Trial EudraCT 2021-002693-10
Publication Mrak D, Nat Commun, 2022
Dates: 2021-07-22 to 2021-09-10
Funding: Public/non profit (The study was supported by the MedUni Vienna Biobank KIP. Provision of vaccines and laboratory testing was provided free of charge by the City of Vienna and the Medical University of Vienna via the Vienna General Hospital. Laboratory testing was supported by the Medical-Scientific fund of the Mayor of the federal capital Vienna to J.A.)
Conflict of interest: Yes
Single center / Austria |
Follow-up duration (months): 0.9
|BNT162b2 or mRNA-1273 (n = 26)
ChAdOx1 (n = 25)
1 IM dose of either 30 mcg BNT16b2 or 100 mcg mRNA-1273, at least 28 days (mean 106) after 2 prime doses of BNT162b2 (89% of participants) or mRNA-1273 (11% of participants)
1 IM dose of 2.5x10^8 U of ChAdOx1(0.5mL), at least 28 days (mean 97) after 2 prime doses of BNT162b2 (89% of participants) or mRNA-1273 (11% of participants)
|Characteristics of participants|
Type of participants: Immunosuppressed adults
Pregnant women: 0
Immunocompromized patients: 46
Age range: NR
|Description of participants|
Immunosuppressed adults including elderly with no history of COVID-19 in a single centre in Austria.
|In the register|
1) 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). 2) The efficacy of a 3rd mRNA boost vaccination in immunocompromised patients with inadequate humoral response (antibody titre <1500U/ml) to standard SARS-CoV-2 vaccination will be compared to low titre heathy controls by assessing the difference in antibody titre change before and after a second boost between the two groups.
|In the report|
Difference in SARS-CoV-2 spike antibody seroconversion rate between vector and mRNA vaccinated patients four weeks after the third dose. According to the manufacturer’s specification, seroconversion was defined as an anti-RBD antibody concentration of over 0.8 BAU/ml.
Yes. In English
Yes, Proposals must be submitted to the corresponding authors and will be reviewed within 2 months.
|Risk of bias
The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review
|General comment||In addition to the published article and its supplement, the study registry and protocol were used in data extraction and risk of bias assessment. Recruitment was stopped early to allow timely completion, due to slowed inclusion rates from routine access to the additional vaccination dose being facilitated for high-risk patients in Austria. As a result, the target sample size (N=300) specified in the registry was not achieved. Some efficacy outcomes were not reported in the paper. There is no change from the trial registration in the intervention and control treatments.|