Safety and immunogenicity of an inactivated Vero cell_derived Japanese encephalitis vaccine (IXIARO ® , JESPECT ® ) in a pediatric population in JE non-endemic countries: An uncontrolled, open-label phase 3 study

Jelı́nek, Tomáš; Cromer, Michael A.; Cramer, Jakob P.; Mills, Deborah; Lessans, Kenneth; Gherardin, Anthony; Barnett, Elizabeth D.; Hagmann, Stefan; Askling, Helena Hervius; Kiermayr, Sigrid; Kadlecek, Vera; Eder-Lingelbach, Susanne; Taucher, Christian; Dubischar, Katrin

doi:10.1016/j.tmaid.2018.03.003

Cited by 18 publications

(11 citation statements)

References 16 publications

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“…IXIARO ® -an inactivated VERO cell cultured JEV vaccine -is now immunogenic and safe in children >2 months old and should be considered in those, including women of childbearing age, travelling to endemic areas. 80,81 Togaviruses: Chikungunya Chikungunya virus (CHIKV) is a non-flavivirid mosquito-borne infection that causes significant morbidity and, on occasion, mortality. CHIKV is a Togavirus first described in the 1950s that has spread from Africa to the Indian Ocean and Asia.…”

Section: Zika Virusmentioning

confidence: 99%

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Vector-borne diseases in pregnancy

O’Kelly

Lambert

2020

Therapeutic Advances in Infection

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Vector-borne infections cause a significant proportion of world-wide morbidity and mortality and many are increasing in incidence. This is due to a combination of factors, primarily environmental change, encroachment of human habitats from urban to peri-urban areas and rural to previously uninhabited areas, persistence of poverty, malnutrition and resource limitation in geographical areas where these diseases are endemic. Pregnant women represent the single largest ‘at risk’ group, due to immune-modulation and a unique physiological state. Many of these diseases have not benefitted from the same level of drug development as other infectious and medical domains, a factor attributing to the ‘neglected tropical disease’ title many vector-borne diseases hold. Pregnancy compounds this issue as data for safety and efficacy for many drugs is practically non-existent, precluding exposure in pregnancy to many first-line therapeutic agents for ‘fear of the unknown’ or overstated adverse pregnancy-foetal outcomes. In this review, major vector-borne diseases, their impact on pregnancy outcomes, current treatment, vaccination and short-comings of current medical practice for pregnant women will be discussed.

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Section: Zika Virusmentioning

confidence: 99%

“…IXIARO® – an inactivated VERO cell cultured JEV vaccine – is now immunogenic and safe in children >2 months old and should be considered in those, including women of childbearing age, travelling to endemic areas. 80 , 81 …”

Section: Mosquito-borne Infections In Pregnancymentioning

confidence: 99%

Vector-borne diseases in pregnancy

O’Kelly

Lambert

2020

Therapeutic Advances in Infection

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“…GMTs were 201 (95% CI = 106–380) and 230 (95% CI = 68–784), respectively. In an observational study of 62 children from countries without endemic JE, all had protective neutralizing antibodies 28 days after the second dose of JE-VC ( 14 , 225 ).…”

Section: Je-vcmentioning

confidence: 99%

“…In the observational study of children from countries without endemic JE, 91% (31 of 34) children had protective neutralizing antibodies 6 months after the second dose of the 2-dose primary series ( 14 , 225 ). Among a subset enrolled in a follow-up study, seroprotection rates were 89% (17 of 19) at 11 months, 91% (21 of 23) at 23 months, and 89% (17 of 19) at 35 months ( 14 ).…”

Section: Je-vcmentioning

confidence: 99%

Japanese Encephalitis Vaccine: Recommendations of the Advisory Committee on Immunization Practices

Hills¹,

Walter²,

Atmar³

et al. 2019

MMWR Recomm. Rep.

