PMID- 31122860 OWN - NLM STAT- MEDLINE DCOM- 20200723 LR - 20200723 IS - 1873-2518 (Electronic) IS - 0264-410X (Linking) VI - 37 IP - 27 DP - 2019 Jun 12 TI - Immunogenicity and safety of a new live attenuated herpes zoster vaccine (NBP608) compared to Zostavax(R) in healthy adults aged 50 years and older. PG - 3605-3610 LID - S0264-410X(19)30510-9 [pii] LID - 10.1016/j.vaccine.2019.04.046 [doi] AB - A multi-centre, randomised, double-blinded, active-controlled, parallel-group clinical trial was carried out to assess the immunogenicity and safety of NBP608-a newly developed live-attenuated zoster vaccine in Korea-relative to Zostavax(R) in healthy adults aged 50 years or older. Immune responses to the vaccine were evaluated by glycoprotein enzyme-linked immunosorbent assay (gpELISA) and enzyme-linked immunosorbent spot (ELISPOT) assays using the interferon (IFN)-gamma and interleukin (IL)-2 FluoroSpot kit 6 weeks after vaccination. Safety was monitored for 26 weeks based on subjects' diaries, spontaneous reports from subjects, and history taking by the investigators. A total of 845 subjects participated in the screening, and 823 received the vaccination (413 in the NBP608 group and 411 in the comparator group). The gpELISA-determined geometric mean fold rise from baseline to post NBP608 vaccination was 2.75 [95% confidence interval, CI (2.57, 2.94)]. The gpELISA-determined adjusted geometric mean titers (GMTs) of NBP608 and the comparator were 1346.37 [95% CI (1273.99, 1422.87)] and 1674.94 [95% CI (1585.35, 1769.58)], respectively. The adjusted GMT ratio of NBP608 to the comparator was 0.80 [95% CI (0.75, 0.87)]. There was no statistically significant difference between two groups in terms of the geometric mean spot numbers determined by IFN-gamma and IL-2 ELISPOT assays at 6 weeks post vaccination (P = 0.7232, 0.3844). The incidence of adverse events (AEs) within 6 weeks post vaccination was 49.82% overall (410/823, 941 cases), 50.73% (209/412, 474 cases) in the NBP608 group, and 48.91% (201/411, 467 cases) in the comparator group. The difference in AE rate between the two groups was not statistically significant (P = 0.6010). Most AEs were mild, with a rate of 83.12% in the NBP608 group and 75.37% in the comparator group. Thus, NBP608 is non-inferior to Zostavax(R) in terms of inducing the immune response and can be safely administered to adults aged 50 years or older. ClinicalTrials.gov Identifier: NCT03120364. CI - Copyright (c) 2019. Published by Elsevier Ltd. FAU - Choi, Won Suk AU - Choi WS AD - Division of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea. FAU - Choi, Jung Hyun AU - Choi JH AD - Division of Infectious Diseases, Department of Internal Medicine, The Catholic University of Korea, Incheon St. Mary's Hospital, Incheon, Republic of Korea. FAU - Jung, Dong Sik AU - Jung DS AD - Division of Infectious Diseases, Department of Internal Medicine, Dong-A University Hospital, Busan, Republic of Korea. FAU - Choi, Hee Jung AU - Choi HJ AD - Division of Infectious Diseases, Department of Internal Medicine, Ewha Womans University Mokdong Hospital, Seoul, Republic of Korea. FAU - Kim, Yeon-Sook AU - Kim YS AD - Division of Infectious Diseases, Department of Internal Medicine, Chungnam National University School of Medicine, Daejon, Republic of Korea. FAU - Lee, Jacob AU - Lee J AD - Division of Infectious Diseases, Department of Internal Medicine, Hallym University College of Medicine, Chuncheon, Republic of Korea. FAU - Jang, Hee-Chang AU - Jang HC AD - Department of Infectious Diseases, Chonnam National University Medical School, Gwangju, Republic of Korea. FAU - Shin, Eui-Cheol AU - Shin EC AD - Laboratory of Immunology and Infectious Diseases, Graduate School of Medical Science & Engineering, KAIST, Daejeon, Republic of Korea. FAU - Park, Jun-Sik AU - Park JS AD - Laboratory of Immunology and Infectious Diseases, Graduate School of Medical Science & Engineering, KAIST, Daejeon, Republic of Korea. FAU - Kim, Hun AU - Kim H AD - Life Science Research Institute, SK Bioscience, Seongnam, Gyeonggi-do, Republic of Korea. FAU - Cheong, Hee Jin AU - Cheong HJ AD - Division of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea. Electronic address: heejinmd@korea.ac.kr. LA - eng SI - ClinicalTrials.gov/NCT03120364 PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20190520 PL - Netherlands TA - Vaccine JT - Vaccine JID - 8406899 RN - 0 (Antibodies, Viral) RN - 0 (Cytokines) RN - 0 (Herpes Zoster Vaccine) RN - 0 (Vaccines, Attenuated) SB - IM MH - Aged MH - Aged, 80 and over MH - Antibodies, Viral/blood MH - Cytokines/analysis MH - Double-Blind Method MH - Drug-Related Side Effects and Adverse Reactions/epidemiology MH - Enzyme-Linked Immunosorbent Assay MH - Enzyme-Linked Immunospot Assay MH - Female MH - Follow-Up Studies MH - Healthy Volunteers MH - Herpes Zoster Vaccine/administration & dosage/*adverse effects/*immunology MH - Humans MH - Immunity, Cellular MH - Immunity, Humoral MH - Male MH - Middle Aged MH - Republic of Korea MH - Vaccines, Attenuated/administration & dosage/adverse effects/immunology OTO - NOTNLM OT - Attenuated vaccine OT - Clinical trial OT - Herpes zoster vaccine OT - Immunogenicity OT - Prevention of herpes zoster OT - Safety EDAT- 2019/05/28 06:00 MHDA- 2020/07/24 06:00 CRDT- 2019/05/25 06:00 PHST- 2018/10/12 00:00 [received] PHST- 2019/04/13 00:00 [revised] PHST- 2019/04/16 00:00 [accepted] PHST- 2019/05/28 06:00 [pubmed] PHST- 2020/07/24 06:00 [medline] PHST- 2019/05/25 06:00 [entrez] AID - S0264-410X(19)30510-9 [pii] AID - 10.1016/j.vaccine.2019.04.046 [doi] PST - ppublish SO - Vaccine. 2019 Jun 12;37(27):3605-3610. doi: 10.1016/j.vaccine.2019.04.046. Epub 2019 May 20.