Comparison of the immunogenicity and safety of<i>Cervarix</i>™ and<i>Gardasil</i>^®human papillomavirus (HPV) cervical cancer vaccines in healthy women aged 18–45 years

TLDR

This observer‑blind study compared the immunogenicity and safety of Cervarix and Gardasil in healthy women aged 18–45 after completing a three‑dose vaccination schedule. Women (n=1106) were stratified by age and randomized to receive Cervarix (0, 1, 6 months) or Gardasil (0, 2, 6 months). Cervarix induced higher seroconversion and neutralizing antibody titers than Gardasil, with 98 % seroconversion for HPV‑16/18 and GMTs 2.3–4.8‑fold (HPV‑16) and 6.8–9.1‑fold (HPV‑18) higher across all age groups.

Abstract

AbstractThis observer-blind study compared the prophylactic human papillomavirus (HPV) vaccines, Cervarix™ (GlaxoSmithKline) and Gardasil® (Merck), by assessing immunogenicity and safety through one month after completion of the three-dose vaccination course. Women (n=1106) were stratified by age (18–26, 27–35, 36–45 years) and randomized (1:1) to receive Cervarix™ (Months 0, 1, 6) or Gardasil® (Months 0, 2, 6). At Month 7 after first vaccination, all women in the according-to-protocol cohort who were seronegative/DNA negative before vaccination for the HPV type analyzed had seroconverted for HPV-16 and HPV-18 serum neutralizing antibodies, as measured by pseudovirion-based neutralization assay (PBNA), except for two women aged 27–35 years in the Gardasil® group who did not seroconvert for HPV-18 (98%). Geometric mean titers of serum neutralizing antibodies ranged from 2.3–4.8-fold higher for HPV-16 and 6.8–9.1-fold higher for HPV-18 after vaccination with Cervarix™ compared with Gardasil®, across all age strata. In the total vaccinated cohort (all women who received at least one vaccine dose, regardless of their serological and DNA status prior to vaccination), Cervarix™ induced significantly higher serum neutralizing antibody titers in all age strata (p