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By invitationNCT03895645ClinicalTrials.gov record

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

Healthy Volunteer Samples

THE QUICK READ

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type
Observational
Phase
Not applicable / not listed
Age range
18 years - 116 years
Sex eligible
All sexes
Healthy volunteers
Not accepted
Participants
1000 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

...

Read the full 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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

  • 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.

Study population

Healthy volunteers

Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment
Not reported
Masking
Not reported
Study Participants

Participants on the studies' samples that are transferred to this protocol

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Continued analysis

Time frame: 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.

No results are flagged as posted.

Review the complete result tables and limitations in the official record.

Open official results ↗

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

National Institute of Allergy and Infectious Diseases (NIAID)Bethesda, Maryland, United StatesStatus unknown

Study team and timeline

Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Study start
Nov 15, 2026 Estimated
Primary completion
Dec 31, 2029 Estimated
Study completion
Dec 31, 2029 Estimated
First posted
Mar 29, 2019 Actual
Last updated
Nov 10, 2026 Actual

Official study contacts

No central contact is listed. Check the locations and the official record.

Official study title

Connors Protocol for the Management and Use of Stored Human Specimens

A HUMAN NEXT STEP

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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.

Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026