ScreeningNCT01375530
Screening Volunteers for Clinical Trials
An observational study of Screening, run by National Institute of Allergy and Infectious Diseases (NIAID) at 4 sites in United States.
Trial summary
Background: The National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health needs healthy volunteers for vaccine clinical trials. This is a screening study that is used to identify healthy volunteers who may be eligible to participate in other clinical trials at the Vaccine… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Screening
- How many people
- 4,000 participants
- Where
- 4 sitesUnited States
- Study dates
- 16 Aug 2011to not given
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy volunteers
Who may be able to join
- Age: 18 years of age or older
- Able and willing to complete the informed consent process
- Agree to have blood and/or tissue samples collected and stored for future studies of investigational products, the immune system, and/or other medical conditions
Who cannot join
- A condition in which repeated blood draws or injections pose more than minimal risk for the subject such as hemophilia, other severe coagulation disorders or significantly impaired venous access
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 1 recruiting
- Completed
Emory University
Atlanta, Georgia, 30030
- Active, not recruiting
Univ of MD School of Medicine Center for Vaccine Development & Global Health
Baltimore, Maryland, 21201-1595
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
VRC Clinic, 301-451-8715, vaccines@nih.gov
- Completed
University of Pennsylvania-UPenn
Philadelphia, Pennsylvania, 19104-6056
About this study
Official title: VRC 500: Screening Volunteers for Clinical Trials of Investigational Products and Licensed Products Evaluated for Research Purposes
Background:
- The National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health needs healthy volunteers for vaccine clinical trials. This is a screening study that is used to identify healthy volunteers who may be eligible to participate in other clinical trials at the Vaccine Research Center that evaluate investigational vaccines, monoclonal antibodies, and injection devices. The VRC conducts studies that will allow researchers to better understand the immune system and how vaccines and monoclonal antibodies work.
Read more
Objectives:
- To screen healthy volunteers for clinical trials at the NIAID VRC.
Eligibility:
- Healthy people between 18 and 60 years of age. They must be available to take part in clinical trials and be able to provide blood for research studies.
Design:
- Screening for healthy volunteers to participate in clinical trials is an ongoing process.
- Volunteers will be asked about their medical history, including sexual activity and drug use, and a detailed physical exam will be performed.
- Blood and urine samples may be collected, and possibly other tests as needed to evaluate the volunteer's health status.
- Volunteers will not receive any investigational product in this screening protocol.
Read the detailed description
The purpose of this study is to recruit and screen potential study subjects, mostly healthy volunteers, to determine if they are eligible for clinical trials of investigational products. This screening study also aims to characterize and analyze demographic information as well as laboratory and other medical findings in terms of how they may affect the eligibility of subjects for specific early phase clinical trials. All work will be conducted by the VRC Clinic of the National Institutes of Health or other IRB-approved sites that are collaborating with NIAID/VRC. Educational and recruitment materials on the investigational products and protocols will be
reviewed with and provided to subjects during participation in the screening protocol.
- Conditions
- Screening
- Keywords
- Prevention, Vaccine, Immunity, Evaluate, Screen
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 |
|---|---|---|
| 1 | Healthy adults 18 - 60 years old |
What is being measured
The primary outcome is the main question the study is designed to answer.
To screen subjects for their eligibility to participate in clinical trials.
Duration of subject participation is variable, and may last from a few weeks to several months for each subject.
Measured: Ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2011 (estimated)
- Study start16 Aug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScreeningStudies 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
- Other
- Time perspective
- Other
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Lasonji A Holman, C.R.N.P., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01375530
- Sponsor's protocol ID
- 110164
- Other IDs
- 11-I-0164
- Status last verified
- 15 Sep 2026
- First submitted
- 16 Jun 2011
- Last updated
- 29 Oct 2026
- 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 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VRC 500: Screening Volunteers for Clinical Trials of Investigational Products and Licensed Products Evaluated for Research Purposes
- ClinicalTrials.gov ID
- NCT01375530
- Acronym / sponsor ID
- 110164
- Conditions
- Screening
- Keywords
- Prevention, Vaccine, Immunity, Evaluate, Screen
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 16 Aug 2011 (actual)
- First posted
- 17 Jun 2011 (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:
- The National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health needs healthy volunteers for vaccine clinical trials. This is a screening study that is used to identify healthy volunteers who may be eligible to participate in other clinical trials at the Vaccine Research Center that evaluate investigational vaccines, monoclonal antibodies, and injection devices. The VRC conducts studies that will allow researchers to better understand the immune system and how vaccines and monoclonal antibodies work.
Objectives:
- To screen healthy volunteers for clinical trials at the NIAID VRC.
Eligibility:
- Healthy people between 18 and 60 years of age. They must be available to take part in clinical trials and be able to provide blood for research studies.
Design:
- Screening for healthy volunteers to participate in clinical trials is an ongoing process.
- Volunteers will be asked about their medical history, including sexual activity and drug use, and a detailed physical exam will be performed.
- Blood and urine samples may be collected, and possibly other tests as needed to evaluate the volunteer's health status.
- Volunteers will not receive any investigational product in this screening protocol.
Detailed description
The purpose of this study is to recruit and screen potential study subjects, mostly healthy volunteers, to determine if they are eligible for clinical trials of investigational products. This screening study also aims to characterize and analyze demographic information as well as laboratory and other medical findings in terms of how they may affect the eligibility of subjects for specific early phase clinical trials. All work will be conducted by the VRC Clinic of the National Institutes of Health or other IRB-approved sites that are collaborating with NIAID/VRC. Educational and recruitment materials on the investigational products and protocols will be
reviewed with and provided to subjects during participation in the screening protocol.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Healthy adults 18 - 60 years old |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy volunteers
Key inclusion criteria (3 listed)
- Age: 18 years of age or older
- Able and willing to complete the informed consent process
- Agree to have blood and/or tissue samples collected and stored for future studies of investigational products, the immune system, and/or other medical conditions
Key exclusion criteria (3 listed)
- A condition in which repeated blood draws or injections pose more than minimal risk for the subject such as hemophilia, other severe coagulation disorders or significantly impaired venous access
- 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
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 screen subjects for their eligibility to participate in clinical trials.
Time frame: Ongoing
Duration of subject participation is variable, and may last from a few weeks to several months for each subject.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents
Binge Eating Disorder, Binge Eating
Not yet recruiting
Effect of a Health Belief Model Based Digital Nudge Intervention on Breast Cancer Screening
Breast Cancer Screening, Breast Cancer Awareness
RecruitingObservational study
Development and Clinical Validation of Artificial Intelligence Algorithms for Sleep Staging and Obstructive Sleep Apnea Screening Based on a Large-Scale Model Trained on Multimodal Physiological Signals From Diverse Populations
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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.
Lasonji A Holman, C.R.N.P. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Screening, run by National Institute of Allergy and Infectious Diseases (NIAID) at 4 sites 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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact VRC Recruitment ((866) 833-5433, vrcrecruitment@mail.nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To screen subjects for their eligibility to participate in clinical trials. (time frame: Ongoing). 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 29 Oct 2026; AzTrials last refreshed its copy on 1 Nov 2026.