Study to Evaluate Safety, Efficacy and Immunogenicity of Acne mRNA Vaccine in Adults With Moderate to Severe Acne

Condition(s) studied

Investigational drug(s) / intervention(s)

Acne mRNA vaccine: Pharmaceutical form: Liquid suspension for injection Route of administration: intramuscular

Placebo: Pharmaceutical form: Liquid solution for injection Route of administration: intramuscular

Study summary

The purpose of the trial is to evaluate the safety, efficacy and immunogenicity of up to 3 intramuscular injections of the Acne mRNA vaccine candidate at up to four dose levels in adult participants aged 18 to 45 years with moderate to severe acne.

This trial will consist of a Core Study followed by an optional Long-Term Extension (LTE).

The Core Study will consist of:

* Two cohorts evaluating the 2-administration regimen (Cohorts A): Sentinel Cohort A and Main Cohort A.
* Two cohorts evaluating the 3-administration regimen (Cohorts B): Sentinel Cohort B and Main Cohort B.

Participants from Sentinel Cohorts A and B and from Main Cohort A will be invited to an additional 30-month follow up after completing their last planned Core Study visit to assess the long-term effects of the vaccine. Participants from Main Cohort B will be invited to another LTE study managed through a separate protocol.

Eligibility

Primary outcome measure(s)

• Core Study - Sentinel Cohorts A and B: Number of participants with unsolicited systemic AEs — 30 minutes after each administration
  Presence of unsolicited systemic adverse events (AEs) reported
• Core Study - Sentinel Cohorts A and B: Number of participants with solicited injection site and systemic reactions — Up to 7 days after each administration
  Presence of solicited injection site and systemic reactions (ie, pre-listed in the participant diary \[PDi\] and in the case report form \[CRF\])
• Core Study - Sentinel Cohorts A and B: Number of participants with unsolicited AEs — Up to 28 days after each administration
• Core Study - Sentinel Cohorts A and B: Number of participants with MAAEs — Up to 6 months after each administration
  Presence of medically attended adverse events (MAAEs)
• Core Study - Sentinel Cohorts A and B: Number of participants with SAEs — Up to 6 months after each administration
  Presence of all serious adverse events (SAEs)
• Core Study - Sentinel Cohorts A and B: Number of participants with AESIs — Up to 6 months after each administration
  Presence of AEs of special interest (AESIs)
• Core Study - Sentinel Cohorts A and B: Number of participants with out-of-range biological test results (including shift from baseline values) — Through 7 days after administration (Day 8)
• Core Study - Main Cohort A: Percentage change from baseline (Day 1) in the number of inflammatory acne lesions on face — At 2 months post last administration
• Core Study - Main Cohort A: Percentage change from baseline (Day 1) in the number of non-inflammatory acne lesions on face — At 2 months post last administration
• Core Study - Main Cohort B: Percentage change from baseline (Day 1) in the total number of acne lesions on face at — At 2 months post last administration
• Long-Term Extension - Sentinel Cohorts A, B and Main Cohort: Number of participants with SAEs and AESIs — Up to 38 or 40 months after first administration
  Presence of all serious adverse events (SAEs) and adverse events of special interest (AESIs)

Trial sites (94)

+ 54 more sites — see the full list on the official registry below.

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