Screening Volunteers for Clinical Trials
|First Received Date ICMJE||June 16, 2011|
|Last Updated Date||February 19, 2014|
|Start Date ICMJE||May 2011|
|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 NCT01375530 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||Screening Volunteers for Clinical Trials|
|Official Title ICMJE||VRC 500:Screening of Volunteers for Clinical Trials of Investigational Products and Licensed Products Evaluated for Research Purposes|
- The National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health needs healthy volunteers for vaccine clinical trials. These trials will allow researchers to study vaccines and injection devices. These studies will also allow researchers to understand the immune system and how vaccines work. In this protocol, researchers will screen healthy volunteers for these future trials.
- To screen healthy volunteers for clinical trials at the NIAID.
- Healthy people between 18 and 70 years of age. They must be available to take part in clinical trials and be able to provide blood for research studies.
The purpose of this study is to screen potential study volunteers to determine if they are eligible for clinical trials of investigational products. All work will be conducted by the VRC Clinic of the National Institutes of Health or other IRB-approved sites that are collaborating with NIAID/VRC. Educational materials on the investigational products and protocols will be reviewed with and provided to subjects during participation in the screening protocol.
To screen subjects for their eligibility to participate in clinical trials of investigational products or licensed products being evaluated for research purposes.
Approximately 3,000 adults; age 18-70 years
Evaluations usually include medical history, physical examination and laboratory tests. Evaluations conducted may be limited to those needed to determine eligibility for the clinical trial(s) for which the subject is being screened and may be expanded to include protocol-specific eligibility assessments or assessments based on investigator judgment to assess the volunteer s health as necessary to determine eligibility for a clinical trial. Blood samples will also be collected and stored for future research.
NIH Clinical Center and other IRB-approved sites.
Duration of Study Participation:
Duration of subject 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 study of an investigational product, is found to be ineligible for any studies, or declines to participate in any clinical trials.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Time Perspective: Prospective|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Condition ICMJE||Human Volunteers|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
|Publications *||Graham BS, Ledgerwood JE, Nabel GJ. Vaccine development in the twenty-first century: changing paradigms for elusive viruses. Clin Pharmacol Ther. 2009 Sep;86(3):234-6. No abstract available.|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE||3000|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
Age: 18-70 years of age
Available to participate for the planned duration of the clinical trial for which the screening is being done
Able and willing to complete the informed consent process
Agree to have blood and/or tissue samples collected and stored for future studies of investigational products, the immune system, and/or other medical conditions
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|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT01375530|
|Other Study ID Numbers ICMJE||110164, 11-I-0164|
|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|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||January 2014|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP