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

NCT07013747 | Recruiting Phase 1 DMC FDA Drug

• 3 other identifiers: VBE000092025-520677-39U1111-1315-4645
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 4

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

Outcome Measures

Primary Outcomes (10)

• 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

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

  Up to 7 days after each administration

• 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)

  Presence of all SAEs

  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

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

  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

  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)

  Presence of all SAEs and AESIs

  Up to 38 months after first administration

Secondary Outcomes (12)

• 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: 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: 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: 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

Study Arms (4)

Sentinel Cohort Arm 1

EXPERIMENTAL

Participants will receive 2 Acne mRNA Vaccine injections

Biological: Acne mRNA vaccine

Sentinel Cohort Arm 2

PLACEBO COMPARATOR

Participants will receive 2 Placebo injections

Other: Placebo

Main Cohort Arm 1

EXPERIMENTAL

Participants will receive 2 Acne mRNA Vaccine injections

Biological: Acne mRNA vaccine

Main Cohort Arm 2

PLACEBO COMPARATOR

Participants will receive 2 Placebo injections

Other: Placebo

Interventions

Acne mRNA vaccine BIOLOGICAL

Pharmaceutical form: suspension for injection Route of administration: intramuscular

Main Cohort Arm 1; Sentinel Cohort Arm 1

Placebo OTHER

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

Main Cohort Arm 2; Sentinel Cohort Arm 2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (4)

Encino Research Center- Site Number : 8400008

Encino, California, 91436, United States

RECRUITING

Moore Clinical Research - Brandon- Site Number : 8400007

Brandon, Florida, 33511, United States

RECRUITING

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

Jacksonville, Florida, 32216, United States

RECRUITING

DelRicht Research- Site Number : 8400003

New Orleans, Louisiana, 70115, United States

RECRUITING

Related Links

• VBE00009 Plain Language Results Summary

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Central Study Contacts

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

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Core Study: Sentinel Cohort: modified double-blind * Investigators, participants, laboratory personnel will be blinded * Clinical site staff preparing/administering the study vaccines will be unblinded * Sponsor study staff involved in early safety data reviews (ESDRs) will be unblinded at the time of the ESDR Main Cohort: modified double-blind * Investigators, participants, laboratory personnel and Sponsor study staff will be blinded * Clinical site staff preparing/administering the study vaccines will be unblinded * Sponsor staff involved in the Internal Firewall Committee will be unblinded at the time of the interim analysis Long-term Extension: Sentinel and Main Cohorts: double-blind • Investigators, participants, laboratory personnel and Sponsor study staff will be blinded
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study will consist of a Core Study followed by an optional Long-Term Extension. Core Study will include a Sentinel Cohort and a Main Cohort, with the Sentinel Cohort assessing the safety in a stepwise manner.

Study Record Dates

• First Submitted: June 2, 2025
• First Posted: June 10, 2025
• Study Start: July 3, 2025
• Primary Completion (Estimated): June 19, 2029
• Study Completion (Estimated): June 19, 2029
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share

Locations

US (4)