accrual, Protocols Recruiting New Patients

Title:
Screening of Healthy Volunteers for Clinical Trials of Investigational Vaccines to Prevent Infectious Diseases
Number:
03-I-0285
Summary:
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.

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 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.

Special Instructions: Currently Not Provided
Keywords:
Biodefense
Therapy
Prevention
Emergent
Threat
Recruitment Keywords:
Healthy Volunteer
HV
Conditions:
Healthy
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:
Fauci AS. Infectious diseases: considerations for the 21st century. Clin Infect Dis. 2001 Mar 1;32(5):675-85. Epub 2001 Feb 23. PMID: 11229834

Active Accrual, Protocols Recruiting New Patients

If you have:


Command Menu Bar

Search The Studies | Help | Questions |
Clinical Center Home | NIH Home


Clinical Center LogoWarren Grant Magnuson Clinical Center (CC)
National Institutes of Health (NIH)
Bethesda, Maryland 20892. Last update: 10/23/2004

Search The Studies Help Questions