Post-Marketing Surveillance of Adverse Events Following Vaccination with the Live-Attenuated Japanese Encephalitis Chimeric Virus Vaccine (Imojev®) in South Korea, 2015-2019
Hee Soo Kim, Yongho Oh, Joanna Korejwo, Valérie Bosch Castells, Kuhyun Yang, Hee Soo Kim, Yongho Oh, Joanna Korejwo, Valérie Bosch Castells, Kuhyun Yang
Abstract
Introduction: The live attenuated Japanese encephalitis chimeric virus vaccine (JE-CV; Imojev®) has been approved in South Korea for use in subjects aged ≥ 12 months since 2015. As part of the license agreement, a post-marketing surveillance study was undertaken to actively monitor the safety profile of JE-CV in the Korean population.
Methods: An observational, active safety surveillance study was conducted from 3 April 2015 through to 2 April 2019 at 12 centers in South Korea. Subjects aged ≥ 12 months who received a single dose of JE-CV (primary or booster) during a routine healthcare visit were recruited and followed up for solicited reactions (7 and 14 days for injection site and systemic reactions, respectively), non-serious unsolicited adverse events and serious adverse events within 42 days after vaccination.
Results: Overall, 810 subjects who received JE-CV were included in our analysis, the majority received the vaccine as a primary vaccination (94.9%; 769/810). There were 179 solicited reactions reported by 111 subjects; the majority of solicited reactions occurred within 0-3 days (80.4%; 144/179), were of 1-3 days' duration (79.3%; 142/179) and of grade 1 intensity (70.9%; 127/179). There were three grade 3 adverse reactions (irritability, pyrexia and malaise); all resolved within a few days. The incidence of solicited reactions were highest in those aged 12 to < 24 months (34.7% [52/150] subjects; 107 events) and 2 to < 10 years (17.8% [8/45] subjects; 14 events). All unsolicited adverse events (serious and non-serious) were unrelated to vaccination. There were no discontinuations due to adverse reactions/events.
Conclusion: JE-CV has a good safety profile under practice conditions in South Korea. No new safety issues were identified.
Trial registration: ClinicalTrials.gov identifier, NCT02933710.
Keywords: Japanese encephalitis; Live-attenuated Japanese encephalitis chimeric virus vaccine; Safety; Vaccine.
References
- Hong YH. Japanese encephalitis in South Korea. Shōni Kansen Men'eki. 2014;26(2):257–262.
- Lee DW, Choe YJ, Kim JH, Song KM, Cho H, Bae GR, et al. Epidemiology of Japanese encephalitis in South Korea, 2007–2010. Int J Infect Dis. 2012;16(6):e448–e452. doi: 10.1016/j.ijid.2012.02.006.
- Sunwoo JS, Jung KH, Lee ST, Lee SK, Chu K. Reemergence of Japanese encephalitis in South Korea, 2010–2015. Emerg Infect Dis. 2016;22(10):1841–1843. doi: 10.3201/eid2210.160288.
- World Health Organization. Immunization coverage or administered doses. 2019. . Accessed 24 Feb 2020.
- World Health Organization. WHO vaccine-preventable diseases: monitoring system (2019 global summary). Incidence time series for Republic of Korea. 2019. . Accessed 24 Feb 2020.
- Hegde NR, Gore MM. Japanese encephalitis vaccines: Immunogenicity, protective efficacy, effectiveness, and impact on the burden of disease. Hum Vaccin Immunother. 2017;13(6):1320–1337. doi: 10.1080/21645515.2017.1285472.
- International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (ICH-E2A). 1995. . Accessed 24 Feb 2020.
- Feroldi E, Pancharoen C, Kosalaraksa P, Chokephaibulkit K, Boaz M, Meric C, et al. Primary immunization of infants and toddlers in Thailand with Japanese encephalitis chimeric virus vaccine in comparison with SA14-14-2: a randomized study of immunogenicity and safety. Pediatr Infect Dis J. 2014;33(6):643–649. doi: 10.1097/INF.0000000000000276.
- Feroldi E, Pancharoen C, Kosalaraksa P, Watanaveeradej V, Phirangkul K, Capeding MR, et al. Single-dose, live-attenuated Japanese encephalitis vaccine in children aged 12–18 months: randomized, controlled phase 3 immunogenicity and safety trial. Hum Vaccin Immunother. 2012;8(7):929–937. doi: 10.4161/hv.20071.
- Torresi J, McCarthy K, Feroldi E, Meric C. Immunogenicity, safety and tolerability in adults of a new single-dose, live-attenuated vaccine against Japanese encephalitis: randomised controlled phase 3 trials. Vaccine. 2010;28(50):7993–8000. doi: 10.1016/j.vaccine.2010.09.035.
- Chokephaibulkit K, Sirivichayakul C, Thisyakorn U, Sabchareon A, Pancharoen C, Bouckenooghe A, et al. Safety and immunogenicity of a single administration of live-attenuated Japanese encephalitis vaccine in previously primed 2- to 5-year-olds and naive 12- to 24-month-olds: multicenter randomized controlled trial. Pediatr Infect Dis J. 2010;29(12):1111–1117. doi: 10.1097/INF.0b013e3181f68e9c.
- Vu TD, Nguyen QD, Tran HTA, Bosch-Castells V, Zocchetti C, Houillon G. Immunogenicity and safety of a single dose of a live attenuated Japanese encephalitis chimeric virus vaccine in Vietnam: a single-arm, single-center study. Int J Infect Dis. 2018;66:137–142. doi: 10.1016/j.ijid.2017.10.010.
- Kim DS, Houillon G, Jang GC, Cha SH, Choi SH, Lee J, et al. A randomized study of the immunogenicity and safety of Japanese encephalitis chimeric virus vaccine (JE-CV) in comparison with SA14-14-2 vaccine in children in the Republic of Korea. Hum Vaccin Immunother. 2014;10(9):2656–2663. doi: 10.4161/hv.29743.
- Chotpitayasunondh T, Pruekprasert P, Puthanakit T, Pancharoen C, Tangsathapornpong A, Oberdorfer P, et al. Post-licensure, phase IV, safety study of a live attenuated Japanese encephalitis recombinant vaccine in children in Thailand. Vaccine. 2017;35(2):299–304. doi: 10.1016/j.vaccine.2016.11.062.
Source: PubMed