NCT06316297 · Sanofi Pasteur, a Sanofi Company
Study to Evaluate Safety, Efficacy and Immunogenicity of Acne mRNA Vaccine in Adults With Moderate to Severe Acne
What this study is about
The purpose of the trial is to evaluate the safety, effectiveness and immunogenicity of up to 3 intramuscular injections of the Acne mRNA vaccine candidate at up to three dose levels in adult participants aged 18 to 45 years with moderate to severe acne. This trial will consist of a Core Study followed by an optional Long-Term Extension (LTE).
View original scientific description
The purpose of the trial is to evaluate the safety, efficacy and immunogenicity of up to 3 intramuscular injections of the Acne mRNA vaccine candidate at up to three dose levels in adult participants aged 18 to 45 years with moderate to severe acne. This trial will consist of a Core Study followed by an optional Long-Term Extension (LTE).
Interventions
BIOLOGICAL
Acne mRNA vaccine
Pharmaceutical form: Liquid suspension for injection Route of administration: intramuscular
OTHER
Placebo
Pharmaceutical form: Liquid solution for injection Route of administration: intramuscular
Primary outcome measures
Core Study - Sentinel Cohorts A and B: Number of participants with unsolicited systemic AEs
Time frame: 30 minutes after each administration
Presence of unsolicited systemic adverse events (AEs) reported
Core Study - Sentinel Cohorts A and B: Number of participants with solicited injection site and systemic reactions
Time frame: Up to 7 days after each administration
Presence of solicited injection site and systemic reactions (ie, pre-listed in the participant diary \[PDi\] and in the case report form \[CRF\])
Core Study - Sentinel Cohorts A and B: Number of participants with unsolicited AEs
Time frame: Up to 28 days after each administration
Core Study - Sentinel Cohorts A and B: Number of participants with MAAEs
Time frame: Up to 6 months after each administration
Presence of medically attended adverse events (MAAEs)
Core Study - Sentinel Cohorts A and B: Number of participants with SAEs
Time frame: Up to 6 months after each administration
Presence of all serious adverse events (SAEs)
Core Study - Sentinel Cohorts A and B: Number of participants with AESIs
Time frame: Up to 6 months after each administration
Presence of AEs of special interest (AESIs)
Core Study - Sentinel Cohorts A and B: Number of participants with out-of-range biological test results (including shift from baseline values)
Time frame: Through 7 days after administration (Day 8)
Core Study - Main Cohort A: Percentage change from baseline (Day 1) in the number of inflammatory acne lesions on face
Time frame: At 2 months post last administration
Core Study - Main Cohort A: Percentage change from baseline (Day 1) in the number of non-inflammatory acne lesions on face
Time frame: At 2 months post last administration
Core Study - Main Cohort B: Percentage change from baseline (Day 1) in the total number of acne lesions on face at
Time frame: At 2 months post last administration
Long-Term Extension - Sentinel Cohorts A, B and Main Cohort: Number of participants with SAEs and AESIs
Time frame: Up to 38 or 40 months after first administration
Presence of all serious adverse events (SAEs) and adverse events of special interest (AESIs)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 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)
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 th
Where
- Scottsdale, Arizona
- Cerritos, California
- Encino, California
- La Mesa, California
- Lafayette, California
- Lancaster, California
- Los Angeles, California
- North Hollywood, California
- Northridge, California
- Oceanside, California
- Oxnard, California
- Palmdale, California
And 55 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 5, 2026 · Source of record for eligibility and locations