Hyöty, Heikki http://orcid.org/0000-0003-0370-4145
Kääriäinen, Susanna
Laiho, Jutta E. http://orcid.org/0000-0002-5443-4651
Comer, Gail M.
Tian, Wei
Härkönen, Taina http://orcid.org/0000-0002-1068-224X
Lehtonen, Jussi P. http://orcid.org/0009-0007-2168-5765
Oikarinen, Sami http://orcid.org/0000-0003-3901-6774
Puustinen, Leena http://orcid.org/0000-0002-6677-8654
Snyder, Michele
León, Francisco
Scheinin, Mika http://orcid.org/0000-0001-7579-9126
Knip, Mikael http://orcid.org/0000-0003-0474-0033
Sanjuan, Miguel
Funding for this research was provided by:
Provention Bio Inc. a Sanofi company
Tampere University
Article History
Received: 18 September 2023
Accepted: 21 November 2023
First Online: 19 February 2024
Acknowledgements
: The authors would like to thank all the participants who agreed to participate in the study. The authors also thank M. Flodström-Tullberg (Karolinska Institutet, Sweden) for her contribution to preclinical mouse studies, M. Rewers (Barbara Davis Center, University of Colorado, USA), for his contribution to islet autoantibody analyses and J. Lempainen (Department of Clinical Medicine, University of Turku, Finland), for her contribution to the HLA genotyping. We acknowledge the important contribution of Leads to Development Ltd (L2D), Paris, France, in various stages of the development of PRV-101, and Intravacc B.V., Bilthoven, Netherlands, in the GMP manufacturing of PRV-101. We also wish to thank the personnel of CRST Oy, as well as the virus laboratory of Tampere University and autoantibody laboratory of the University of Helsinki, for their skilful work. Statfinn Oy, Espoo, Finland, is acknowledged for the data management and analyses. We appreciate the work of R. Harju, of Vactech Oy, for administrative contribution to the study.
: The datasets are available from the corresponding author upon reasonable request.
: Provention Bio, Inc., a Sanofi company, was the study sponsor, responsible for funding and involved in study design, partnership with collaborators and data collection. The sponsor was involved in the analysis and interpretation of data and writing the report, but did not impose restrictions regarding the submission of the report for publication.
: WT, MSa, GMC, FL and MSn are employed by Provention Bio, Inc, a Sanofi company, which is developing PRV-101. Provention Bio was involved in the design and management of the trial, data collection and analysis. MK and HH are board members and stock owners of Vactech Oy, a Finnish biotech company that has contributed to the early-stage development of the vaccine and participated in the trial design and laboratory analyses. SK and MSc are employees of CRST Oy, a clinical contract research organisation that was contracted by Provention Bio to perform the study. The authors declare that there are no other relationships or activities that might bias, or be perceived to bias, their work.
: FL, MK, MSc, HH, SK, MSn and GMC were responsible for the overall design of the study and MSa and FL for the overall management of the study. SK and MSc were responsible for the recruitment of study participants and management of the study at CRST Oy. JEL and HH were responsible for project administration in the Tampere virus laboratory and TH and MK in the Helsinki islet autoantibody laboratory. TH was responsible for the autoantibody data analyses, JEL was responsible for the virus-neutralising antibody analyses and SO and LP for the virus PCR and ELISA analyses. WT, MSa and JPL were responsible for the overall data analyses. HH, MSa and JEL were primary contributors in the preparation of the manuscript. All authors reviewed and edited the manuscript and approved the final version. MSc is the guarantor of this work and accepts full responsibility for the work and/or the conduct of the study, had access to the data and controlled the decision to publish.