Investigational HPV Vaccine Efficacious in Gynecological Pre-Cancers

Merck announced that in a pivotal Phase 3 efficacy study, its investigational 9-valent HPV vaccine (V503) prevented about 97% of cervical, vaginal, and vulvar pre-cancers caused by HPV types 31, 33, 45, 52, and 58. V503 also generated immune responses to HPV types 6, 11, 16, and 18 that were non-inferior to those generated by Gardasil [human papillomavirus quadrivalent (Types 6, 11, 16, and 18) vaccine, recombinant].

RELATED: Immunization Resource Center

V503 includes five more HPV types (31, 33, 45, 52, 58) in addition to the four original HPV types (6, 11, 16, 18) in Gardasil.

The Phase 3 study (Protocol 001) evaluated the efficacy, safety and immunogenicity of V503 (n=7099) compared to Gardasil (n=7,105) in 16–26 year old females. The primary efficacy analysis was conducted in those who received all three doses of vaccine within one year, who were not infected with the relevant HPV types at enrollment, and who remained free of infection with the relevant HPV types through Month 7 (per-protocol population).

The results were as follows:

  • 96.7% reduction (95% CI; 80.9, 99.8) in the combined incidence of high-grade cervical/vulvar/vaginal disease [CIN (cervical intraepithelial neoplasia) 2/3+, VIN (vulvar intraepithelial neoplasia) 2/3+, and VaIN (vaginal intraepithelial neoplasia) 2/3+] caused by HPV types 31, 33, 45, 52, 58 (1 case in the V503 group vs. 30 cases in the Gardasil group).
  • 97.1% reduction (95% CI; 91.8, 99.2) in the combined incidence of cervical/vulvar/vaginal disease of any grade (all CIN, VIN, VaIN) caused by HPV types 31, 33, 45, 52, 58 (3 cases in the V503 group vs. 103 cases in the Gardasil group).
  • 96% efficacy (95% CI; 94.4, 97.2) against six-month persistent HPV infection with HPV types 31, 33, 45, 52, 58 (35 cases in the V503 group vs. 810 cases in the Gardasil group).
For more information call (800) 672-6372 or visit Merck.com.
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