| アブストラクト | BACKGROUND: Evidence on the real-world use of the MAV/06-strain live attenuated varicella vaccine (BARYCELA inj.) in adolescents and adults is limited. We described postvaccination ELISA seropositivity and recorded medically attended events in recipients aged >/= 13 years. METHODS: This retrospective cohort study included recipients vaccinated at a tertiary academic medical center in South Korea. Serologic analyses included selected participants documented as VZV IgG-negative at baseline who subsequently underwent postvaccination testing during routine care; dose scheduling and testing were individualized according to prior vaccination documentation and clinical need. Hospital encounters within 42 days after vaccination and institution-associated reports in the national adverse-event reporting system were reviewed. RESULTS: Of 1715 administered doses, 988 patients aged >/= 13 years received 1295 doses and comprised the safety cohort. The serology cohort included 199 participants and 202 dose-specific assessments. ELISA seropositivity was observed in 80/98 participants (81.6%; 95% CI, 72.8-88.1%) in the post-dose 1 cohort and 90/104 (86.5%; 95% CI, 78.7-91.8%) in the post-dose 2 cohort. Nine medically attended events were identified within 42 days (0.69% per administered dose; 95% CI, 0.32-1.32%), of which one mild fever episode was considered possibly related to vaccination. Substantial postvaccination ELISA seropositivity was observed in this selected cohort of adolescents and adults. Few medically attended events were identified in the available institutional records and national adverse-event reports, and one mild fever episode was considered possibly related to vaccination. Prospective studies with paired, protocol-timed sampling and cellular immune assessments are needed. |
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| 組織名 | Vaccine Bio Research Institute, College of Medicine, The Catholic University of;Korea, Seoul 06591, Republic of Korea.;Department of Pediatrics, Seoul St. Mary's Hospital, College of Medicine, The;Catholic University of Korea, Seoul 06591, Republic of Korea.;Regulatory Science & Product Development Division, GC Biopharma Corporation,;Yongin 16950, Republic of Korea.;Division of Infectious Diseases, Department of Internal Medicine, Seoul St.;Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul;06591, Republic of Korea. |
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