NCT07013747 Study to Evaluate Safety, Efficacy and Immunogenicity of Acne mRNA Vaccine in Participants With Mild Acne
| NCT ID | NCT07013747 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Sanofi Pasteur, a Sanofi Company |
| Condition | Acne |
| Study Type | INTERVENTIONAL |
| Enrollment | 228 participants |
| Start Date | 2025-07-03 |
| Primary Completion | 2029-06-19 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 228 participants in total. It began in 2025-07-03 with a primary completion date of 2029-06-19.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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; 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 or undergoing (suspected or confirmed) 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 The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Contact & Investigator
Trial Transparency email recommended (Toll free for US & Canada)
✉ Contact-US@sanofi.com📞 800-633-1610
Frequently Asked Questions
Who can join the NCT07013747 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 45 Years, studying Acne. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07013747 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07013747 currently recruiting?
Yes, NCT07013747 is actively recruiting participants. Contact the research team at Contact-US@sanofi.com for enrollment information.
Where is the NCT07013747 trial being conducted?
This trial is being conducted at Encino, United States, Brandon, United States, Jacksonville, United States, New Orleans, United States.
Who is sponsoring the NCT07013747 clinical trial?
NCT07013747 is sponsored by Sanofi Pasteur, a Sanofi Company. The trial plans to enroll 228 participants.