Head-to-head immunogenicity comparison of one-dose Cecolin and Gardasil in Chinese girls aged 9-14 years: A randomized and open-label clinical trial

Vaccine. 2025 May 10:55:127015. doi: 10.1016/j.vaccine.2025.127015. Epub 2025 Mar 21.

Abstract

Background: The World Health Organization (WHO) urges global administration of at least one dose of the HPV vaccine, particularly for girls aged 9-14, to work towards the elimination of cervical cancer. However, data on the efficacy of a single dose of Cecolin®, a bivalent HPV vaccine, remain quite limited. Therefore, it is crucial to design studies investigating the protective effects of a single dose of Cecolin® in Chinese girls.

Methods: The randomized clinical trial began on February 23, 2023 (NCT06345885). 198 Chinese girls aged 9-14 received a single dose of Cecolin® or Gardasil®. Seroconversion rates and geometric mean titers (GMTs) for HPV16 and HPV18 were assessed at one and two months post-vaccination. Non-inferiority was declared if the lower limit of the 95 % confidence interval (CI) exceeded -5 %. Safety of vaccine was evaluated in all vaccinated participants.

Results: At one month post-vaccination, both the Cecolin® and Gardasil® groups achieved 100 % seroconversion for HPV16 antibodies. The seroconversion rates for HPV18 were 97.9 % (95 % CI: 92.5 %, 99.7 %) in the Cecolin® group and 95.6 % (95 % CI: 89.1 %, 98.8 %) in the Gardasil® group. The GMTs in the Cecolin® group were significantly higher than those in the Gardasil® group for both HPV types, with GMT ratios of 1.5 (1.1, 2.1) for HPV16 and 2.84 (2.0, 4.1) for HPV18. The seroconversion rates and GMT ratios one month after a single dose of Cecolin® were non-inferior to those of Gardasil®, with results remaining consistent at two months. The incidence of adverse events was similar between the two groups throughout the study, with no statistically significant differences.

Conclusion: The immunogenicity and safety of a single dose of Cecolin® in Chinese girls aged 9-14 years were comparable to those of Gardasil. These findings support the use of single-dose Cecolin® to enhance HPV vaccination coverage for cervical cancer prevention.

Keywords: Human papillomavirus vaccine; Immunogenicity; Randomized controlled clinical trial; Safety; Single dose.

Publication types

  • Randomized Controlled Trial
  • Comparative Study

MeSH terms

  • Adolescent
  • Antibodies, Viral / blood
  • Child
  • China
  • East Asian People
  • Female
  • Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18* / administration & dosage
  • Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18* / immunology
  • Human papillomavirus 16 / immunology
  • Human papillomavirus 18 / immunology
  • Humans
  • Immunogenicity, Vaccine*
  • Papillomavirus Infections* / immunology
  • Papillomavirus Infections* / prevention & control
  • Papillomavirus Vaccines* / administration & dosage
  • Papillomavirus Vaccines* / adverse effects
  • Papillomavirus Vaccines* / immunology
  • Seroconversion
  • Uterine Cervical Neoplasms / prevention & control
  • Uterine Cervical Neoplasms / virology
  • Vaccination

Substances

  • Papillomavirus Vaccines
  • Antibodies, Viral
  • Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18

Supplementary concepts

  • Chinese people