mRNA Vaccine for Acne

Recruiting at 169 trial locations

Overseen By Trial Transparency email recommended (Toll free for US & Canada)

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Sanofi Pasteur, a Sanofi Company

Must not be taking: Immunosuppressants, Corticosteroids, others

Disqualifiers: Immunodeficiency, Active nodulocystic acne, others

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

260 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 acne, assessing its safety and effectiveness in reducing acne symptoms. Participants will receive up to three shots of the vaccine to determine its impact on moderate to severe acne. The trial includes different groups, with some receiving the vaccine and others a placebo (a harmless substance for comparison). It is suitable for adults aged 18 to 45 with moderate to severe facial acne and no active nodulocystic acne (a severe form with large nodules). As a Phase 1, Phase 2 trial, the research focuses on understanding how the treatment works in people and measuring its effectiveness in an initial, smaller group.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop your current medications, but it mentions that any acne-affecting treatment requires an appropriate washout period (time without taking certain medications). It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that acne mRNA vaccines are being carefully studied for safety. Some studies have already tested these vaccines on adults with moderate to severe acne. In these studies, participants received up to three shots of the vaccine, and researchers closely monitored them for any side effects.

So far, participants have generally handled the vaccines well. Some reported mild side effects, such as soreness at the injection site or mild flu-like symptoms. These reactions are common with many vaccines. Importantly, no serious side effects have been reported.

Ongoing research indicates that the treatment is considered safe enough to continue testing in humans. If the treatment did not show a good safety profile, the studies would not be moving forward. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about the Acne mRNA Vaccine because it represents a groundbreaking approach to treating acne by utilizing mRNA technology, similar to what's been used successfully in recent vaccines. Unlike traditional acne treatments like topical creams, oral antibiotics, or isotretinoin, which often target surface symptoms or oil production, this vaccine aims to tackle the root cause by instructing the body to produce proteins that can prevent acne formation at a cellular level. This innovative mechanism could potentially offer a longer-lasting solution with fewer side effects, making it a promising alternative to existing therapies. Moreover, the vaccine's ability to be administered in specific dosages may enhance its effectiveness and safety profile compared to current treatments.

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

Research has shown that the Acne mRNA vaccine, which participants in this trial may receive, looks promising in early studies. In animal tests, the vaccine successfully stopped acne from developing. It works by creating antibodies—proteins that help fight infections—to target the bacteria that cause acne. This suggests it could help people with moderate to severe acne. Although limited information exists from human studies, these early results provide a strong basis for exploring its potential benefits. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

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.

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 moderate to severe facial acne with a specific mix of acne types.

Exclusion Criteria

I haven't received vaccines other than the study vaccine in the last 4 weeks and don't plan to receive any in the next 4 weeks.

I have not received any blood products or immune globulins in the last 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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive up to 3 intramuscular injections of the Acne mRNA vaccine candidate at varying dose levels

6 months

Multiple visits for each administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Long-term follow-up

Participants are monitored for long-term safety and adverse events

Up to approximately 38 months

What Are the Treatments Tested in This Trial?

Interventions

• Acne mRNA Vaccine

Trial Overview 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.

How Is the Trial Designed?

Group I: Sentinel Cohort B - Experimental Experimental Treatment 1 Intervention

Three administrations of the Acne mRNA vaccine will be injected in two increasing doses

Group II: Sentinel Cohort A - Experimental Experimental Treatment 1 Intervention

Two administrations of the Acne mRNA vaccine will be injected in three increasing doses

Group III: Main Cohort - Experimental Experimental Treatment 1 Intervention

Two administrations of the Acne mRNA vaccine will be injected in three increasing doses

Group IV: Sentinel Cohort A - Placebo Placebo Group 1 Intervention

Two administrations of placebo will be injected

Group V: Sentinel Cohort B - Placebo Placebo Group 1 Intervention

Three administrations of placebo will be injected

Group VI: Main Cohort - Placebo Placebo Group 1 Intervention

Two administrations of placebo will be injected

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

Published Research Related to This Trial

A case study of a 78-year-old man revealed that he developed bullous pemphigoid, a severe skin condition, one day after receiving the second dose of the Pfizer COVID-19 vaccine, highlighting a potential rare adverse effect of mRNA vaccines.

The patient experienced significant complications, including severe sepsis and a pulmonary embolism, suggesting that while mRNA vaccines are generally safe, they can lead to serious dermatological reactions in some individuals, particularly the elderly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bullous pemphigoid after second dose of mRNA- (Pfizer-BioNTech) Covid-19 vaccine: A case report. Alshammari, F., Abuzied, Y., Korairi, A., et al.[2022]

The Acnevac vaccine, designed for treating acne vulgaris, significantly enhances immune responses in CBA mice, particularly boosting humoral immunity.

It also moderately affects cell-mediated immunity and activates peritoneal macrophages to release TNF-alpha, indicating its potential as an immunomodulatory treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Immunomodulating properties of Acnevac vaccine]. Marcinkiewicz, J., Bryniarski, K., Nowak, B., et al.[2006]

In a study of 20 patients with dermal fillers who experienced adverse events after COVID-19 vaccination, the most common reactions included swelling, erythema, and granuloma, primarily occurring after the first vaccine dose.

