Connors Protocol for the Management and Use of Stored Human Specimens (Stored Human Specimens)
NCT ID: NCT03895645
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
1000 participants
OBSERVATIONAL
2025-11-17
2029-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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CASE_ONLY
OTHER
Study Groups
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Study Participants
Participants on the studies' samples that are transferred to this protocol
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
populations of other protocols.
18 Years
116 Years
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Mark Connors, M.D.
Role: PRINCIPAL_INVESTIGATOR
National Institute of Allergy and Infectious Diseases (NIAID)
Locations
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National Institute of Allergy and Infectious Diseases (NIAID)
Bethesda, Maryland, United States
Countries
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Other Identifiers
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19-I-N074
Identifier Type: -
Identifier Source: secondary_id
999919074
Identifier Type: -
Identifier Source: org_study_id