mRNA Vaccine for Acne

Recruiting at 19 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

Trial Summary

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.

What data supports the effectiveness of the acne mRNA vaccine treatment?

Research shows that vaccines targeting the bacteria Propionibacterium acnes, which is involved in acne, can reduce inflammation and provide protective immunity in mice. These vaccines have been shown to neutralize harmful effects and decrease inflammation-related molecules, suggesting they could be a promising new treatment for acne. ^{1 2 3 4 5}

Is the mRNA vaccine for acne safe for humans?

Research on mRNA COVID-19 vaccines shows that they generally have a good safety profile, with common side effects like skin reactions being mild and temporary. These findings suggest that mRNA vaccines, in general, are safe for humans. ^{6 7 8 9 10}

How is the Acne mRNA Vaccine treatment different from other acne treatments?

The Acne mRNA Vaccine is unique because it specifically targets the bacteria responsible for acne, Propionibacterium acnes, without disrupting the skin's natural balance, unlike traditional treatments that broadly kill bacteria and can lead to antibiotic resistance. This vaccine approach aims to stimulate the immune system to neutralize the bacteria and reduce inflammation, offering a novel way to manage acne. ^{1 3 4 5 11}

What is the purpose of 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 three dose levels in adult participants aged 18 to 45 years with moderate to severe acne.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States 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. [2021]

2. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Vaccine therapy for P. acnes-associated diseases. [2019]

3. Poland pubmed.ncbi.nlm.nih.gov

[Immunomodulating properties of Acnevac vaccine]. [2006]

4. New Zealand pubmed.ncbi.nlm.nih.gov

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

5. Italy pubmed.ncbi.nlm.nih.gov

Acne vaccines targeting Propionibacterium acnes. [2012]

6. England pubmed.ncbi.nlm.nih.gov

Bullous pemphigoid after second dose of mRNA- (Pfizer-BioNTech) Covid-19 vaccine: A case report. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Cutaneous Adverse Reactions to COVID-19 Vaccines: Insights from an Immuno-Dermatological Perspective. [2022]

8. United States 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! [2022]

9. Switzerland 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. [2023]

10. England 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. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Prospects of acne vaccines targeting secreted virulence factors of Cutibacterium acnes. [2020]