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

• Conditions: Healthy Volunteer Samples

• Registration Number: NCT03895645
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

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.

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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.

Study Timeline

• Study First Submitted: 2019-03-27
• Study First Submitted QC: 2019-03-28
• Study First Posted: 2019-03-29
• Status Verified: 2024-10-23
• Last Update Submitted: 2025-01-09
• Last Update Posted: 2025-01-10
• Study Start: 2025-01-15
• Primary Completion: 2029-12-31
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Continued analysis	Ongoing	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.

Trial Locations

Locations (1)

National Institute of Allergy and Infectious Diseases (NIAID); 🇺🇸 Bethesda, Maryland, United States