Clinical trial NCT03895645: Connors Protocol for the Management and Use of Stored Human Specimens (Stored Human Specimens)
Official title: Connors Protocol for the Management and Use of Stored Human Specimens
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Healthy Volunteer Samples
Keywords: Stored Samples
Natural History
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2019-03-29
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 116
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers

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.

...

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.

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.

Primary outcomes:
measure: Continued analysis
timeFrame: Ongoing
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institute of Allergy and Infectious Diseases (NIAID)
state: Maryland
Study officials:
affiliation: National Institute of Allergy and Infectious Diseases (NIAID)
name: Mark Connors, M.D.
role: PRINCIPAL_INVESTIGATOR
References: