Zhuhang Huang1, Jianfeng He2, Jiali Su1, Zhiqiang Ou1, Guixiu Liu3, Rong Fu4, Qiong Shou5, Minghuan Zheng6, Thomas Group7, Alain Luxembourg8, Xueyan Liao9, Jikai Zhang10. 1. Guangdong Provincial Institute of Biological Products and Materia Medica, 200 Xipengling Road, Guangzhou, Guangdong Province 510440, PR China. 2. Guangdong Provincial Center for Disease Control and Prevention, 160 Qunxian Road, Guangzhou, Guangdong Province 511430, PR China. 3. MSD R&D (China) Co., Ltd., 21 Rong Da Road, Beijing 100012, PR China. Electronic address: gui.xiu.liu@merck.com. 4. MSD R&D (China) Co., Ltd., 21 Rong Da Road, Beijing 100012, PR China. Electronic address: rong.fu1@merck.com. 5. MSD R&D (China) Co., Ltd., 21 Rong Da Road, Beijing 100012, PR China. Electronic address: qiong.shou@merck.com. 6. MSD R&D (China) Co., Ltd., 21 Rong Da Road, Beijing 100012, PR China. Electronic address: ming.huan.zheng@merck.com. 7. Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ 07033, USA. Electronic address: thomas_group@merck.com. 8. Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ 07033, USA. Electronic address: alain_luxembourg@merck.com. 9. MSD R&D (China) Co., Ltd., 21 Rong Da Road, Beijing 100012, PR China. Electronic address: xue.yan.liao@merck.com. 10. Guangdong Provincial Institute of Biological Products and Materia Medica, 200 Xipengling Road, Guangzhou, Guangdong Province 510440, PR China. Electronic address: 56061237@qq.com.
Abstract
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.
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.