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Learn more about norovirus and the development of HIL-214

Norovirus

Norovirus is the most common viral cause of acute gastroenteritis worldwide and is responsible for greater than 90% of epidemic non-bacterial outbreaks of gastroenteritis.[1, 2] It is estimated to cause 685 million cases of gastroenteritis and approximately 212,000 deaths worldwide annually.[2, 3]

Norovirus is highly infectious and contagious; it primarily spreads through person-to-person contact and impacts all age groups.[4]

Norovirus disease incidence is highest in young children less than 5 years of age where it is responsible for about 200 million acute gastroenteritis cases and an estimated 50,000 deaths each year.[2] Approximately 70% of pediatric norovirus cases occur between 6 and 23 months of age.[5]

Adults greater than 65 years of age have the greatest risk for norovirus associated deaths.[6]

The global economic burden of norovirus is estimated to be $4.2 billion in direct health care costs and $56.2 billion in productivity losses annually, resulting in total annual costs of $60.3 billion .[7]

The impact of norovirus in the United States results in an average of 19 to 21 million cases of acute gastroenteritis, 2,270,000 outpatient clinic visits, 465,000 emergency department visits, and 109,000 hospitalizations annually.[8] This has been estimated to cost between $163.8 million to $2.4 billion in direct medical costs and $1.5 billion to $20.9 billion in productivity losses.[9]

HIL-214

HilleVax is developing HIL-214, a norovirus bivalent GI.1/GII.4 virus-like particle (VLP) vaccine intended for active immunization for the prevention of acute gastroenteritis (AGE) caused by norovirus.

HIL-214 has been studied in nine human clinical trials, generating safety data from over 4,000 subjects and immunogenicity data from over 2,000 subjects.

In a randomized, placebo-controlled Phase IIb field efficacy study in 4,712 adult subjects, HIL-214 was shown to be well-tolerated and demonstrated clinical proof of concept in preventing moderate-to-severe cases of acute gastroenteritis from norovirus infection.[9]

REFERENCES

[1] Karst SM. Pathogenesis of noroviruses, emerging RNA viruses. Viruses. 2010;2(3):748-781. doi:10.3390/v2030748

[2] Centers for Disease Control (CDC). Norovirus Worldwide [Accessed on: 22 October 2019], available from: https://www.cdc.gov/norovirus/trends-outbreaks/worldwide.html

[3] Pires, S.M., et al., Aetiology-Specific Estimates of the Global and Regional Incidence and Mortality of Diarrhoeal Diseases Commonly Transmitted through Food, PLoS ONE 2015, DOI:10.1371/journal.pone. 0142927

[4] Teunis PF, Moe CL, Liu P, et al. Norwalk virus: how infectious is it? J Med Virol 2008;80(8):1468–76

[5] Shioda K, Kambhampati A, Hall AJ, Lopman BA. Global age distribution of pediatric norovirus cases. Vaccine. 2015 Aug 7;33(33):4065-8. doi: 10.1016/j.vaccine.2015.05.051. Epub 2015 Jun 4. PMID: 26051514; PMCID: PMC4612353

[6] Lindsay, L., Wolter, J., De Coster, I. et al. A decade of norovirus disease risk among older adults in upper-middle and high income countries: a systematic review. BMC Infect Dis 15, 425 (2015)

[7] Bartsch SM, Lopman BA, Ozawa S, Hall AJ, Lee BY. Global Economic Burden of Norovirus Gastroenteritis. PLoS One. 2016; 11(4): e0151219

[8] Centers for Disease Control (CDC). Burden of Norovirus Illness in the U.S. Accessed on: 20 February 2021], available from: https://www.cdc.gov/norovirus/trends-outbreaks/burden-US.html

[9] Bartsch, S. M., OShea, K. J., & Lee, B. Y. (2020). The Clinical and Economic Burden of Norovirus Gastroenteritis in the United States. The Journal of Infection, Volume 222 (11), 1 December 2020, 1910–1919