Covid-19 Living Data

Trial NCT04927936
Publication Sablerolles R, Clin Infect Dis, 2022

Funding: Public/non profit (the Netherlands Organization for Health Research and Development ZonMw.)
Conflict of interest: no COI

Methods
	RCT
	Location : Multicenter / The Netherlands Follow-up duration (months): 5
	Ad26.COV2.S boost (n = 116) mRNA-1273 boost (n = 116) BNT162b2 boost (n = 115) No boost (n = 114)
Inclusion criteria	18-65 years of age health care worker without severe comorbidities no known history of SARS-CoV-2 infection (either laboratory-confirmed or self-reported) primed with the Ad26.COV2.S vaccine 3 months before enrollment
Exclusion criteria	Younger than 18 or older than 65 years already vaccinated with other vaccine then Janssen Previously had a COVID-19 infection History of allergic reaction likely to be exacerbated by any component of study vaccines (e.g. hypersensitivity to the active substance or any of the ingredients of the Janssen/Pfizer/Moderna vaccine) pregnant or have a wish to become pregnant within 6 months Currently being treated for cancer Severe kidney failure or dialyses dependent Status after organ-, stem cell- or bone marrow transplantation Use of immunosuppressants Epilepsy HIV Bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding of bruising following injections of vene puncture Continuous use of anticoagulants, such as coumarins (e.g. acenocoumarol) or novel oral anticoagulants (i.e. apixaban, dabigatran etc) currently participating in another research trial All regular contra-indications of the vaccines will be applied.
Interventions
	Intervention No booster after Ad26.COV2.S primary vaccination 1 IM dose mRNA-1273 84 days (−7/+21) after primary Ad26.COV2.S vaccination 1 IM dose BNT162b2 84 days (−7/+21) after primary Ad26.COV2.S vaccination
	Control 1 IM dose Ad26.COV2.S 84 days (−7/+21) after primary Ad26.COV2.S vaccination
Participants
	Randomized 461 participants
	Characteristics of participants Type of participants: Healthcare workers N=461 153 males Children: 0 Pregnant women: 0 Immunocompromized patients: 0 Mean age: Age range: NR
	Description of participants Healthcare workers aged 18-65 years, without severe comorbidities, and no known history of SARS-CoV-2 infection who received a single Ad26.COV2.S primary vaccination at 4 centers in the Netherlands.
Primary outcome
	In the register Determination of antibodies by a quantitative IgG assay (LIAISON SARS-CoV-2 TrimericS IgG essay) 28 days after booster [ Time Frame: 28 days after booster ]
	In the report SARS-CoV-2-specific binding antibodies at day 0 and 28 days after the boost
Documents available	Protocol Yes. In English Statistical plan Yes Data-sharing stated: Yes, Data will become available within 12 months after the end of the study. Data accessibility: All data produced in the present study are available upon reasonable request to the authors. Corresponding author: P.H.M. van der Kuy. E-mail: h.vanderkuy@erasmusmc.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 pre-print article, the trial registry and supplementary materials were used in data extraction and assessment of risk of bias. Neither protocol nor statistical analysis plan was available. There were no important differences between protocol/registry and published report in population, procedures, interventions or outcomes. The article presented interim analyses for a study with ongoing follow-up. The study (n = 461) achieved the target sample size in the registry (n = 432). This trial was updates on Mars 8th, 2022, after publication of study report. This trial was further updated on November 30th 2022 after publication of results at a longer follow up.