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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06316297
Registration number
NCT06316297
Ethics application status
Date submitted
12/03/2024
Date registered
18/03/2024
Date last updated
12/09/2025
Titles & IDs
Public title
Study to Evaluate Safety, Efficacy and Immunogenicity of Acne mRNA Vaccine in Adults With Moderate to Severe Acne
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Scientific title
A Phase I/II, Randomized, Placebo-controlled, Multi-arm, Dose-finding Study to Evaluate the Safety, Efficacy and Immunogenicity of an Acne mRNA Vaccine Candidate in Adults With Moderate to Severe Acne 18 to 45 Years of Age
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Secondary ID [1]
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U1111-1295-3154
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Secondary ID [2]
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VBE00001
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Acne
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Condition category
Condition code
Skin
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Dermatological conditions
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - Acne mRNA vaccine
Other interventions - Placebo
Experimental: Sentinel Cohort A - Experimental - Two administrations of the Acne mRNA vaccine will be injected in three increasing doses
Placebo comparator: Sentinel Cohort A - Placebo - Two administrations of placebo will be injected
Experimental: Sentinel Cohort B - Experimental - Three administrations of the Acne mRNA vaccine will be injected in two increasing doses
Placebo comparator: Sentinel Cohort B - Placebo - Three administrations of placebo will be injected
Experimental: Main Cohort - Experimental - Two administrations of the Acne mRNA vaccine will be injected in three increasing doses
Placebo comparator: Main Cohort - Placebo - Two administrations of placebo will be injected
Treatment: Other: Acne mRNA vaccine
Pharmaceutical form: Liquid suspension for injection Route of administration: intramuscular
Other interventions: Placebo
Pharmaceutical form: Liquid solution for injection Route of administration: intramuscular
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Intervention code [1]
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Treatment: Other
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Core Study - Sentinel Cohort A and B: Number of participants with unsolicited systemic AEs
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Assessment method [1]
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Presence of unsolicited systemic adverse events (AEs) reported
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Timepoint [1]
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30 minutes after each administration
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Primary outcome [2]
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Core Study - Sentinel Cohort A and B: Number of participants with solicited injection site and systemic reactions
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Assessment method [2]
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Presence of solicited injection site and systemic reactions (ie, pre-listed in the participant diary \[PDi\] and in the case report form \[CRF\])
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Timepoint [2]
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Up to 7 days after each administration
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Primary outcome [3]
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Core Study - Sentinel Cohort A and B: Number of participants with unsolicited AEs
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Assessment method [3]
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Timepoint [3]
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Up to 28 days after each administration
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Primary outcome [4]
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Core Study - Sentinel Cohort A and B: Number of participants with MAAEs
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Assessment method [4]
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Presence of medically attended adverse events (MAAEs)
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Timepoint [4]
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Up to 6 months after each administration
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Primary outcome [5]
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Core Study - Sentinel Cohort A and B: Number of participants with SAEs
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Assessment method [5]
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Presence of all serious adverse events (SAEs)
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Timepoint [5]
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Up to 6 months after each administration
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Primary outcome [6]
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Core Study - Sentinel Cohort A and B: Number of participants with AESIs
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Assessment method [6]
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Presence of AEs of special interest (AESIs)
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Timepoint [6]
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Up to 6 months after each administration
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Primary outcome [7]
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Core Study - Sentinel Cohort A and B: Number of participants with out-of-range biological test results (including shift from baseline values)
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Assessment method [7]
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Timepoint [7]
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Through 7 days after administration (Day 8)
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Primary outcome [8]
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Core Study - Main Cohort: Percentage change from baseline (Day 1) in the number of inflammatory acne lesions on face
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Assessment method [8]
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Timepoint [8]
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At 2 months post last administration
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Primary outcome [9]
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Core Study - Main Cohort: Percentage change from baseline (Day 1) in the number of non-inflammatory acne lesions on face
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Assessment method [9]
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Timepoint [9]
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At 2 months post last administration
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Primary outcome [10]
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Long-Term Extension - Sentinel Cohort A, B and Main Cohort: Number of participants with SAEs and AESIs
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Assessment method [10]
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Presence of all serious adverse events (SAEs) and adverse events of special interest (AESIs)
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Timepoint [10]
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Up to 38 months after first administration
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Secondary outcome [1]
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Core Study - Sentinel Cohort A, B and Main Cohort: Vaccine-antigen-specific serum antibody titers
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Assessment method [1]
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Timepoint [1]
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From baseline (Day 1) to 6 months post last administration
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Secondary outcome [2]
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Core Study - Main Cohort: Absolute change from baseline (Day 1) in the number of inflammatory acne lesions on face
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Assessment method [2]
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Timepoint [2]
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At1 month post first administration until 6 months post last administration
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Secondary outcome [3]
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Core Study - Main Cohort: Percentage change from baseline (Day 1) in the number of inflammatory acne lesions on face
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Assessment method [3]
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Timepoint [3]
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At 1 month post first administration until 6 months post last administration
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Secondary outcome [4]
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Core Study - Main Cohort: Absolute change from baseline (Day 1) in the number of non-inflammatory acne lesions on face
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Assessment method [4]
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Timepoint [4]
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At 1 month post first administration until 6 months post last administration
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Secondary outcome [5]
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Core Study - Main Cohort: Percentage change from baseline (Day 1) in the number of non-inflammatory acne lesions on face
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Assessment method [5]
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Timepoint [5]
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At 1 month post first administration until 6 months post last administration
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Secondary outcome [6]
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Core Study - Main Cohort: Absolute change from baseline in IGA score
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Assessment method [6]
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Timepoint [6]
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At 1 month post first administration until 6 months post last administration
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Secondary outcome [7]
