Immunogenicity noninferiority study of 2 doses and 3 doses of an Escherichia coli-produced HPV bivalent vaccine in girls vs. 3 doses in young women.

A new HPV-16/18 bivalent vaccine expressed by the Escherichia coli has been proven to be efficacious in adult women. A randomized, immunogenicity noninferiority study of this candidate vaccine was conducted in December 2015 in China. Girls aged 9-14 years were randomized to receive 2 doses at months 0 and 6 (n=301) or 3 doses at months 0, 1 and 6 (n=304). Girls aged 15-17 years (n=149) and women aged 18-26 years (n=225) received 3 doses. The objectives included noninferiority analysis of the IgG geometric mean concentration (GMC) ratio (95% CI, lower bound>0.5) to HPV-16 and HPV-18 at month 7 in girls compared with women. In the per-protocol set, the GMC ratio of IgG was noninferior for girls aged 9-17 years receiving 3 doses compared with women (1.76 (95% CI, 1.56, 1.99) for HPV-16 and 1.93 (95% CI, 1.69, 2.21) for HPV-18) and noninferior for girls aged 9-14 years receiving 2 doses compared with women (1.45 (95% CI, 1.25, 1.62) for HPV-16 and 1.17 (95% CI, 1.02, 1.33) for HPV-18). Noninferiority was also demonstrated for neutralizing antibodies. The immunogenicity of the HPV vaccine in girls receiving 3 or 2 doses was noninferior compared with that in young adult women.

RCT Entities:   Population Interventions Outcomes

Supplementary material, approximately 272 KB.

Supplementary Table 1. Noninferiority Analysis of Seroconversion Rate in the ITT cohort

Supplementary Table 2. Noninferiority Analysis of Geometric Mean Concentrations (GMCs) in the PPS cohort

Supplementary Table 3. Noninferiority Analysis of Geometric Mean Concentrations (GMCs) in the ITT cohort

Supplementary Table 4. Noninferiority Analysis of Geometric Mean Concentrations (GMCs) in girls who received 2 doses vs 3 doses

Supplementary Table 5. Adverse Events Reported within 30 days after Each Dose

Supplementary Table 6. Listing of Serious Adverse Events (SAEs) reported during the study (From day 0 to month 7)

Supplementary Table 7. The Study inclusion and exclusion criteria for the study