🔎 Trials Near Me

Home › Acne › NCT07013747

Study to Evaluate Safety, Efficacy and Immunogenicity of Acne mRNA Vaccine in Participants With Mild Acne

RecruitingPhase 1/2

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

Who can join

Ages 18 to 45 · All sexes

Full 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.

About the study

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.

What is being tested

Sponsor: Sanofi Pasteur, a Sanofi Company · Participants: 228 · Started: Jul 3, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07013747

Locations in the U.S.

CaliforniaEncino Research Center- Site Number : 8400008, Encino
FloridaMoore Clinical Research - Brandon- Site Number : 8400007, Brandon
Encore Research Group-Jacksonville Center for Clinical Research- Site Number : 8400006, Jacksonville
LouisianaDelRicht Research- Site Number : 8400003, New Orleans

Conditions

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.