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Long-term follow-up of Japanese encephalitis chimeric virus vaccine: Immune responses in children.
Vaccine. 2016 11 04; 34(46):5664-5669.V

Abstract

BACKGROUND

A single dose of live attenuated Japanese encephalitis chimeric virus vaccine (JE-CV) was shown to be immunogenic and well tolerated when given either as a booster to formalin-inactivated Japanese encephalitis (JE)-vaccine (mouse brain-derived vaccine [MBDV])-primed 2-5-year-olds, or as a primary vaccination to JE-vaccine-naïve 12-24-month-old toddlers in Thailand. A 5-year follow-up assessment of immune response persistence over time was conducted.

METHODS

Four additional visits (at 2, 3, 4, and 5years) for immunologic assessments were added to the original 12-month open-label crossover study, in which 100 healthy children aged 2-5years with a history of two-dose primary vaccination with MBDV (according to the Thai Expanded Program for Immunization schedule), and 200 healthy JE-vaccine-naïve 12-24-month-old toddlers, were randomized 1:1 to receive JE-CV, containing ⩾4 log10 plaque forming units, 1month before or after hepatitis A control vaccine.

RESULTS

In MBDV-primed 2-5-year-olds (n=78), the immune response to the JE-CV vaccine persisted up to at least 5years after vaccination with a single dose of JE-CV, with all (n=78) children seroprotected at the year 5 visit (geometric mean titers [GMT]: 2521/dil). There was no decrease of seroprotection rate over time (100% at 6months post-vaccination and 96.8% (90.3-98.9) at 5yearspost-vaccination). In JE-vaccine-naïve toddlers, a protective immune response persisted up to at least 5years in 58.8% (50.9-66.4) after a single-dose administration of JE-CV (GMT 26.71/dil; sensitivity analysis).

CONCLUSIONS

A single-dose of JE-CV as a booster following MBDV administration provided long-lasting immunity. In JE-vaccine-naïve toddlers, despite relatively high seroprotection rates persisting over time, a subsequent booster dose is recommended following a JE-CV primary vaccination for long-term protection. This study was registered on www.clinicaltrials.gov (NCT00621764).

Authors+Show Affiliations

Division of Infectious Diseases, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand. Electronic address: kulkanya.cho@mahidol.ac.th.Department of Tropical Pediatrics, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand. Electronic address: chukiat.sir@mahidol.ac.t.Department of Pediatrics, Chulalongkorn Hospital, Bangkok, Thailand. Electronic address: uthisyakorn@gmail.com.Department of Pediatrics, Chulalongkorn Hospital, Bangkok, Thailand. Electronic address: Chitsanu.P@chula.ac.th.Global Clinical Immunology, Sanofi Pasteur, Swiftwater, PA, USA. Electronic address: markjboaz@gmail.com.Medical Affairs & Clinical Sciences, Sanofi Pasteur, Singapore. Electronic address: Alain.Bouckenooghe@sanofipasteur.com.Clinical Sciences, Sanofi Pasteur, Marcy l'Etoile, France. Electronic address: Emmanuel.Feroldi@sanofipasteur.com.

Pub Type(s)

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

Language

eng

PubMed ID

27686833

Citation

Chokephaibulkit, Kulkanya, et al. "Long-term Follow-up of Japanese Encephalitis Chimeric Virus Vaccine: Immune Responses in Children." Vaccine, vol. 34, no. 46, 2016, pp. 5664-5669.
Chokephaibulkit K, Sirivichayakul C, Thisyakorn U, et al. Long-term follow-up of Japanese encephalitis chimeric virus vaccine: Immune responses in children. Vaccine. 2016;34(46):5664-5669.
Chokephaibulkit, K., Sirivichayakul, C., Thisyakorn, U., Pancharoen, C., Boaz, M., Bouckenooghe, A., & Feroldi, E. (2016). Long-term follow-up of Japanese encephalitis chimeric virus vaccine: Immune responses in children. Vaccine, 34(46), 5664-5669. https://doi.org/10.1016/j.vaccine.2016.09.018
Chokephaibulkit K, et al. Long-term Follow-up of Japanese Encephalitis Chimeric Virus Vaccine: Immune Responses in Children. Vaccine. 2016 11 4;34(46):5664-5669. PubMed PMID: 27686833.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Long-term follow-up of Japanese encephalitis chimeric virus vaccine: Immune responses in children. AU - Chokephaibulkit,Kulkanya, AU - Sirivichayakul,Chukiat, AU - Thisyakorn,Usa, AU - Pancharoen,Chitsanu, AU - Boaz,Mark, AU - Bouckenooghe,Alain, AU - Feroldi,Emmanuel, Y1 - 2016/09/27/ PY - 2016/04/27/received PY - 2016/08/26/revised PY - 2016/09/12/accepted PY - 2016/10/25/pubmed PY - 2017/12/12/medline PY - 2016/10/1/entrez KW - Attenuated KW - Children KW - Encephalitis virus, Japanese KW - Follow-up KW - Immunization KW - Vaccine SP - 5664 EP - 5669 JF - Vaccine JO - Vaccine VL - 34 IS - 46 N2 - BACKGROUND: A single dose of live attenuated Japanese encephalitis chimeric virus vaccine (JE-CV) was shown to be immunogenic and well tolerated when given either as a booster to formalin-inactivated Japanese encephalitis (JE)-vaccine (mouse brain-derived vaccine [MBDV])-primed 2-5-year-olds, or as a primary vaccination to JE-vaccine-naïve 12-24-month-old toddlers in Thailand. A 5-year follow-up assessment of immune response persistence over time was conducted. METHODS: Four additional visits (at 2, 3, 4, and 5years) for immunologic assessments were added to the original 12-month open-label crossover study, in which 100 healthy children aged 2-5years with a history of two-dose primary vaccination with MBDV (according to the Thai Expanded Program for Immunization schedule), and 200 healthy JE-vaccine-naïve 12-24-month-old toddlers, were randomized 1:1 to receive JE-CV, containing ⩾4 log10 plaque forming units, 1month before or after hepatitis A control vaccine. RESULTS: In MBDV-primed 2-5-year-olds (n=78), the immune response to the JE-CV vaccine persisted up to at least 5years after vaccination with a single dose of JE-CV, with all (n=78) children seroprotected at the year 5 visit (geometric mean titers [GMT]: 2521/dil). There was no decrease of seroprotection rate over time (100% at 6months post-vaccination and 96.8% (90.3-98.9) at 5yearspost-vaccination). In JE-vaccine-naïve toddlers, a protective immune response persisted up to at least 5years in 58.8% (50.9-66.4) after a single-dose administration of JE-CV (GMT 26.71/dil; sensitivity analysis). CONCLUSIONS: A single-dose of JE-CV as a booster following MBDV administration provided long-lasting immunity. In JE-vaccine-naïve toddlers, despite relatively high seroprotection rates persisting over time, a subsequent booster dose is recommended following a JE-CV primary vaccination for long-term protection. This study was registered on www.clinicaltrials.gov (NCT00621764). SN - 1873-2518 UR - https://www.unboundmedicine.com/medline/citation/27686833/Long_term_follow_up_of_Japanese_encephalitis_chimeric_virus_vaccine:_Immune_responses_in_children_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0264-410X(16)30831-3 DB - PRIME DP - Unbound Medicine ER -