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

The purpose of the trial is to evaluate the safety, efficacy and immunogenicity of one or two intramuscular injections of the Acne mRNA vaccine candidate at three dose levels in adult participants aged 18 to 45 years with moderate to severe acne in the US.

Study Overview

• Status: Recruiting
• Conditions: Acne
• Intervention / Treatment: Biological: Acne mRNA vaccine; Other: Placebo

Detailed Description

Acne vulgaris (acne) is a highly prevalent inflammatory skin disease, especially in adolescents and young adults. Acne is estimated to affect 231 million people worldwide, therefore being one of the most prevalent diseases globally. Acne is also one of the top causes of years lived with disability and nonfatal disease burden. Despite being one of the most prevalent diseases worldwide, the mainstays of acne treatment have remained largely unchanged over the past 30 years. To date there is still no effective treatment that can prevent and cure this disease.

The aim of this first-in-human (FIH), Phase I/II trial is to evaluate the safety, efficacy and immunogenicity of the Acne mRNA vaccine candidate at three different dose levels in adults aged 18 to 45 years with moderate to severe acne. The study is designed to assess the safety profile and efficacy (also long-term) of the vaccine candidate, select the dose for the further clinical development steps and to describe the immunogenicity profile of the vaccine.

• Study Type: Interventional
• Enrollment (Estimated): 386
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Trial Transparency email recommended (Toll free for US & Canada); Phone Number: option 6 800-633-1610; Email: contact-us@sanofi.com

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32216
      • Recruiting
      • Jacksonville Center for Clinical Research Site Number : 8400006
  • Massachusetts
    • Brighton, Massachusetts, United States, 02135
      • Recruiting
      • Metro Boston Clinical Partners Site Number : 8400008

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 ≥ 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)

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 (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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental 1; Two administrations of the Acne mRNA vaccine will be injected in three increasing doses	Biological: Acne mRNA vaccine; Pharmaceutical form:Liquid suspension for injection-Route of administration:intramuscular
Experimental: Experimental 2; One administration of the Acne mRNA vaccine in three increasing doses and one administration of placebo will be injected	Biological: Acne mRNA vaccine; Pharmaceutical form:Liquid suspension for injection-Route of administration:intramuscular
Placebo Comparator: Placebo 1; Two administrations of placebo will be injected	Other: Placebo; Pharmaceutical form:Liquid solution for injection-Route of administration:intramuscular

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with unsolicited systemic AEs	Presence of unsolicited systemic adverse events (AEs) reported	30 minutes after each administration
Number of participants with solicited injection site and systemic reactions	Presence of solicited injection site and systemic reactions (ie, pre-listed in the participant diary [PDi] and in the case report form [CRF])	Up to 7 days after each administration
Number of participants with unsolicited AEs		Up to 28 days after each administration
Number of participants with MAAEs	Presence of medically attended adverse events (MAAEs)	Up to 6 months after each administration
Number of patients with SAEs	Presence of all serious adverse events (SAEs)	Up to 6 months after each administration
Number of patients with related SAEs, fatal SAEs and AESIs	Presence of related SAEs, fatal SAEs (regardless of causality) and AEs of special interest (AESIs)	Up to approximately 38 months
Change in grade from baseline in biological test results		Up to 7 days after each administration
Absolute change from baseline in the number of inflammatory acne lesions on face		3 and 6 months post last administration
Percentage change from baseline in the number of inflammatory acne lesions on face		3 and 6 months post last administration
Absolute change from baseline in the number of non-inflammatory acne lesions on face		3 and 6 months post last administration
Percentage change from baseline in the number of non-inflammatory acne lesions on face		3 and 6 months post last administration
At least two-grade improvement in IGA scores	At least two-grade improvement in IGA score from baseline (day 1) and post-administration IGA score of either 0 or 1	3 and 6 months post last administration

Secondary Outcome Measures

Outcome Measure	Time Frame
Assessment of vaccine-antigen-specific serum antibody titers	At study day 1 and 28 days post last administration

Collaborators and Investigators

• Sponsor: Sanofi Pasteur, a Sanofi Company

Study record dates

Study Major Dates

• Study Start (Estimated): April 15, 2024
• Primary Completion (Estimated): December 22, 2027
• Study Completion (Estimated): December 22, 2027

Study Registration Dates

• First Submitted: March 12, 2024
• First Submitted That Met QC Criteria: March 12, 2024
• First Posted (Actual): March 18, 2024

Study Record Updates

• Last Update Posted (Actual): March 28, 2024
• Last Update Submitted That Met QC Criteria: March 27, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris
• Other Study ID Numbers: VBE00001; U1111-1295-3154 (Registry Identifier: ICTRP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No