Testing Acne mRNA vaccine against a placebo for acne
Official title: Study to Evaluate Safety, Efficacy and Immunogenicity of Acne mRNA Vaccine in Adults With Moderate to Severe Acne
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
- Phase 1
- 8 groups
- Sites in Edmonton, Barrie and 4 more cities
- Recruiting
Interventions
- Biological therapy
Acne mRNA vaccine
Pharmaceutical form: Liquid suspension for injection Route of administration: intramuscular
- Other intervention
Placebo
Pharmaceutical form: Liquid solution for injection Route of administration: intramuscular
Canadian Sites (6)
6 of 6 recruiting
- Recruiting
Investigational Site Number : 1240006
Edmonton, Alberta
- Recruiting
Investigational Site Number : 1240001
Barrie, Ontario
- Recruiting
Investigational Site Number : 1240004
Toronto, Ontario
- Recruiting
Investigational Site Number : 1240009
Montreal, Quebec
- Recruiting
Investigational Site Number : 1240007
Québec, Quebec
- Recruiting
Investigational Site Number : 1240008
Sherbrooke, Quebec
Eligibility Criteria
See who this study is looking for12 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, and laboratory tests as judged by the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →
- +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
- −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
- −Self-reported or documented seropositivity for human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus.
- −Participants are excluded from the study if any of the following criteria apply:
- −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 periodWashout periodA gap with no treatment, so the previous one clears your system.Read more →
- −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
- −The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trialInterventional studyA study where participants are given something to see what happens.Read more →.
- −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)
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 1Phase 1The earliest stage of human testing, in a small group, focused on safety.Read more →/2 — a combined study that starts with early safety and continues into what the treatment does.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 8 groups in this study.
Groups A, C, E and G receive Acne mRNA vaccine.
Registry label: A: Sentinel Cohort A - Experimental · C: Sentinel Cohort B - Experimental · E: Main Cohort A - Experimental · G: Main Cohort B - Experimental
Groups B, D, F and H, the placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group, receive Placebo.
Registry label: B: Sentinel Cohort A - Placebo · D: Sentinel Cohort B - Placebo · F: Main Cohort A - Placebo · H: Main Cohort B - Placebo
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists an age range of 18 years to 45 years.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 800 people.
The study is currently expected to finish around November 2028.
The main measurement is taken over: 30 minutes after each administration.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Core Study - Sentinel CohortsCohortA group of participants sharing a characteristic, followed together.Read more → A and B: Number of participants with unsolicited systemic AEs — measured over 30 minutes after each administration.
Core Study - Sentinel Cohorts A and B: Number of participants with solicited injection siteTrial siteA hospital or clinic where a study is actually run.Read more → and systemic reactions — measured over Up to 7 days after each administration.
Core Study - Sentinel Cohorts A and B: Number of participants with unsolicited AEs — measured over Up to 28 days after each administration.
Core Study - Sentinel Cohorts A and B: Number of participants with MAAEs — measured over Up to 6 months after each administration.
The study lists 7 further main measurements.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06316297 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Acne mRNA vaccineBiological
Pharmaceutical form: Liquid suspension for injection Route of administration: intramuscular
From the trial registry — its own words, unedited.
What a biological is here: A treatment made from or by living systems — such as antibodies, vaccines, or cell-based therapies.
Read the full explanation → · in clinical review
About PlaceboOther
Pharmaceutical form: Liquid solution for injection Route of administration: intramuscular
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 18 years to 45 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 18 years to 45 years.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 30 minutes after each administration.
The study as a whole is currently expected to finish around 2028-11-30.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 800 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 11 locations, including: Edmonton, Alberta, Canada; Barrie, Ontario, Canada; Toronto, Ontario, Canada; Montreal, Quebec, Canada; Québec, Quebec, Canada; Sherbrooke, Quebec, Canada, and 5 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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 four 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: * Two cohorts evaluating the 2-administration regimen (Cohorts A): Sentinel Cohort A and Main Cohort A. * Two cohorts evaluating the 3-administration regimen (Cohorts B): Sentinel Cohort B and Main Cohort B. Participants from Sentinel Cohorts A and B and from Main Cohort A will be invited to an additional 30-month follow up after completing their last planned Core Study visit to assess the long-term effects of the vaccine. Participants from Main Cohort B will be invited to another LTE study managed through a separate protocol.
Other Sites (5)
Michigan Institute of Research- Site Number : 8400092
Allen Park, Michigan, United States
Vida Clinical Studies - Dearborn Heights- Site Number : 8400074
Dearborn Heights, Michigan, United States
Clinical Research Institute - Minneapolis- Site Number : 8400080
Minneapolis, Minnesota, United States
Boeson Research - Missoula- Site Number : 8400069
Missoula, Montana, United States
Seattle Clinical Research Center- Site Number : 8400038
Seattle, Washington, United States
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.