Pope Kosalaraksa1, Veerachai Watanaveeradej, Chitsanu Pancharoen, Maria Rosario Capeding, Emmanuel Feroldi, Alain Bouckenooghe. 1. From the *Department of Pediatrics, Srinagarind Hospital, Khon Kaen, Thailand; †Department of Pediatrics, Phramongkutklao Hospital, Bangkok, Thailand; ‡Department of Pediatrics, King Chulalongkorn Memorial Hospital, Bangkok, Thailand; §Research Institute for Tropical Medicine, Muntinlupa City, Philippines; ¶Clinical Sciences Department, Sanofi Pasteur, Marcy l'Etoile, France; and ‖Clinical Sciences and Medical Affairs Asia Department, Sanofi Pasteur, Singapore.
Abstract
BACKGROUND:Japanese encephalitis (JE) is an important mosquito-borne viral disease that is endemic in Asia, Western Pacific countries and Northern Australia. Although there is no antiviral treatment, vaccination is effective in preventing this disease. METHODS: We followed a cohort of 596 children for 5 years after primary vaccination at 12-18 months of age withJE chimeric virus vaccine (JE-CV; IMOJEV) in a multicenter, phase III trial in Thailand and the Philippines to assess antibody persistence and safety. At the end of the 5 years, a subgroup of 85 participants, at 1 site in Thailand, was followed after administration of a JE-CV booster vaccination. JE antibody titers were measured annually after primary vaccination and 28 days after booster vaccination using a 50% plaque reduction neutralization test. Seroprotection was defined as a JE-CV neutralizing antibody titer ≥10 (1/dil). Kaplan-Meier survival analysis was used to estimate the proportion of participants maintaining protective JE-CV neutralizing antibody titers. RESULTS: At 1, 2, 3, 4 and 5 years after vaccination with JE-CV, 88.5%, 82.9%, 78.2%, 74.0% and 68.6% of the participants followed remained seroprotected. Geometric mean titers in the subgroup assessed after receipt of a booster dose increased from 61.2 (95% confidence interval: 43.8-85.7) pre-booster to 4951 (95% confidence interval: 3928-6241) 28 days post-booster, with all participants seroprotected. There were no safety concerns identified. CONCLUSIONS:Protective immune responses persisted for at least 5 years after a JE-CV primary immunization in the majority of participants. JE-CV booster induced a robust immune response even after a 5-year interval.
RCT Entities:
BACKGROUND:Japanese encephalitis (JE) is an important mosquito-borne viral disease that is endemic in Asia, Western Pacific countries and Northern Australia. Although there is no antiviral treatment, vaccination is effective in preventing this disease. METHODS: We followed a cohort of 596 children for 5 years after primary vaccination at 12-18 months of age with JE chimeric virus vaccine (JE-CV; IMOJEV) in a multicenter, phase III trial in Thailand and the Philippines to assess antibody persistence and safety. At the end of the 5 years, a subgroup of 85 participants, at 1 site in Thailand, was followed after administration of a JE-CV booster vaccination. JE antibody titers were measured annually after primary vaccination and 28 days after booster vaccination using a 50% plaque reduction neutralization test. Seroprotection was defined as a JE-CV neutralizing antibody titer ≥10 (1/dil). Kaplan-Meier survival analysis was used to estimate the proportion of participants maintaining protective JE-CV neutralizing antibody titers. RESULTS: At 1, 2, 3, 4 and 5 years after vaccination with JE-CV, 88.5%, 82.9%, 78.2%, 74.0% and 68.6% of the participants followed remained seroprotected. Geometric mean titers in the subgroup assessed after receipt of a booster dose increased from 61.2 (95% confidence interval: 43.8-85.7) pre-booster to 4951 (95% confidence interval: 3928-6241) 28 days post-booster, with all participants seroprotected. There were no safety concerns identified. CONCLUSIONS: Protective immune responses persisted for at least 5 years after a JE-CV primary immunization in the majority of participants. JE-CV booster induced a robust immune response even after a 5-year interval.
Authors: K Zaman; Md Yunus; Asma B Aziz; Jodi Feser; Jessica Mooney; Yuxiao Tang; Damon W Ellison; Butsaya Thaisomboonsuk; Lei Zhang; Kathleen M Neuzil; Anthony A Marfin; G William Letson Journal: Vaccine X Date: 2022-02-05