A Phase I/II, randomized, placebo-controlled, multi-arm, dose-finding study to evaluate the safety, efficacy and immunogenicity of an Acne mRNA vaccine candidate in adults with moderate to severe acne 18 to 45 years of age (NCT06316297)

The aim of the trial is to evaluate the safety, efficacy and immunogenicity of up to 3 administrations of the Acne mRNA vaccine candidate at up to 3 dose levels (45 µg, 120 µg and 225 µg total mRNA) in adults aged 18 to 45 years with moderate to severe acne. This is a phase I/II trial, in which about 260 people will take part in this study worldwide. 36/260 will be randomized in Sentinel cohort A, 200 participants in the main cohort A and 24 participants in Sentinel cohort B.

Trial phase

Phase 1

Trial participation type

This trial has been designed for the Clinical Research of a Drug.

Principal investigator

Prof Johannes S Kern

Key inclusion data

Participants are eligible (inclusion) for the study only if all of the following criteria are met: Aged 18 to 45 years on the day of the first study intervention administration; Participants who are overtly healthy as judged by the investigator; Refrain from use of any other acne treatments for the duration of the study (pre-specified non-medicated cleansers and sunscreen will be allowed). Participants are not eligible for the study if any of the following criteria are met: Use of any acne-affecting treatment without an appropriate washout period; Receipt of any vaccine (other than the study vaccine) in the 4 weeks preceding any study intervention administration or planned receipt of any vaccine (other than the study vaccine) in the 4 weeks following any study intervention administration; Receipt of any mRNA vaccine in the 60 days preceding any study intervention administration or planned receipt of any mRNA vaccine in the 60 days following any study intervention administration; Previous vaccination against C. acnes with an investigational vaccine.