PMID- 30691396 OWN - NLM STAT- MEDLINE DCOM- 20190307 LR - 20200225 IS - 1471-2334 (Electronic) IS - 1471-2334 (Linking) VI - 19 IP - 1 DP - 2019 Jan 28 TI - Safety of live attenuated varicella-zoster vaccine in patients with underlying illnesses compared with healthy adults: a prospective cohort study. PG - 95 LID - 10.1186/s12879-019-3719-7 [doi] LID - 95 AB - BACKGROUND: In Japan, freeze-dried live attenuated varicella-zoster vaccine is available for adults aged >/=50 years to prevent herpes zoster. However, limited evidence has been accumulated regarding vaccine safety for patients with underlying illnesses, who have been considered as the high-risk group for herpes zoster. METHODS: A prospective cohort study of 1200 healthy adults and 300 patients with underlying illnesses such as malignancy, diabetes mellitus, autoimmune diseases, and renal diseases was conducted. All subjects were vaccinated and then their adverse events (AEs) were followed for 28 days after vaccination. Key safety measures included any AEs, severe AEs (SAEs), and vaccine-related AEs such as injection-site AEs and systemic AEs. The frequencies and 95% confidence intervals of AEs were calculated. RESULTS: During the follow-up period, 2 SAEs (bone fracture and acute cholecystitis) among healthy adults and 1 SAE (disseminated mycobacteriosis) among patients with underlying illnesses were reported, although none of them was diagnosed as vaccine-related. Vaccine-related AEs were reported in 42% of healthy adults and patients with underlying illnesses, and the proportions were similar between the groups. The most frequent AEs were injection-site AEs in both groups (i.e., 41 and 39%), and systemic AEs were observed in 4% of both groups. Only among healthy adults, those with a history of herpes zoster were more likely to report injection-site AEs than those without a history of herpes zoster (53% vs 39%). CONCLUSIONS: The present study confirmed the safety of freeze-dried, live attenuated varicella-zoster vaccine even in patients with underlying illnesses. A history of herpes zoster might be related to development of injection-site AEs in healthy adults. TRIAL REGISTRATION: The study was prospectively registered on Japic-Clinical Trials Information as JapicCTI-163415 on October 31, 2016. FAU - Ohfuji, Satoko AU - Ohfuji S AD - Department of Public Health, Osaka City University Graduate School of Medicine, 1-4-3, Asahi-machi, Abeno-ku, Osaka-city, Osaka, 545-8585, Japan. satop@med.osaka-cu.ac.jp. AD - Research Center for Infectious Disease Sciences, Osaka City University Graduate School of Medicine, 1-4-3, Asahi-machi, Abeno-ku, Osaka-city, Osaka, 545-8585, Japan. satop@med.osaka-cu.ac.jp. FAU - Ito, Kazuya AU - Ito K AD - Department of Public Health, Osaka City University Graduate School of Medicine, 1-4-3, Asahi-machi, Abeno-ku, Osaka-city, Osaka, 545-8585, Japan. AD - Research Center for Infectious Disease Sciences, Osaka City University Graduate School of Medicine, 1-4-3, Asahi-machi, Abeno-ku, Osaka-city, Osaka, 545-8585, Japan. FAU - Inoue, Megumi AU - Inoue M AD - PS Clinic, Medical Co. LTA, 6-18, Ten-ya-machi, Hakata-ku, Fukuoka-city, Fukuoka, 812-0025, Japan. FAU - Ishibashi, Motoki AU - Ishibashi M AD - PS Clinic, Medical Co. LTA, 6-18, Ten-ya-machi, Hakata-ku, Fukuoka-city, Fukuoka, 812-0025, Japan. FAU - Kumashiro, Hiroko AU - Kumashiro H AD - PS Clinic, Medical Co. LTA, 6-18, Ten-ya-machi, Hakata-ku, Fukuoka-city, Fukuoka, 812-0025, Japan. FAU - Hirota, Yoshio AU - Hirota Y AD - Clinical Epidemiology Research Center, Medical Co. LTA, 3-6-1 Kashii-Teriha Higashi-ku, Fukuoka, 813-0017, Japan. FAU - Kayano, Eiji AU - Kayano E AD - Kanonji Institute, Research Foundation for Microbial Diseases of Osaka University, 4-1-70, Seto-Cho, Kanonji, Kagawa, 768-0065, Japan. FAU - Ota, Naoshi AU - Ota N AD - Kanonji Institute, Research Foundation for Microbial Diseases of Osaka University, 4-1-70, Seto-Cho, Kanonji, Kagawa, 768-0065, Japan. LA - eng PT - Controlled Clinical Trial PT - Journal Article PT - Multicenter Study DEP - 20190128 PL - England TA - BMC Infect Dis JT - BMC infectious diseases JID - 100968551 RN - 0 (Herpes Zoster Vaccine) RN - 0 (Vaccines, Attenuated) SB - IM MH - Aged MH - Aged, 80 and over MH - Autoimmune Diseases/*epidemiology/immunology MH - Chickenpox/epidemiology/*prevention & control MH - Chronic Disease MH - Comorbidity MH - Diabetes Mellitus/*epidemiology/immunology MH - Female MH - Healthy Volunteers MH - Herpes Zoster/epidemiology/etiology MH - Herpes Zoster Vaccine/administration & dosage/*adverse effects MH - Herpesvirus 3, Human/immunology MH - Humans MH - Injection Site Reaction/epidemiology MH - Japan/epidemiology MH - Kidney Diseases/*epidemiology/immunology MH - Male MH - Middle Aged MH - Neoplasms/*epidemiology/immunology MH - Vaccination/adverse effects/statistics & numerical data MH - Vaccines, Attenuated/administration & dosage/*adverse effects PMC - PMC6350288 OTO - NOTNLM OT - Adverse events OT - Autoimmune diseases OT - Diabetes mellitus OT - Herpes zoster OT - Malignancy OT - Reactogenicity OT - Renal diseases OT - Safety OT - Varicella-zoster vaccine COIS- ETHICS APPROVAL AND CONSENT TO PARTICIPATE: The study protocols were approved by the Clinical Study Review Board of SOUSEIKAI (No. 1668CP) and BIKEN Ethical and COI Review Board (No.16-03), and was performed in accordance with the Declaration of Helsinki. All participants received an explanation of the study from their physician and provided written, informed consent prior to participation. CONSENT FOR PUBLICATION: Not applicable. COMPETING INTERESTS: EK and NO are members of the Research Foundation for Microbial Diseases of Osaka University (funding company). Other authors declare that they have no conflict of interest. PUBLISHER'S NOTE: Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. EDAT- 2019/01/30 06:00 MHDA- 2019/03/08 06:00 PMCR- 2019/01/28 CRDT- 2019/01/30 06:00 PHST- 2018/11/13 00:00 [received] PHST- 2019/01/11 00:00 [accepted] PHST- 2019/01/30 06:00 [entrez] PHST- 2019/01/30 06:00 [pubmed] PHST- 2019/03/08 06:00 [medline] PHST- 2019/01/28 00:00 [pmc-release] AID - 10.1186/s12879-019-3719-7 [pii] AID - 3719 [pii] AID - 10.1186/s12879-019-3719-7 [doi] PST - epublish SO - BMC Infect Dis. 2019 Jan 28;19(1):95. doi: 10.1186/s12879-019-3719-7.