Monitoring response on COVID-19 vaccination in children with cancer

Phase 1

• Conditions: Children with cancer, receiving COVID-19 vaccination; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2021-003388-90-NL
• Lead Sponsor: Princess Máxima Center for Pediatric Oncology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-21
• Last Update Posted: 18 July 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

-Willing to receive routine COVID-19 vaccination with Pfizer or Moderna vaccine as part of the national vaccination program (cohort I)
-Having received SARS-CoV-2 vaccination with Pfizer or Moderna as part of the national vaccination program with the last vaccination less than 6 weeks before study entry (cohort II + cohort III + cohort IV)
-Written informed consent
Are the trial subjects under 18? yes
Number of subjects for this age range: 130
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

-History of severe adverse reaction associated with a vaccine and/or severe allergic reaction to any component of the study intervention
-Not able to give informed consent (e.g. language problems, illiteracy)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the antibody response after mRNA (Pfizer, Moderna) SARS-CoV-2 vaccination in children with cancer as compared to healthy children;Secondary Objective: To assess in children with cancer after SARS-CoV-2 vaccination:<br>-durability of the antibody response<br>-SARS-CoV-2 specific T and B cell response<br>-the contribution of a 3rd vaccination<br>;Primary end point(s): The primary study parameter is the antibody based immune response to vaccination 28 days (t=3) after the second vaccination compared to controls. Participants will be classified as responders or non-responders;Timepoint(s) of evaluation of this end point: 28 days after second vaccination (t=3)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): -Longevity of SARS-CoV-2 specific antibodies<br>-SARS-CoV-2 specific T-cell response<br>-Additional effect of a 3rd vaccination by measuring antibody based immune response;Timepoint(s) of evaluation of this end point: -21-28 days after vaccination 1 (t=2)<br>-21-28 days after vaccination 2 (t=3)<br>-21-28 days after vaccination 3 (t=4)<br>-12 months after vaccination (t=5)