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Summary This report updates the 2010 recommendations from the CDC Advisory Committee on Immunization Practices (ACIP) regarding prevention of Japanese encephalitis (JE) among U.S. travelers and laboratory workers (Fischer M, Lindsey N, Staples JE, Hills S. Japanese encephalitis vaccines: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep 2010;59[No. RR-1]). The report summarizes the epidemiology of JE, describes the JE vaccine that is licensed and available in the United States, and provides recommendations for its use among travelers and laboratory workers. JE virus, a mosquitoborne flavivirus, is the most common vaccine-preventable cause of encephalitis in Asia. JE occurs throughout most of Asia and parts of the western Pacific. Approximately 20%–30% of patients die, and 30%–50% of survivors have neurologic, cognitive, or behavioral sequelae. No antiviral treatment is available. Inactivated Vero cell culture–derived JE vaccine (Ixiaro [JE-VC]) is the only JE vaccine that is licensed and available in the United States. In 2009, the U.S. Food and Drug Administration (FDA) licensed JE-VC for use in persons aged ≥17 years; in 2013, licensure was extended to include children aged ≥2 months. Most travelers to countries where the disease is endemic are at very low risk for JE. However, some travelers are at increased risk for infection on the basis of their travel plans. Factors that increase the risk for JE virus exposure include 1) traveling for a longer period; 2) travel during the JE virus transmission season; 3) spending time in rural areas; 4) participating in extensive outdoor activities; and 5) staying in accommodations without air conditioning, screens, or bed nets. All travelers to countries where JE is endemic should be advised to take precautions to avoid mosquito bites to reduce the risk for JE and other vectorborne diseases. For some persons who might be at increased risk for JE, the vaccine can further reduce the risk for infection. The decision about whether to vaccinate should be individualized and consider the 1) risks related to the specific travel itinerary, 2) likelihood of future travel to countries where JE is endemic, 3) high morbidity and mortality of JE, 4) availability of an effective vaccine, 5) possibility (but low probability) of serious adverse events after vaccination, and 6) the traveler’s personal perception and tolerance of risk. JE vaccine is recommended for persons moving to a JE-endemic country to take up residence, longer-term (e.g., ≥1 month) travelers to JE-endemic areas, and frequent travelers to JE-endemic areas. JE vaccine also should be considered for shorter-term (e.g., <1 month) travelers with an increased risk for JE on the basis of planned travel duration, season, location, activities, and accommodations and for travelers to JE-endemic areas who are uncertain about their specific travel duration, destinations, or activities. JE vaccine is not recommended for travelers w...

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“…Zudem scheinen der Klimawandel und Faktoren, welche mit zunehmenden landwirtschaftlichen Aktivitäten in Verbindung stehen, die geografische Ausbreitung der Erkrankung zu begünstigen, sodass zuletzt eine Ausweitung der JBE-Impfindikation gefordert wurde (23). Der in Deutschland zugelassene inaktivierte Totimpfstoff mit JBE-Virus Stamm SA-14-2 (Ixiaro ® ) wird in Verozellen hergestellt, an Aluminiumhydroxid adsorbiert und ist im Gegensatz zu der alten in Mäusehirnen hergestellten Nakayama-Vakzine sehr gut ver-träglich (24)(25)(26). Die Grundimmunisierung erfolgt zweimal im Abstand von 28 Tagen bis zum vollendeten 3.…”

Section: Ab 2 Monaten Japanische Enzephalitisunclassified

Reiseimpfungen bei Kindern und Jugendlichen

Rau¹,

Kobbe²

2018

Kinder- und Jugendmedizin

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ZusammenfassungImpfungen sind ein wichtiger Teil der medizinischen Beratung vor Auslandsreisen mit Kindern und Jugendlichen. Viele impfpräventable Krankheiten stellen für diese Altersgruppen ein besonderes Risiko dar. Für die meisten verfügbaren Impfstoffe gelten bestimmte Mindestaltersgrenzen. Bei der Beratung sollte zunächst der aktuelle Impfstatus gemäß STIKO-Empfehlungen überprüft werden. Die Reiseimpfempfehlung richtet sich vor allem nach Reiseziel, Reisedauer und Reisestandard. Daneben sind Einreisebestimmungen des Ziellandes und aktuelle Ausbrüche zu beachten. Bei besonderen Reiseanlässen wie Besuchen von Freunden und Verwandten, Großveranstaltungen, Langzeitaufenthalten, Backpacking oder Freiwilligendiensten ist die Indikation zur Immunisierung großzügiger zu stellen. Die Impfserie sollte idealerweise zwei Wochen vor Ausreise abgeschlossen sein. Auch kurzfristigere Impfungen können noch sinnvoll sein.

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Safety and immunogenicity of an inactivated Vero cell_derived Japanese encephalitis vaccine (IXIARO ® , JESPECT ® ) in a pediatric population in JE non-endemic countries: An uncontrolled, open-label phase 3 study

Abstract: IXIARO was generally well tolerated in children, with an overall AE profile similar to adults. IXIARO was highly immunogenic in both dose groups.

Cited by 18 publications

References 16 publications

Vector-borne diseases in pregnancy

Vector-borne diseases in pregnancy

Japanese Encephalitis Vaccine: Recommendations of the Advisory Committee on Immunization Practices

Reiseimpfungen bei Kindern und Jugendlichen

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