Covid-19 Living Data

Trial NCT05030974
Publication Kho M, Lancet Infect Dis, 2022
Dates: 2021-10-20 to 2022-02-02
Funding: Public/non profit (The Netherlands Organization for Health Research and Development ; Dutch Kidney Foundation)
Conflict of interest: no COI

Methods
	RCT
	Location : Multicenter / Netherlands Follow-up duration (months): 0.9
	Booster: 100 μg mRNA-1273 (n = 75) 2 × 100 μg mRNA-1273 (n = 77) Ad26.COV2-S 5 × 10^10 vp (n = 78) .
Inclusion criteria	Eligible for COVID-19 vaccination as described by the instructions of the manufacturers Age of 18 years or older Capable of understanding purpose and risks of the study written informed consent At least 6 months after kidney transplantation Received 2 doses of mRNA-1273 or BNT162b2 and the last administration within the last 9 months Negative seroresponse 14 to 56 days after vaccination, measured by a validated anti-spike IgG assay.
Exclusion criteria	History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s) Multi-organ transplant recipient Previous or active COVID-19 disease Active malignancy, except non-melanoma skin cancer Inherited immune deficiency Infection with Human Immunodeficiency Virus (HIV) Administration of T-cell, B cell, or plasma cell depleting antibodies during the last 6 months Any vaccination within a week before enrolment Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection History of recurrent venous thrombosis or venous thrombosis <2 years before baseline Immune-mediated diseases associated with thrombocytopenia such as immune thrombocytopenia and atypical hemolytic uremic syndrome.
Interventions
	Intervention 1 IM dose of 5 × 10^10 vp Ad26.COV2-S, <9 months after 2 doses mRNA-1273 or BNT162b2 2 IM doses of 100 mcg mRNA-1273, <9 months after 2 doses mRNA-1273 or BNT162b2
	Control 1 IM dose of 100 mcg mRNA-1273, <9 months after 2 doses mRNA-1273 or BNT162b2
Participants
	Randomized 230 participants
	Characteristics of participants Type of participants: Adult kidney transplant recipients N=230 141 males Children: 0 Immunocompromized patients: 218 Mean age: Age range: NR
	Description of participants Adult kidney transplant recipients without seroconversion after two doses of an mRNA vaccine and no history of COVID-19 at 4 centers in the Netherlands.
Primary outcome
	In the register Positive SARS-CoV-2 seroresponse [ Time Frame: 28 days after third vaccination ] The percentage of subjects with a serum anti-S1 IgG concentration ≥10 BAU/mL after the third or fourth vaccine administration
	In the report The percentage of participants with a spike protein (S1)-specific IgG concentration of at least 10 binding antibody units per mL at 28 days after vaccination.
Documents available	Protocol NR Statistical plan * Data-sharing stated: Yes Data accessibility: The data that support the findings of this study are available from the corresponding author, on reasonable request. Research proposals can be submitted to the consortium members via the corresponding author. Prof Luuk B Hilbrands - luuk.hilbrands@radboudumc.nl
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 published article, the trial registry and supplementary appendices were used in data extraction and assessment of risk of bias. Neither protocol nor statistical analysis plan was available. There is no change from the trial registration in the intervention and control treatments. The primary outcome in the article reflects that in the registry. The trial (n = 230) did not achieve its target sample size (n = 300).