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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

Title
Safety and immunogenicity of a vaccine targeting human papillomavirus types 6, 11, 16 and 18: A randomized, placebo-controlled trial in 176 Korean subjects
Authors
Kang S.Kim K.H.Kim Y.T.Kim J.H.Song Y.S.Shin S.H.Ryu H.S.Han J.W.Kang J.H.Park S.Y.
Ewha Authors
김경효
SCOPUS Author ID
김경효scopus
Issue Date
2008
Journal Title
International Journal of Gynecological Cancer
ISSN
1048-891XJCR Link
Citation
vol. 18, no. 5, pp. 1013 - 1019
Indexed
SCI; SCIE; SCOPUS WOS scopus
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. © 2007, Copyright the Authors.
DOI
10.1111/j.1525-1438.2007.01123.x
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의학전문대학원 > 의학과 > Journal papers
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