Study to Evaluate Safety, Efficacy and Immunogenicity of Acne mRNA Vaccine in Participants With Mild Acne
- Registration Number
- NCT07013747
- Lead Sponsor
- Sanofi Pasteur, a Sanofi Company
- Brief Summary
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 Sentinel Cohort and a Main Cohort, with the Sentinel Cohort assessing the safety in a stepwise manner.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 120
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 mild facial acne vulgaris with:
- IGA score of mild (grade 2 on the 5-grade IGA scale) AND
- between 10 to 24 non-inflammatory lesions (ie, open and closed comedones) AND
- between 5 to 19 inflammatory lesions (ie, papules and pustules) AND
- no 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
- Previous history of myocarditis and/or pericarditis and/or myopericarditis
- 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
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Sentinel Cohort Arm 1 Acne mRNA vaccine Participants will receive 2 Acne mRNA Vaccine injections Sentinel Cohort Arm 2 Placebo Participants will receive 2 Placebo injections Main Cohort Arm 1 Acne mRNA vaccine Participants will receive 2 Acne mRNA Vaccine injections Main Cohort Arm 2 Placebo Participants will receive 2 Placebo injections
- Primary Outcome Measures
Name Time Method Sentinel Cohort Arm 1 and 2: Number of participants with unsolicited systemic adverse events (AEs) In 30 minutes after each administration Sentinel Cohort Arm 1 and 2: Number of participants with unsolicited AEs reported Up to 28 days after each administration Sentinel Cohort Arm 1 and 2: Number of participants with medically attended adverse events (MAAEs) Up to 6 months after each administration Sentinel Cohort Arm 1 and 2: Number of participants with AEs of special interest (AESIs) Up to 6 months after each administration Sentinel Cohort Arm 1 and 2: Number of participants with solicited injection site and systemic reactions Up to 7 days after each administration pre-listed in the participant diary \[PDi\] and in the case report form \[CRF\]
Sentinel Cohort Arm 1 and 2: Number of participants with serious AEs (SAEs) Up to 6 months after each administration Presence of all SAEs
Sentinel Cohort Arm 1 and 2: Number of participants with out-of-range biological test results Through 7 days after administration (Day 08) Presence of out-of-range biological test results (including shift from baseline values)
Main Cohort Arm 1 and 2: Percentage change from baseline (Day 01) in the number of inflammatory acne lesions on face At 2 months post last administration Main Cohort Arm 1 and 2: Percentage change from baseline (Day 01) in the number of non-inflammatory acne lesions on face At 2 months post last administration
- Secondary Outcome Measures
Name Time Method Sentinel and Main Cohort Arm 1 and 2: Vaccine-antigen-specific serum antibody titers From baseline (Day 01) to 6 months post last administration Main Cohort Arm 1 and 2: Absolute change from baseline (Day 01) in the number of inflammatory acne lesions on face At 1 month post first administration to 6 months post last administration Main Cohort Arm 1 and 2: Percentage change from baseline (Day 01) in the number of inflammatory acne lesions on face At 1 month post first administration to 6 months post last administration Main Cohort Arm 1 and 2: Absolute change from baseline (Day 01) in the number of non-inflammatory acne lesions on face At 1 month post first administration to 6 months post last administration Main Cohort Arm 1 and 2: Percentage change from baseline (Day 01) in the number of non-inflammatory acne lesions on face At 1 month post first administration to 6 months post last administration Main Cohort Arm 1 and 2: Number of participants with unsolicited systemic adverse events (AEs) In 30 minutes after each administration Main Cohort Arm 1 and 2: Number of participants with solicited injection site and systemic reactions Up to 7 days after each administration pre-listed in the participant diary \[PDi\] and in the case report form \[CRF\]
Main Cohort Arm 1 and 2: Number of participants with unsolicited AEs reported Up to 28 days after each administration Main Cohort Arm 1 and 2: Number of participants with medically attended adverse events (MAAEs) Up to 6 months after each administration Main Cohort Arm 1 and 2: Number of participants with AEs of special interest (AESIs) Up to 6 months after each administration Main Cohort Arm 1 and 2: Number of participants with serious AEs (SAEs) Up to 6 months after each administration Presence of all SAEs
Main Cohort Arm 1 and 2: Number of participants with out-of-range biological test results Through 7 days after administration (Day 08) Presence of out-of-range biological test results (including shift from baseline values)