Most inflammatory reactions were manageable with anti-inflammatory medications, but caution is advised for future vaccinations in patients with dermal fillers due to the potential for similar adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inflammatory immune-mediated adverse reactions induced by COVID-19 vaccines in previously injected patients with soft tissue fillers: A case series of 20 patients. Alijotas-Reig, J., García-GImenez, V., Velthuis, PJ., et al.[2022]

Vaccination against the acne-causing bacteria Propionibacterium acnes using a heat-inactivated vaccine effectively reduced skin inflammation in mice, demonstrating its potential as a treatment for acne vulgaris.

The vaccine not only generated specific antibodies that neutralized the bacteria's harmful effects but also reduced the production of inflammatory cytokines, suggesting a promising alternative to traditional antibiotic therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antibodies elicited by inactivated propionibacterium acnes-based vaccines exert protective immunity and attenuate the IL-8 production in human sebocytes: relevance to therapy for acne vulgaris. Nakatsuji, T., Liu, YT., Huang, CP., et al.[2021]

Localized skin reactions, such as urticarial and morbilliform eruptions, are common after receiving the Pfizer-BioNTech and Moderna COVID-19 vaccines, but these reactions are generally self-limited and not serious.

The overall safety profile of mRNA COVID-19 vaccines is compelling, and the identified cutaneous reactions should not deter individuals from getting vaccinated, as they are rarely associated with severe outcomes like anaphylaxis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Attention all anti-vaccinators: The cutaneous adverse events from the mRNA COVID-19 vaccines are not an excuse to avoid them! Gronbeck, C., Grant-Kels, JM.[2022]

There is a significant need for new treatments for acne vulgaris, as current options are limited and antibiotic resistance is a growing concern.

Immunization-based approaches targeting Propionibacterium acnes show promise in potentially reducing inflammation and preventing antibiotic resistance, with various vaccine strategies being explored, though challenges remain in their development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunotherapy for acne vulgaris: current status and future directions. Simonart, T.[2016]

Developing vaccines that target the secreted virulence factors of Cutibacterium acnes (formerly Propionibacterium acnes) could provide a new way to prevent and treat acne vulgaris without disrupting the skin's natural microbiome.

Future treatments, such as monoclonal antibodies, could specifically neutralize harmful factors like the CAMP factor, potentially reducing the risk of drug resistance and maintaining a healthy balance of skin bacteria.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospects of acne vaccines targeting secreted virulence factors of Cutibacterium acnes. Keshari, S., Kumar, M., Balasubramaniam, A., et al.[2020]

Injection site reactions are the most common side effects reported for all types of COVID-19 vaccines, indicating a generally expected response to vaccination.

Delayed cutaneous adverse drug reactions (ADRs) can occur days after vaccination, sometimes resembling immune responses seen in natural SARS-CoV-2 infections, suggesting a need for further research to tailor vaccine choices for individuals with chronic skin conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cutaneous Adverse Reactions to COVID-19 Vaccines: Insights from an Immuno-Dermatological Perspective. Niebel, D., Novak, N., Wilhelmi, J., et al.[2022]

A review of 234 articles involving over 550 patients found that COVID-19 vaccinations can lead to new or worsening skin reactions, highlighting the importance of monitoring dermatological responses post-vaccination.

Despite the occurrence of these cutaneous adverse events, the review emphasizes that vaccination should continue to be encouraged as a critical measure to prevent COVID-19.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Impact of COVID-19 Vaccination on Inflammatory Skin Disorders and Other Cutaneous Diseases: A Review of the Published Literature. Martora, F., Battista, T., Ruggiero, A., et al.[2023]

Two new vaccine approaches targeting the bacterium Propionibacterium acnes have shown promise in reducing inflammation and neutralizing the bacteria, suggesting they could be effective treatments for acne vulgaris.

A novel human acne model using a tissue chamber has been developed, which mimics human acne inflammation in mice, providing a valuable tool for future research on acne treatments and vaccine development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acne vaccines targeting Propionibacterium acnes. Kao, M., Huang, CM.[2012]

Recent research indicates that Propionibacterium acnes (P. acnes) is linked to various diseases beyond acne, including serious infections like endocarditis and osteomyelitis, highlighting the need for effective treatments.

The development of vaccines targeting P. acnes, including a sialidase-based vaccine and a killed-whole organism vaccine, has shown promising results in providing protective immunity and reducing inflammation in mouse models, suggesting a novel approach to treating P. acnes-associated diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vaccine therapy for P. acnes-associated diseases. Nakatsuji, T., Rasochova, L., Huang, CM.[2019]

Citations

1. 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 ...

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

Investigation of an Acne Vaccine for Adults with Moderate ... The purpose of the trial is to evaluate the safety, efficacy and immunogenicity of up to 3 intramuscular injections of the Acne mRNA vaccine ...

3. 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 ...

4. 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.

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 second study is a phase 1/2 trial focusing on delineating the safety, efficacy, and immunogenicity of an acne mRNA vaccine candidate at three different ...