Acne mRNA vaccine for adults with mild facial acne

A Phase 1/2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Efficacy and Immunogenicity of an Acne mRNA Vaccine Candidate in Participants With Mild Acne

This trial will test two injections of an acne mRNA vaccine versus placebo in adults 18–45 with mild facial acne to see if it's safe, triggers an immune response, and improves acne.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years to 45 Years
• Sex: All
• Sponsor: Sanofi (industry)
• Drugs / interventions: chemotherapy, radiation, prednisone
• Locations: 4 sites (Encino, California and 3 other locations)
• Trial ID: NCT07013747 on ClinicalTrials.gov

What this trial studies

This randomized, placebo-controlled Phase 1/2 trial gives two administrations of a single-dose level acne mRNA vaccine to adults aged 18–45 with mild facial acne, starting with a sentinel cohort followed by a main cohort to monitor safety. Primary outcomes include safety, immunogenicity, and preliminary efficacy compared with placebo, with participants required to meet specific IGA and lesion-count criteria. The Core Study covers initial dosing and follow-up visits, and consenting participants may enter an optional long-term extension for an additional 30 months of follow-up. Study procedures require in-person visits at clinical sites in California and Florida for injections and assessments.

Who should consider this trial

Good fit: Adults aged 18–45 who are otherwise healthy and have mild facial acne (IGA grade 2) with 10–24 non-inflammatory lesions and 5–19 inflammatory lesions and no nodulocystic disease.

Not a fit: People with moderate-to-severe or nodulocystic acne, those who are immunocompromised or recently on immunosuppressive therapy, pregnant individuals, or those outside the 18–45 age range are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, the vaccine could reduce acne lesions by inducing a targeted immune response and offer a durable, non-antibiotic treatment option for people with mild acne.

How similar studies have performed: Applying mRNA vaccine technology to acne is a novel approach with limited prior clinical data in acne specifically, although mRNA platforms have been highly successful in other diseases.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

Participants are excluded from the study if any of the following criteria apply:

* 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 (eg, polyethylene glycol \[PEG\], polysorbate); 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 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

Where this trial is running

Encino, California and 3 other locations

• Encino Research Center- Site Number : 8400008 — Encino, California, United States (RECRUITING)
• Moore Clinical Research - Brandon- Site Number : 8400007 — Brandon, Florida, United States (RECRUITING)
• Encore Research Group-Jacksonville Center for Clinical Research- Site Number : 8400006 — Jacksonville, Florida, United States (RECRUITING)
• DelRicht Research- Site Number : 8400003 — New Orleans, Louisiana, United States (RECRUITING)

Study contacts

• Study coordinator: Trial Transparency email recommended (Toll free for US & Canada)

Conditions: Acne