After Rotavirus, Shigella is the second most deadly pathogen that causes severe diarrhoea in children, according to Gill. The bacteria were included in the World Health Organization's first-ever list of antibiotic-resistant bacteria posing "the biggest threat to human health" in February.
According to Shanta Dutta, Director, NICED, there is currently no licenced Shigella vaccine.
Simultaneously, a few firms and organisations, such as GSK Vaccines Institute for Global Health, are already working on a vaccine. Immuron, an Australian biotech business, also signed a deal with Walter Reed Army Institute of Research, the US Army's biomedical research facility, in June to develop a Shigella vaccine.
According to Gill, Hilleman's recent partnership represents a strategy shift for the company, which had previously focused on optimising existing vaccines. He went on to say that the organisation would now try to establish an altogether new therapeutic line.
Hilleman Labs will commence human testing of the institute's principal Shigella vaccine candidate under an arrangement with NICED, an organisation under the Indian Council of Medical Research (ICMR).
Shigella is a pathogenic gram-negative enterobacteria that causes severe diarrhoea and dysentery in people. Fever, stomach pain, tenesmus, watery diarrhoea, vomiting, dehydration, and convulsions are all symptoms of Shigella infection. Shigella dysenteriae, S. flexneri, S. sonnei, and S. boydii are among the Shigella strains covered. Shigella species are divided into serotypes based on the structure of O-antigens repeats, which are the polysaccharides moiety of the lipopolysaccharide, a virulence factor made up of toxic lipid.
The average yearly incidence of shigellosis in the United States was roughly 5 cases per 100,000 people in 2013, according to the Centers for Disease Control and Prevention (CDC). S. dysenteriae causes bacillary dysentery with vicious outbreaks by producing shiga toxins, whereas S. flexneri and S. sonnei cause the endemic form of the disease. Fever, rectal irritation, and abdominal cramps are all symptoms of bacillary dysentery.
Shigella infection kills over one million people per year, according to the World Health Organization (WHO). Furthermore, children under the age of five, travellers, and military personnel from developed economies have a high incidence rate. Shigella species have been known for decades, and they pose a serious threat to public health due to the lack of a licenced vaccine, which has harmed the total Shigella vaccine market.
Due to the diversity of Shigella species and serotypes, developing a vaccination against Shigella infections is difficult. Shigella's genome is constantly changing due to gene loss and acquisition mediated by mobile genetic components such plasmids, insertion sequences, and integrons. These changes lie at the heart of the development of novel antibiotic-resistant strains, as well as the emergence of new Shigella serotype variants. In April 2017, the Centers for Disease Control and Prevention (CDC) issued a warning to physicians and public health officials in the United States, claiming that new Shigella bacterium strains exhibit lower susceptibility to ciprofloxacin.
The Shigella vaccines market is likely to gain traction as a result of joint ventures and partnerships between firms to develop and commercialise Shigella vaccines. The European Vaccine Initiative (EVI) and Hilleman Laboratories, for example, established a partnership in October 2019 to develop a new shigella vaccine. Furthermore, the European and Developing Countries Clinical Trials Partnership (EDCTP) has awarded the EVI a grant of US$ 9.5 million to create a safe and effective shigella vaccine.
In March 2017, Hilleman Laboratories, a non-profit company founded by Merck & Co. and the Wellcome Trust, announced that it had reached an agreement with the National Institute of Cholera and Enteric Disease (NICED) for the development and commercialization of Shigella vaccines by 2024. Furthermore, in June 2016, Immuron, an Australian biopharmaceutical business, signed an agreement to create Shigella vaccine with the Walter Reed Army Institute of Research, a biomedical research facility of the United States Army (WRAIR).
In January 2017, Prokarium and Probiomed teamed up to develop an orally administered vaccination to prevent diarrhoea. The new vaccine will be produced as part of a two-year cooperation and will be thermostable for a longer period of time. The new vaccine will most likely be provided to persons living in rural areas. Thermostable vaccines, which are generated for a third of the cost of traditional injectable vaccines, are helping to fuel the market for Shigella vaccines.
The National Institute of Allergy and Infectious Diseases (NIAID) awarded the University of Maryland School of Medicine (UM SOM) a $2.47 million grant in August 2017 to develop a vaccine against Shigella and Enterotoxigenic Escherichia coli (ETEC) for the treatment of diarrheal illness. The Center for Vaccine Development (CVD) at the University of Michigan School of Medicine has produced a Shigella-ETEC prototype vaccine that has been successfully tested in animals. Furthermore, the latest money will aid in the development of a human vaccine for Phase 1 clinical trials. Similarly, EveliQure Biotechnologies got a grant of US$ 9,470,750 from Horizon2020, the European Union's Research and Innovation Programme, in September 2019.
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