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J Korean Med Assoc > Volume 52(12); 2009 > Article
Kim, No, and Song: Human Papillomavirus Vaccine

Abstract

Cervical cancer is the second most common cancer affecting women worldwide. Cervical cancer is caused by persistent infection with high-risk types of human papillomavirus (HPV). The most common oncogenic HPV genotypes are 16 and 18, causing approximately 70% of all cervical cancers. Recently, two HPV vaccines, quadrivalent (HPV 6, 11, 16, 18) and bivalent (HPV 16, 18) vaccines, have been licensed and are now marketed in Korea. HPV vaccines are prepared from virus-like particles (VLPs) produced by recombinant technology. Clinical trials have confirmed that both vaccines have high efficiency against persistent infection of HPV 16 or 18 and moderate to severe precancerous lesions. In women who have no evidence of past or current infection with the HPV genotypes in the vaccine, both vaccines show > 90% protection against persistent HPV infection for up to 5 years after vaccination. In addition, vaccine efficacy against precancerous lesions associated with HPV 16/18 was reported to be 100%. Although most clinical trials to date have investigated the effectiveness of HPV vaccines in young females, elderly females and males may also be candidates for HPV vaccines. Since HPV vaccines are prophylactic, the largest impact of vaccination is expected to result from high coverage of young adolescents before exposure to HPV. Cervical cancer screening will still be required, even after HPV vaccines are introduced, although the screening program may need to be adapted to achieve cost-effective reductions in the burden of cervical cancer prevention strategies.

Figure 1.
HPV prevalence in HPV-associated cancers. Adapted from (6).
jkma-52-1180f1-l.jpg
Table 1.
Characteristics of the two HPV vaccines
  Quadrivalent vaccine Bivalent vaccine
Manufacturer and trade name Merck; Gardasil Glaxo Smith Kline; Cervarix
VLPs of genotypes 6, 11, 16, 18 16, 18
Substrate Yeast Baculovirus expression system
Adjuvant Aluminum ASO4
Schedule 0, 2, 6 month 0, 1, 6 month
Adolescent safety and immunogenicity bridging trials Females and males, 9∼15 years Females 10∼14 years; males 10∼18 years
Other trials in progress or due to start Efficacy study in males
Efficacy study in women > 26 years
Studies of administration at the same time as other vaccines
Safety and immunogenicity in HIV-infected and other immunocompromised groups
Efficacy, immunogenicity, bridging and safety studies in women > 26 years
Studies of administration at the same time as other vaccines
Safety and immunogenicity in African populations, including HIV-infected women
Table 2.
Efficacy of the quadrivalent HPV vaccine among women who received three doses of vaccine according to protocol and had no evidence of past or current infection with the vaccine-related HPV genotypes.
Clinical endpoint Vaccine Placebo Vaccine efficacy
No. of women No. of cases No. of women No. of cases
HPV 16/18-related CIN 2/3 or AIS 8,579 1 8,550 85 99% (93∼100)
HPV 16/18-related VIN 2/3 7,811 0 7,785 8 100% (42∼100)
HPV 16/18-related VaIN 2/3 7,811 0 7,785 7 100% (31∼100)
HPV 6/11/16/18-related genital warts (condyloma) 7,897 1 7,899 91 98.9% (93.7∼100)

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