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 | |
Variants description | |
Variants | |
Description * | |
Documents avalaible |
Protocol Yes. In English Statistical plan Yes Data-sharing stated:
Yes |
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. |