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


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.


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


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


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


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.


Sequence: 48563867
Agency Class NIH
Lead Or Collaborator lead
Name National Institute of Allergy and Infectious Diseases (NIAID)

Overall Officials

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


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


Sequence: 30662400
Observational Model Case-Only
Time Perspective Other

Responsible Parties

Sequence: 29029085
Responsible Party Type Sponsor

Ipd Information Types

Sequence: 3356489
Name Statistical Analysis Plan (SAP)