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Immunogenicity of the Inactivated Japanese Encephalitis Virus Vaccine IXIARO in Children From a Japanese Encephalitis Virus-endemic Region.
Pediatr Infect Dis J. 2017 Sep; 36(9):898-904.PI

Abstract

BACKGROUND

Japanese encephalitis (JE) is a major public health concern in Asia and poses a small but potentially fatal threat to travelers from nonendemic countries, including children. No JE vaccine for pediatric use has been available in Europe and the United States.

METHODS

Age-stratified cohorts of children between 2 months and 17 years received 2 doses of Vero cell-derived inactivated JE virus vaccine (IXIARO; Valneva Austria GmbH, Vienna, Austria) administered 28 days apart [<3 years, 0.25 mL (half adult dose); ≥3 years, 0.5 mL (full adult dose)]. Immunogenicity endpoints were seroconversion rate, 4-fold increase in JE neutralizing antibody titer and geometric mean titer assessed 56 days and 7 months after the first vaccination in 496 subjects of the intent-to-treat population. The immune response to JE virus at both time points was also analyzed according to prevaccination JE virus and dengue virus serostatus.

RESULTS

At day 56, seroconversion was attained in ≥99.2% of subjects with age-appropriate dosing, 4-fold increases in titer were reported for 77.4%-100% in various age groups, and geometric mean titers ranged from 176 to 687, with younger children having the strongest immune response. At month 7, seroconversion was maintained in 85.5%-100% of subjects. Pre-existing JE virus immunity did not impact on immune response at day 56; however, it led to a better persistence of protective antibody titers at month 7.

CONCLUSIONS

IXIARO is highly immunogenic at both doses tested in the pediatric population, leading to protective antibody titers at day 56 in >99% of subjects who received the age-appropriate dose.

Authors+Show Affiliations

From the *Valneva Austria Gmbh, Vienna, Austria; †Department of Pediatrics, University of the Philippines, ‡Department of Health, Research Institute for Tropical Medicine, and §Section of Infectious and Tropical Diseases, Department of Pediatrics, University of the Philippines, College of Medicine, Philippine General Hospital, Manila, Philippines; and ¶Department of Health, Research Institute for Tropical Medicine, Muntinlupa, Philippines.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

28430748

Citation

Dubischar, Katrin L., et al. "Immunogenicity of the Inactivated Japanese Encephalitis Virus Vaccine IXIARO in Children From a Japanese Encephalitis Virus-endemic Region." The Pediatric Infectious Disease Journal, vol. 36, no. 9, 2017, pp. 898-904.
Dubischar KL, Kadlecek V, Sablan JB, et al. Immunogenicity of the Inactivated Japanese Encephalitis Virus Vaccine IXIARO in Children From a Japanese Encephalitis Virus-endemic Region. Pediatr Infect Dis J. 2017;36(9):898-904.
Dubischar, K. L., Kadlecek, V., Sablan, J. B., Borja-Tabora, C. F., Gatchalian, S., Eder-Lingelbach, S., Kiermayr, S., Spruth, M., & Westritschnig, K. (2017). Immunogenicity of the Inactivated Japanese Encephalitis Virus Vaccine IXIARO in Children From a Japanese Encephalitis Virus-endemic Region. The Pediatric Infectious Disease Journal, 36(9), 898-904. https://doi.org/10.1097/INF.0000000000001615
Dubischar KL, et al. Immunogenicity of the Inactivated Japanese Encephalitis Virus Vaccine IXIARO in Children From a Japanese Encephalitis Virus-endemic Region. Pediatr Infect Dis J. 2017;36(9):898-904. PubMed PMID: 28430748.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Immunogenicity of the Inactivated Japanese Encephalitis Virus Vaccine IXIARO in Children From a Japanese Encephalitis Virus-endemic Region. AU - Dubischar,Katrin L, AU - Kadlecek,Vera, AU - Sablan,Jr Benjamin, AU - Borja-Tabora,Charissa Fay, AU - Gatchalian,Salvacion, AU - Eder-Lingelbach,Susanne, AU - Kiermayr,Sigrid, AU - Spruth,Martin, AU - Westritschnig,Kerstin, PY - 2017/4/22/pubmed PY - 2017/9/19/medline PY - 2017/4/22/entrez SP - 898 EP - 904 JF - The Pediatric infectious disease journal JO - Pediatr. Infect. Dis. J. VL - 36 IS - 9 N2 - BACKGROUND: Japanese encephalitis (JE) is a major public health concern in Asia and poses a small but potentially fatal threat to travelers from nonendemic countries, including children. No JE vaccine for pediatric use has been available in Europe and the United States. METHODS: Age-stratified cohorts of children between 2 months and 17 years received 2 doses of Vero cell-derived inactivated JE virus vaccine (IXIARO; Valneva Austria GmbH, Vienna, Austria) administered 28 days apart [<3 years, 0.25 mL (half adult dose); ≥3 years, 0.5 mL (full adult dose)]. Immunogenicity endpoints were seroconversion rate, 4-fold increase in JE neutralizing antibody titer and geometric mean titer assessed 56 days and 7 months after the first vaccination in 496 subjects of the intent-to-treat population. The immune response to JE virus at both time points was also analyzed according to prevaccination JE virus and dengue virus serostatus. RESULTS: At day 56, seroconversion was attained in ≥99.2% of subjects with age-appropriate dosing, 4-fold increases in titer were reported for 77.4%-100% in various age groups, and geometric mean titers ranged from 176 to 687, with younger children having the strongest immune response. At month 7, seroconversion was maintained in 85.5%-100% of subjects. Pre-existing JE virus immunity did not impact on immune response at day 56; however, it led to a better persistence of protective antibody titers at month 7. CONCLUSIONS: IXIARO is highly immunogenic at both doses tested in the pediatric population, leading to protective antibody titers at day 56 in >99% of subjects who received the age-appropriate dose. SN - 1532-0987 UR - https://www.unboundmedicine.com/medline/citation/28430748/full_citation L2 - http://dx.doi.org/10.1097/INF.0000000000001615 DB - PRIME DP - Unbound Medicine ER -