Study to Evaluate Safety, Efficacy and Immunogenicity of Acne mRNA Vaccine in Adults With Moderate to Severe Acne

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.

Conditions

Acne

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Study Overview

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Study Details

Study overview

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.

A Phase I/II, Randomized, Placebo-controlled, Multi-arm, Dose-finding Study to Evaluate the Safety, Efficacy and Immunogenicity of an Acne mRNA Vaccine Candidate in Adults With Moderate to Severe Acne 18 to 45 Years of Age

Study to Evaluate Safety, Efficacy and Immunogenicity of Acne mRNA Vaccine in Adults With Moderate to Severe Acne

Condition
Acne
Intervention / Treatment

-

Contacts and Locations

Encino

Encino Research Center Site Number : 8400033, Encino, California, United States, 91436

Jacksonville

Jacksonville Center for Clinical Research- Site Number : 8400006, Jacksonville, Florida, United States, 32216

Tampa

True Blue Clinical Research- Site Number : 8400016, Tampa, Florida, United States, 33609

Oakbrook Terrace

Alliance for Multispecialty Research Site Number : 8400019, Oakbrook Terrace, Illinois, United States, 60181

Ames

Accellacare of McFarland Site Number : 8400045, Ames, Iowa, United States, 50010

Baton Rouge

Louisiana Dermatology Associates LLC, DelRicht Research at LA Dermatology Associates Site Number : 8400043, Baton Rouge, Louisiana, United States, 70809

New Orleans

DelRicht Research Site Number : 8400013, New Orleans, Louisiana, United States, 70115

Brighton

Metro Boston Clinical Partners Site Number : 8400008, Brighton, Massachusetts, United States, 02135

Stony Brook

DermResearch Center of New York, Inc Site Number : 8400010, Stony Brook, New York, United States, 11790

Oklahoma City

Lynn Health Science Institute (LHSI)- Site Number : 8400004, Oklahoma City, Oklahoma, United States, 73112

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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)
  • * 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 (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
  • * Active nodulocystic acne, acne conglobate, acne fulminans, secondary acne (eg, chloracne, drug-induced acne) or other forms of acne (eg, acne mechanica)
  • * Use of any acne-affecting treatment without an appropriate washout period
  • * Receipt of any vaccine (other than the study vaccine) in the 4 weeks preceding any study intervention administration or planned receipt of any vaccine (other than the study vaccine) in the 4 weeks following any study intervention administration
  • * Previous vaccination against C. acnes with an investigational vaccine
  • * 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.

Ages Eligible for Study

18 Years to 45 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Sanofi Pasteur, a Sanofi Company,

Study Record Dates

2028-08-31