Five-Year Antibody Persistence Following a Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) Booster in JE-CV–Primed Children in the Philippines

Capeding, María Rosario; Alberto, Edison; Bouckenooghe, Alain; Laot, Thelma; Chansinghakul, Danaya; Monfredo, Céline; Machabert, Tifany; Feroldi, Emmanuel

doi:10.1093/infdis/jix601

Cited by 20 publications

(9 citation statements)

References 13 publications

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“…In JEC15, among children who received a JE-CV booster dose 2 years after primary vaccination with a single dose of JE-CV, 100% (95% CI 98.9-100%) were seroprotected at D28 and nearly all (99.4% [95% CI 97.9-99.99%]) were seroprotected 1 year later 18 ; 98.2% (95% CI, 96.2%-99.3%) of subjects remained seroprotected (Kaplan-Meier analysis) 5 years after booster with GMT of 161, 1/dil (95% CI 141-184). 19 A further subset of JE-CV primed children from the JEC02/JEC05 study received a JE-CV booster after a longer interval of 5 years following primary vaccination. A strong booster response was elicited, with 100% seroprotected at 28 days after booster; 92.8% had antibody titers ≥ 1,280 (1/dil).…”

Section: Discussionmentioning

confidence: 99%

Modeling the long-term persistence of neutralizing antibody in children and toddlers after vaccination with live attenuated Japanese encephalitis chimeric virus vaccine

Bouckenooghe¹,

Bailleux

Feroldi

2018

Human Vaccines & Immunotherapeutics

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The live-attenuated Japanese encephalitis chimeric virus vaccine JE-CV (IMOJEV®, Sanofi Pasteur) elicits a robust antibody response in children, which wanes over time. Clinical efficacy is based on a correlate of protection against JE infection defined as neutralizing antibody levels equal to or greater than the threshold of 10 (1/dil). Information on the duration of persistence of the JE antibody response above this threshold is needed. We constructed statistical models using 5-year persistence data from a randomised clinical trial (NCT00621764) in children (2-5 years old) primed with inactivated JE vaccine who received a booster dose of JE-CV, and in JE-naïve toddlers (12-24 months) who received a JE-CV single dose primary vaccination. Models were constructed using a Bayesian Monte-Carlo Markov Chain approach and implemented with OpenBugs V3.2.1. Antibody persistence was predicted for up to 10 years following JE-CV vaccination. Findings from a piecewise model with 2 phases (children) and a classic linear model (toddlers) are presented. For children, predicted median antibody titers (77 [2.5th-97.5th percentile range 41-144] 1/dil) remained above the threshold for seroprotection over the 10 years following booster JE-CV vaccination; the predicted median duration of protection was 19.5 years. For toddlers, 10 years after JE-CV primary vaccination median antibody titers were predicted to wane to around the level required for seroprotection (10.8 [5.8-20.1] 1/dil). A booster dose of JE-CV in children is predicted to provide long-term protection against JE. Such data are useful to facilitate decisions on implementation of and recommendations for future vaccination strategies.

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Section: Discussionmentioning

confidence: 99%

Modeling the long-term persistence of neutralizing antibody in children and toddlers after vaccination with live attenuated Japanese encephalitis chimeric virus vaccine

Bouckenooghe¹,

Bailleux

Feroldi

2018

Human Vaccines & Immunotherapeutics

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“…Headache, weariness, myalgia, and malaise were the most common side effects observed in its clinical trials in 17-24% of vaccine recipients. Till date, the CV-JE vaccine is approved in 14 countries including Thailand, Australia, Malaysia, Philippines, Hong Kong, and Singapore [162].…”

Section: Je-cvmentioning

confidence: 99%

Japanese Encephalitis Virus: An Emerging Threat in the Indo-Pacific Region

Jeswani¹,

Pal²,

Bohra³

et al. 2022

Preprint

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Japanese Encephalitis (JE) is a disease caused by the Japanese Encephalitis Virus (JEV). JEV is an arbovirus that spreads primarily through the bite of a female Culex spp. mosquito. JE shows predominance over the Asia-pacific region and has the potential to spread globally with a higher rate of morbidity and mortality. JE, a neuro-invasive disease, initiates with mild fever which may lead to encephalitis with severe neurological sequelae in some cases. Efforts have been made to identify and select various target molecules essential in JEV progression, but until now, no licensed anti-JE drugs have been available. From a prophylactic point of view, a few licensed JE vaccines are available but various factors viz. high cost and different side effects imposed by them has narrowed their global use. With an average occurrence of >67,000 cases of JE annually, there is an urgent need to find a suitable antiviral drug to treat patients at the acute phase, as only supportive care is available to mitigate infection. This systematic review highlights the current status of efforts put in to develop antivirals against JE and the available vaccines along with their effectiveness. It also summarizes epidemiology, structure, pathogenesis, and potential drug targets that can be explored to develop a new range of anti-JEV drugs to combat JEV infection globally.

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“…[3]. Imojev ® -живая вирусная векторная вакцина для профилактики японского энцефалита, сконструированная путем вставки нуклеотидных последовательностей, кодирующих белки prM и Е вируса японского энцефалита, в геном вируса желтой лихорадки 17D [4,5]. Вакцина рекомендована к применению у лиц от 9 месяцев (в Таиланде), от 12 месяцев (в Австралии) и старше.…”

Section: живые рекомбинантные вирусные векторные вакцины для медицинс...unclassified

Approaches to quality control, preclinical and clinical studies of live recombinant viral vector vaccines

Хантимирова¹,

Горенков²,

Guseva³

et al. 2021

Biological Products. Prevention, Diagnosis, Treatment

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At present, there are not much data on the clinical use of live recombinant viral vector vaccines. Characteristics of new vaccines should be factored into requirements/recommendations for quality control, preclinical and clinical studies of vaccines in order to enable further risk/benefit assessment. The aim of this study was to analyse current approaches to quality control, preclinical and clinical studies of live recombinant viral vector vaccines. The paper provides an overview of the licensed live viral vector vaccines and those at various stages of clinical trials. The authors analysed Russian, European, American, and Japanese guidelines related to quality issues, preclinical and clinical studies of live viral vector vaccines. The analysis demonstrated that the regulatory requirements for live recombinant viral vector vaccines include assessment of a detailed rationale for vaccine development, including information on the choice of the vector, the origin of the heterologous antigen gene(s), elements related to the transgene(s) expression, as well as assessment of the genetic and phenotypic stability of the recombinant virus, the risk of reversion to virulence or recombination with wild type strains, the potential for virus genome integration into the host cell chromosome, the pre-existing immunity to the vector, the intensity of the immune response elicited by the vector, and the reusability of the vector. The choice and number of applicable toxicological and pharmacological models will depend on these aspects. The results of the analysis of approaches to quality control, preclinical and clinical studies of live recombinant viral vector vaccines may be used in the development of Russian regulatory guidelines harmonised with the international norms and regulations.

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Five-Year Antibody Persistence Following a Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) Booster in JE-CV–Primed Children in the Philippines

Cited by 20 publications

References 13 publications

Modeling the long-term persistence of neutralizing antibody in children and toddlers after vaccination with live attenuated Japanese encephalitis chimeric virus vaccine

Modeling the long-term persistence of neutralizing antibody in children and toddlers after vaccination with live attenuated Japanese encephalitis chimeric virus vaccine

Japanese Encephalitis Virus: An Emerging Threat in the Indo-Pacific Region

Approaches to quality control, preclinical and clinical studies of live recombinant viral vector vaccines

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