Safety of the Acne mRNA Vaccine in Adolescents 12 to 17 Years of Age With Moderate to Severe Acne

NCT07756957 | Not Yet Recruiting Phase 2 FDA Drug

• 2 other identifiers: VBE21128U1111-1334-7693
• Study Type: interventional
• Target: 410
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to assess the safety profile of intramuscular injections of the Acne mRNA vaccine at 3 dose levels compared with placebo in 12 to 17 years old participants with moderate to severe acne. An early safety data review (ESDR) will be conducted after each subcohort has completed an injection round; enrollment of the next higher dose level subcohort or progression of a subcohort to the subsequent injection round will only proceed if no safety concerns are identified. This sequential process will allow a cautious approach to vaccine injection in the adolescent population. Study details are as follows:

• Before being enrolled in the study, participants complete a 4-week (ie, 1-month) screening period during which they will be called over the telephone approximately in the middle of the screening period to check they are not using prohibited medications and to remind them about the facial hygiene requirements.
• Once the screening period has been completed, the study duration will be up to 13 months for each participant
• Participants will be invited to a long-term extension study through a separate protocol.

Conditions

Acne

Outcome Measures

Primary Outcomes (5)

• Unsolicited systemic AEs (Adverse Events)

  Presence of unsolicited systemic adverse events (AEs) reported

  30 minutes after each injection

• Solicited injection site and systemic adverse reactions

  Presence of solicited injection site and systemic reactions (ie, pre-listed in the participant diary \[PDi\] and in the case report form \[CRF\])

  8 days, including the day of each injection

• Unsolicited AEs

  Presence of unsolicited adverse events (AEs) reported

  28 days, including the day of each injection

• SAEs (Serious Adverse Events), MAAEs (Medically Attended Adverse Event), AESIs (Adverse Event of Special Interest) and AEs (Adverse Events) leading to study discontinuation

  Presence of SAEs (Serious Adverse Events), MAAEs (Medically Attended Adverse Event), AESIs (Adverse Event of Special Interest) and AEs (Adverse Events) leading to study discontinuation

  Up to 2 months after last injection

• Out-of-range biological test results (including shift from baseline values)

  Within 8 days after each injection, including the day of injection

Secondary Outcomes (5)

• Percentage change from baseline in total number of acne lesions on the face

  At 2 months after last injection

• SAEs (Serious Adverse Events), MAAEs (Medically Attended Adverse Event), AESIs (Adverse Event of Special Interest) and AEs (Adverse Events) leading to study discontinuation

  Up to 13 months

• Absolute and percentage change from baseline in the number of inflammatory acne lesions on the face

  At 1 month after first injection until 9 months after last injection

• Absolute and percentage change from baseline in the number of non- inflammatory acne lesions on the face

  At 1 month after first injection until 9 months after last injection

• Absolute and percentage change from baseline in total number of acne lesions on the face

  At 1 month after first injection until 9 months after last injection

Study Arms (10)

Dose 1 sub-cohort - Group 1

EXPERIMENTAL

3 injections

Biological: Acne mRNA (messenger ribonucleic acid) vaccine

Dose 1 sub-cohort - Group 2

PLACEBO COMPARATOR

3 injections

Biological: Placebo

Dose 2 sub-cohort - Group 3

EXPERIMENTAL

3 injections

Biological: Acne mRNA (messenger ribonucleic acid) vaccine

Dose 2 sub-cohort - Group 4

PLACEBO COMPARATOR

3 injections

Biological: Placebo

Dose 3 sub-cohort - Group 5

EXPERIMENTAL

3 injections

Biological: Acne mRNA (messenger ribonucleic acid) vaccine

Dose 3 sub-cohort - Group 6

PLACEBO COMPARATOR

3 injections

Biological: Placebo

Dose 1 main cohort - Group 7

EXPERIMENTAL

3 injections

Biological: Acne mRNA (messenger ribonucleic acid) vaccine

Dose 2 main cohort - Group 8

EXPERIMENTAL

3 injections

Biological: Acne mRNA (messenger ribonucleic acid) vaccine

Dose 3 main cohort - Group 9

EXPERIMENTAL

3 injections

Biological: Acne mRNA (messenger ribonucleic acid) vaccine

Main cohort - Group 10

PLACEBO COMPARATOR

3 injections

Biological: Placebo

Interventions

Acne mRNA (messenger ribonucleic acid) vaccine BIOLOGICAL

IM injection

Dose 1 main cohort - Group 7; Dose 1 sub-cohort - Group 1; Dose 2 main cohort - Group 8; Dose 2 sub-cohort - Group 3; Dose 3 main cohort - Group 9; Dose 3 sub-cohort - Group 5

Placebo BIOLOGICAL

IM injection

Dose 1 sub-cohort - Group 2; Dose 2 sub-cohort - Group 4; Dose 3 sub-cohort - Group 6; Main cohort - Group 10

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Aged 12 to 17 years on the day of the first study intervention administration
• 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 moderate or severe facial acne vulgaris with Investigator's Global Assessment (IGA) score of Moderate or Severe (grade 3 or grade 4 on the 5-grade IGA scale) and ≥ 25 non-inflammatory lesions (ie, open and closed comedones) and ≥ 20 inflammatory lesions (ie, papules and pustules) and ≤ 2 nodulocystic lesions (ie, nodules and cysts)

You may not qualify if:

• 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 study intervention components or history of life-threatening reaction to study intervention(s) or products with the same substances
• Active nodulocystic acne, acne conglobate, acne fulminans, secondary acne (eg, chloracne, drug-induced acne) or other forms of acne (eg, acne mechanica)
• Use of any acne-affecting treatment without an appropriate wash-out period
• Any vaccine given in the 4 weeks before or after any injection of study intervention
• Previous vaccination against C. acnes with an investigational vaccine
• 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 participant's potential participation in a clinical trial.

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

MeSH Terms

Conditions

Acne Vulgaris

Interventions

RNA, Messenger; Vaccines

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

RNA; Nucleic Acids; Nucleic Acids, Nucleotides, and Nucleosides; Biological Products; Complex Mixtures

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 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2026
• First Posted: August 11, 2026
• Study Start (Estimated): October 30, 2026
• Primary Completion (Estimated): July 19, 2028
• Study Completion (Estimated): February 19, 2029
• Last Updated: August 11, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share