Acne
Conditions
Brief summary
The purpose of this study is to assess the safety profile of intramuscular injections of the Acne mRNA vaccine at 3 dose levels compared with placebo in 12 to 17 years old participants with moderate to severe acne. An early safety data review (ESDR) will be conducted after each subcohort has completed an injection round; enrollment of the next higher dose level subcohort or progression of a subcohort to the subsequent injection round will only proceed if no safety concerns are identified. This sequential process will allow a cautious approach to vaccine injection in the adolescent population. Study details are as follows: * Before being enrolled in the study, participants complete a 4-week (ie, 1-month) screening period during which they will be called over the telephone approximately in the middle of the screening period to check they are not using prohibited medications and to remind them about the facial hygiene requirements. * Once the screening period has been completed, the study duration will be up to 13 months for each participant * Participants will be invited to a long-term extension study through a separate protocol.
Interventions
BIOLOGICALAcne mRNA (messenger ribonucleic acid) vaccine
IM injection
BIOLOGICALPlacebo
IM injection
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Aged 12 to 17 years on the day of the first study intervention administration * 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
* 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 study intervention components or history of life-threatening reaction to study intervention(s) or products with the same substances * 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 wash-out period * Any vaccine given in the 4 weeks before or after any injection of study intervention * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Unsolicited systemic AEs (Adverse Events) | 30 minutes after each injection | Presence of unsolicited systemic adverse events (AEs) reported |
| Solicited injection site and systemic adverse reactions | 8 days, including the day of each injection | Presence of solicited injection site and systemic reactions (ie, pre-listed in the participant diary \[PDi\] and in the case report form \[CRF\]) |
| Unsolicited AEs | 28 days, including the day of each injection | Presence of unsolicited adverse events (AEs) reported |
| SAEs (Serious Adverse Events), MAAEs (Medically Attended Adverse Event), AESIs (Adverse Event of Special Interest) and AEs (Adverse Events) leading to study discontinuation | Up to 2 months after last injection | Presence of SAEs (Serious Adverse Events), MAAEs (Medically Attended Adverse Event), AESIs (Adverse Event of Special Interest) and AEs (Adverse Events) leading to study discontinuation |
| Out-of-range biological test results (including shift from baseline values) | Within 8 days after each injection, including the day of injection | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage change from baseline in total number of acne lesions on the face | At 2 months after last injection | — |
| SAEs (Serious Adverse Events), MAAEs (Medically Attended Adverse Event), AESIs (Adverse Event of Special Interest) and AEs (Adverse Events) leading to study discontinuation | Up to 13 months | Presence of SAEs (Serious Adverse Events), MAAEs (Medically Attended Adverse Event), AESIs (Adverse Event of Special Interest) and AEs (Adverse Events) leading to study discontinuation |
| Absolute and percentage change from baseline in the number of inflammatory acne lesions on the face | At 1 month after first injection until 9 months after last injection | — |
| Absolute and percentage change from baseline in the number of non- inflammatory acne lesions on the face | At 1 month after first injection until 9 months after last injection | — |
| Absolute and percentage change from baseline in total number of acne lesions on the face | At 1 month after first injection until 9 months after last injection | — |
Contacts
CONTACTTrial Transparency email recommended (Toll free for US & Canada)
Outcome results
None listed