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

RecruitingPhase 1, Phase 2Ages 18 Years - 45 YearsAllSanofi Pasteur, a Sanofi Company
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In plain words

What the trial is, and whether it could suit you

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 four dose levels in adult participants aged 18 to 45 years with moderate to severe acne. This trial will consist of a Core Study followed by an optional Long-Term Extension (LTE). The Core Study will consist of: * Two cohorts evaluating the 2-administration regimen (Cohorts A): Sentinel Cohort A and Main Cohort A. * Two cohorts evaluating the 3-administration regimen (Cohorts B): Sentinel Cohort B and Main Cohort B. Participants from Sentinel Cohorts A and B and from Main Cohort A will be invited to an additional 30-month follow up after completing their last planned Core Study visit to assess the long-term effects of the vaccine. Participants from Main Cohort B will be invited to another LTE study managed through a separate p

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 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 โ‰ฅ 25 non-inflammatory lesions (ie, open and closed comedones) and โ‰ฅ 20 inflammatory lesions (ie, papules and pustules) and โ‰ค 2 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 * 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. The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
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What it tests

  • Acne mRNA vaccine
  • Placebo
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Where

94 sites
Center for Dermatology and Plastic Surgery- Site Number : 8400111
Scottsdale, United States
Private Practice - Dr. Francisco Badar- Site Number : 8400067
Cerritos, United States
Encino Research Center- Site Number : 8400033
Encino, United States
Paradigm Clinical Research Centers- Site Number : 8400064
La Mesa, United States
Sunwise Clinical Research- Site Number : 8400108
Lafayette, United States
Chemidox Clinical Trials- Site Number : 8400075
Lancaster, United States
Kaiser Permanente - Los Angeles Medical Center- Site Number : 8400058
Los Angeles, United States
LA Universal Research Center- Site Number : 8400059
Los Angeles, United States

โ€ฆand 86 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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