Screening Protocol for HIV Vaccine Studies
|First Received Date ICMJE||February 28, 2002|
|Last Updated Date||May 3, 2013|
|Start Date ICMJE||February 2002|
|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 NCT00031304 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 Protocol for HIV Vaccine Studies|
|Official Title ICMJE||Screening Subjects for HIV Vaccine Research Studies|
Healthy volunteers will be screened under this protocol for possible participation in a study testing a vaccine against HIV, the virus that causes AIDS.
Healthy adults 18 to 60 years of age may be eligible for this study. Participants must be in good general health with no history of significant medical problems or abnormal laboratory test results. Pregnant or breast-feeding women and people infected with HIV will not be enrolled.
Participants enrolled in this protocol will undergo the following tests and procedures within 8 weeks before the start of the experimental vaccine study:
Individuals who are identified through this screening protocol as possible candidates for an HIV vaccine trial will be provided additional information about study options.
Study Design: The purpose of this study is to screen subjects to determine if they are suitable candidates for HIV vaccine trials.
Healthy, HIV-negative subjects will be recruited and screened. The results of this study will be used to determine if the subject meets eligibility requirements for participation in H1V vaccine trials. Educational materials on vaccines will be reviewed with and provided to subjects before enrollment into the study.
Subjects: Healthy adults
Number of Subjects: Approximately 3,000
Outline of Protocol: There are one or more visits to evaluate the subject for their eligibility for an HIV vaccine trial. The evaluation will usually include laboratory studies, physical assessment, and counseling on avoidance of HIV infection, pregnancy and other HIV-related issues. Only those evaluations needed to determine eligibility for a particular study will be done. Evaluations of blood and urine samples other than those described in this protocol may be done if necessary for eligibility for a study.
If it is determined that the subject might be eligible for an HIV vaccine trial, the subject will receive additional information about trial options by telephone, mail and/or visit with study coordinator. Several visits may occur if needed to confirm eligibility for participation in a vaccine clinical trial.
Study Duration: Varies from about 2 weeks to six months for each subject
Monitoring of Trial: Principal Investigator and designated staff of the Vaccine Research Center Regulatory, Affairs and Clinical Trials Core
Sponsoring Agency: Vaccine Research Center (VRC), National Institute of Allergy and Infectious Diseases (NIAID), NIH
Clinical Sites: NIH Clinical Center [including satellite locations such as the VRC Mobile Clinical Trials Unit (MCTU) or the VRC Clinic at Cedar Lane] and IRB-approved extramural sites
Principal Investigator: Barney S. Graham, M.D., Ph.D., VRC/NIAID/NIH
|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 *||Not Provided|
* 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||April 2013|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
Age: 18-60 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.
Known to be HIV infected.
Women who are known to be pregnant and/or breast feeding.
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.
|Ages||18 Years to 60 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||NCT00031304|
|Other Study ID Numbers ICMJE||020127, 02-I-0127|
|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||April 2013|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP