RECRUITING

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

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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. 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.

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

Quick Facts

Study Start:2025-07-03
Study Completion:2029-06-19
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07013747

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 45 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, and laboratory tests as judged by the investigator
  2. * Clinical diagnosis of mild facial acne vulgaris with:
  3. * IGA score of mild (grade 2 on the 5-grade IGA scale) AND
  4. * between 10 to 24 non-inflammatory lesions (ie, open and closed comedones) AND
  5. * between 5 to 19 inflammatory lesions (ie, papules and pustules) AND
  6. * no nodulocystic lesions (ie, nodules and cysts)
  1. * 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)
  2. * 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
  3. * Previous history of myocarditis and/or pericarditis and/or myopericarditis
  4. * 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
  5. * 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
  6. * Receipt of immune globulins, blood or blood-derived products in the past 3 months
  7. * Self-reported or documented seropositivity for human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus

Contacts and Locations

Study Contact

Trial Transparency email recommended (Toll free for US & Canada)
CONTACT
800-633-1610
Contact-US@sanofi.com

Study Locations (Sites)

Encino Research Center- Site Number : 8400008
Encino, California, 91436
United States
Moore Clinical Research - Brandon- Site Number : 8400007
Brandon, Florida, 33511
United States
Encore Research Group-Jacksonville Center for Clinical Research- Site Number : 8400006
Jacksonville, Florida, 32216
United States
DelRicht Research- Site Number : 8400003
New Orleans, Louisiana, 70115
United States

Collaborators and Investigators

Sponsor: Sanofi Pasteur, a Sanofi Company

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-03
Study Completion Date2029-06-19

Study Record Updates

Study Start Date2025-07-03
Study Completion Date2029-06-19

Terms related to this study

Additional Relevant MeSH Terms

  • Acne