Recruiting

VRC 900

Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Code:

NCT01132859

Conditions

Immunity, Mucosal

Immune System Processes

Blood Specimen Collection

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Study Details

Brief summary:

Background:

\- The Vaccine Research Center (VRC) is dedicated to understanding immune responses associated with prevention and treatment of infectious diseases. To study these immune responses, researchers need to collect specimens and images from individuals who have recently had a vaccination or recovered from an infection. These specimens and images are used to study different diseases and immune responses, and can be used to investigate ways to prevent or treat different medical conditions.

Objectives:

\- To evaluate blood and other tissue samples for immune responses to vaccines and natural infections.

Eligibility:

\- Healthy volunteers at least 18 years of age who agree to donate specimens for research purposes.

Design:

  • Participants will have clinical evaluations and will be asked to provide some of the following samples, depending on the research question being addressed. All procedures and sample donations are optional and voluntary:
  • Blood samples through regular blood draws (for whole blood) and apheresis (to collect specific parts of the blood such as plasma or white blood cells)
  • Urine, semen, saliva, or vaginal swab samples
  • Tissue samples or biopsy specimens
  • Undergo procedures such as bronchoscopy (lung and respiratory tract), gastrointestinal endoscopy (stomach and upper intestinal tract), or colonoscopy (lower intestinal tract) to obtain tissue samples
  • Undergo imaging studies such as positron emission tomography (PET) or computed tomography (CT) scans

Duration of participation is variable depending on the research question but will usually last up to 1 year.

\- Participants will be compensated for participation.

Conditions

Immunity, Mucosal

Immune System Processes

Blood Specimen Collection

Study ID

NCT01132859

Start date

May 18, 2010

Status verified date

Jul 17, 2026

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

  • INCLUSION CRITERIA:

1. 18 years of age or older.
2. Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process.
3. Able and willing to complete the informed consent process.
4. Willing to donate specimens for storage to be used for research.

EXCLUSION CRITERIA:

1. Any medical, psychiatric, occupational condition or other condition that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a participant s ability to give informed consent.
2. Bleeding disorder diagnosed by a doctor (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions), use of anticoagulant medications for an ongoing medical condition, significant bruising or bleeding difficulties with intramuscular injections or blood draws. \[Note: Participants taking anticoagulants, such as aspirin, prophylactically may be considered on a case to case basis.\]

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

1

Participants 18 years of age or older willing to donate blood and tissue specimens and participate in imaging studies to evaluate the components of the immune system

Primary outcome measure

  • To use specimens and accumulated data for enhancement of understanding the correlates of immune protection. [ Time Frame: Throughout the study ]
  • To evaluate blood, body fluid, and tissue immune responses and pathogen dynamics of naturally infected and antigen-na(SqrRoot) ve subjects [ Time Frame: Throughout the study ]
  • To evaluate innate, humoral, and cellular immune responses and pathogen dynamics in the context of vaccination in the blood, body fluids, excretions, and tissues [ Time Frame: Throughout the study ]

Central Contacts and Locations

Central contacts

OPS Team, VRC

Not Listedvrcops@nih.gov

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

VRC Clinic

301-451-8715vaccines@nih.gov

More Information

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Last update posted

Sep 1, 2026

Last verified

Jul 17, 2026

Keywords

  • Specimen Collection
  • Mucosal Immunity
  • Immune Responses
  • Immunity
  • Vaccines
  • Natural History
  • Healthy Volunteer
  • HV

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 2026-09-01.