NCT06316297

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

Recruiting now Phase 1, PHASE2 Last updated 24 November 2025

What this trial tests

Phase 1, PHASE2 trial testing Acne mRNA vaccine in Acne in 260 participants. Currently enrolling.

Timeline

5 April 2024

Primary endpoint
31 August 2028

31 August 2028

Quick facts

Lead sponsor	Sanofi Pasteur, a Sanofi Company
Phase	Phase 1, PHASE2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	triple
Primary purpose	treatment
Enrollment	260
Start date	5 April 2024
Primary completion	31 August 2028
Estimated completion	31 August 2028
Sites	93 locations across Canada, United States, Australia

Drugs / interventions tested

• Acne mRNA vaccine — full drug profile →
• Placebo

Conditions studied

• Acne — all drugs for Acne →

Sponsor

Sanofi Pasteur, a Sanofi Company — full company profile →

Who can join

Adults 18 to 45, any sex, with Acne. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 three 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 a Sentinel Cohort A paired with a Main Cohort, evaluating the safety and efficacy of the 2-administration regimen and a Sentinel Cohort B, evaluating the safety of the 3- administration regimen. The Sentinel Cohorts will assess the safety of the dose levels and regimens in a stepwise manner. If the participants consent to the LTE, they will be followed up for an additional 30 months after the last planned visit in the Core Study, to assess the long-term effects of the vaccine.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Clinical development of therapeutic mRNA applications.
   Żak MM, Zangi L. · · 2025 · cited 28× · PMID 40143545 · DOI 10.1016/j.ymthe.2025.03.034
2. Therapeutic mRNA vaccine applications in oncology.
   Elliott L, Foster T, Castillo P, Mendez-Gomez H, et al · · 2025 · cited 4× · PMID 40336197 · DOI 10.1016/j.ymthe.2025.04.044
3. Nonviral targeted mRNA delivery: principles, progresses, and challenges.
   He X, Li G, Huang L, Shi H, et al · · 2025 · cited 3× · PMID 39760110 · DOI 10.1002/mco2.70035
4. mRNA Vaccine Technology Beyond COVID-19.
   Oloruntimehin S, Akinyi F, Paul M, Ariyo O. · · 2025 · cited 2× · PMID 40573932 · DOI 10.3390/vaccines13060601
5. Immunology of RNA-based vaccines: The critical interplay between inflammation and expression.
   Tregoning JS, Wang Z, Sridhar S, Shattock RJ, et al · · 2025 · cited 1× · PMID 40926412 · DOI 10.1016/j.ymthe.2025.09.011
6. Is There a Place for Biologics in Acne?
   Kemény L, Degovics D, Szabó K. · · 2025 · cited 1× · PMID 40474034 · DOI 10.1007/s40257-025-00954-8
7. Update on novel acne treatments: a narrative review focused on microbiome modulation and non-pharmacological approaches.
   Burckhardt-Bravo V, Funes-Ferrada R, Valenzuela F. · · 2026 · PMID 41544313 · DOI 10.1016/j.abd.2025.501249