Connors Protocol for the Management and Use of Stored Human Specimens (Stored Human Specimens)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Healthy Volunteer Samples. Basic parameters: 18 years — 116 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Connors Protocol for the Management and Use of Stored Human Specimens
Overview
Background: The HIV research program is part of the National Institute of Allergy and Infectious Diseases. The program aims to learn more about HIV. It also aims to improve the health of people with HIV and create HIV vaccines. People enrolled in prior HIV studies provided samples or data. They consented for their samples or data to be used for future research. Researchers want to keep studying the stored samples and data. Objective: To give approved researchers access to stored samples and data after the study of sample origin is over. To do this with human subjects protection oversight by the NIH institutional review board (IRB). Eligibility: The study populations were defined by the protocols under which the samples or data were obtained: 11-I-0259, 13-I-0081, and 14-I-0011. Design: All participants consented to provide blood or other samples. Their consent included future use of the samples. Researchers will not contact participants without prior approval of the IRB or the original study protocol. Samples will be labeled with a code. They will not be labeled with information that identifies the participants. Participants data will be stored in computers. The computers will be protected with passwords. This protocol will be kept open as long as the samples or data can be used for future research. When there is no longer a need, the samples may be moved if the IRB approves this. Otherwise they will be destroyed. ...
Detailed description
The HIV intramural research program of NIAID conducts clinical investigations to increase our
knowledge of the biology, pathogenesis and immunology of HIV infection and vaccine
development. After all study-related interventions, follow-up, and primary specimen and data
analyses are complete for an IRB-approved protocol, some human specimens may remain in
storage, and data may continue to be analyzed to meet secondary and exploratory objectives. This protocol will allow for additional laboratory and data analyses to be continued to complete the analyses described under closed NIAID protocol #14-I-0011, Phase 1 Study of Safety and Immunogenicity of Ad4-HIV Vaccine Vectors in Healthy Volunteers.
Primary outcome measures
- Continued analysis [Time frame: Ongoing]
Eligibility criteria
- The study populations were defined by the original protocols under which the stored specimens and/or data were collected. The total population included on this omnibus protocol comprises the
populations of other protocols.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
United States · 1 center
- National Institute of Allergy and Infectious Diseases (NIAID) — Bethesda
Identifiers
NCT: NCT03895645 · 999919074 · 19-I-N074