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Acne mRNA Vaccine Study for Moderate to Severe Acne

This study is testing an experimental Acne mRNA vaccine to see how safe and effective it is for adults aged 18 to 45 who have moderate to severe acne. Researchers will also look at immunogenicity, which is how well your body creates an immune response to the vaccine. You would receive up to three injections of either the Acne mRNA vaccine or a placebo (an inactive substance that looks like the vaccine). The main goals are to track any side effects, especially right after injections, and over the first 28 days. To join, you need to be generally healthy and have a clinical diagnosis of moderate or severe facial acne.

Study design
This study plans to enroll 800 participants in different groups, some receiving two doses and others three doses of the vaccine or placebo.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for side effects for up to 28 days after each injection.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06316297

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

Recruiting
PHASE1Ages 18–45InterventionalTreatment
Sanofi Pasteur, a Sanofi Company
~800 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:Acne mRNA vaccinePlacebo

At a glance

Recruiting sites
94 of 94 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Core Study - Sentinel Cohorts A and B: Number of participants with unsolicited systemic AEs
Measured over 30 minutes after each administration
+10 more outcomes measured

Conditions

Acne

Explore related trials

Acne

Where it's being run

94 sites across 33 states
Florida23
California18
Texas6
Utah4
Illinois3
Louisiana3
New South Wales3
Victoria3

Who to contact

Trial Transparency email recommended (Toll free for US & Canada)
[email protected]
800-633-1610 · ext. option 6
Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, and laboratory tests as judged by the investigator
Clinical diagnosis of moderate or severe facial acne vulgaris with Investigator's Global Assessment (IGA) score of Moderate or Severe (grade 3 or grade 4 on the 5-grade IGA scale) and ≥ 25 non-inflammatory lesions (ie, open and closed comedones) and ≥ 20 inflammatory lesions (ie, papules and pustules) and ≤ 2 nodulocystic lesions (ie, nodules and cysts)

Exclusion

Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within 6 months prior to the first study intervention administration; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
Known systemic hypersensitivity to any of the study intervention components; history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances; any allergic reaction (eg, anaphylaxis) after administration of mRNA coronavirus disease 2019 (COVID-19) vaccine
Active nodulocystic acne, acne conglobate, acne fulminans, secondary acne (eg, chloracne, drug-induced acne) or other forms of acne (eg, acne mechanica)
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
Previous vaccination against C. acnes with an investigational vaccine
Receipt of immune globulins, blood or blood-derived products in the past 3 months
Self-reported or documented seropositivity for human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus.

What this trial measures

  • Core Study - Sentinel Cohorts A and B: Number of participants with unsolicited systemic AEs30 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 reactionsUp 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 AEsUp to 28 days after each administration
  • Core Study - Sentinel Cohorts A and B: Number of participants with MAAEsUp to 6 months after each administration

    Presence of medically attended adverse events (MAAEs)

  • Core Study - Sentinel Cohorts A and B: Number of participants with SAEsUp to 6 months after each administration

    Presence of all serious adverse events (SAEs)

  • Core Study - Sentinel Cohorts A and B: Number of participants with AESIsUp 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 faceAt 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 faceAt 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 atAt 2 months post last administration
  • Long-Term Extension - Sentinel Cohorts A, B and Main Cohort: Number of participants with SAEs and AESIsUp to 38 or 40 months after first administration

    Presence of all serious adverse events (SAEs) and adverse events of special interest (AESIs)