PMID- 33965257 OWN - NLM STAT- MEDLINE DCOM- 20210708 LR - 20210708 IS - 1873-2518 (Electronic) IS - 0264-410X (Linking) VI - 39 IP - 25 DP - 2021 Jun 8 TI - Immunogenicity and safety of 7-valent pneumococcal conjugate vaccine (PCV7) in children aged 2-5 years in China. PG - 3428-3434 LID - S0264-410X(21)00484-9 [pii] LID - 10.1016/j.vaccine.2021.04.037 [doi] AB - BACKGROUND: The widespread use of pneumococcal conjugate vaccines (PCVs) has significantly decreased pneumococcal disease worldwide. However, China has not adopted PCVs in their national immunization schedules and had only approved these vaccines for children aged 2-15 months by 2020. METHODS: In an open-label trial, enrolled healthy children aged 2-5 years old were randomized 1:1 and divided into a 7-valent pneumococcal conjugate vaccine (PCV7) group and a Haemophilus influenzae type b conjugate vaccine (Hib) group. Children in the PCV7 group received a single dose of PCV7, and the Hib group received a single dose of Hib vaccine. Blood samples were collected before and 6 months after vaccination. Immunogenicity and safety of PCV7 were assessed at prespecified time points. RESULTS: Six months after a single dose of PCV7, children in the PCV7 group for all 7 serotypes, IgG mean concentrations (GMCs) and opsonophagocytic geometric mean titres (GMTs) were significantly higher (P < .001) than at baseline, and the proportion of IgG >/= 0.35 microg/mL ranged from 90.0% to 100%. Although the antibody level increased with age, preexisting antibodies did not induce hyporesponsiveness to PCV7. In the Hib group, the antibody levels were not significantly different or had changed slightly at 6 months. PCV7 was well tolerated in all age groups, and no serious adverse events (AEs) emerged during this study. CONCLUSIONS: A single dose of PCV7 was immunogenic and safe for Chinese children aged 2-5 years, and the preexisting antibodies against the PCV7 serotypes did not change the response to vaccination. The findingssupported the effectiveness of PCV7 in this age group. PCVs with broader serotype coverage are expected to expand pneumococcal disease protection. CI - Copyright (c) 2021 The Authors. Published by Elsevier Ltd.. All rights reserved. FAU - Wang, Jian AU - Wang J AD - Beijing Center for Disease Prevention and Control, Beijing, China; Beijing Research Center for Preventive Medicine, Beijing, China. FAU - Bai, Shuang AU - Bai S AD - Beijing Center for Disease Prevention and Control, Beijing, China; Beijing Research Center for Preventive Medicine, Beijing, China. FAU - Zhou, Shanshan AU - Zhou S AD - Beijing Center for Disease Prevention and Control, Beijing, China; Beijing Research Center for Preventive Medicine, Beijing, China. FAU - Zhao, Wei AU - Zhao W AD - Beijing Center for Disease Prevention and Control, Beijing, China; Beijing Research Center for Preventive Medicine, Beijing, China. FAU - Li, Qin AU - Li Q AD - Department of Laboratory, Yanjing Medical College, Capital Medical University, Beijing, China. FAU - Lv, Min AU - Lv M AD - Beijing Center for Disease Prevention and Control, Beijing, China; Beijing Research Center for Preventive Medicine, Beijing, China. FAU - Zhang, Peng AU - Zhang P AD - Beijing Center for Disease Prevention and Control, Beijing, China; Beijing Research Center for Preventive Medicine, Beijing, China. FAU - Zhang, Haizhou AU - Zhang H AD - Beijing Center for Disease Prevention and Control, Beijing, China; Beijing Research Center for Preventive Medicine, Beijing, China. FAU - Lan, Wenwen AU - Lan W AD - Beijing Center for Disease Prevention and Control, Beijing, China; Beijing Research Center for Preventive Medicine, Beijing, China. FAU - Kang, Yanli AU - Kang Y AD - Beijing Center for Disease Prevention and Control, Beijing, China; Beijing Research Center for Preventive Medicine, Beijing, China. FAU - Wang, Yali AU - Wang Y AD - Beijing Center for Disease Prevention and Control, Beijing, China; Beijing Research Center for Preventive Medicine, Beijing, China. FAU - Li, Jin AU - Li J AD - Beijing Center for Disease Prevention and Control, Beijing, China; Beijing Research Center for Preventive Medicine, Beijing, China. FAU - Gao, Xiaotong AU - Gao X AD - Beijing Center for Disease Prevention and Control, Beijing, China; Beijing Research Center for Preventive Medicine, Beijing, China. FAU - Tong, Xiaomei AU - Tong X AD - Beijing Center for Disease Prevention and Control, Beijing, China; Beijing Research Center for Preventive Medicine, Beijing, China. FAU - Wu, Jiang AU - Wu J AD - Beijing Center for Disease Prevention and Control, Beijing, China; Beijing Research Center for Preventive Medicine, Beijing, China. FAU - Zheng, Qun AU - Zheng Q AD - Experimental Center for Basic Medical Teaching, Capital Medical University, Beijing, China. Electronic address: zhengqun@ccmu.edu.cn. LA - eng PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20210506 PL - Netherlands TA - Vaccine JT - Vaccine JID - 8406899 RN - 0 (Antibodies, Bacterial) RN - 0 (Pneumococcal Vaccines) RN - 0 (Vaccines, Conjugate) SB - IM MH - Antibodies, Bacterial MH - Child MH - Child, Preschool MH - China MH - Humans MH - Immunization Schedule MH - Infant MH - *Pneumococcal Infections/prevention & control MH - *Pneumococcal Vaccines/adverse effects MH - Vaccines, Conjugate/adverse effects OTO - NOTNLM OT - Children OT - Immunogenicity OT - PCV7 OT - Preexisting antibodies COIS- Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. EDAT- 2021/05/10 06:00 MHDA- 2021/07/09 06:00 CRDT- 2021/05/09 20:29 PHST- 2021/01/20 00:00 [received] PHST- 2021/04/16 00:00 [revised] PHST- 2021/04/19 00:00 [accepted] PHST- 2021/05/10 06:00 [pubmed] PHST- 2021/07/09 06:00 [medline] PHST- 2021/05/09 20:29 [entrez] AID - S0264-410X(21)00484-9 [pii] AID - 10.1016/j.vaccine.2021.04.037 [doi] PST - ppublish SO - Vaccine. 2021 Jun 8;39(25):3428-3434. doi: 10.1016/j.vaccine.2021.04.037. Epub 2021 May 6.