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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.
Yun, Ki Wook; Lee, Hoan Jong; Park, Ji Young; Cho, Hye-Kyung; Kim, Yae-Jean; Kim, Kyung-Hyo; Kim, Nam Hee; Hong, Young Jin; Kim, Dong Ho; Kim, Hwang Min; Cha, Sung-Ho.
Affiliation
  • Yun KW; Department of Pediatrics, Seoul National University College of Medicine, Seoul, Republic of Korea. Electronic address: pedwilly@snu.ac.kr.
  • Lee HJ; Department of Pediatrics, Seoul National University College of Medicine, Seoul, Republic of Korea. Electronic address: hoanlee@snu.ac.kr.
  • Park JY; Department of Pediatrics, Seoul National University College of Medicine, Seoul, Republic of Korea. Electronic address: jiyoung320.park@samsung.com.
  • Cho HK; Department of Pediatrics, Gachon University College of Medicine, Incheon, Republic of Korea. Electronic address: hkcho@gilhospital.com.
  • Kim YJ; Departments of Pediatrics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea. Electronic address: yaejeankim@skku.edu.
  • Kim KH; Department of Pediatrics, School of Medicine, Ewha Womans University, Seoul, Republic of Korea. Electronic address: kaykim@ewha.ac.kr.
  • Kim NH; Department of Pediatrics, Ilsan Paik Hospital, Inje University College of Medicine, Goyang, Republic of Korea. Electronic address: peddream@medimail.co.kr.
  • Hong YJ; Department of Pediatrics, Inha University College of Medicine, Incheon, Republic of Korea. Electronic address: hongyjin@inha.ac.kr.
  • Kim DH; Department of Pediatrics, Korea Cancer Center Hospital, Seoul, Republic of Korea. Electronic address: kdh@kcch.re.kr.
  • Kim HM; Department of Pediatrics, Yonsei University Wonju College of Medicine, Wonju, Republic of Korea. Electronic address: khm9120@yonsei.ac.kr.
  • Cha SH; Department of Pediatrics, College of Medicine, Kyunghee University, Seoul, Republic of Korea. Electronic address: sunghocha@khu.ac.kr.
Vaccine ; 36(11): 1398-1404, 2018 03 07.
Article in En | MEDLINE | ID: mdl-29429815
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.
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Vaccines, Inactivated / Immunization, Secondary / Encephalitis, Japanese / Japanese Encephalitis Vaccines / Encephalitis Virus, Japanese / Immunogenicity, Vaccine Type of study: Clinical_trials Limits: Animals / Child / Child, preschool / Humans Language: En Journal: Vaccine Year: 2018 Document type: Article
Fulltext
Add to My VHL
Print
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Vaccines, Inactivated / Immunization, Secondary / Encephalitis, Japanese / Japanese Encephalitis Vaccines / Encephalitis Virus, Japanese / Immunogenicity, Vaccine Type of study: Clinical_trials Limits: Animals / Child / Child, preschool / Humans Language: En Journal: Vaccine Year: 2018 Document type: Article