Actively Recruiting

Age: 3Years +
All Genders
Healthy Volunteers
ID00067054

VRC 200: A Multicenter Specimen Collection Protocol to Obtain Human Biological Samples for Research Studies

Led by National Institute of Allergy and Infectious Diseases (NIAID) ยท Updated on 2026-05-22

3000

Participants Needed

3

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are collecting various biological samples, such as blood, urine, body fluids, skin swabs, and skin biopsies, to support medical research conducted by the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center. The samples help study infectious diseases like HIV and hepatitis, immune system responses, and the development of vaccines and monoclonal antibodies. The study includes children from 3 years old and adults, including healthy volunteers and those with infections or allergic or autoimmune conditions. Specimens are collected through standard blood draws (phlebotomy) or apheresis, which involves removing blood, separating desired components like plasma or white blood cells, and returning the rest to the participant. The apheresis procedure takes about 1 to 3 hours with the participant reclining. Samples may also include mucosal secretions, skin swabs, and biopsies. Collection can occur at clinic visits, outside labs, or at home, with shipments sent to the research center. Participants may donate samples once or repeatedly over a 1-year enrollment period, which can be extended. Participants undergo sample collection and provide basic medical and demographic information linked to their samples by ID number only. The study monitors safety during procedures and collects data on participant identity proof and consent. There are no specific study endpoints as samples support various research projects. Participation can last a year or more, with ongoing review by an ethics committee. The primary outcome measured is the successful collection of samples for research use.

CONDITIONS

Brief Title

Apheresis and Specimen Collection Procedures to Obtain Plasma, Peripheral Blood Mononuclear Cells (PBMCs) and Other Specimens for Research Studies

Who Can Participate

Age: 3Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older
  • Able and willing to complete the informed consent process
  • Willing to provide blood or other samples for indefinite storage and research use
  • Able to provide proof of identity as required
  • Children aged 3 to 17 years, at least 12 kg in weight
  • Legal guardian able to understand and comply with study procedures and provide informed consent
  • Willing to have blood drawn or provide other biological samples for research
  • Legal guardian able to provide proof of identity for child and self to the clinician's satisfaction
Not Eligible

You will not qualify if you...

  • Any condition considered by the attending physician to contraindicate specimen collection
  • For children: acute or chronic illness that precludes participation
  • For children: factors affecting legal guardian's objective decision-making
  • For adults undergoing skin biopsy: allergies to local anesthetic, history of keloid formation, coagulation disorders, pregnancy, or breastfeeding
  • For adults undergoing apheresis: medical contraindications, inadequate venous access, cardiovascular instability, lung or kidney disease, coagulation disorders, sickle cell disease, active or chronic hepatitis, recent intravenous drug use, breastfeeding, or positive pregnancy test
  • For healthy volunteers before apheresis: fever, weight under 110 pounds, low hemoglobin or platelet counts, unstable cardiovascular signs
  • For patients with infectious disease before apheresis: unstable cardiovascular signs, low blood counts, recent clotting factor treatment, breastfeeding, or positive pregnancy test
  • Receipt of clotting factor concentrates in past 5 years

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Monitoring

Duration - Indefinite, as often as permitted by institutional guidelines

Participants provide biological samples such as blood, plasma, PBMCs, mucosal secretions, skin swabs, skin biopsies, or body fluids for research studies. Samples may be collected at clinic visits, outside laboratories, healthcare providers, or at home and shipped to the research center.

Visits occur as needed for sample collection, which may vary by participant and sample type

Trial Site Locations

Total: 3 locations

1

National Institutes of Health Clinical Center

Bethesda, Maryland, United States, 20892

Actively Recruiting

2

EvergreenHealth Medical Center

Kirkland, Washington, United States, 98034

Completed

3

University of Puerto Rico Medical Sciences Campus

San Juan, Puerto Rico, 00921

Active, Not Recruiting

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Research Team

O

OPS Team, VRC

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

Frequently Asked Questions

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Published Research Related To This Trial

Peripheral blood lymphocyte numbers, lymphocyte proliferative responses in vitro, and serum immunoglobulins in regular hemapheresis donors.

H G Braine, G J Elfenbein, E D Mellits

https://pubmed.ncbi.nlm.nih.gov/4030708

Structure-Based Design with Tag-Based Purification and In-Process Biotinylation Enable Streamlined Development of SARS-CoV-2 Spike Molecular Probes.

Tongqing Zhou, I-Ting Teng, Adam S Olia...

https://pubmed.ncbi.nlm.nih.gov/32742241