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

Phase 1

Recruiting

• Conditions: Acne
• Interventions: Biological: Acne mRNA vaccine; Other: Placebo

• Registration Number: NCT07013747
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-06-02
• Study First Submitted QC: 2025-06-02
• Study First Posted: 2025-06-10
• Study Start: 2025-07-03
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-28
• Last Update Posted: 2025-09-05
• Primary Completion: 2029-06-19
• Study Completion: 2029-06-19

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Sentinel Cohort Arm 1	Acne mRNA vaccine	Participants will receive 2 Acne mRNA Vaccine injections
Sentinel Cohort Arm 2	Placebo	Participants will receive 2 Placebo injections
Main Cohort Arm 1	Acne mRNA vaccine	Participants will receive 2 Acne mRNA Vaccine injections
Main Cohort Arm 2	Placebo	Participants will receive 2 Placebo injections

Primary Outcome Measures

Name	Time	Method
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 reactions	Up 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 reported	Up 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 results	Through 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 face	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	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)	Up to 38 months after first administration	Presence of all SAEs and AESIs

Secondary Outcome Measures

Name	Time	Method
Core Study - Main Cohort Arm 1 and 2: Percentage change from baseline (Day 01) in the number of inflammatory acne lesions on face	At 1 month post first administration to 6 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	At 1 month post first administration to 6 months post last administration
Core Study - Sentinel and Main Cohort Arm 1 and 2: Vaccine-antigen-specific serum antibody titers	From baseline (Day 01) to 6 months post last administration
Core Study - Main Cohort Arm 1 and 2: Absolute change from baseline (Day 01) in the number of inflammatory acne lesions on face	At 1 month post first administration to 6 months post last administration
Core Study - Main Cohort Arm 1 and 2: Absolute change from baseline (Day 01) in the number of non-inflammatory acne lesions on face	At 1 month post first administration to 6 months post last administration
Core Study - Main Cohort Arm 1 and 2: Number of participants with unsolicited AEs reported	Up to 28 days after each administration
Core Study - Main Cohort Arm 1 and 2: Number of participants with medically attended adverse events (MAAEs)	Up to 6 months after each administration
Core Study - Main Cohort Arm 1 and 2: Number of participants with AEs of special interest (AESIs)	Up to 6 months after each administration
Core Study - Main 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 - Main Cohort Arm 1 and 2: Number of participants with out-of-range biological test results	Through 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: Number of participants with unsolicited systemic adverse events (AEs)	In 30 minutes after each administration
Core Study - Main Cohort Arm 1 and 2: Number of participants with solicited injection site and systemic reactions	Up to 7 days after each administration	pre-listed in the participant diary \[PDi\] and in the case report form \[CRF\]

Trial Locations

Locations (4)

Moore Clinical Research - Brandon- Site Number : 8400007; 🇺🇸 Brandon, Florida, United States

Encore Research Group-Jacksonville Center for Clinical Research- Site Number : 8400006; 🇺🇸 Jacksonville, Florida, United States

Encino Research Center- Site Number : 8400008; 🇺🇸 Encino, California, United States

DelRicht Research- Site Number : 8400003; 🇺🇸 New Orleans, Louisiana, United States