Recruiting

Observational Study

Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Code:

NCT01375530

Conditions

Screening

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

Study Details

Brief 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 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.

Conditions

Screening

Study ID

NCT01375530

Start date

Aug 16, 2011

Status verified date

Aug 25, 2026

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

  • INCLUSION CRITERIA:

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

EXCLUSION CRITERIA:

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

Study Design

Enrollment

4000 participants

Anticipated

Interventions and Outcome Measures

Arms

1

Healthy adults 18 - 60 years old

Primary outcome measure

  • To screen subjects for their eligibility to participate in clinical trials. [ Time Frame: Ongoing ]

Central Contacts and Locations

Central contacts

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

More Information

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Last update posted

Sep 8, 2026

Last verified

Aug 25, 2026

Keywords

  • Prevention
  • Vaccine
  • Immunity
  • Evaluate
  • Screen

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Institute of Allergy and Infectious Diseases (NIAID) on 2026-09-08.