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Safety and immunogenicity of a vaccine targeting human papillomavirus types 6, 11, 16 and 18: a randomized, placebo-controlled trial in 176 Korean subjects
  1. S. Kang*,
  2. K. H. Kim,
  3. Y. T. Kim,
  4. Y. T. Kim§,
  5. J. H. Kim,
  6. Y. S. Song,
  7. S. H. Shin#,
  8. H. S. Ryu**,
  9. J. W. Han,,
  10. J. H. Kang, and
  11. S. Y. Park*
  1. * Branch of Uterine Cancer Research, National Cancer Center, Goyang, Korea;
  2. Division of Pediatrics, Ewha Womans University Dongdaemun Hospital, Seoul, Korea;
  3. Division of Obstetrics and Gynecology, Asan Medical Center, Seoul, Korea;
  4. § Division of Obstetrics and Gynecology, Yonsei University Severance Hospital, Seoul, Korea;
  5. Division of Pediatrics, St. Vincent's Hospital, Seoul, Korea;
  6. Division of Obstetrics and Gynecology, Seoul National University Hospital, Seoul, Korea;
  7. # Division of Pediatrics, Kangnam Sacred Heart Hospital, Seoul, Korea;
  8. ** Division of Obstetrics and Gynecology, Ajou University Hospital, Seoul, Korea;
  9. †† Division of Pediatrics, Kangnam St. Mary's Hospital, Seoul, Korea;
  10. ‡‡ Division of Pediatrics, Our Lady of Mercy Hospital, Seoul, Korea
  1. Address correspondence and reprint requests to: Address correspondence and reprint requests to: Jin Han Kang, MD, PhD, Department of Pediatrics, Division of Infectious Disease, Our Lady of Mercy Hospital, Seoul, Korea. Email: kjhan{at}olmh.cuk.ac.kr; and Sang Yoon Park, Branch of Uterine Cancer Research, National Cancer Center, Goyang, Korea. Email: parksang{at}ncc.re.kr

Abstract

Human papillomavirus (HPV) is a major causative agent of anogenital warts and a necessary cause of cervical cancer. This report will serve to assess the safety and immunogenicity of quadrivalent (types 6, 11, 16, and 18) HPV L1 virus-like particle (VLP) vaccine in the Korean population. We performed a randomized, double-blind, placebo-controlled study in 176 volunteers aged 9–23 years. Using a 2:1 ratio for randomization, 117 women were assigned to quadrivalent HPV (20 μg type 6, 40 μg type 11, 40 μg type 16, and 20 μg type 18) vaccine and 59 women to placebo. Individuals received vaccine at day 1, month 2, and month 6 and provided blood samples for analysis at enrollment at month 7. Analyses were done as specified in the study protocol. Quadrivalent HPV vaccine was generally well tolerated, with no vaccine-related serious adverse experiences. Quadrivalent HPV vaccine induced seroconversion for each vaccine-related HPV type. At month 7, vaccine-induced type-specific antibody titer was high. In conclusion, administration of quadrivalent HPV VLP vaccine to Korean women aged 9–23 years was generally well tolerated and highly immunogenic

  • cervical cancer
  • human papillomavirus
  • prevention
  • randomized trial
  • vaccine

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