NCT07013747 · Sanofi Pasteur, a Sanofi Company
Study to Evaluate Safety, Efficacy and Immunogenicity of Acne mRNA Vaccine in Participants With Mild Acne
What this study is about
The purpose of the VBE00009 study is to evaluate the safety, effectiveness 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).
View original scientific description
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.
Interventions
BIOLOGICAL
Acne mRNA vaccine
Pharmaceutical form: 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 Cohort Arm 1 and 2: Number of participants with unsolicited systemic adverse events (AEs)
Time frame: In 30 minutes after each administration
Core Study - Sentinel Cohort Arm 1 and 2: Number of participants with solicited injection site and systemic reactions
Time frame: 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
Time frame: Up to 28 days after each administration
Core Study - Sentinel Cohort Arm 1 and 2: Number of participants with medically attended adverse events (MAAEs)
Time frame: Up to 6 months after each administration
Core Study - Sentinel Cohort Arm 1 and 2: Number of participants with AEs of special interest (AESIs)
Time frame: Up to 6 months after each administration
Core Study - Sentinel Cohort Arm 1 and 2: Number of participants with serious AEs (SAEs)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: Up to 38 months after first administration
Presence of all SAEs and 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 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
Where
- Encino, California
- Brandon, Florida
- Jacksonville, Florida
- New Orleans, Louisiana
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 Jul 9, 2026 · Source of record for eligibility and locations