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| Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT00068926 |
Purpose
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:
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 |
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Healthy |
| Study Type: | Observational |
| Official Title: | VRC 300: Screening of Healthy Volunteers for Clinical Trials of Investigational Vaccines to Prevent Infectious Diseases |
| Estimated Enrollment: | 3000 |
| Study Start Date: | September 2003 |
STUDY DESIGN: 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.
SUBJECTS: Approximately 3,000 healthy adults; age 18-65 years.
STUDY DURATION: Approximately six months for each subject. Study participation is complete when the subject enrolls in a vaccine study, is found to be ineligible for all vaccine studies or declines to participate in any vaccine studies.
STUDY EVALUATIONS: Evaluations usually include history and physical examinations, CBC with differential and platelets, PT/PTT, chemistry panel, urinalysis, pregnancy test for women of reproductive potential, hepatitis B surface antigen, hepatitis C antibody, RPR, ELISA and Western blot for HIV, anti-dsDNA, quantitative immunoglobulins, and adenovirus serology. Only those evaluations needed to determine eligibility for a particular study will be done. Evaluations other than those described in this protocol may be done if necessary for eligibility for a study. Blood will also be collected for storage.
Eligibility
| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Age: 18 to 65 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.
Contacts and Locations| Contact: Patient Recruitment and Public Liaison Office | (800) 411-1222 | prpl@mail.cc.nih.gov |
| Contact: TTY | 1-866-411-1010 |
| United States, Maryland | |||||
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting | ||||
| Bethesda, Maryland, United States, 20892 | |||||
More Information
NIH Clinical Center Detailed Web Page
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| Study ID Numbers: | 030285, 03-I-0285 |
| First Received: | September 11, 2003 |
| Last Updated: | July 18, 2008 |
| ClinicalTrials.gov Identifier: | NCT00068926 |
| Health Authority: | United States: Federal Government |
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