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Immunogenicity of a Japanese encephalitis chimeric virus vaccine as a booster dose after primary vaccination with SA14-14-2 vaccine in Thai children.
Vaccine. 2016 10 17; 34(44):5279-5283.V

Abstract

BACKGROUND

Japanese Encephalitis chimeric virus vaccine (JE-CV) and SA14-14-2 vaccine are live-attenuated JE vaccines produced from the same virus strain. Data on interchangeability is limited.

OBJECTIVES

To evaluate the immunogenicity and safety of JE-CV booster after primary vaccination with SA14-14-2 vaccine.

METHODS

This study was an open-label clinical trial in Thai children who had received a primary SA14-14-2 vaccination at 12-24monthsbefore enrollment (ClinicalTrials.gov NCT02602652). JE-CV was administered. A 50% plaque reduction neutralization test (PRNT50) against three virus strains; JE-CV, SA-14-14-2andwild-type JE virus was measured before and 28-days post vaccination. The laboratory was performed at PRNT50 titers ⩾10 (1/dil) were considered seroprotective against JE. Geometric mean titer (GMT) of PRNT50 was calculated. Adverse events were observed for 28days.

RESULTS

From March 2014 to June 2015, 50 children (64% male) were enrolled. Mean age and duration after primary vaccination was 26.9 (SD 4.6) and 12.8 (SD 2.7) months, respectively. The proportion of participants who had PRNT50pre and post-booster vaccination were 92% and 96% against JE-CV virus, 56% and 98% against SA-14-14-2 strain and 70% and 98% against wild-type JE virus, respectively. Solicited injection site reactions including erythema, pain and swelling occurred in 18%, 10% and 4% of subjects, respectively. Four children (8%) had fever (⩾37.7Celsius). Eight children (16%) had adverse events, which were not related to the vaccine.

CONCLUSIONS

AJE-CV booster dose is highly immunogenic and safe among children who previously received SA14-14-2 vaccine.

Authors+Show Affiliations

Division of Infectious Diseases, Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Rama IV Road, Bangkok 10330, Thailand.Division of Infectious Diseases, Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Rama IV Road, Bangkok 10330, Thailand; Research Unit in Pediatric Infectious Diseases and Vaccine, Chulalongkorn University, Bangkok, Thailand. Electronic address: thanyawee.p@chula.ac.th.Division of Infectious Diseases, Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Rama IV Road, Bangkok 10330, Thailand; Research Unit in Pediatric Infectious Diseases and Vaccine, Chulalongkorn University, Bangkok, Thailand.Division of Infectious Diseases, Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Rama IV Road, Bangkok 10330, Thailand; Research Unit in Pediatric Infectious Diseases and Vaccine, Chulalongkorn University, Bangkok, Thailand.Division of Infectious Diseases, Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Rama IV Road, Bangkok 10330, Thailand; Research Unit in Pediatric Infectious Diseases and Vaccine, Chulalongkorn University, Bangkok, Thailand.Division of Infectious Diseases, Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Rama IV Road, Bangkok 10330, Thailand; Research Unit in Pediatric Infectious Diseases and Vaccine, Chulalongkorn University, Bangkok, Thailand.Center for Vaccine Development, Institute of Molecular Biosciences, Mahidol University, Bangkok, Thailand.Division of Infectious Diseases, Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Rama IV Road, Bangkok 10330, Thailand; Research Unit in Pediatric Infectious Diseases and Vaccine, Chulalongkorn University, Bangkok, Thailand.

