AntiBody response in Risk groups to COrona Vaccination treated in the Adrz hospital:

• Conditions: immunocompromised patients; patients with decreased defense against infections; 10003816; 10027656; 10038430

• Registration Number: NL-OMON50794
• Lead Sponsor: Interne Geneeskunde

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 120

Inclusion Criteria

•Study participant belongs to either of the 6 defined groups and is planned for
vaccination with the BNT162b2 or the mRNA1273 vaccine according to the National
Institute for Public Health guideline, i.e.:
• Inflammatory bowel disease and on treatment for at least 6 weeks with
anti-TNF agents (infliximab, adalimumab and biosimilars)
• post kidney transplantation and on immunosuppressants
• Treated with B-cell depleting, antiCD20 (Obinituzumab or Rituximab)
monotherapy for a hematological malignancy in the past 6 months
• Chronic lymphocytic leukemia (CLL), irrespective of stage, not treated for
CLL in the past 6 months prior to the first vaccination and no treatment
expected within 4 weeks of the second vaccination
• Advanced solid malignancy and on treatment for at least 6 weeks with one or
more of the following agents: doxorubicin, cyclophosphamide, docetaxel,
cisplatinum, etoposide, irinotecan
• healthy volunteers

• Study participant is older than 17 years and willing to undergo vaccination
• Study participant is able to give written informed consent
• Study participant is able to visit the ADRZ for the scheduled laboratory
visits

Exclusion Criteria

History of a documented SARS COV-2 infection
Considered as high risk for a hypersensitivity reaction

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Vaccine efficacy ( SARS CoV incidence within a follow up of at least 2 years)<br /><br><br /><br>Quality and quantity of the antbody response to the vaccines in 5 patient<br /><br>groups compared to healthy volunteers </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Adverse effects after first and second vaccination </p><br>