Acne mRNA Vaccine for Acne

Recruiting at 3 trial locations

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Sanofi Pasteur, a Sanofi Company

Must not be taking: Immunosuppressants, Corticosteroids

Disqualifiers: Immunodeficiency, Myocarditis, Skin disorders, others

Compensation: Varies

Number of Visits: 2

Duration: 2 weeks

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new mRNA vaccine for treating mild acne. Researchers aim to determine if the vaccine is safe and effective in reducing acne symptoms. Participants will receive either the vaccine or a placebo, an inactive substance, to compare results. Individuals with mild facial acne, characterized by specific types and amounts of pimples and no nodules or cysts, may qualify for this study. The trial includes an optional follow-up period to examine long-term effects. As a Phase 1 and Phase 2 trial, this study focuses on understanding how the treatment works in people and measuring its effectiveness in an initial, smaller group, offering participants a chance to be among the first to benefit from this innovative approach.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are on immunosuppressive therapy or long-term systemic corticosteroids, you may not be eligible to participate.

Is there any evidence suggesting that the Acne mRNA Vaccine is likely to be safe for humans?

Research has shown that the Acne mRNA vaccine has been tested in several studies to ensure its safety. In earlier trials, participants received up to three shots of the vaccine. These studies evaluated how well people tolerated the vaccine and how their immune systems responded.

Results from these trials indicated that most participants tolerated the vaccine well. Some reported mild side effects, such as soreness at the injection site or slight fatigue, but these effects were typically brief and not serious.

As this trial is in the early stages, it primarily focuses on ensuring the vaccine's safety for people. Safety remains the top priority, and any issues are monitored closely. Overall, existing research suggests the Acne mRNA vaccine is generally safe for humans. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard acne treatments that often rely on topical creams or oral antibiotics, the Acne mRNA Vaccine offers a novel approach by using mRNA technology. This mechanism works by instructing the body to produce specific proteins that can trigger an immune response against the bacteria causing acne. Researchers are excited about this treatment because it has the potential to offer a more targeted and long-lasting solution, reducing the reliance on daily medications and minimizing side effects. Additionally, the use of mRNA technology, similar to that used in some COVID-19 vaccines, represents a cutting-edge advancement in dermatology treatments.

What evidence suggests that the Acne mRNA Vaccine might be an effective treatment for acne?

Research shows that the Acne mRNA Vaccine is designed to help the immune system fight the bacteria that cause acne. Early results from animal studies suggest that this vaccine can prevent acne by creating antibodies against these bacteria. While these findings are encouraging, more information is needed about the vaccine's effectiveness in people. In this trial, some participants will receive the Acne mRNA Vaccine, while others will receive a placebo. Further studies are necessary to confirm its effectiveness in humans. However, the vaccine's mechanism offers hope for new acne treatments in the future. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for healthy individuals aged 18 to 45 with mild acne, characterized by a specific number of non-inflammatory and inflammatory lesions but no severe nodulocystic lesions. Participants must pass a medical evaluation including history, physical exam, and lab tests.

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

I have mild facial acne with specific numbers of acne spots and no severe acne cysts.

Exclusion Criteria

I have not taken immunosuppressives or long-term steroids in the last 6 months.

Self-reported or documented seropositivity for HIV, hepatitis B virus, or hepatitis C virus

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 after administration of mRNA COVID-19 vaccine

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 2 administrations of the Acne mRNA vaccine or placebo

2 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Regular follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

• Acne mRNA Vaccine

Trial Overview The study evaluates an Acne mRNA vaccine's safety, effectiveness, and immune response in people with mild acne. It involves two doses of the vaccine or placebo given to separate groups: first a smaller Sentinel Cohort for initial safety assessment followed by a larger Main Cohort.

How Is the Trial Designed?

Group I: Sentinel Cohort Arm 1 Experimental Treatment 1 Intervention

Participants will receive 2 Acne mRNA Vaccine injections

Group II: Main Cohort Arm 1 Experimental Treatment 1 Intervention

Participants will receive 2 Acne mRNA Vaccine injections

Group III: Main Cohort Arm 2 Placebo Group 1 Intervention

Participants will receive 2 Placebo injections

Group IV: Sentinel Cohort Arm 2 Placebo Group 1 Intervention

Participants will receive 2 Placebo injections

Who Is Running the Clinical Trial?

Sanofi Pasteur, a Sanofi Company

Lead Sponsor

Trials

429

Recruited

6,140,000+

Paul Hudson

Sanofi Pasteur, a Sanofi Company

Chief Executive Officer since 2019

Degree in Economics from Manchester Metropolitan University

Dr. Thomas Triomphe

Sanofi Pasteur, a Sanofi Company

Chief Medical Officer since 2020

MD from Tehran University of Medical Sciences

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07013747

NCT07013747 | Study to Evaluate Safety, Efficacy and ... The purpose of the VBE00009 study is to evaluate the safety, efficacy and immunogenicity of 2 administrations of the Acne mRNA vaccine candidate at single ...

2. sanofistudies.com sanofistudies.com/cwout/CW-V9DEXS//us/en/listing/312917/study-to-evaluate-safety/

Study to Evaluate Safety, Efficacy and Immunogenicity of This study investigates the safety, efficacy, and immune response of an investigational mRNA vaccine for adults with moderate to severe acne ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06316297/study-to-evaluate-safety-efficacy-and-immunogenicity-of-acne-mrna-vaccine-in-adults-with-moderate-to-severe-acne

Study to Evaluate Safety, Efficacy and Immunogenicity of ... 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.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06316297

NCT06316297 | Study to Evaluate Safety, Efficacy and ... 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 ...

5. nature.com nature.com/articles/d41586-025-02652-1.pdf

The hunt for an acne vaccine The result clearly showed that the vaccine prevented the onset of acne in mice. It does this, says Liu, by inducing anti- bodies that bind to ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11860801/

Vaccines in Dermatology—Present and Future: A Review - PMC The first sought to evaluate the safety, tolerability, and immunogenicity of an acne vulgaris vaccine (ORI-A-ce001) based on recombinant proteins (which have ...