Starting in May 2022, the monkeypox outbreak has raised public health concerns. The small pox vaccine shows to be effective, but availability is limited. Moreover, the clinical image of a rash varies on different skin tones.
Before May 2022, Monkeypox had been endemic in African regions and had rarely been reported in non-endemic countries . Since substantial knowledge about risk factors, transmission, clinical presentation, and long-term outcomes are not well known, the ongoing outbreak with over 3000 infections in over 50 countries was declared a moderate public health concern. Monkeypox was first discovered in humans in 1970 in the Democratic Republic of the Congo and since then, it has caused several outbreaks, mainly in Central and West Africa, and travel-associated infections . It is known to spread through respiratory droplets, close or direct contact with skin lesions or scabs, and possibly through contaminated fomites, as well as infected rodents . Although the overwhelming majority includes homosexual or bisexual men, direct sexual transmission through seminal or vaginal fluids could not be confirmed.
The common distinguishable symptom is a skin rash that appears within the first five days after developing symptoms [2, 4]. The rash is often located in the genital or anal region but can also be found in other areas such as the face, hands, feet, or chest. As incubation time can vary between 5-21 days, the time frame for unknowingly spreading the infection can be long before experiencing first infection symptoms such as fever, chills, or muscle aches. The infection can cause complications such as pneumonia and encephalitis. The skin rash can present differently on varying skin tones, meaning symptoms as the skin rash have to be examined carefully. The individual typology angle (ITA°) can help with measuring different skin types and changes on their skin.
The Monkeypox virus belongs to the group of the Orthopoxvirus genus  and is usually a self-limited disease [1[. Smallpox, in older times known as the ‘Red Plaque’, belongs to the same group, and displayed mortality of the variola major subtype of around 30%. With humans being the only host of smallpox, the virus was eradicated in 1989 due to successful vaccine mandates. Clinical research into monkeypox and a possible vaccine has been highly neglected , likely, due to the low amount of cases outside of endemic regions. On the brighter side, the smallpox vaccine has proven to be preventive of monkeypox in 85% of the cases. However, waning smallpox immunity, due to eradication and therefore discontinuation of vaccine mandates and production, is leaving many people, especially when born after 1982, more vulnerable to the monkeypox infection. The current version of the smallpox vaccine, Imvanex®, was approved by the European Medicines Agency (EMA) in 2013 and has been extended for the use in monkeypox patients since July 2022 . Studies estimate a case fatality of monkeypox of approximately 10%, with healthcare and frontline workers and therefore the already fragile healthcare system at a high risk. Due to limited availability and vaccine efficacy, clinical trials are ongoing .
How can Scarletred®Vision be used in clinical trials for monkey pox vaccines and therapy?
Digitalizing clinical trials from the beginning by using the skin imaging software Scarletred®Vision, a CE Class 1m medical device, provides high-quality and standardized data to create an efficient work flow during clinical testing. The AI-based software provides hybrid trial options while maintaining easy documentation, measurement, and analysis of skin changes for healthcare personnel and patients. Scarletred®Vision can document the progression of the disease by quantifying the characteristic skin lesions and injection site reaction (ISR) after vaccine injections. It can improve image quality for the individual typology angle (ITA°) assessment and can detect even minor changes in the ITA°. The software also measures the Standardized Erythema Value (SEV), which enables quantity-based severity scoring of erythema and therefore, provides superior sensitivity. Using both the SEV and ITA°, the degree of pigmentation and clinical presentation in varying skin tones is taken into account. Beyond skin changes based on color, the Tissue Classifyer tool is able to measure skin texture of the pustules and the relative difference compared to the healthy skin. It is therefore applicable for clinical trials testing a vaccine as well as medications by supporting severity scoring of the disease and quantifying skin lesion size. The measurement tools are clinically validated and certified, and can also be integrated in later stages of clinical research.
As a flexible Software as a Service (SaaS), the software and applications can be completely customized based on the specific requirements of clinical trials. Furthermore, patients can record electronic patient reported outcomes (ePROs) using our customizable questionnaires on the mobile app to
determine the Dermatology Life Quality Index (DLQI). The data is centrally saved on the platform, according to European data safety regulations, and allow for real-time tracking of symptoms during trials.
Contact us for more information!
- Thornhill JP et al. Monkeypox Virus Infection in Humans across 16 Countries — April–June 2022 (2022). N Engl J Med 2022; 387:679-691 DOI: 10.1056/NEJMoa2207323
- WHO. Monkeypox. Retrieved 14.09.22 from www. who.int
- NHS. Monkeypox. Retrieved 14.09.22 from www. nhs.uk
- CDC. Momkeypox. Retrieved 14.09.22 from www. cdc.gov
- Robert Koch Institut. Schutzimpfung gegen Affenpocken. Retrieved from 14.09.22 from www.rki.de
- NIH. IMVAMUNE® Smallpox Vaccine in Adult Healthcare Personnel at Risk for Monkeypox in the Democratic Republic of the Congo. Retrieved from 14.09.22 from www. clinicaltrials.gov