NCT00339911

Collection and Distribution of Samples From Healthy Donors for In Vitro Research at the NCI-Frederick

ENROLLING BY INVITATION Last updated 24 December 2025

What this trial tests

trial in Healthy Donors in 1,200 participants. Enrolling by invitation.

Timeline

1 November 1999

Primary endpoint
1 October 2030

13 October 2030

Quick facts

Lead sponsor	National Cancer Institute (NCI)
Status	ENROLLING BY INVITATION
Study type	OBSERVATIONAL
Enrollment	1,200
Start date	1 November 1999
Primary completion	1 October 2030
Estimated completion	13 October 2030
Sites	1 location across United States

Conditions studied

• Healthy Donors — all drugs for Healthy Donors →

Sponsor

National Cancer Institute (NCI)

Who can join

18 and older, any sex, with Healthy Donors. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background

-NCI-Frederick scientists performing in vitro studies involving human specimens have a need for a reliable and consistent source of samples which protects the donor from research risks.

Objective

-The purpose of this protocol is to establish a centralized repository for the collection and distribution of samples (either blood, buccal mucosal cells, semen, urine, or nail clippings) from paid, healthy volunteer donors for in vitro research conducted by NIH investigators located at NCI-Frederick and Ft. Detrick. Research will include, but are not limited to, genotype analysis, immune function studies, drug screening, vaccine development, method development, quality control testing of reagents, and propagation of infectious agents, including HIV.

Eligibility:

Healthy NCI-Frederick employees and other NIH staff located at Ft. Detrick will be recruited. Potential donors will be excluded if screening indicates exposure to HIV, HTLV, Hepatitis C or Hepatitis B virus infection.

Study Design:

Investigators requesting to participate to the Research Donor Program (RDP) by receiving samples for research use will be required to submit a written memo of request, briefly describing the nature of the research and providing assurance that samples provided through this protocol will be used solely for in vitro research.

These Investigators will receive samples that will be either anonymous or coded, depending on the specific need.

Codes will be securely maintained and under no circumstances will donor identity be released to Investigators.

Donors will receive financial compensation for their time, discomfort and inconvenience according to an established schedule; compensation for blood donation is based on the volume donated.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Longitudinal Assessment of BNT162b2- and mRNA-1273-Induced Anti-SARS-CoV-2 Spike IgG Levels and Avidity Following Three Doses of Vaccination.
   Bullock JL, Hickey TE, Kemp TJ, Metz J, et al · · 2024 · cited 10× · PMID 38793767 · DOI 10.3390/vaccines12050516
2. Influence of sample collection tube method, anticoagulant-containing plasma versus serum, on influenza virus hemagglutination inhibition titer and microneutralization titer serological assays.
   Morrison BJ, Martin NJ, Rehman T, Ewing D, et al · · 2018 · cited 10× · PMID 30134892 · DOI 10.1186/s12913-018-3465-3
3. Evaluation of alcohol-free mouthwash for studies of the oral microbiome.
   Yano Y, Vogtmann E, Shreves AH, Weinstein SJ, et al · · 2023 · cited 8× · PMID 37104300 · DOI 10.1371/journal.pone.0284956
4. WHO International Standards for antibodies to HPV6 HPV11 HPV31 HPV33 HPV45 HPV52 and HPV58.
   Kemp TJ, Panicker G, Eklund C, Nie J, et al · · 2024 · cited 7× · PMID 39256440 · DOI 10.1038/s41541-024-00949-2
5. Development of HPV 35 serology assays for assessment of immune responses to HPV 35 after infection and vaccination.
   Kim K, Porras C, Kreimer AR, Hempel H, et al · · 2026 · PMID 41591792 · DOI 10.1080/21645515.2025.2610897
6. Comparison of oral collection methods for 16S rRNA gene and shotgun metagenomic sequencing.
   Herrera G, Zouiouich S, Diaz-Mayoral N, Purandare V, et al · · 2026 · PMID 41396065 · DOI 10.1128/spectrum.01806-25
7. Structure-function relationship of S protein cleavage in cowpea mosaic virus intratumoral immunotherapy.
   Simms A, Affonso de Oliveira JF, Minasov N, Cedrone E, et al · · 2025 · PMID 40856604 · DOI 10.1039/d5bm00969c
8. Proteomic and serologic assessments of responses to mRNA-1273 and BNT162b2 vaccines in human recipient sera.
   Hickey TE, Mudunuri U, Hempel HA, Kemp TJ, et al · · 2024 · PMID 39931577 · DOI 10.3389/fimmu.2024.1502458