Pub Type(s)

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

Language

eng

PubMed ID

27628323

Citation

Janewongwirot, Pakpoom, et al. "Immunogenicity of a Japanese Encephalitis Chimeric Virus Vaccine as a Booster Dose After Primary Vaccination With SA14-14-2 Vaccine in Thai Children." Vaccine, vol. 34, no. 44, 2016, pp. 5279-5283.
Janewongwirot P, Puthanakit T, Anugulruengkitt S, et al. Immunogenicity of a Japanese encephalitis chimeric virus vaccine as a booster dose after primary vaccination with SA14-14-2 vaccine in Thai children. Vaccine. 2016;34(44):5279-5283.
Janewongwirot, P., Puthanakit, T., Anugulruengkitt, S., Jantarabenjakul, W., Phasomsap, C., Chumket, S., Yoksan, S., & Pancharoen, C. (2016). Immunogenicity of a Japanese encephalitis chimeric virus vaccine as a booster dose after primary vaccination with SA14-14-2 vaccine in Thai children. Vaccine, 34(44), 5279-5283. https://doi.org/10.1016/j.vaccine.2016.09.005
Janewongwirot P, et al. Immunogenicity of a Japanese Encephalitis Chimeric Virus Vaccine as a Booster Dose After Primary Vaccination With SA14-14-2 Vaccine in Thai Children. Vaccine. 2016 10 17;34(44):5279-5283. PubMed PMID: 27628323.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Immunogenicity of a Japanese encephalitis chimeric virus vaccine as a booster dose after primary vaccination with SA14-14-2 vaccine in Thai children. AU - Janewongwirot,Pakpoom, AU - Puthanakit,Thanyawee, AU - Anugulruengkitt,Suvaporn, AU - Jantarabenjakul,Watsamon, AU - Phasomsap,Chayapa, AU - Chumket,Sompong, AU - Yoksan,Sutee, AU - Pancharoen,Chitsanu, Y1 - 2016/09/12/ PY - 2016/01/21/received PY - 2016/09/02/revised PY - 2016/09/04/accepted PY - 2016/9/16/pubmed PY - 2017/12/12/medline PY - 2016/9/16/entrez KW - Children KW - Immunogenicity KW - Japanese encephalitis vaccine KW - Safety SP - 5279 EP - 5283 JF - Vaccine JO - Vaccine VL - 34 IS - 44 N2 - BACKGROUND: Japanese Encephalitis chimeric virus vaccine (JE-CV) and SA14-14-2 vaccine are live-attenuated JE vaccines produced from the same virus strain. Data on interchangeability is limited. OBJECTIVES: To evaluate the immunogenicity and safety of JE-CV booster after primary vaccination with SA14-14-2 vaccine. METHODS: This study was an open-label clinical trial in Thai children who had received a primary SA14-14-2 vaccination at 12-24monthsbefore enrollment (ClinicalTrials.gov NCT02602652). JE-CV was administered. A 50% plaque reduction neutralization test (PRNT50) against three virus strains; JE-CV, SA-14-14-2andwild-type JE virus was measured before and 28-days post vaccination. The laboratory was performed at PRNT50 titers ⩾10 (1/dil) were considered seroprotective against JE. Geometric mean titer (GMT) of PRNT50 was calculated. Adverse events were observed for 28days. RESULTS: From March 2014 to June 2015, 50 children (64% male) were enrolled. Mean age and duration after primary vaccination was 26.9 (SD 4.6) and 12.8 (SD 2.7) months, respectively. The proportion of participants who had PRNT50pre and post-booster vaccination were 92% and 96% against JE-CV virus, 56% and 98% against SA-14-14-2 strain and 70% and 98% against wild-type JE virus, respectively. Solicited injection site reactions including erythema, pain and swelling occurred in 18%, 10% and 4% of subjects, respectively. Four children (8%) had fever (⩾37.7Celsius). Eight children (16%) had adverse events, which were not related to the vaccine. CONCLUSIONS: AJE-CV booster dose is highly immunogenic and safe among children who previously received SA14-14-2 vaccine. SN - 1873-2518 UR - https://www.unboundmedicine.com/medline/citation/27628323/Immunogenicity_of_a_Japanese_encephalitis_chimeric_virus_vaccine_as_a_booster_dose_after_primary_vaccination_with_SA14_14_2_vaccine_in_Thai_children_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0264-410X(16)30801-5 DB - PRIME DP - Unbound Medicine ER -