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Core Study - Main Cohort: Number of participants with unsolicited systemic AEs
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Assessment method [7]
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Presence of unsolicited systemic adverse events (AEs) reported
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Timepoint [7]
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30 minutes after each administration
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Secondary outcome [8]
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Core Study - Main Cohort: Number of participants with solicited injection site and systemic reactions
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Assessment method [8]
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Presence of solicited injection site and systemic reactions (ie, pre-listed in the participant diary \[PDi\] and in the case report form \[CRF\])
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Timepoint [8]
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Up to 7 days after each administration
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Secondary outcome [9]
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Core Study - Main Cohort: Number of participants with unsolicited AEs
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Assessment method [9]
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Timepoint [9]
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Up to 28 days after each administration
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Secondary outcome [10]
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Core Study - Main Cohort: Number of participants with MAAEs
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Assessment method [10]
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Presence of medically attended adverse events (MAAEs)
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Timepoint [10]
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Up to 6 months after each administration
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Secondary outcome [11]
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Core Study - Main Cohort: Number of participants with SAEs
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Assessment method [11]
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Presence of all serious adverse events (SAEs)
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Timepoint [11]
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Up to 6 months after each administration
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Secondary outcome [12]
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Core Study - Main Cohort: Number of participants with AESIs
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Assessment method [12]
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Presence of AEs of special interest (AESIs)
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Timepoint [12]
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Up to 6 months after each administration
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Secondary outcome [13]
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Core Study - Main Cohort: Number of participants with out-of-range biological test results (including shift from baseline values)
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Assessment method [13]
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Timepoint [13]
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Through 7 days after administration (Day 8)
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Eligibility
Key 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 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)
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Minimum age
18
Years
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Maximum age
45
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
* 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Other
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
5/04/2024
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/08/2028
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Actual
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Sample size
Target
260
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,VIC
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Recruitment hospital [1]
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Investigational Site Number : 0360001 - Phillip
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Recruitment hospital [2]
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Investigational Site Number : 0360003 - Darlinghurst
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Recruitment hospital [3]
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Investigational Site Number : 0360006 - Waitara
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Recruitment hospital [4]
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Investigational Site Number : 0360009 - Camberwell
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Recruitment hospital [5]
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Investigational Site Number : 0360007 - Carlton
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Recruitment postcode(s) [1]
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2606 - Phillip
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Recruitment postcode(s) [2]
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2010 - Darlinghurst
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Recruitment postcode(s) [3]
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2077 - Waitara
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Recruitment postcode(s) [4]
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3124 - Camberwell
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Recruitment postcode(s) [5]
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3053 - Carlton
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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United States of America
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State/province [2]
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Florida
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United States of America
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State/province [3]
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Illinois
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United States of America
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State/province [4]
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Indiana
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Country [5]
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United States of America
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State/province [5]
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Iowa
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Country [6]
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United States of America
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State/province [6]
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Louisiana
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Country [7]
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United States of America
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State/province [7]
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Massachusetts
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United States of America
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Michigan
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Minnesota
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United States of America
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Missouri
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United States of America
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State/province [11]
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Montana
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Country [12]
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United States of America
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State/province [12]
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Nevada
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Country [13]
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United States of America
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State/province [13]
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North Carolina
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Country [14]
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United States of America
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State/province [14]
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Oklahoma
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Country [15]
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United States of America
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State/province [15]
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Pennsylvania
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Country [16]
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United States of America
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State/province [16]
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South Carolina
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Country [17]
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United States of America
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Tennessee
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Country [18]
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United States of America
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State/province [18]
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Texas
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Utah
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Virginia
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United States of America
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Washington
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Sanofi Pasteur, a Sanofi Company
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT06316297
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Trial Transparency email recommended (Toll free for US & Canada)
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Address
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Country
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Phone
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800-633-1610
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06316297
Download to PDF