VaccinesNCT02242968
Screening of Volunteers for Clinical Trials of Investigational or Licensed Vaccines or Antiviral Products
An observational study of Vaccines and Antiviral Agents, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
Background: Vaccines and antiviral therapies help prevent and treat diseases. Researchers need a group of healthy volunteers for clinical trials. Clinical trials are studies that test these vaccines and therapies in people. Read more about this study
- Who is it for?
- Ages 18 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Vaccines, Antiviral Agents, Immunologic Factors
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Apr 2023to 15 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 120 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy volunteers, male or female ages 18-65.@@@
Who may be able to join
- Age: 18 or older
- Available to participate for the planned duration of at least one clinical trial for which screening is being done or to donate blood, nasal swab, throat swab, and/or urine in support of assay development
- Able and willing to complete the informed consent process
- Agree to have blood and/or urine, stool, nasal swab, or wash samples collected as needed for the clinical trial screening or sample donation process
- Agree to participate in procedures, such as electrocardiogram or pulmonary function tests, as may be needed for the clinical trial screening process
- Do not have plans to become pregnant while on this study
- Able to provide a medical history and other relevant personal information as appropriate
Who cannot join
- A condition that requires active medical intervention or monitoring to avert serious danger to the participant s health or well-being
- Known to be pregnant or breast-feeding
- If planning to enroll in a clinical trial, the receipt of immunoglobulin within the past 6 months or anticipated within the next year
- Any other condition that in the opinion of the investigator would make the subject unsuitable for enrollment or could interfere with the subject participating in and completing the study or a specimen donation.
- Use of recreational drugs or alcohol dependency or abuse
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Background:
- Vaccines and antiviral therapies help prevent and treat diseases. Researchers need a group of healthy volunteers for clinical trials. Clinical trials are studies that test these vaccines and therapies in people.
Read more
Objective:
- To screen volunteers for clinical trials for investigational or licensed vaccines or drugs to treat or prevent virus infections.
Eligibility:
- Healthy adults age 18 or older.
Design:
- Participants will be asked questions about their health history, including sexual activity and drug use. They will give blood samples. They may have a physical exam. They may give a urine sample.
- Participants may have the inside of their nose either swabbed or washed with some fluid. The fluid will be collected. They may give a stool sample.
- Participants may have an electrocardiogram. Soft, sticky patches will be attached to participants chest, arms, and legs. They will lie still on a table while the patches detect the heart s electrical signals. A machine will record these signals.
- Participants may have lung function tests. These tests measure the volume of air moving in and out of the lungs. Participants will forcibly blow air into a machine.
- Participants will be told if any tests show a medical problem.
- If a participant is eligible and decides to join an investigational clinical trial, researchers will explain the study and the risks involved. Participants will sign a separate consent for that clinical trial.
Read the detailed description
Vaccines and antiviral therapies are critical for prevention and treatment of viral diseases. Among other things, testing of vaccines or antiviral medications requires knowing whether the prospective subject has been previously infected by the virus to be studied. We will recruit healthy persons for this study and screen them for their eligibility to potentially participate in clinical trials of investigational or licensed vaccines or antiviral products. In most cases this will involve a medical history, physical examination, and obtaining blood to test for past exposure to one or more viruses being studied in ongoing and upcoming vaccine or antiviral therapy trials. In some cases, blood may be tested for viral DNA or RNA and urine, stool, nasal swab, or nasal wash may be tested for viruses. Additional testing, such as an electrocardiogram (EKG) and pulmonary function tests (PFTs) may also be done. In a subset of volunteers not screening for enrollment in a clinical trial but willing to donate a small volume of blood, nasal swab, throat swab, and/or urine in support of research assay development, no additional testing is anticipated. Overall, this study should 1) help us to identify a group of healthy volunteers who will be eligible, based on testing for their prior exposure to viruses, to participate in vaccine or antiviral therapy trials, and 2) allow for ready procurement of biological specimens from healthy volunteers to facilitate rapid research assay development.
- Conditions
- Vaccines, Antiviral Agents, Immunologic Factors, Physiological Effects of Drugs, Anti-Infective Agents
- Keywords
- Licensed Vaccines, Blood Draw, Investigational Vaccines, Healthy Volunteers, Eligibility Screening
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 |
|---|---|---|
| Healthy Volunteers | Male and Female healthy volunteers between aged 18 and 65 years. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To develop a pool of subject eligible to participate in clinical trials of investigational or licensed vaccines or antiviral products.
A pool of subjects qualified to participate in clinical trials.
