Comparison of the safety and persistence of immunogenicity of bivalent HPV16/18 vaccine in healthy 9–14-year-old and 18–26-year-old Chinese females: A randomized, double-blind, non-inferiority clinical trial

• Published in: Vaccine 2023-11, Vol.41 (48), p.7212-7219
• Main Authors: Li, Juan, Shi, Li-Wei, Li, Ke, Huang, Li-Rong, Li, Jian-Biao, Dong, Yu-Lian, Li, Wei, Ji, Min, Yang, Qing, Zhou, Ling-Yun, Yuan, Lin, Yan, Xue-Mei, Chen, Jing-Jing, Jiang, Zhi-Wei, Qi, Yang-Yang, Li, Rong-Cheng, Li, Yan-Ping, Xia, Jie-Lai, Yu, Bang-Wei, Mo, Zhao-Jun, Li, Chang-Gui
• Format: Article
• Language: English
• Subjects: Adolescents; adults; Aluminum; Antibodies; Cervical cancer; China; Clinical trials; Drug dosages; Females; Girls; Guardians; Human Papilloma Virus; Human papillomavirus; Immune response; Immunogenicity; Neutralizing; Proteins; Safety; Schedules; Tolerability; uterine cervical neoplasms; vaccination; Vaccine: girls; Vaccines; Women; Womens health
• ISSN: 0264-410X; 1873-2518; 1873-2518
• DOI: 10.1016/j.vaccine.2023.10.041

We assessed the safety, immunogenicity and antibody persistence of two- and three-dose schedules of the novel bivalent HPV16/18 vaccine (HPV-2, Walrinvax) in the per-protocol target population of initially seronegative 9–14 year-old girls, including a non-inferiority comparison with the three-dose schedule in 18–26 year-old women. This randomized phase 3b trial in Guangxi Zhuang Autonomous Region, China, involved healthy Chinese females in two age cohorts; 600 girls aged 9–14 years and 300 women aged 18–26 years. Girls were randomly assigned (1:1) to receive either two (Months 0,6) or three (Months 0,2,6) intramuscular doses of HPV-2. All participants were monitored for immunogenicity as neutralizing antibodies up to 36 months. Primary objectives were non-inferiority analyses of immunogenicity between two- and three-dose girl groups and adult women at Month 7; safety assessments were based on participant-completed diary cards. All groups demonstrated marked increases in neutralizing antibodies against HPV 16 and 18 that persisted above baseline to 36 months. Month 7 responses in both girl groups were non-inferior to those in the women and were statistically higher after two-doses than girls or women who received three doses. GMTs waned after month 7, but then maintained a plateau level until month 36. Vaccination was well tolerated in all groups with no serious adverse events reported. Immune responses to two doses of HPV-2 vaccine in adolescent girls were non-inferior to those after three doses in young women, an age cohort in which clinical efficacy of HPV-2 against cervical cancer has been demonstrated.