Immunogenicity of bivalent omicron (BA.1) booster vaccination after different priming regimens in health-care workers in the Netherlands (SWITCH ON):results from the direct boost group of an open-label, multicentre, randomised controlled trial

Verfasser:	Tan, Ngoc H Geers, Daryl Sablerolles, Roos S G Rietdijk, Wim J R Goorhuis, Abraham Postma, Douwe F Visser, Leo G Bogers, Susanne van Dijk, Laura L A Gommers, Lennert van Leeuwen, Leanne P M Boerma, Annemarie Nijhof, Sander H van Dort, Karel A Koopmans, Marion P G Dalm, Virgil A S H Lafeber, Melvin Kootstra, Neeltje A Huckriede, Anke L W van Baarle, Debbie Zaeck, Luca M GeurtsvanKessel, Corine H de Vries, Rory D van der Kuy, P Hugo M
Dokumenttyp:	Artikel
Erscheinungsdatum:	2023
Reihe/Periodikum:	SWITCH ON Research Group , Tan , N H , Geers , D , Sablerolles , R S G , Rietdijk , W J R , Goorhuis , A , Postma , D F , Visser , L G , Bogers , S , van Dijk , L L A , Gommers , L , van Leeuwen , L P M , Boerma , A , Nijhof , S H , van Dort , K A , Koopmans , M P G , Dalm , V A S H , Lafeber , M , Kootstra , N A , Huckriede , A L W , van Baarle , D , Zaeck , L M , GeurtsvanKessel , C H , de Vries , R D & van der Kuy , P H M 2023 , ' Immunogenicity of bivalent omicron (BA.1) booster vaccination after different priming regimens in health-care workers in the Netherlands (SWITCH ON) : results from the direct boost group of an open-label, multicentre, randomised controlled trial ' , Lancet Infectious Diseases , vol. 23 , no. 8 , pp. 901-913 . https://doi.org/10.1016/S1473-3099(23)00140-8
Sprache:	Englisch
Permalink:	https://search.fid-benelux.de/Record/base-26826142
Datenquelle:	BASE; Originalkatalog
Powered By:	BASE
Link(s) :	https://hdl.handle.net/11370/a8e22d3d-ad25-42f1-93ea-baf1f04d9649

BACKGROUND: Bivalent mRNA-based COVID-19 vaccines encoding the ancestral and omicron spike (S) protein were developed as a countermeasure against antigenically distinct SARS-CoV-2 variants. We aimed to assess the (variant-specific) immunogenicity and reactogenicity of mRNA-based bivalent omicron (BA.1) vaccines in individuals who were primed with adenovirus-based or mRNA-based vaccines encoding the ancestral spike protein. METHODS: We analysed results of the direct boost group of the SWITCH ON study, an open-label, multicentre, randomised controlled trial. Health-care workers from four academic hospitals in the Netherlands aged 18-65 years who had completed a primary COVID-19 vaccination regimen and received one booster of an mRNA-based vaccine, given no later than 3 months previously, were eligible. Participants were randomly assigned (1:1) using computer software in block sizes of 16 and 24 to receive an omicron BA.1 bivalent booster straight away (direct boost group) or a bivalent omicron BA.5 booster, postponed for 90 days (postponed boost group), stratified by priming regimen. The BNT162b2 OMI BA.1 boost was given to participants younger than 45 years, and the mRNA-1273.214 boost was given to participants 45 years or older, as per Dutch guidelines. The direct boost group, whose results are presented here, were divided into four subgroups for analysis: (1) Ad26.COV2.S (Johnson & Johnson) prime and BNT162b2 OMI BA.1 (BioNTech-Pfizer) boost (Ad/P), (2) mRNA-based prime and BNT162b2 OMI BA.1 boost (mRNA/P), (3) Ad26.COV2.S prime and mRNA-1273.214 (Moderna) boost (Ad/M), and (4) mRNA-based prime and mRNA-1273.214 boost (mRNA/M). The primary outcome was fold change in S protein S1 subunit-specific IgG antibodies before and 28 days after booster vaccination. The primary outcome and safety were assessed in all participants except those who withdrew, had a SARS-CoV-2 breakthrough infection, or had a missing blood sample at day 0 or day 28. This trial is registered with ClinicalTrials.gov, NCT05471440. FINDINGS: ...