mRNA Vaccine for Acne
Recruiting in Palo Alto (17 mi)
+18 other locations
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1 & 2
Recruiting
Sponsor: Sanofi Pasteur, a Sanofi Company
Must not be taking: Immunosuppressants, Corticosteroids, others
Disqualifiers: Immunodeficiency, Active nodulocystic acne, others
Trial Summary
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.
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.
12345Is 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.
678910How 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.
134511Eligibility 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
+5 more
Trial 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
Participant Groups
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.
6Treatment groups
Experimental Treatment
Placebo Group
Group I: Sentinel Cohort B - ExperimentalExperimental Treatment1 Intervention
Three administrations of the Acne mRNA vaccine will be injected in two increasing doses
Group II: Sentinel Cohort A - ExperimentalExperimental Treatment1 Intervention
Two administrations of the Acne mRNA vaccine will be injected in three increasing doses
Group III: Main Cohort - ExperimentalExperimental Treatment1 Intervention
Two administrations of the Acne mRNA vaccine will be injected in three increasing doses
Group IV: Sentinel Cohort A - PlaceboPlacebo Group1 Intervention
Two administrations of placebo will be injected
Group V: Sentinel Cohort B - PlaceboPlacebo Group1 Intervention
Three administrations of placebo will be injected
Group VI: Main Cohort - PlaceboPlacebo Group1 Intervention
Two administrations of placebo will be injected
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Vial Health @DermDox Dermatology Site Number : 8400017Camp Hill, PA
DelRicht Research Site Number : 8400013New Orleans, LA
Alliance for Multispecialty Research Site Number : 8400019Oakbrook Terrace, IL
Best Skin Research, LLC Site Number : 8400017Camp Hill, PA
More Trial Locations
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Who Is Running the Clinical Trial?
Sanofi Pasteur, a Sanofi CompanyLead Sponsor
References
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]Propionibacterium acnes is a key pathogen involved in the progression of inflammation in acne vulgaris. We examined whether vaccination against P. acnes suppressed P. acnes-induced skin inflammation. Inactivation of P. acnes with heat was employed to create a P. acnes-based vaccine. Intranasal immunization in mice with this inactivated vaccine provoked specific antibodies against P. acnes. Most notably, immunization with inactivated vaccines generated in vivo protective immunity against P. acnes challenge and facilitated the resolution of ear inflammation in mice. In addition, antibodies elicited by inactivated vaccines effectively neutralized the cytotoxicity of P. acnes and attenuated the production of proinflammatory cytokine IL-8 in human sebocyte SZ95 cells. Intranasal immunization using heat-inactivated P. acnes-based vaccines provided a simple modality to develop acne vaccines. These observations highlight the concept that development of vaccines targeting microbial products may represent an alternative strategy to conventional antibiotic therapy.
Vaccine therapy for P. acnes-associated diseases. [2019]Recent studies have afforded abundant evidences showing that Propionibacterium acnes (P. acnes) is involved not only in acne vulgaris, but also in many diseases, including endocarditis, endophthalmitis, osteomyelitis, joint, nervous system, cranial neurosurgery infections, and implanted biomaterial contamination. In spite of a range of P. acnes pathogenicity, its vaccine therapies have been studied much less intensively than antibiotic therapies which have been mainstay of treatment for P. acnes-associated diseases. Therefore, we have recently developed effective vaccines for P. acnes-associated inflammatory acne, consisting of a cell wall-anchored sialidase of P. acnes or killed-whole organism of P. acnes. Our data strongly show that immunization of ICR mice with the vaccines provides in vivo protective immunity against P. acnes challenge and decreases P. acnes-induced elevation of cytokine production. This review highlights the potential functions of killed P. acnes- and sialidase-based vaccines as novel treatments for P. acnes-associated diseases.
[Immunomodulating properties of Acnevac vaccine]. [2006]The influence of Acnevac vaccine on immune responses of CBA mice was tested. Acnevac, the vaccine used in a treatment of patient with acne vulgaris, was produced by a Cracow Sera and Vaccines Manufacturer from cultures of Propionibacteria-strains. It was shown that Acnevac has strong immunomodulatory properties. It strongly stimulates humoral responses, has moderate effect on cell-mediated immune responses and it also activates peritoneal macrophages to release TNF-alpha.
