Connors Protocol for the Management and Use of Stored Human Specimens (Stored Human Specimens)

NCT03895645 | Enrolling By Invitation

• 2 other identifiers: 99991907419-I-N074
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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. ...

Conditions

Healthy Volunteer Samples

Keywords

Stored Samples; Natural History

Outcome Measures

Primary Outcomes (1)

• Continued analysis

  The objective of this protocol is to continue to have human subjects' protection oversight by the NIH IRB while making stored specimens and/or data available to approved research laboratories and investigators after the study of specimen origin has been terminated. Continued analyses will be for the purpose of research, exploratory immunology, and infectious disease research within the original study objectives and consents under which the specimens and data were collected. Manuscript completion for the primary study objectives will also be covered under this or the original study protocol.

  Ongoing

Study Arms (1)

Study Participants

Participants on the studies' samples that are transferred to this protocol

Eligibility Criteria

• Age: 18 Years - 116 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteers

* 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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

National Institute of Allergy and Infectious Diseases (NIAID)

Bethesda, Maryland, 20892, United States

Location

Study Officials

• Mark Connors, M.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2019
• First Posted: March 29, 2019
• Study Start (Estimated): June 17, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: June 12, 2026

Record last verified: 2025-12-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: Immediately following publication
• Access Criteria: Anyone who wishes to access the data

Locations

US (1)