Clinical trial NCT07013747: Study to Evaluate Safety, Efficacy and Immunogenicity of Acne mRNA Vaccine in Participants With Mild Acne
Official title: A Phase 1/2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Efficacy and Immunogenicity of an Acne mRNA Vaccine Candidate in Participants With Mild Acne
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Acne
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2025-06-10
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: This study will consist of a Sentinel Cohort and a Main Cohort, with the Sentinel Cohort assessing the safety in a stepwise manner.
Primary purpose: TREATMENT

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 Sentinel Cohort and a Main Cohort, with the Sentinel Cohort assessing the safety in a stepwise manner.


Eligibility criteria: 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

Primary outcomes:
measure: Sentinel Cohort Arm 1 and 2: Number of participants with unsolicited systemic adverse events (AEs)
timeFrame: In 30 minutes after each administration
measure: Sentinel Cohort Arm 1 and 2: Number of participants with solicited injection site and systemic reactions
timeFrame: Up to 7 days after each administration
measure: Sentinel Cohort Arm 1 and 2: Number of participants with unsolicited AEs reported
timeFrame: Up to 28 days after each administration
measure: Sentinel Cohort Arm 1 and 2: Number of participants with medically attended adverse events (MAAEs)
timeFrame: Up to 6 months after each administration
measure: Sentinel Cohort Arm 1 and 2: Number of participants with AEs of special interest (AESIs)
timeFrame: Up to 6 months after each administration
measure: Sentinel Cohort Arm 1 and 2: Number of participants with serious AEs (SAEs)
timeFrame: Up to 6 months after each administration
measure: Sentinel Cohort Arm 1 and 2: Number of participants with out-of-range biological test results
timeFrame: Through 7 days after administration (Day 08)
measure: Main Cohort Arm 1 and 2: Percentage change from baseline (Day 01) in the number of inflammatory acne lesions on face
timeFrame: At 2 months post last administration
measure: Main Cohort Arm 1 and 2: Percentage change from baseline (Day 01) in the number of non-inflammatory acne lesions on face
timeFrame: At 2 months post last administration
Secondary outcomes:
measure: Sentinel and Main Cohort Arm 1 and 2: Vaccine-antigen-specific serum antibody titers
timeFrame: From baseline (Day 01) to 6 months post last administration
measure: Main Cohort Arm 1 and 2: Absolute change from baseline (Day 01) in the number of inflammatory acne lesions on face
timeFrame: At 1 month post first administration to 6 months post last administration
measure: Main Cohort Arm 1 and 2: Percentage change from baseline (Day 01) in the number of inflammatory acne lesions on face
timeFrame: At 1 month post first administration to 6 months post last administration
measure: Main Cohort Arm 1 and 2: Absolute change from baseline (Day 01) in the number of non-inflammatory acne lesions on face
timeFrame: At 1 month post first administration to 6 months post last administration
measure: Main Cohort Arm 1 and 2: Percentage change from baseline (Day 01) in the number of non-inflammatory acne lesions on face
timeFrame: At 1 month post first administration to 6 months post last administration
measure: Main Cohort Arm 1 and 2: Number of participants with unsolicited systemic adverse events (AEs)
timeFrame: In 30 minutes after each administration
measure: Main Cohort Arm 1 and 2: Number of participants with solicited injection site and systemic reactions
timeFrame: Up to 7 days after each administration
measure: Main Cohort Arm 1 and 2: Number of participants with unsolicited AEs reported
timeFrame: Up to 28 days after each administration
measure: Main Cohort Arm 1 and 2: Number of participants with medically attended adverse events (MAAEs)
timeFrame: Up to 6 months after each administration
measure: Main Cohort Arm 1 and 2: Number of participants with AEs of special interest (AESIs)
timeFrame: Up to 6 months after each administration
measure: Main Cohort Arm 1 and 2: Number of participants with serious AEs (SAEs)
timeFrame: Up to 6 months after each administration
measure: Main Cohort Arm 1 and 2: Number of participants with out-of-range biological test results
timeFrame: Through 7 days after administration (Day 08)
Other outcomes:
Locations:
Study officials:
References: