Repository of specimens collected as part of the DAIDS VAX004 Clinical Trial.
Main Areas of Focus
- To increase basic knowledge of the pathogenesis and transmission of HIV, promote the development of therapies for HIV infection and its complications and co-infections, and encourage the development of vaccines and other prevention strategies
- To provide the scientific community with an invaluable research resource for multidisciplinary investigation
- Repository of HIV/AIDS specimens
Who Can Use This Resource
All investigators seeking access to these DAIDS VAX004 clinical trial specimens or data must complete and submit the following documents:
How To Get Started
- To protect the scientific integrity of the Division of AIDS (DAIDS) and to ensure optimal use of limited specimens, all proposals requesting access to clinical trial specimens collected from VAX004 must undergo a review and approval process.
- To assist in the process, investigators should review the Scientific Priorities developed by a specially convened DAIDS VAX004 Specimen Access Approval Panel.
Assurance to Requestors
Although these specimens were obtained from trial participants who signed informed consents releasing these specimens for research purposes, certain restrictions may apply.
The DAIDS VAX004 Specimen Access Approval Panel has reviewed the protections offered by the Common Rule and the Health Information Protection Act Amendments (HIPAA). In general, consent is required for the storage and future use of samples that contain identifiable private information about living individuals. In the case of VAX004, the original consent form was modified to include taking and storing cells for future "testing," but the tests that would be performed were not specified.
In the Panel's opinion, the vast majority of institutional review boards (IRBs) will allow future research if the specimens are de-linked from personal information (i.e., other than male/female, placebo/vaccine, infected/ uninfected). The Panel felt that, in particular, future research on genetic and host factors should be carefully evaluated by the relevant IRB(s). Investigators could also consider seeking a waiver from HIPAA based on minimal risk, efforts to protect identities, the impracticality of reconsenting the volunteers, and the impossibility of doing the desired research without certain information.