Cervical cancer is the second most common cancer affecting women worldwide. Cervical

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1 Continuing Education Column Human Papillomavirus Vaccine Mi-Kyung Kim, MD Jae Hong No, MD Yong -Sang Song, MD Department of Obstetrics and Gynecology, Seoul National University College of Medicine E - mail : yssong@snu.ac.kr J Korean Med Assoc 2009; 52(12): 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. Keywords: Cervical cancer; Human papillomavirus; Vaccination; Prevention 1180

2 Human Papillomavirus Vaccine Figure 1. HPV prevalence in HPV-associated cancers. Adapted from (6). 1181

3 Kim MK No JH Song YS 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 Females and males, 9~15 years Females 10~14 years; males 10~18 years immunogenicity bridging trials Other trials in progress or Efficacy study in males Efficacy, immunogenicity, bridging and due to start Efficacy study in women > 26 years safety studies in women > 26 years Studies of administration at the same Studies of administration at the same time as other vaccines time as other vaccines Safety and immunogenicity in HIV-infected Safety and immunogenicity in African and other immunocompromised groups populations, including HIV-infected women 1182

4 Human Papillomavirus Vaccine 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 No. of No. of No. of women cases women cases HPV 16/18 -related CIN 2/3 or AIS 8, , % (93~100) HPV 16/18-related VIN 2/3 7, , % (42~100) HPV 16/18-related VaIN 2/3 7, , % (31~100) HPV 6/11/16/18- related 7, , % (93.7~100) genital warts (condyloma) 1183

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