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Long-term immunogenicity of an initial booster dose of an inactivated, Vero cell culture-derived Japanese encephalitis vaccine (JE-VC) and the safety and immunogenicity of a second JE-VC booster dose in children previously vaccinated with an inactivated, mouse brain-derived Japanese encephalitis vaccine.
Vaccine. 2018 03 07; 36(11):1398-1404.V

Abstract

BACKGROUND

This study was performed with the aim of determining the long-term immunogenicity of an inactivated, Vero cell culture-derived Japanese encephalitis (JE) vaccine (JE-VC) and an inactivated, mouse brain-derived JE vaccine (JE-MB) after the 1st booster dose at 2 years of age, as well as the safety and immunogenicity of the 2nd booster dose of JE-VC at 6 years of age, in children primed and given a 1st booster dose of either JE-VC or JE-MB.

METHOD

In this multicenter, open-label clinical trial, the study population consisted of healthy Korean children (aged 6 years) who participated in the previous JE vaccine trial. All subjects were subcutaneously vaccinated once for the booster immunization with Boryung Cell Culture Japanese Encephalitis Vaccine® (JE-VC).

RESULT

Approximately 4 years after the 1st booster dose of JE-VC, the seroprotection rate (SPR) and geometric mean titer (GMT) of the neutralizing antibody were 100% and 1113.8, respectively. In children primed and given a 1st booster dose of JE-MB, the SPR and GMT were 88.5% and 56.3, respectively. After the 2nd booster dose of JE-VC, all participants primed and given a 1st booster dose of either JE-MB or JE-VC were seroprotective against JE virus. The GMT of the neutralizing antibody was higher in children primed and given a 1st booster dose of JE-VC (8144.1) than in those primed and given a 1st booster dose of JE-MB (942.5) after the vaccination (p < 0.001). In addition, the 2nd booster dose of JE-VC showed a good safety profile with no serious vaccine-related adverse events.

CONCLUSION

The 1st booster dose of JE-VC and JE-MB showed long-term immunogenicity of at least 4 years, and the 2nd booster dose of JE-VC showed a good safety and immunogenicity profile in children primed and given a 1st booster dose of either JE-VC or JE-MB. ClinicalTtrials.gov Identifier: NCT02532569.

Authors+Show Affiliations

Department of Pediatrics, Seoul National University College of Medicine, Seoul, Republic of Korea. Electronic address: pedwilly@snu.ac.kr.Department of Pediatrics, Seoul National University College of Medicine, Seoul, Republic of Korea. Electronic address: hoanlee@snu.ac.kr.Department of Pediatrics, Seoul National University College of Medicine, Seoul, Republic of Korea. Electronic address: jiyoung320.park@samsung.com.Department of Pediatrics, Gachon University College of Medicine, Incheon, Republic of Korea. Electronic address: hkcho@gilhospital.com.Departments of Pediatrics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea. Electronic address: yaejeankim@skku.edu.Department of Pediatrics, School of Medicine, Ewha Womans University, Seoul, Republic of Korea. Electronic address: kaykim@ewha.ac.kr.Department of Pediatrics, Ilsan Paik Hospital, Inje University College of Medicine, Goyang, Republic of Korea. Electronic address: peddream@medimail.co.kr.Department of Pediatrics, Inha University College of Medicine, Incheon, Republic of Korea. Electronic address: hongyjin@inha.ac.kr.Department of Pediatrics, Korea Cancer Center Hospital, Seoul, Republic of Korea. Electronic address: kdh@kcch.re.kr.Department of Pediatrics, Yonsei University Wonju College of Medicine, Wonju, Republic of Korea. Electronic address: khm9120@yonsei.ac.kr.Department of Pediatrics, College of Medicine, Kyunghee University, Seoul, Republic of Korea. Electronic address: sunghocha@khu.ac.kr.

