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Vaccine

Observational (survey, biospecimen collection) for Coronavirus Disease

N/A
Recruiting
Led By Emad K Salman
Research Sponsored by Children's Oncology Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 6, 12 and 18 months after each dose
Awards & highlights
No Placebo-Only Group

Summary

This study evaluates immunologic response following COVID-19 vaccination in children, adolescents, and young adults with cancer. Vaccines work by stimulating the body's immune cells to respond against a specific disease. The immune response produces protection from that disease. Effects from cancer and from treatments for cancer can reduce the body's natural disease fighting ability (called immunity). Factors such as vaccine type, timing of vaccine dosing related to treatment for cancer and number of vaccine doses or "boosts" (extra vaccine shots) may strengthen or diminish the body's protective immune response. This study may help researchers learn more about how the body's immune system responds to the COVID-19 vaccine when the vaccination is given during or after cancer treatment.

Eligible Conditions
  • Cancer
  • Coronavirus Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 6, 12 and 18 months after each dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 6, 12 and 18 months after each dose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Seroprevalence of SARS-CoV-2-specific protective antibodies
Other study objectives
Durability of immune response at 6 months
Post-vaccination symptomatic SARS-CoV-2 infections

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Observational (survey, biospecimen collection)Experimental Treatment2 Interventions
Patients receive COVID-19 vaccine per standard of care. Patients also complete a survey at 1 month and undergo collection of blood samples at 1, 3, 6, 12, 18, and 24 months. Patients may complete an additional survey at 1 month after each vaccine boost and undergo collection of blood samples before each vaccine boost, 1 month after each vaccine boost, and at the time of COVID-19 infection.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 3
~2020

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,887 Previous Clinical Trials
41,020,479 Total Patients Enrolled
1 Trials studying Coronavirus Disease
189 Patients Enrolled for Coronavirus Disease
Children's Oncology GroupLead Sponsor
459 Previous Clinical Trials
239,378 Total Patients Enrolled
Emad K SalmanPrincipal InvestigatorChildren's Oncology Group
~296 spots leftby Sep 2027
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