Immunotherapy for acne vulgaris: current status and future directions. [2016]There is a high unmet clinical need for new and better treatments in acne vulgaris. Propionibacterium acnes has a strong proinflammatory activity and targets molecules involved in the innate cutaneous immunity, keratinocytes and sebaceous glands of the pilosebaceous follicle. The role of P. acnes in acne confers legitimacy on the possible benefits of immunization-based approaches, which may represent a solution for limiting the development of antibiotic-resistant P. acnes. Various immunization-based approaches have been developed over the last decades, including killed pathogen-based vaccines, vaccination against cell wall-anchored sialidase, monoclonal antibodies to the Christie, Atkins, Munch-Peterson factor of P. acnes, anti-Toll-like receptors vaccines and natural antimicrobial peptides. This review summarizes the current evidence and explores the challenges to making this a realistic treatment option for the future.
Acne vaccines targeting Propionibacterium acnes. [2012]Acne vulgaris is one of the most common skin diseases and can affect a large number of individuals at some point in their lives. Though the disease is multi-factorial, the Gram-positive, anaerobic bacterium Propionibacterium acnes (P. acnes), a member of resident skin microflora, is implicated in acne inflammation and associated with acne lesions. Common treatments such as antibiotic or benzoyl peroxide nonspecifically reduce bacteria population on the skin, which may disrupt homeostasis and cause further complications such as promoting growth of antibiotic-resistant bacteria strains. A component vaccine and an inactivated whole bacteria vaccine are made to target specifically P. acnes. The component vaccine targeting P. acnes surface sialidase and heat-inactivated P. acnes vaccine have both been shown to reduce P. acnes- induced inflammation in vivo and neutralize P. acnes in vitro, suggesting their potentials as new treatment for acne vulgaris. To facilitate acne studies, a bioengineering approach was utilized to design a new human acne model using tissue chamber. The tissue chamber of human sebocytes is shown to produce in mice a microenvironment similar to human acne inflammation. This approach can also be utilized in future studies in developing therapeutic acne vaccines and designing possible combined treatment of acne vaccine with alternative acne treatments.
Bullous pemphigoid after second dose of mRNA- (Pfizer-BioNTech) Covid-19 vaccine: A case report. [2022]Messenger RNA vaccines, commonly known as mRNA vaccines, are the first COVID-19 vaccines that have been authorized and licensed in the United States. Two mRNA vaccines, BNT162b2 (Pfizer-BioNTech) and mRNA-1273 (Moderna) are available. Mass vaccination remains the most critical way to halt the spread of the COVID pandemic. The most common adverse effects of the COVID vaccines are headache, muscular soreness, weariness, redness, swelling, and tenderness at the injection site. The dermatological adverse effects of mRNA vaccines, on the other hand, are little understood. We present a case of bullous fixed medication eruption following delivery of the second dose of Pfizer's Covid-19 vaccination.
Cutaneous Adverse Reactions to COVID-19 Vaccines: Insights from an Immuno-Dermatological Perspective. [2022](1) Background: Numerous vaccines are under preclinical and clinical development for prevention of severe course and lethal outcome of coronavirus disease 2019 (COVID-19). In light of high efficacy rates and satisfactory safety profiles, some agents have already reached approval and are now distributed worldwide, with varying availability. Real-world data on cutaneous adverse drug reactions (ADRs) remain limited. (2) Methods: We performed a literature research concerning cutaneous ADRs to different COVID-19 vaccines, and incorporated our own experiences. (3) Results: Injection site reactions are the most frequent side effects arising from all vaccine types. Moreover, delayed cutaneous ADRs may occur after several days, either as a primary manifestation or as a flare of a pre-existing inflammatory dermatosis. Cutaneous ADRs may be divided according to their cytokine profile, based on the preponderance of specific T-cell subsets (i.e., Th1, Th2, Th17/22, Tregs). Specific cutaneous ADRs mimic immunogenic reactions to the natural infection with SARS-CoV-2, which is associated with an abundance of type I interferons. (4) Conclusions: Further studies are required in order to determine the best suitable vaccine type for individual groups of patients, including patients suffering from chronic inflammatory dermatoses.
