PMID- 33239228 OWN - NLM STAT- MEDLINE DCOM- 20210427 LR - 20210427 IS - 1873-2518 (Electronic) IS - 0264-410X (Linking) VI - 39 IP - 4 DP - 2021 Jan 22 TI - Immunogenicity and safety of the quadrivalent human papillomavirus vaccine in Chinese females aged 9 to 26 years: A phase 3, open-label, immunobridging study. PG - 760-766 LID - S0264-410X(20)31434-1 [pii] LID - 10.1016/j.vaccine.2020.11.008 [doi] AB - BACKGROUND: The quadrivalent human papillomavirus (qHPV; HPV6/11/16/18) vaccine was approved for use in Chinese women aged 20-45 years in 2017. This Phase 3, open-label study (NCT03493542) aimed to assess immunogenicity and safety of the qHPV vaccine in Chinese girls aged 9-19 years versus Chinese young women aged 20-26 years; we report results from Day 1 through Month 7. The study will continue through Month 60 to assess antibody persistence in Chinese girls aged 9-19 years. METHODS: Participants aged 9-26 years received three doses of the qHPV vaccine (Day 1, Month 2, Month 6). Geometric mean titers (GMTs) and seroconversion percentages for anti-HPV6/11/16/18 antibodies were determined by competitive Luminex immunoassay (cLIA) in serum samples obtained on Day 1 and at Month 7. Injection-site adverse events (AEs) and systemic AEs within 30 days post-vaccination, and serious AEs (SAEs) occurring at any time during the study, were recorded. RESULTS: In total, 766 participants (383 aged 9-19 years; 383 aged 20-26 years) were enrolled and received >/=1 vaccine dose. All participants in the per-protocol immunogenicity population of both age groups seroconverted to each of the vaccine HPV types at Month 7. Anti-HPV6/11/16/18 antibody GMTs at Month 7 in participants aged 9-19 years were non-inferior to those in participants aged 20-26 years. Injection-site AEs and systemic AEs were reported by 36.6% and 49.3% of 9-19-year-olds, and 40.7% and 54.8% of 20-26-year-olds, respectively. There were no vaccine-related SAEs. No participants discontinued the vaccine due to an AE and no deaths were reported. CONCLUSION: Antibody responses induced by the 3-dose qHPV vaccination regimen in Chinese girls aged 9-19 years were non-inferior to those in Chinese young women aged 20-26 years. The vaccine was generally well tolerated in the study population. ClinicalTrials.gov Identifier: NCT03493542. CI - Copyright (c) 2020 The Authors. Published by Elsevier Ltd.. All rights reserved. FAU - Huang, Zhuhang AU - Huang Z AD - Guangdong Provincial Institute of Biological Products and Materia Medica, 200 Xipengling Road, Guangzhou, Guangdong Province 510440, PR China. FAU - He, Jianfeng AU - He J AD - Guangdong Provincial Center for Disease Control and Prevention, 160 Qunxian Road, Guangzhou, Guangdong Province 511430, PR China. FAU - Su, Jiali AU - Su J AD - Guangdong Provincial Institute of Biological Products and Materia Medica, 200 Xipengling Road, Guangzhou, Guangdong Province 510440, PR China. FAU - Ou, Zhiqiang AU - Ou Z AD - Guangdong Provincial Institute of Biological Products and Materia Medica, 200 Xipengling Road, Guangzhou, Guangdong Province 510440, PR China. FAU - Liu, Guixiu AU - Liu G AD - MSD R&D (China) Co., Ltd., 21 Rong Da Road, Beijing 100012, PR China. Electronic address: gui.xiu.liu@merck.com. FAU - Fu, Rong AU - Fu R AD - MSD R&D (China) Co., Ltd., 21 Rong Da Road, Beijing 100012, PR China. Electronic address: rong.fu1@merck.com. FAU - Shou, Qiong AU - Shou Q AD - MSD R&D (China) Co., Ltd., 21 Rong Da Road, Beijing 100012, PR China. Electronic address: qiong.shou@merck.com. FAU - Zheng, Minghuan AU - Zheng M AD - MSD R&D (China) Co., Ltd., 21 Rong Da Road, Beijing 100012, PR China. Electronic address: ming.huan.zheng@merck.com. FAU - Group, Thomas AU - Group T AD - Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ 07033, USA. Electronic address: thomas_group@merck.com. FAU - Luxembourg, Alain AU - Luxembourg A AD - Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ 07033, USA. Electronic address: alain_luxembourg@merck.com. FAU - Liao, Xueyan AU - Liao X AD - MSD R&D (China) Co., Ltd., 21 Rong Da Road, Beijing 100012, PR China. Electronic address: xue.yan.liao@merck.com. FAU - Zhang, Jikai AU - Zhang J AD - Guangdong Provincial Institute of Biological Products and Materia Medica, 200 Xipengling Road, Guangzhou, Guangdong Province 510440, PR China. Electronic address: 56061237@qq.com. LA - eng SI - ClinicalTrials.gov/NCT03493542 PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20201122 PL - Netherlands TA - Vaccine JT - Vaccine JID - 8406899 RN - 0 (Antibodies, Viral) RN - 0 (Papillomavirus Vaccines) SB - IM MH - Adolescent MH - Adult MH - Antibodies, Viral MH - Child MH - China MH - Female MH - Humans MH - Immunogenicity, Vaccine MH - Middle Aged MH - Papillomaviridae MH - *Papillomavirus Infections/prevention & control MH - *Papillomavirus Vaccines/adverse effects MH - Young Adult OTO - NOTNLM OT - China OT - Immunobridging OT - Immunogenicity OT - Prophylaxis OT - Quadrivalent human papillomavirus vaccine OT - Safety COIS- Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: G.L., R.F., Q.S., M.Z., T.G., A.L., and X.L. are current or former employees of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, and may own stock and/or stock options in Merck & Co., Inc., Kenilworth, NJ, USA. EDAT- 2020/11/27 06:00 MHDA- 2021/04/28 06:00 CRDT- 2020/11/26 05:33 PHST- 2020/07/30 00:00 [received] PHST- 2020/11/02 00:00 [revised] PHST- 2020/11/04 00:00 [accepted] PHST- 2020/11/27 06:00 [pubmed] PHST- 2021/04/28 06:00 [medline] PHST- 2020/11/26 05:33 [entrez] AID - S0264-410X(20)31434-1 [pii] AID - 10.1016/j.vaccine.2020.11.008 [doi] PST - ppublish SO - Vaccine. 2021 Jan 22;39(4):760-766. doi: 10.1016/j.vaccine.2020.11.008. Epub 2020 Nov 22.