Overview of the clinical development and results of a quadrivalent HPV (types 6, 11, 16, 18) vaccine.
BACKGROUND
Human papillomaviruses (HPVs) play an obligatory role in cervical cancer development. Thus, immunization of women using a prophylactic vaccine against the most common high-oncogenic risk types (e.g., HPV 16 and 18) and HPV 6 and 11, which contribute to development of low-grade cervical lesions and cause most anogenital warts, represents a logical primary prevention strategy.


CONCLUSIONS
At the time of licensure, Phase II/Phase III studies showed that administration of a quadrivalent HPV (types 6, 11, 16, 18) vaccine to young women (16 to 26 years) naïve to the vac- cine HPV types resulted in 100% efficacy against HPV 16- and 18-related precancerous cervical lesions, 100% efficacy against HPV 16- and 18-related high-grade vulvar/vaginal neoplasias, 95% efficacy against HPV 6, 11, 16, or 18-related cervical intraepithelial neoplasia/adenocarcinoma in situ, and 99% efficacy against HPV 6, 11, 16, or 18-related genital lesions. The quadrivalent HPV vaccine is highly immunogenic in adolescent males and females, and long-term follow up of young women did not detect evidence of waning immunity through 5 years.


CONCLUSIONS
The quadrivalent vaccine is generally well tolerated. The efficacy and safety of the quadrivalent vaccine is continuing to be investigated in young men and mid-adult women. Nordic cancer registries are providing ongoing long-term pharmacovigilance.
Villa
Luisa Lina
LL
Ludwig Institute for Cancer Research - Hospital Alemão Oswaldo Cruz, São Paulo, SP, Brazil. llvilla@ludwig.org.br
D000293:Adolescent; D000328:Adult; D052685:Alphapapillomavirus / Q000276:immunology*; D017322:Clinical Trials, Phase II as Topic; D017326:Clinical Trials, Phase III as Topic; D005260:Female; D006801:Humans; D008297:Male; D030361:Papillomavirus Infections / Q000276:immunology* / Q000517:prevention & control* / Q000821:virology; D053918:Papillomavirus Vaccines / Q000009:adverse effects / Q000276:immunology* / Q000627:therapeutic use*; D014614:Vaccines, Synthetic / Q000009:adverse effects / Q000276:immunology / Q000627:therapeutic use
D053918:Papillomavirus Vaccines; D014614:Vaccines, Synthetic