Clinical trial experience with prophylactic HPV 6/11/16/18 VLP vaccine in young women from the Asia-Pacific region

Int J Gynaecol Obstet. 2008 Sep;102(3):275-83. doi: 10.1016/j.ijgo.2008.03.021. Epub 2008 Jun 16.


Objective: To evaluate results of three phase 3 clinical trials of quadrivalent HPV 6/11/16/18 vaccination of young Asia-Pacific women.

Methods: A total of 814 women from the Asia-Pacific region (aged 16 to 26 years) received vaccine or placebo in 1 of 3 protocols. Descriptive analyses focused on the efficacy, safety, and immunogenicity of the vaccine and the natural history of HPV disease.

Results: Vaccine efficacy against disease caused by HPV types 6, 11, 16, or 18 was 100% for cervical intraepithelial neoplasia (0 vs 12 cases; 95% confidence interval [CI], 63.1%-100%) and 100% for vulvar and vaginal intraepithelial neoplasia or condylomata accuminata (0 vs 5 cases; 95% CI, -11.8% to 100%). The vaccination was highly immunogenic. Vaccine recipients experienced a significantly higher injection site adverse event rate (P=0.002). Compared with other world regions, lower rates of smoking and baseline positivity to 14 HPV types (including the vaccine types) were observed among Asia-Pacific participants.

Conclusion: Prophylactic quadrivalent HPV 6/11/16/18 vaccination of young Asia-Pacific women demonstrated high efficacy, safety, and tolerability. Together with an observed low baseline HPV positivity rate, the Asia-pacific population is potentially an important cohort to benefit from vaccination.

Publication types

  • Clinical Trial, Phase III
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Adolescent
  • Adult
  • Alphapapillomavirus / immunology*
  • Asian People
  • Condylomata Acuminata / prevention & control*
  • Double-Blind Method
  • Female
  • Humans
  • Papillomavirus Vaccines / adverse effects
  • Papillomavirus Vaccines / immunology
  • Papillomavirus Vaccines / therapeutic use*
  • Uterine Cervical Dysplasia / prevention & control*
  • Uterine Cervical Neoplasms / prevention & control*
  • White People


  • Papillomavirus Vaccines