Attention all anti-vaccinators: The cutaneous adverse events from the mRNA COVID-19 vaccines are not an excuse to avoid them! [2022]Despite the growing availability of coronavirus disease 2019 (COVID-19) vaccines in the general population, a significant proportion of individuals demonstrate vaccine hesitancy. We sought to consolidate and update current evidence on cutaneous adverse events from COVID-19 vaccines to aid in the education and counseling of patients concerned about potential cutaneous side effects. We conducted a literature review of PubMed in May 2021 to identify reports of cutaneous events after vaccination with the Pfizer-BioNTech and Moderna vaccines (postauthorization clinical reports pertaining to the Johnson & Johnson and AstraZeneca vaccines were limited). Event reports in the Vaccine Adverse Event Reporting System were reviewed. Localized cutaneous reactions were common after the mRNA vaccines, consistent with clinical trial findings. Reported urticarial and morbilliform eruptions may reflect immediate hypersensitivity but have rarely been associated with anaphylaxis. There are infrequent reports of herpes zoster, dermatologic filler reactions, and immune thrombocytopenia, mainly occurring in high-risk patient groups. Ultimately, the identified cutaneous reactions are largely self-limited and should not discourage vaccination. Existing reports should reassure patients of the overall compelling safety profiles of the mRNA COVID-19 vaccines and benignity of skin reactions after vaccination.
The Impact of COVID-19 Vaccination on Inflammatory Skin Disorders and Other Cutaneous Diseases: A Review of the Published Literature. [2023]Background: Four vaccines have been authorized by the European Medicines Agency (EMA): viral vector-based vaccines (AstraZeneca; AZD1222 and Johnson & Johnson; Ad26.COV2. and 2 mRNA-based vaccines (Pfizer/BioNTech; BNT162b2 and Moderna; mRNA-1273). Adverse events (AEs) related to vaccination have been described in the literature. The main aim of the dermatological practice was to avoid the diffusion of COVID-19, allowing the continuity of care for patients. Objective: The aim of this review article is to investigate current literature regarding cutaneous reactions following COVID-19 vaccination, mainly inflammatory dermatological diseases. Materials and methods: Investigated manuscripts included metanalyses, reviews, letters to the editor, real-life studies, case series, and reports. Results: We selected a total of 234 articles involving more than 550 patients. We have divided the results section into various sub-sections to ensure greater understanding for readers. Conclusions: Clinicians should keep in mind the possibility of new onsets or the worsening of several dermatoses following vaccination in order to promptly recognize and treat these AEs. Certainly, vaccination should not be discouraged.
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]Adverse events (AE) after COVID-19 vaccines, particularly, but not solely, with those messenger RNA (mRNA)-based vaccines, have rarely been reported in patients previously treated with dermal fillers (DF).
Prospects of acne vaccines targeting secreted virulence factors of Cutibacterium acnes. [2020]Acne vulgaris afflicts many people, and despite the multitude of the anti-acne products on the market, there is still no effective treatment that can prevent and cure this disease. The severity of acne vulgaris is highly associated with the inflammatory response to Propionibacterium acnes (P. acnes) now referred to as Cutibacterium acnes (C. acnes), an opportunistic skin bacterium in the human skin microbiome. Areas covered: We here provide the prospects of creating acne vaccines targeting secreted virulence factors of C. acnes including secretory Christie-Atkins-Munch-Peterson (CAMP) factor. Neutralization of secreted virulence factors by either active or passive vaccination may have a lower risk of disturbing the microbial ecosystem in the human skin microbiome. Expert opinion: Major steps could be taken to start a public vaccination program at an early age to prevent the future occurrence of acne vulgaris. Future therapeutic monoclonal antibodies can be designed to specifically neutralize virulence factors of C. acnes including CAMP factors without disrupting the optimal balance of C. acnes in the human skin microbiome and lowering the risk of creating drug-resistant C. acnes. Targeting secreted virulence factors without disturbing the commensal relationship of host can be a novel gateway towards the therapeutic treatment of acne vulgaris.