The purpose of this study is to assess the safety profile of intramuscular injections of the Acne mRNA vaccine at 3 dose levels compared with placebo in 12 to 17 years old participants with moderate to severe acne. An early safety data review (ESDR) will be conducted after each subcohort has completed an injection round; enrollment of the next higher dose level subcohort or progression of a subcohort to the subsequent injection round will only proceed if no safety concerns are identified. This sequential process will allow a cautious approach to vaccine injection in the adolescent population. Study details are as follows: * Before being enrolled in the study, participants complete a 4-week (ie, 1-month) screening period during which they will be called over the telephone approximately in the middle of the screening period to check they are not using prohibited medications and to remind them about the facial hygiene requirements. * Once the screening period has been completed, the study duration will be up to 13 months for each participant * Participants will be invited to a long-term extension study through a separate protocol.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
410
IM injection
IM injection
Unsolicited systemic AEs (Adverse Events)
Presence of unsolicited systemic adverse events (AEs) reported
Time frame: 30 minutes after each injection
Solicited injection site and systemic adverse reactions
Presence of solicited injection site and systemic reactions (ie, pre-listed in the participant diary \[PDi\] and in the case report form \[CRF\])
Time frame: 8 days, including the day of each injection
Unsolicited AEs
Presence of unsolicited adverse events (AEs) reported
Time frame: 28 days, including the day of each injection
SAEs (Serious Adverse Events), MAAEs (Medically Attended Adverse Event), AESIs (Adverse Event of Special Interest) and AEs (Adverse Events) leading to study discontinuation
Presence of SAEs (Serious Adverse Events), MAAEs (Medically Attended Adverse Event), AESIs (Adverse Event of Special Interest) and AEs (Adverse Events) leading to study discontinuation
Time frame: Up to 2 months after last injection
Out-of-range biological test results (including shift from baseline values)
Time frame: Within 8 days after each injection, including the day of injection
Percentage change from baseline in total number of acne lesions on the face
Time frame: At 2 months after last injection
SAEs (Serious Adverse Events), MAAEs (Medically Attended Adverse Event), AESIs (Adverse Event of Special Interest) and AEs (Adverse Events) leading to study discontinuation
Presence of SAEs (Serious Adverse Events), MAAEs (Medically Attended Adverse Event), AESIs (Adverse Event of Special Interest) and AEs (Adverse Events) leading to study discontinuation
Time frame: Up to 13 months
Absolute and percentage change from baseline in the number of inflammatory acne lesions on the face
Time frame: At 1 month after first injection until 9 months after last injection
Absolute and percentage change from baseline in the number of non- inflammatory acne lesions on the face
Time frame: At 1 month after first injection until 9 months after last injection
Absolute and percentage change from baseline in total number of acne lesions on the face
Time frame: At 1 month after first injection until 9 months after last injection
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