Study to Evaluate Safety, Efficacy and Immunogenicity of Acne mRNA Vaccine in Adults With Moderate to Severe Acne
- Registration Number
- NCT06316297
- Lead Sponsor
- Sanofi Pasteur, a Sanofi Company
- Brief Summary
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.
This trial will consist of a Core Study followed by an optional Long-Term Extension (LTE). The Core Study will consist of a Sentinel Cohort A paired with a Main Cohort, evaluating the safety and efficacy of the 2-administration regimen and a Sentinel Cohort B, evaluating the safety of the 3- administration regimen. The Sentinel Cohorts will assess the safety of the dose levels and regimens 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.
- 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 safe and 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 results of this FIH and proof of concept study will allow selection of the vaccine dose level to be used in Phase III pivotal efficacy trial(s) and to generate preliminary data to further select the vaccine regimen.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 260
- 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)
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.
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Sentinel Cohort A - Placebo Placebo Two administrations of placebo will be injected Sentinel Cohort B - Experimental Acne mRNA vaccine Three administrations of the Acne mRNA vaccine will be injected in two increasing doses Sentinel Cohort B - Placebo Placebo Three administrations of placebo will be injected Main Cohort - Placebo Placebo Two administrations of placebo will be injected Sentinel Cohort A - Experimental Acne mRNA vaccine Two administrations of the Acne mRNA vaccine will be injected in three increasing doses Main Cohort - Experimental Acne mRNA vaccine Two administrations of the Acne mRNA vaccine will be injected in three increasing doses
- Primary Outcome Measures
Name Time Method Core Study - Sentinel Cohort A and B: Number of participants with unsolicited systemic AEs 30 minutes after each administration Presence of unsolicited systemic adverse events (AEs) reported
Core Study - Sentinel Cohort A and B: Number of participants with solicited injection site and systemic reactions Up to 7 days after each administration Presence of solicited injection site and systemic reactions (ie, pre-listed in the participant diary \[PDi\] and in the case report form \[CRF\])
Core Study - Sentinel Cohort A and B: Number of participants with unsolicited AEs Up to 28 days after each administration Core Study - Sentinel Cohort A and B: Number of participants with MAAEs Up to 6 months after each administration Presence of medically attended adverse events (MAAEs)
Core Study - Sentinel Cohort A and B: Number of participants with SAEs Up to 6 months after each administration Presence of all serious adverse events (SAEs)
Core Study - Sentinel Cohort A and B: Number of participants with AESIs Up to 6 months after each administration Presence of AEs of special interest (AESIs)
Core Study - Sentinel Cohort A and B: Number of participants with out-of-range biological test results (including shift from baseline values) Through 7 days after administration (Day 8) Core Study - Main Cohort: Percentage change from baseline (Day 1) in the number of inflammatory acne lesions on face At 2 months post last administration Core Study - Main Cohort: Percentage change from baseline (Day 1) in the number of non-inflammatory acne lesions on face At 2 months post last administration Long-Term Extension - Sentinel Cohort A, B and Main Cohort: Number of participants with SAEs and AESIs Up to 38 months after first administration Presence of all serious adverse events (SAEs) and adverse events of special interest (AESIs)
- Secondary Outcome Measures
Name Time Method Core Study - Sentinel Cohort A, B and Main Cohort: Vaccine-antigen-specific serum antibody titers From baseline (Day 1) to 6 months post last administration Core Study - Main Cohort: Absolute change from baseline (Day 1) in the number of inflammatory acne lesions on face At1 month post first administration until 6 months post last administration Core Study - Main Cohort: Percentage change from baseline (Day 1) in the number of inflammatory acne lesions on face At 1 month post first administration until 6 months post last administration Core Study - Main Cohort: Absolute change from baseline (Day 1) in the number of non-inflammatory acne lesions on face At 1 month post first administration until 6 months post last administration Core Study - Main Cohort: Percentage change from baseline (Day 1) in the number of non-inflammatory acne lesions on face At 1 month post first administration until 6 months post last administration Core Study - Main Cohort: Absolute change from baseline in IGA score At 1 month post first administration until 6 months post last administration Core Study - Main Cohort: Number of participants with unsolicited systemic AEs 30 minutes after each administration Presence of unsolicited systemic adverse events (AEs) reported
Core Study - Main Cohort: Number of participants with solicited injection site and systemic reactions Up to 7 days after each administration Presence of solicited injection site and systemic reactions (ie, pre-listed in the participant diary \[PDi\] and in the case report form \[CRF\])
Core Study - Main Cohort: Number of participants with unsolicited AEs Up to 28 days after each administration Core Study - Main Cohort: Number of participants with MAAEs Up to 6 months after each administration Presence of medically attended adverse events (MAAEs)
Core Study - Main Cohort: Number of participants with SAEs Up to 6 months after each administration Presence of all serious adverse events (SAEs)
Core Study - Main Cohort: Number of participants with AESIs Up to 6 months after each administration Presence of AEs of special interest (AESIs)
Core Study - Main Cohort: Number of participants with out-of-range biological test results (including shift from baseline values) Through 7 days after administration (Day 8)
Trial Locations
- Locations (94)
Center for Dermatology and Plastic Surgery- Site Number : 8400111
🇺🇸Scottsdale, Arizona, United States
Private Practice - Dr. Francisco Badar- Site Number : 8400067
🇺🇸Cerritos, California, United States
Kaiser Permanente - Los Angeles Medical Center- Site Number : 8400058
🇺🇸Los Angeles, California, United States
L.A. Universal Research Center, INC- Site Number : 8400059
🇺🇸Los Angeles, California, United States
Carbon Health - North Hollywood - NoHo West- Site Number : 8400076
🇺🇸North Hollywood, California, United States
Amicis Research Center - Northridge - Nordhoff Street- Site Number : 8400110
🇺🇸Northridge, California, United States
Northridge Clinical Trials - Northridge- Site Number : 8400053
🇺🇸Northridge, California, United States
Profound Research LLC- Site Number : 8400099
🇺🇸Oceanside, California, United States
Cura Clinical Research - Oxnard- Site Number : 8400062
🇺🇸Oxnard, California, United States
Empire Clinical Research - Pomona- Site Number : 8400055
🇺🇸Pomona, California, United States
Scroll for more (84 remaining)Center for Dermatology and Plastic Surgery- Site Number : 8400111🇺🇸Scottsdale, Arizona, United States