Long-term follow-up of Japanese encephalitis chimeric virus vaccine: Immune responses in children |
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| Affiliation: | 1. Division of Infectious Diseases, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand;2. Department of Tropical Pediatrics, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand;3. Department of Pediatrics, Chulalongkorn Hospital, Bangkok, Thailand;4. Global Clinical Immunology, Sanofi Pasteur, Swiftwater, PA, USA;5. Medical Affairs & Clinical Sciences, Sanofi Pasteur, Singapore;6. Clinical Sciences, Sanofi Pasteur, Marcy l’Etoile, France;1. J.J.M. Medical College, Davangere, Karnataka, India;2. Department of Pediatrics, Bronx-Lebanon Hospital Center, Bronx, NY, USA;3. Division of Pediatric Intensive Care, Bronx-Lebanon Hospital Center, Bronx, NY, USA;4. Division of Pediatric Infectious Diseases, Bronx-Lebanon Hospital Center, Bronx, NY, USA;1. Department of Obstetrics & Gynaecology, Ampang Hospital, Ampang, Selangor, Malaysia;2. Royal Children''s Hospital, Melbourne, VIC, Australia;1. Florida State University, Department of Scientific Computing, 400 Dirac Science Library, Tallahassee, FL 32306, United States of America;2. Los Alamos National Laboratory, P.O. Box 1663, T-3, MS-B216, Los Alamos, NM 87545, United States of America;1. Assistant Professor, Department of Microbiology, Armed Forces Medical College, Pune 411040, India;2. Professor & Head, Department of Microbiology, Armed Forces Medical College, Pune 411040, India;3. PMO, HQ Central Air Command, Allahabad, India;4. Principal, College of Nursing, Armed Forces Medical College, Pune 411040, India;5. Dean and Deputy Commandant, Armed Forces Medical College, Pune 411040, India |
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| Abstract: | BackgroundA 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.MethodsFour additional visits (at 2, 3, 4, and 5 years) for immunologic assessments were added to the original 12-month open-label crossover study, in which 100 healthy children aged 2–5 years 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, 1 month before or after hepatitis A control vaccine.ResultsIn MBDV-primed 2–5-year-olds (n = 78), the immune response to the JE-CV vaccine persisted up to at least 5 years after vaccination with a single dose of JE-CV, with all (n = 78) children seroprotected at the year 5 visit (geometric mean titers [GMT]: 252 1/dil). There was no decrease of seroprotection rate over time (100% at 6 months post-vaccination and 96.8% (90.3–98.9) at 5 years post-vaccination). In JE-vaccine-naïve toddlers, a protective immune response persisted up to at least 5 years in 58.8% (50.9–66.4) after a single-dose administration of JE-CV (GMT 26.7 1/dil; sensitivity analysis).ConclusionsA 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). |
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| Keywords: | Encephalitis virus, Japanese Vaccine Attenuated Children Immunization Follow-up |
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