Healthy Volunteer SamplesNCT03895645
Connors Protocol for the Management and Use of Stored Human Specimens (Stored Human Specimens)
An observational study of Healthy Volunteer Samples, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 116 years
- Conditions the study is for
- Healthy Volunteer Samples
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Oct 2026to 31 Dec 2029
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 116 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Healthy volunteers
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
National Institute of Allergy and Infectious Diseases (NIAID)
Bethesda, Maryland, 20892
About this study
Official title: Connors Protocol for the Management and Use of Stored Human Specimens
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.
Read more
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.
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Read the 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.
- Conditions
- Healthy Volunteer Samples
- Keywords
- Stored Samples, Natural History
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study Participants | Participants on the studies' samples that are transferred to this protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2019
- Study start28 Oct 2026 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Volunteer SamplesStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Mark Connors, M.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03895645
- Sponsor's protocol ID
- 999919074
- Other IDs
- 19-I-N074
- Status last verified
- 2 Dec 2025
- First submitted
- 27 Mar 2019
- Last updated
- 23 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in the article after deidentification