Safety of the Acne mRNA Vaccine in Adolescents 12 to 17 Years of Age With Moderate to Severe Acne
ConditionAcne
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age12-17
SponsorSanofi
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Sequential
Treatments tested in this trial
Acne mRNA (messenger ribonucleic acid) vaccine
Biological/VaccineIM injection
Placebo
Biological/VaccineIM injection
Treatment groups
410 Participants
are divided into 10 treatment groups10
Treatment groupsSee each treatment group below.
Group A: Dose 1 sub-cohort - Group 1Experimental treatment 1 intervention
Group B: Dose 1 sub-cohort - Group 2Placebo comparator 1 intervention
Group C: Dose 2 sub-cohort - Group 3Experimental treatment 1 intervention
Group D: Dose 2 sub-cohort - Group 4Placebo comparator 1 intervention
Group E: Dose 3 sub-cohort - Group 5Experimental treatment 1 intervention
Group F: Dose 3 sub-cohort - Group 6Placebo comparator 1 intervention
Group G: Dose 1 main cohort - Group 7Experimental treatment 1 intervention
Group H: Dose 2 main cohort - Group 8Experimental treatment 1 intervention
Group I: Dose 3 main cohort - Group 9Experimental treatment 1 intervention
Group J: Main cohort - Group 10Placebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Unsolicited systemic AEs (Adverse Events)
Presence of unsolicited systemic adverse events (AEs) reported
Time frame
30 minutes after each injection2
Solicited injection site and systemic adverse reactions
Presence of solicited injection site and systemic reactions (ie, pre-listed in the participant diary \[PDi\] and in the case report form \[CRF\])
Time frame
8 days, including the day of each injection3
Unsolicited AEs
Presence of unsolicited adverse events (AEs) reported
Time frame
28 days, including the day of each injection4
SAEs (Serious Adverse Events), MAAEs (Medically Attended Adverse Event), AESIs (Adverse Event of Special Interest) and AEs (Adverse Events) leading to study discontinuation
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
Time frame
Up to 2 months after last injectionSecondary outcomes
1
Percentage change from baseline in total number of acne lesions on the face
Time frame
At 2 months after last injection2
SAEs (Serious Adverse Events), MAAEs (Medically Attended Adverse Event), AESIs (Adverse Event of Special Interest) and AEs (Adverse Events) leading to study discontinuation
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
Time frame
Up to 13 months3
Absolute and percentage change from baseline in the number of inflammatory acne lesions on the face
Time frame
At 1 month after first injection until 9 months after last injection4
Absolute and percentage change from baseline in the number of non- inflammatory acne lesions on the face
Time frame
At 1 month after first injection until 9 months after last injectionLocations
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: