Connors Protocol for the Management and Use of Stored Hum... | NCT03895645

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

NCT03895645

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Status

Enrolling by invitation

Last Update Posted

Jul 10, 2026Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Healthy Volunteer Samples

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
19-I-N074

Status Module

Record Verification Date

Dec 2, 2025

Overall Recruitment Status or Expanded Access Status

Enrolling by invitation

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 15, 2026Estimated

Primary Completion Date

Dec 31, 2029Estimated

Completion Date

Dec 31, 2029Estimated

First Submitted Date

Mar 27, 2019

First Submission Date that Met QC Criteria

Mar 28, 2019

First Posted Date

Mar 29, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 9, 2026

Last Update Posted Date

Jul 10, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study Participants		Participants on the studies' samples that are transferred to this protocol

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

116 Years

Standard Ages

AdultOlder Adult

Study Population

Healthy volunteers

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Institute of Allergy and Infectious Diseases (NIAID)		Bethesda	Maryland	20892	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Individual participant data that underlie the results reported in the article after deidentification

Types

Statistical Analysis Plan (SAP)

Time Frame

Immediately following publication

Access Criteria

Anyone who wishes to access the data

URL

Not provided