Measured: Within one year from enrollment of each individual.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2014 (estimated)
- Study start24 Apr 2023
- Primary completion15 May 2025
- Study completion15 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VaccinesStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Richard T Davey, M.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02242968
- Sponsor's protocol ID
- 140194
- Other IDs
- 14-I-0194
- Status last verified
- May 2025
- First submitted
- 16 Sep 2014
- Last updated
- 16 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening of Volunteers for Clinical Trials of Investigational or Licensed Vaccines or Antiviral Products
- ClinicalTrials.gov ID
- NCT02242968
- Acronym / sponsor ID
- 140194
- Conditions
- Vaccines, Antiviral Agents, Immunologic Factors, Physiological Effects of Drugs, Anti-Infective Agents
- Keywords
- Licensed Vaccines, Blood Draw, Investigational Vaccines, Healthy Volunteers, Eligibility Screening
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 24 Apr 2023 (actual)
- Primary completion
- 15 May 2025 (actual)
- Study completion
- 15 May 2025 (actual)
- First posted
- 17 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
- Vaccines and antiviral therapies help prevent and treat diseases. Researchers need a group of healthy volunteers for clinical trials. Clinical trials are studies that test these vaccines and therapies in people.
Objective:
- To screen volunteers for clinical trials for investigational or licensed vaccines or drugs to treat or prevent virus infections.
Eligibility:
- Healthy adults age 18 or older.
Design:
- Participants will be asked questions about their health history, including sexual activity and drug use. They will give blood samples. They may have a physical exam. They may give a urine sample.
- Participants may have the inside of their nose either swabbed or washed with some fluid. The fluid will be collected. They may give a stool sample.
- Participants may have an electrocardiogram. Soft, sticky patches will be attached to participants chest, arms, and legs. They will lie still on a table while the patches detect the heart s electrical signals. A machine will record these signals.
- Participants may have lung function tests. These tests measure the volume of air moving in and out of the lungs. Participants will forcibly blow air into a machine.
- Participants will be told if any tests show a medical problem.
- If a participant is eligible and decides to join an investigational clinical trial, researchers will explain the study and the risks involved. Participants will sign a separate consent for that clinical trial.
Detailed description
Vaccines and antiviral therapies are critical for prevention and treatment of viral diseases. Among other things, testing of vaccines or antiviral medications requires knowing whether the prospective subject has been previously infected by the virus to be studied. We will recruit healthy persons for this study and screen them for their eligibility to potentially participate in clinical trials of investigational or licensed vaccines or antiviral products. In most cases this will involve a medical history, physical examination, and obtaining blood to test for past exposure to one or more viruses being studied in ongoing and upcoming vaccine or antiviral therapy trials. In some cases, blood may be tested for viral DNA or RNA and urine, stool, nasal swab, or nasal wash may be tested for viruses. Additional testing, such as an electrocardiogram (EKG) and pulmonary function tests (PFTs) may also be done. In a subset of volunteers not screening for enrollment in a clinical trial but willing to donate a small volume of blood, nasal swab, throat swab, and/or urine in support of research assay development, no additional testing is anticipated. Overall, this study should 1) help us to identify a group of healthy volunteers who will be eligible, based on testing for their prior exposure to viruses, to participate in vaccine or antiviral therapy trials, and 2) allow for ready procurement of biological specimens from healthy volunteers to facilitate rapid research assay development.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | – | –Male and Female healthy volunteers between aged 18 and 65 years. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers, male or female ages 18-65.@@@
Key inclusion criteria (7 listed)
- Age: 18 or older
- Available to participate for the planned duration of at least one clinical trial for which screening is being done or to donate blood, nasal swab, throat swab, and/or urine in support of assay development
- Able and willing to complete the informed consent process
- Agree to have blood and/or urine, stool, nasal swab, or wash samples collected as needed for the clinical trial screening or sample donation process
- Agree to participate in procedures, such as electrocardiogram or pulmonary function tests, as may be needed for the clinical trial screening process
Key exclusion criteria (5 listed)
- A condition that requires active medical intervention or monitoring to avert serious danger to the participant s health or well-being
- Known to be pregnant or breast-feeding
- If planning to enroll in a clinical trial, the receipt of immunoglobulin within the past 6 months or anticipated within the next year
- Any other condition that in the opinion of the investigator would make the subject unsuitable for enrollment or could interfere with the subject participating in and completing the study or a specimen donation.
- Use of recreational drugs or alcohol dependency or abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To develop a pool of subject eligible to participate in clinical trials of investigational or licensed vaccines or antiviral products.
Time frame: Within one year from enrollment of each individual.
A pool of subjects qualified to participate in clinical trials.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard T Davey, M.D. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vaccines and Antiviral Agents, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To develop a pool of subject eligible to participate in clinical trials of investigational or licensed vaccines or antiviral products. (time frame: Within one year from enrollment of each individual.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025.