Recruiting
Phase 1
Phase 2

Acne mRNA Vaccine

Sponsor:

Sanofi Pasteur, a Sanofi Company

Code:

NCT07013747

Conditions

Acne

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Not accepted

Interventions

Acne mRNA vaccine

Placebo

Study Details

Brief summary:

The purpose of the VBE00009 study is to evaluate the safety, efficacy and immunogenicity of 2 administrations of the Acne mRNA vaccine candidate at single dose level in participants aged 18 to 45 years with mild acne. This study will consist of a Core Study followed by an optional Long-Term Extension (LTE). Core Study will include a Sentinel Cohort and a Main Cohort, with the Sentinel Cohort assessing the safety 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.

Conditions

Acne

Study ID

NCT07013747

Start date

Jul 3, 2025

Status verified date

Jul, 2026

Completion date

Mar 13, 2030

Anticipated

Primary completion date

Jun 19, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Not accepted

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; 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

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Design

Enrollment

228 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Sentinel Cohort Arm 1

Participants will receive 2 Acne mRNA Vaccine injections

placebo comparator: Sentinel Cohort Arm 2

Participants will receive 2 Placebo injections

experimental: Main Cohort Arm 1

Participants will receive 2 Acne mRNA Vaccine injections

placebo comparator: Main Cohort Arm 2

Participants will receive 2 Placebo injections

Interventions

Acne mRNA vaccine

Pharmaceutical form: suspension for injection Route of administration: intramuscular

Placebo

Pharmaceutical form: liquid solution for injection Route of administration: intramuscular

Primary outcome measure

  • Core Study - Sentinel Cohort Arm 1 and 2: Number of participants with unsolicited systemic adverse events (AEs) [ Time Frame: In 30 minutes after each administration ]
  • Core Study - Sentinel Cohort Arm 1 and 2: Number of participants with solicited injection site and systemic reactions [ Time Frame: Up to 7 days after each administration ]
  • Core Study - Sentinel Cohort Arm 1 and 2: Number of participants with unsolicited AEs reported [ Time Frame: Up to 28 days after each administration ]
  • Core Study - Sentinel Cohort Arm 1 and 2: Number of participants with medically attended adverse events (MAAEs) [ Time Frame: Up to 6 months after each administration ]
  • Core Study - Sentinel Cohort Arm 1 and 2: Number of participants with AEs of special interest (AESIs) [ Time Frame: Up to 6 months after each administration ]
  • Core Study - Sentinel Cohort Arm 1 and 2: Number of participants with serious AEs (SAEs) [ Time Frame: Up to 6 months after each administration ]
  • Core Study - Sentinel Cohort Arm 1 and 2: Number of participants with out-of-range biological test results [ Time Frame: Through 7 days after administration (Day 08) ]
  • Core Study - Main Cohort Arm 1 and 2: Percentage change from baseline (Day 01) in the number of inflammatory acne lesions on face [ Time Frame: At 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 face [ Time Frame: At 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) [ Time Frame: Up to 38 months after first administration ]

Central Contacts and Locations

Central contacts

Trial Transparency email recommended (Toll free for US & Canada)

800-633-1610Contact-US@sanofi.com

Locations

Encino Research Center- Site Number : 8400008

Recruiting

Encino, California, United States, 91436

Moore Clinical Research - Brandon- Site Number : 8400007

Recruiting

Brandon, Florida, United States, 33511

Encore Research Group-Jacksonville Center for Clinical Research- Site Number : 8400006

Recruiting

Jacksonville, Florida, United States, 32216

DelRicht Research- Site Number : 8400003

Recruiting

New Orleans, Louisiana, United States, 70115

More Information

Sponsor

Sanofi Pasteur, a Sanofi Company

Last update posted

Jul 9, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Sanofi Pasteur, a Sanofi Company on 2026-07-09.