PvDBPII elicits multiple antibody-mediated mechanisms that reduce growth in a Plasmodium vivax challenge trial.

"Competing interests SJD has provided consultation services to GSK on malaria vaccines, is an inventor on patent applications relating to adenovirus-based vaccines and is an inventor on intellectual property licensed by Oxford University Innovation to AstraZeneca. AMM has provided consultation services to GSK on malaria vaccines and has an immediate family member who is an inventor on patents relating to adenovirus-based vaccines, and is an inventor on intellectual property licensed by Oxford University Innovation to AstraZeneca. CEC is an inventor on patents that relate to binding domains of erythrocyte-binding proteins of Plasmodium parasites including PvDBP. JMR is an employee of Novavax, developer of the Matrix-MTM adjuvant. All other authors declare no financial or non-financial competing interests."

"Development of PvDBPII as a vaccine candidate was supported by grants from the Biotechnology Industry Research Assistance Council (BIRAC), New Delhi and PATH Malaria Vaccine Initiative. MVDP was supported by grants from the Bill and Melinda Gates Foundation and Department of Biotechnology (DBT), Government of India. This work was also supported in part by grants from Agence Nationale de Recherche to CEC [ANR-18-CE15-0026 and ANR-21-CE15-0013-01]. CEC is supported by the French Government’s Laboratoire d’Excellence “PARAFRAP” [ANR-11-LABX-0024-PARAFRAP] in addition to core funding from Institut Pasteur. FJM was supported by a Fellowship from Ecole Doctorale BioSPC (ED562), F-75006, Université Paris Cité. The authors are grateful for the assistance of the VAC069, VAC071 and VAC079 clinical trial teams and all the study volunteers. The VAC069 and VAC071 trials were funded by the European Union’s Horizon 2020 research and innovation program under grant agreement 733073 for MultiViVax. The VAC079 trial was funded by the Wellcome Trust Malaria Infection Study in Thailand (MIST) program [212336/Z/18/Z]. For the purpose of open access, the author has applied a CC BY public copyright licence to any Author Accepted Manuscript version arising from this submission. This work was also supported in part by the UK Medical Research Council (MRC) [G1100086] and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (BRC). The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health. CMN held a Wellcome Trust Sir Henry Wellcome Postdoctoral Fellowship [209200/Z/17/Z]. SJD is a Jenner Investigator and held a Wellcome Trust Senior Fellowship [106917/Z/15/Z]."

"Sera from volunteers participating in the three clinical trials conducted at the University of Oxford, UK were sent to Institut Pasteur, Paris under a Material Transfer Agreement. The clinical trial studies had received ethical approval from UK National Health Service Research Ethics Services, (VAC069: Hampshire A Research Ethics Committee, Ref 18/SC/0577; VAC071: Oxford A Research Ethics Committee, Ref 19/SC/0193; VAC079: Oxford A Research Ethics Committee, Ref 19/SC/0330). The vaccine trials were approved by the UK Medicines and Healthcare products Regulatory Agency (VAC071: EudraCT 2019-000643-27; VAC079: EudraCT 2019-002872-14). The trials are registered under the following ClinicalTrials.gov numbers: VAC069 NCT03797989, VAC071 NCT04009096, VAC079 NCT04201431. The research conducted at the Institut Pasteur received approval from the Institutional Review Board (IRB) of the Institut Pasteur (Research Ref IRB2022-03)."