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Cancer Vaccine

mRNA Vaccine for Acne

Phase 1 & 2
Recruiting
Research Sponsored by Sanofi Pasteur, a Sanofi Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 38 months

Summary

This trial will test a new acne vaccine on adults aged 18 to 45 with moderate to severe acne in the US to see if it is safe, effective, and can trigger an immune response.

Who is the study for?
This trial is for healthy adults aged 18 to 45 with moderate to severe facial acne. Participants must have a specific number of different types of acne lesions and be judged as eligible by the investigator based on medical history, physical exam, and lab tests.
What is being tested?
The study is testing an Acne mRNA vaccine given through one or two shots in the muscle at three different doses. It aims to check how safe it is, how well it works against acne, and if it causes an immune response.
What are the potential side effects?
Potential side effects are not detailed here but may include typical reactions to vaccines such as soreness at injection site, fever, fatigue, headache and possible allergic reactions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 38 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 38 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
At least two-grade improvement in IGA scores
Number of participants with MAAEs
Number of participants with solicited injection site and systemic reactions
+3 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Experimental 2Experimental Treatment1 Intervention
One administration of the Acne mRNA vaccine in three increasing doses and one administration of placebo will be injected
Group II: Experimental 1Experimental Treatment1 Intervention
Two administrations of the Acne mRNA vaccine will be injected in three increasing doses
Group III: Placebo 1Placebo Group1 Intervention
Two administrations of placebo will be injected

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Who is running the clinical trial?

Sanofi Pasteur, a Sanofi CompanyLead Sponsor
416 Previous Clinical Trials
6,107,022 Total Patients Enrolled
1 Trials studying Acne
38 Patients Enrolled for Acne
~257 spots leftby Dec 2027
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