VRC 300: Screening of Healthy Volunteers for Clinical Trials of Investigational Vaccines to Prevent Infectious Diseases
|First Received Date ICMJE||September 11, 2003|
|Last Updated Date||June 30, 2011|
|Start Date ICMJE||September 2003|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00068926 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||VRC 300: Screening of Healthy Volunteers for Clinical Trials of Investigational Vaccines to Prevent Infectious Diseases|
|Official Title ICMJE||VRC 300: Screening of Healthy Volunteers for Clinical Trials of Investigational Vaccines to Prevent Infectious Diseases|
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 70 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.
STUDY DESIGN: The purpose of the study is to screen potential study volunteers to determine if they are eligible for infectious disease vaccine clinical trials being sponsored by the Vaccine Research Center (VRC) at the NIH Clinical Center. All work will be conducted by the VRC Clinic of the National Institutes of Health or IRB-approved extramural sites that are collaborating with the VRC Clinic. Educational materials on vaccines will be reviewed with and provided to subjects before enrollment into the study.
SUBJECTS: Approximately 3,000 healthy adults; age 18-70 years.
STUDY DURATION: Duration of participation is variable, and may last from a few weeks to several 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, physical examinations and laboratory tests. 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.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Not Provided|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
|Publications *||Fauci AS. Infectious diseases: considerations for the 21st century. Clin Infect Dis. 2001 Mar 1;32(5):675-85. Epub 2001 Feb 23.|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||June 2011|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
Age: 18 to 70 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.
Known to be infected with HIV, syphilis, tuberculosis, hepatitis B or hepatitis C.
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.
Known to be pregnant or breast-feeding.
|Ages||18 Years to 70 Years|
|Accepts Healthy Volunteers||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00068926|
|Other Study ID Numbers ICMJE||030285, 03-I-0285|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Institute of Allergy and Infectious Diseases (NIAID)|
|Collaborators ICMJE||Not Provided|
|Investigators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||June 2011|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP