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Cancer Vaccine

Experimental 2 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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 38 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Absolute change from baseline in the number of inflammatory acne lesions on face

Absolute change from baseline in the number of non-inflammatory acne lesions on face

At least two-grade improvement in IGA scores

+9 more

Secondary outcome measures

Assessment of vaccine-antigen-specific serum antibody titers

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Sanofi Pasteur, a Sanofi CompanyLead Sponsor

407 Previous Clinical Trials

6,091,595 Total Patients Enrolled

1 Trials studying Acne

38 Patients Enrolled for Acne

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible for individuals to participate in this clinical trial?

"Individuals aged between 18 and 45 with a diagnosis of acne are eligible for inclusion in this study. The trial aims to enroll a total of 386 participants."

Answered by AI

What is the current number of individuals being recruited for participation in this medical research study?

"Affirmative, as per clinicaltrials.gov data, this trial is presently in search of suitable candidates. The trial was made public on April 15th, 2024 and last amended on March 27th, 2024. A total of 386 participants are being sought from two distinct locations."

Answered by AI

Are there any ongoing efforts to enroll patients in this research study?

"Indeed, as per clinicaltrials.gov, this research investigation is currently in the process of recruiting suitable participants. The trial was initially listed on 4/15/2024 and underwent its latest update on 3/27/2024. Enrollment is open for up to 386 individuals at two specified locations."

Answered by AI