Acne
Conditions
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 Core Study followed by an optional Long-Term Extension (LTE). Core Study will include a Sentinel Cohort and a Main Cohort, with the Sentinel Cohort assessing the safety 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.
Interventions
BIOLOGICALAcne mRNA vaccine
Pharmaceutical form: suspension for injection Route of administration: intramuscular
OTHERPlacebo
Pharmaceutical form: liquid solution for injection Route of administration: intramuscular
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Core Study: Sentinel Cohort: modified double-blind * Investigators, participants, laboratory personnel will be blinded * Clinical site staff preparing/administering the study vaccines will be unblinded * Sponsor study staff involved in early safety data reviews (ESDRs) will be unblinded at the time of the ESDR Main Cohort: modified double-blind * Investigators, participants, laboratory personnel and Sponsor study staff will be blinded * Clinical site staff preparing/administering the study vaccines will be unblinded * Sponsor staff involved in the Internal Firewall Committee will be unblinded at the time of the interim analysis Long-term Extension: Sentinel and Main Cohorts: double-blind • Investigators, participants, laboratory personnel and Sponsor study staff will be blinded
Intervention model description
This study will consist of a Core Study followed by an optional Long-Term Extension. Core Study will include a Sentinel Cohort and a Main Cohort, with the Sentinel Cohort assessing the safety in a stepwise manner.
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
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; 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 or undergoing (suspected or confirmed) 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 The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Core Study - Sentinel Cohort Arm 1 and 2: Number of participants with unsolicited systemic adverse events (AEs) | In 30 minutes after each administration | — |
| Core Study - 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 \[CRF\] |
| Core Study - Sentinel Cohort Arm 1 and 2: Number of participants with unsolicited AEs reported | Up to 28 days after each administration | — |
| Core Study - Sentinel Cohort Arm 1 and 2: Number of participants with medically attended adverse events (MAAEs) | Up to 6 months after each administration | — |
| Core Study - Sentinel Cohort Arm 1 and 2: Number of participants with AEs of special interest (AESIs) | Up to 6 months after each administration | — |
| Core Study - Sentinel Cohort Arm 1 and 2: Number of participants with serious AEs (SAEs) | Up to 6 months after each administration | Presence of all SAEs |
| Core Study - 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) |
| Core Study - 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 | — |
| Core Study - 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 | — |
| Long-Term Extension - Sentinel and Main Cohort Arm 1 and 2: Number of participants with serious adverse events (SAEs) and adverse events of special interest (AESIs) | Up to 38 months after first administration | Presence of all SAEs and AESIs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Core Study - Sentinel and Main Cohort Arm 1 and 2: Vaccine-antigen-specific serum antibody titers | From baseline (Day 01) to 6 months post last administration | — |
| Core Study - 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 | — |
| Core Study - 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 | — |
| Core Study - 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 | — |
| Core Study - 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 | — |
| Core Study - Main Cohort Arm 1 and 2: Number of participants with unsolicited systemic adverse events (AEs) | In 30 minutes after each administration | — |
| Core Study - 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 \[CRF\] |
| Core Study - Main Cohort Arm 1 and 2: Number of participants with unsolicited AEs reported | Up to 28 days after each administration | — |
| Core Study - Main Cohort Arm 1 and 2: Number of participants with medically attended adverse events (MAAEs) | Up to 6 months after each administration | — |
| Core Study - Main Cohort Arm 1 and 2: Number of participants with AEs of special interest (AESIs) | Up to 6 months after each administration | — |
| Core Study - Main Cohort Arm 1 and 2: Number of participants with serious AEs (SAEs) | Up to 6 months after each administration | Presence of all SAEs |
| Core Study - 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) |
Countries
United States
Contacts
CONTACTTrial Transparency email recommended (Toll free for US & Canada)
Outcome results
None listed