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

NCT ID: NCT03895645
Time Stamp: April 5, 2024 7:00 PM
Source Node: 444255
Name: NA
Email: NA
Phone: NA

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. ...

Studies

Study First Submitted Date	2019-03-27
Study First Posted Date	2019-03-29
Last Update Posted Date	2023-04-19
Start Month Year	April 6, 2024
Primary Completion Month Year	December 31, 2029
Verification Month Year	March 29, 2023
Verification Date	2023-03-29
Last Update Posted Date	2023-04-19

Detailed Descriptions

Sequence:

20824434

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.

Facilities

Sequence:	201052748
Name	National Institute of Allergy and Infectious Diseases (NIAID)
City	Bethesda
State	Maryland
Zip	20892
Country	United States

Conditions

Sequence:	52435529
Name	Healthy Volunteer Samples
Downcase Name	healthy volunteer samples

Id Information

Sequence:	40346715	Sequence:	40346716
Id Source	org_study_id	Id Source	secondary_id
Id Value	999919074	Id Value	19-I-N074

Countries

Sequence:	42779426
Name	United States
Removed	False

Design Groups

Sequence:	55886251
Title	Study Participants
Description	Participants on the studies' samples that are transferred to this protocol

Keywords

Sequence:	80225755	Sequence:	80225756
Name	Stored Samples	Name	Natural History
Downcase Name	stored samples	Downcase Name	natural history

Design Outcomes

Sequence:	178373069
Outcome Type	primary
Measure	Continued analysis
Time Frame	Ongoing
Description	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.

Overall Officials

Sequence:	29422614
Role	Principal Investigator
Name	Mark Connors, M.D.
Affiliation	National Institute of Allergy and Infectious Diseases (NIAID)

Eligibilities

Sequence:	30916715
Sampling Method	Non-Probability Sample
Gender	All
Minimum Age	18 Years
Maximum Age	116 Years
Healthy Volunteers	No
Population	Healthy volunteers
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.
Adult	True
Child	False
Older Adult	True

Calculated Values

Sequence:	254183089
Number Of Facilities	1
Registered In Calendar Year	2019
Were Results Reported	False
Has Us Facility	True
Has Single Facility	True
Minimum Age Num	18
Maximum Age Num	116
Minimum Age Unit	Years
Maximum Age Unit	Years
Number Of Primary Outcomes To Measure	1