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

29429815

Citation

Yun, Ki Wook, et al. "Long-term Immunogenicity of an Initial Booster Dose of an Inactivated, Vero Cell Culture-derived Japanese Encephalitis Vaccine (JE-VC) and the Safety and Immunogenicity of a Second JE-VC Booster Dose in Children Previously Vaccinated With an Inactivated, Mouse Brain-derived Japanese Encephalitis Vaccine." Vaccine, vol. 36, no. 11, 2018, pp. 1398-1404.
Yun KW, Lee HJ, Park JY, et al. Long-term immunogenicity of an initial booster dose of an inactivated, Vero cell culture-derived Japanese encephalitis vaccine (JE-VC) and the safety and immunogenicity of a second JE-VC booster dose in children previously vaccinated with an inactivated, mouse brain-derived Japanese encephalitis vaccine. Vaccine. 2018;36(11):1398-1404.
Yun, K. W., Lee, H. J., Park, J. Y., Cho, H. K., Kim, Y. J., Kim, K. H., Kim, N. H., Hong, Y. J., Kim, D. H., Kim, H. M., & Cha, S. H. (2018). Long-term immunogenicity of an initial booster dose of an inactivated, Vero cell culture-derived Japanese encephalitis vaccine (JE-VC) and the safety and immunogenicity of a second JE-VC booster dose in children previously vaccinated with an inactivated, mouse brain-derived Japanese encephalitis vaccine. Vaccine, 36(11), 1398-1404. https://doi.org/10.1016/j.vaccine.2018.01.075
Yun KW, et al. Long-term Immunogenicity of an Initial Booster Dose of an Inactivated, Vero Cell Culture-derived Japanese Encephalitis Vaccine (JE-VC) and the Safety and Immunogenicity of a Second JE-VC Booster Dose in Children Previously Vaccinated With an Inactivated, Mouse Brain-derived Japanese Encephalitis Vaccine. Vaccine. 2018 03 7;36(11):1398-1404. PubMed PMID: 29429815.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Long-term immunogenicity of an initial booster dose of an inactivated, Vero cell culture-derived Japanese encephalitis vaccine (JE-VC) and the safety and immunogenicity of a second JE-VC booster dose in children previously vaccinated with an inactivated, mouse brain-derived Japanese encephalitis vaccine. AU - Yun,Ki Wook, AU - Lee,Hoan Jong, AU - Park,Ji Young, AU - Cho,Hye-Kyung, AU - Kim,Yae-Jean, AU - Kim,Kyung-Hyo, AU - Kim,Nam Hee, AU - Hong,Young Jin, AU - Kim,Dong Ho, AU - Kim,Hwang Min, AU - Cha,Sung-Ho, PY - 2017/11/01/received PY - 2018/01/25/revised PY - 2018/01/29/accepted PY - 2018/2/13/pubmed PY - 2018/9/19/medline PY - 2018/2/13/entrez KW - Children KW - Clinical trial KW - Japanese encephalitis KW - Vaccine KW - Vero cells SP - 1398 EP - 1404 JF - Vaccine JO - Vaccine VL - 36 IS - 11 N2 - BACKGROUND: This study was performed with the aim of determining the long-term immunogenicity of an inactivated, Vero cell culture-derived Japanese encephalitis (JE) vaccine (JE-VC) and an inactivated, mouse brain-derived JE vaccine (JE-MB) after the 1st booster dose at 2 years of age, as well as the safety and immunogenicity of the 2nd booster dose of JE-VC at 6 years of age, in children primed and given a 1st booster dose of either JE-VC or JE-MB. METHOD: In this multicenter, open-label clinical trial, the study population consisted of healthy Korean children (aged 6 years) who participated in the previous JE vaccine trial. All subjects were subcutaneously vaccinated once for the booster immunization with Boryung Cell Culture Japanese Encephalitis Vaccine® (JE-VC). RESULT: Approximately 4 years after the 1st booster dose of JE-VC, the seroprotection rate (SPR) and geometric mean titer (GMT) of the neutralizing antibody were 100% and 1113.8, respectively. In children primed and given a 1st booster dose of JE-MB, the SPR and GMT were 88.5% and 56.3, respectively. After the 2nd booster dose of JE-VC, all participants primed and given a 1st booster dose of either JE-MB or JE-VC were seroprotective against JE virus. The GMT of the neutralizing antibody was higher in children primed and given a 1st booster dose of JE-VC (8144.1) than in those primed and given a 1st booster dose of JE-MB (942.5) after the vaccination (p < 0.001). In addition, the 2nd booster dose of JE-VC showed a good safety profile with no serious vaccine-related adverse events. CONCLUSION: The 1st booster dose of JE-VC and JE-MB showed long-term immunogenicity of at least 4 years, and the 2nd booster dose of JE-VC showed a good safety and immunogenicity profile in children primed and given a 1st booster dose of either JE-VC or JE-MB. ClinicalTtrials.gov Identifier: NCT02532569. SN - 1873-2518 UR - https://www.unboundmedicine.com/medline/citation/29429815/Long_term_immunogenicity_of_an_initial_booster_dose_of_an_inactivated_Vero_cell_culture_derived_Japanese_encephalitis_vaccine__JE_VC__and_the_safety_and_immunogenicity_of_a_second_JE_VC_booster_dose_in_children_previously_vaccinated_with_an_inactivated_mouse_brain_derived_Japanese_encephalitis_vaccine_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0264-410X(18)30148-8 DB - PRIME DP - Unbound Medicine ER -