Immunogenicity and safety of a single dose of a live attenuated Japanese encephalitis chimeric virus vaccine in Vietnam: A single-arm, single-center study

Thiem, Vu Dinh; Nguyen, Quan; Tran, Huong Thi Ai; Bosch-Castells, Valérie; Zocchetti, Céline; Houillon, G

doi:10.1016/j.ijid.2017.10.010

Cited by 4 publications

(5 citation statements)

References 20 publications

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“…No new safety issues were identified. Solicited adverse reactions following vaccination were most frequently reported in the 12 to < 24 months age group, consistent with a previous clinical study that assessed single dose of JE-CV in both children and adults [ 12 ].…”

Section: Discussionsupporting

confidence: 88%

“…Our post-marketing, observational, active safety surveillance study supports the good safety profile of JE-CV when administered under reallife use in South Korea. The safety profile of JE-CV described here is consistent with that reported in previous clinical studies in children and adults [8][9][10][11][12][13] and a large phase IV, postlicensure, safety study in children [14]. No new safety issues were identified.…”

Section: Discussionsupporting

confidence: 87%

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Post-Marketing Surveillance of Adverse Events Following Vaccination with the Live-Attenuated Japanese Encephalitis Chimeric Virus Vaccine (Imojev®) in South Korea, 2015–2019

Kim

Oh²,

Korejwo

et al. 2020

Infect Dis Ther

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Introduction: The live attenuated Japanese encephalitis chimeric virus vaccine (JE-CV; Imojev Ò) has been approved in South Korea for use in subjects aged C 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 C 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.

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Section: Discussionsupporting

confidence: 88%

Section: Discussionsupporting

confidence: 87%

Post-Marketing Surveillance of Adverse Events Following Vaccination with the Live-Attenuated Japanese Encephalitis Chimeric Virus Vaccine (Imojev®) in South Korea, 2015–2019

Kim

Oh²,

Korejwo

et al. 2020

Infect Dis Ther

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“…For humans, two viral-vector vaccines are available: Imojev, a Japanese encephalitic virus (JEV) vaccine; and Dengvaxia, a Dengue vaccine (both from Sanofi Pasteur). Both are produced using the chimeric YFV as vector: two of the YFV genes have been replaced by genes encoding the pre-membrane (prM) and the envelope (E) protein of JEV or DENV, and the chimeric viruses are propagated in cell culture (83,84). Conversely, several viral vector vaccines have been licensed for veterinary use because of the less stringent regulatory requirements (76).…”

Section: Viral-vector Vaccinesmentioning

confidence: 99%

Viral Emerging Diseases: Challenges in Developing Vaccination Strategies

et al. 2020

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In the last decades, a number of infectious viruses have emerged from wildlife or reemerged, generating serious threats to the global health and to the economy worldwide. Ebola and Marburg hemorrhagic fevers, Lassa fever, Dengue fever, Yellow fever, West Nile fever, Zika, and Chikungunya vector-borne diseases, Swine flu, Severe acute respiratory syndrome (SARS), Middle East respiratory syndrome (MERS), and the recent Coronavirus disease 2019 (COVID-19) are examples of zoonoses that have spread throughout the globe with such a significant impact on public health that the scientific community has been called for a rapid intervention in preventing and treating emerging infections. Vaccination is probably the most effective tool in helping the immune system to activate protective responses against pathogens, reducing morbidity and mortality, as proven by historical records. Under health emergency conditions, new and alternative approaches in vaccine design and development are imperative for a rapid and massive vaccination coverage, to manage a disease outbreak and curtail the epidemic spread. This review gives an update on the current vaccination strategies for some of the emerging/re-emerging viruses, and discusses challenges and hurdles to overcome for developing efficacious vaccines against future pathogens.

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“…59,60 Moreover, clinical studies and post-marketing surveillance all showed favorable safety profile of JE-CV (Table 1). [61][62][63][64][65][66][67][68] The most common adverse effects were injection site reaction with incidence of 6.3% to 37.8% and fever (3.6%-39.0%). Solicited adverse reactions following vaccination were most frequently reported in children younger than 24 months of age.…”

Section: Live-attenuated Chimeric Je Vaccinementioning

confidence: 99%

“…Solicited adverse reactions following vaccination were most frequently reported in children younger than 24 months of age. 63 , 68 Few serious adverse reactions had been reported, but further investigations showed unrelatedness to JE–CV vaccination.…”

Section: Safety Of Japanese Encephalitis Vaccinesmentioning

confidence: 99%

Safety of Japanese encephalitis vaccines

Lee

2021

Human Vaccines & Immunotherapeutics

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Japanese encephalitis (JE) is an endemic disease dominantly in the Asia-Pacific region with mortality rate varying between 3% and 30%. Long-term neuropsychiatric sequelae developed in 30-50% of the survivors. There is no available antiviral therapy for JE. JE vaccines play a major role in preventing this devastating disease. The incidence of JE declined over years and the age distribution shifted toward adults in countries where JE immunization program exists. Mouse brain-JE vaccine is currently replaced by inactivated Vero cell-derived vaccine and live-attenuated vaccine using SA14-14-2 strain, and live chimeric JE vaccines. These three types of JE vaccines are associated with favorable efficacy and safety profiles. Common adverse reactions include injection site reactions and fever, and severe adverse reactions are rare.

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Immunogenicity and safety of a single dose of a live attenuated Japanese encephalitis chimeric virus vaccine in Vietnam: A single-arm, single-center study

Abstract: A single dose of JE-CV in children and adults aged 9 months to 60 years in Vietnam elicited a protective immune response and was well tolerated with no safety concerns. Registered at www.clinicaltrials.gov (NCT02492165).

Cited by 4 publications

References 20 publications

Post-Marketing Surveillance of Adverse Events Following Vaccination with the Live-Attenuated Japanese Encephalitis Chimeric Virus Vaccine (Imojev®) in South Korea, 2015–2019

Post-Marketing Surveillance of Adverse Events Following Vaccination with the Live-Attenuated Japanese Encephalitis Chimeric Virus Vaccine (Imojev®) in South Korea, 2015–2019

Viral Emerging Diseases: Challenges in Developing Vaccination Strategies

Safety of Japanese encephalitis vaccines

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