Trial EudraCT 2021-002348-57
Publication Bonelli M, Ann Rheum Dis , 2022
Dates: 2021-05-25 to 2021-05-08
Funding: Public/non profit (Medical University of Vienna; City of Vienna; Medical-Scientific fund of the Mayor of the federal capital Vienna.)
Conflict of interest: Yes

Methods
RCT
Location : Single center / Austria
Follow-up duration (months): 1
Third boost dose BNT162b2 or mRNA-1273 (n=30) Third boost dose ChAdOx1 (n=30)
Inclusion criteria
  • Adults (≥ 18 years)
  • with chronic-inflammatory rheumatic or neurologic diseases under current rituximab therapy
  • without detectable SARS-CoV-2 spike protein antibodies at least four weeks after their second standard vaccination with an mRNA vaccine (BNT162b2 or mRNA-1273)
Exclusion criteria
  • Humoral response to the SARS-CoV-2 vaccination
  • grade 3 adverse effects from the mRNA vaccination reported
  • pregnancy and breast feeding
  • signs of SARS-CoV-2 infection (including previous positive PCR testing)
  • any other contraindication to any of the study compounds
  • urgent need for next rituximab application
Interventions
Intervention
1 IM booster dose >4 weeks after full primary vaccination schedule
Control
1 IM booster dose >4 weeks after full primary vaccination schedule
Participants
Randomized
60 participants
Characteristics of participants
Type of participants: Adults under rituximab therapy
N=60
14 males
Children: 0
Pregnant women: 0
Immunocompromized patients: 60
Mean age:
Age range: NR
Description of participants
Adults under current rituximab therapy who did not develop humoral response against SARS-CoV-2 after their standard vaccination with Biontech/Pfizer or Moderna in a single center in Austria
Primary outcome
In the register
Difference in SARS-CoV-2 antibody seroconversion rate by week 4 after vaccination boost at baseline between 3rd mRNA SARS-CoV-2 (Biontech/Pfizer or Moderna) and vector SARS-CoV-2 vaccine (AstraZeneca)
In the report
Difference in antibody seroconversion rates between the vector and mRNA vaccinated groups
Documents
available

Protocol

Yes. In English

Statistical plan

Yes

Data-sharing stated: Yes
Data accessibility: Anonymous participant data is available under specific conditions. Proposals will be reviewed and approved by the sponsor, scientific committee, and staff on the basis of scientific merit and absence of competing interests. Once the proposal has been approved, data can be transferred through a secure online platform after the signing of a data access agreement and a confidentiality agreement. Corresponding author: Daniel Aletaha, daniel.aletaha@meduniwien.ac.at
Risk of bias
Overall
The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review
Some concerns
General comment In addition to the pre-print article, the supplementary materials, prospective study registry, and protocol were used in data extraction and risk of bias assessment. There were no important differences between protocol/registry and published report in population, procedures, interventions or outcomes.