NCT05682625

Brief Summary

The purpose of this study is to understand the effects of COVID-19 vaccines on the immune system and how the COVID-19 vaccines provide protection and induce long term memory. Adults who are receiving a COVID-19 vaccine will be invited to participate in this study.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
41mo left

Started Oct 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress33%
Oct 2024Sep 2029

First Submitted

Initial submission to the registry

January 9, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 12, 2023

Completed
1.7 years until next milestone

Study Start

First participant enrolled

October 1, 2024

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2029

Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

4.9 years

First QC Date

January 9, 2023

Last Update Submit

September 10, 2024

Conditions

COVID-19 (Coronavirus Disease 2019)

Keywords

ImmunityVaccine

Outcome Measures

Primary Outcomes (3)

  • Testing immune response to the COVID-19 vaccine over time

    1 day

  • Testing immune response to the COVID-19 vaccine over time

    7 days

  • Testing immune response to the COVID-19 vaccine over time

    28 days

Study Arms (1)

Participants

Adults who are receiving a COVID-19 vaccine

Other: No intervention

Interventions

No interventionOTHER

No intervention

Participants

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults (18 years and older) receiving a COVID-19 vaccine

You may qualify if:

  • Adults 18yrs old and higher who are receiving a COVID-19 vaccine

You may not qualify if:

  • Pregnancy
  • Patients with contraindications for lymph node biopsy
  • Active cancer
  • Current use of immunosuppression drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University

Palo Alto, California, 94304, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

lymph node biopsy and blood samples

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • R. Sharon Chinthrajah, MD

    Stanford University, Sean N. Parker Center for Allergy and Asthma Research

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

January 9, 2023

First Posted

January 12, 2023

Study Start

October 1, 2024

Primary Completion (Estimated)

September 1, 2029

Study Completion (Estimated)

September 1, 2029

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)