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Safety and immunogenicity of a mRNA rabies vaccine in healthy adults: an open-label, non-randomised, prospective, first-in-human phase 1 clinical trial by Martin Alberer; Ulrike Gnad-Vogt; Henoch Sangjoon Hong; Keyvan Tadjalli Mehr; Linus Backert; Greg Finak; Raphael Gottardo; Mihai Alexandru Bica; Aurelio Garofano; Sven Dominik Koch; Mariola Fotin-Mleczek; Ingmar Hoerr; Ralf Clemens; Frank von Sonnenburg is a Social Sciences article available to read on EtoBox.

What is Safety and immunogenicity of a mRNA rabies vaccine in healthy adults: an open-label, non-randomised, prospective, first-in-human phase 1 clinical trial about?

## Background: Vaccines based on mrna coding for antigens have been shown to be safe and immunogenic in preclinical models. we aimed to report results of the first-in-human proof-of-concept clinical trial in healthy adults of a prophylactic mrna-based vaccine encoding rabies virus glycoprotein (cv7201). ## Methods: We did an open-label, uncontrolled, prospective, phase 1 clinical trial at one centre in munich, germany. healthy male and female volunteers (aged 18-40 years) with no history of rabies vaccination were sequentially enrolled. they received three doses of cv7201 intradermally or intramuscularly by needle-syringe or one of three needle-free devices. escalating doses were given to subsequent cohorts, and one cohort received a booster dose after 1 year. the primary endpoint was safety and tolerability. the secondary endpoint was to determine the lowest dose of cv7201 to elicit rabies virus neutralising titres equal to or greater than the who-specified protective antibody titre of 0·5 iu/ml. the study is continuing for long-term safety and immunogenicity follow-up. this trial is registered with clinicaltrials.gov, number nct02241135. ## Findings: Between oct 21, 2013, and jan

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Author

Martin Alberer; Ulrike Gnad-Vogt; Henoch Sangjoon Hong; Keyvan Tadjalli Mehr; Linus Backert; Greg Finak; Raphael Gottardo; Mihai Alexandru Bica; Aurelio Garofano; Sven Dominik Koch; Mariola Fotin-Mleczek; Ingmar Hoerr; Ralf Clemens; Frank von Sonnenburg

Publisher

Elsevier BV

Published

2017

Language

EN

Field

Social Sciences