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Study of Acne mRNA Vaccine for Mild Acne

This study is testing an experimental Acne mRNA vaccine to see how safe and effective it is for people aged 18 to 45 who have mild acne. Researchers will also look at immunogenicity, which means how your body's immune system responds to the vaccine. You would receive either the Acne mRNA vaccine or a placebo (an inactive liquid solution) through an injection into your muscle. The main goal is to track any side effects, both at the injection site and throughout your body, shortly after each vaccine dose and for up to 28 days afterward. To join, you need to be generally healthy and have a clinical diagnosis of mild facial acne, with 10 to 24 non-inflammatory lesions (like blackheads and whiteheads). The study plans to enroll 228 participants.

Study design
This interventional study is evaluating the Acne mRNA vaccine against a placebo. It includes a Core Study with a Sentinel Cohort to assess safety in steps, and a Main Cohort.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants in the Core Study will be followed for up to 28 days after each administration. If you choose to, you can join an optional Long-Term Extension for an additional 30 months after the Core Study.

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

NCT07013747

Study to Evaluate Safety, Efficacy and Immunogenicity of Acne mRNA Vaccine in Participants With Mild Acne

Recruiting
PHASE1Ages 18–45InterventionalTreatment
Sanofi Pasteur, a Sanofi Company
~228 participants
Updated 2026-07-09 on ClinicalTrials.gov
What's tested:Acne mRNA vaccinePlacebo

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Core Study - Sentinel Cohort Arm 1 and 2: Number of participants with unsolicited systemic adverse events (AEs)
Measured over In 30 minutes after each administration
+9 more outcomes measured

Conditions

Acne

Explore related trials

Acne

Where it's being run

4 sites across 3 states
Florida2
California1
Louisiana1

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?

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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 mild facial acne vulgaris with:
IGA score of mild (grade 2 on the 5-grade IGA scale) AND
between 10 to 24 non-inflammatory lesions (ie, open and closed comedones) AND
between 5 to 19 inflammatory lesions (ie, papules and pustules) AND
no 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
Previous history of or undergoing (suspected or confirmed) myocarditis and/or pericarditis and/or myopericarditis
Skin pathology or condition that, in the investigator's opinion, could interfere with the evaluation of the study intervention or requires use of interfering topical, systemic, or surgical therapy
Excessive facial hair, facial tattoos, facial skin disorders, skin reactions that may interfere with the study assessments in the investigator's opinion (including - but not limited to - actinic keratosis, eczema, psoriasis, seborrheic dermatitis, rosacea, acute or recent sunburn) or skin infection
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 Cohort Arm 1 and 2: Number of participants with unsolicited systemic adverse events (AEs)In 30 minutes after each administration
  • Core Study - Sentinel Cohort Arm 1 and 2: Number of participants with solicited injection site and systemic reactionsUp to 7 days after each administration

    pre-listed in the participant diary \[PDi\] and in the case report form \[CRF\]

  • Core Study - Sentinel Cohort Arm 1 and 2: Number of participants with unsolicited AEs reportedUp to 28 days after each administration
  • Core Study - Sentinel Cohort Arm 1 and 2: Number of participants with medically attended adverse events (MAAEs)Up to 6 months after each administration
  • Core Study - Sentinel Cohort Arm 1 and 2: Number of participants with AEs of special interest (AESIs)Up to 6 months after each administration
  • Core Study - Sentinel Cohort Arm 1 and 2: Number of participants with serious AEs (SAEs)Up to 6 months after each administration

    Presence of all SAEs

  • Core Study - Sentinel Cohort Arm 1 and 2: Number of participants with out-of-range biological test resultsThrough 7 days after administration (Day 08)

    Presence of out-of-range biological test results (including shift from baseline values)

  • Core Study - Main Cohort Arm 1 and 2: Percentage change from baseline (Day 01) in the number of inflammatory acne lesions on faceAt 2 months post last administration
  • Core Study - Main Cohort Arm 1 and 2: Percentage change from baseline (Day 01) in the number of non-inflammatory acne lesions on faceAt 2 months post last administration
  • Long-Term Extension - Sentinel and Main Cohort Arm 1 and 2: Number of participants with serious adverse events (SAEs) and adverse events of special interest (AESIs)Up to 38 months after first administration

    Presence of all SAEs and AESIs