title: Safety and immunogenicity of a vaccine targeting human papillomavirus types 6, 11, 16 and 18: a randomized, double-blind, placebo-controlled trial in Chinese males and females.
abstract: In this randomized, double-blind, placebo-controlled trial, 9-15 year old Chinese males (n=100) and 9-45 year old Chinese females (n=500) from Wuzhou, Guangxi, China were randomized (1:1) to receive either quadrivalent HPV vaccine or adjuvant-containing placebo. Blood samples were obtained at day 1 and one month post-dose 3 to determine the level of vaccine-induced antibodies. Among vaccine recipients, high antibody levels were observed for each of the four HPV types and seroconversion was >96%. The vaccine was generally well tolerated, with no vaccine-related serious adverse events. This study demonstrated that the quadrivalent HPV vaccine is highly immunogenic and generally well tolerated among Chinese males and females.
authors.affiliation: Guangxi Center for Disease Prevention and Control, #18 Jin Zhou Road, Nanning 530028, Guangxi, PR China. lrch2001@163.com
authors.forename: Rongcheng
authors.initials: R
authors.lastname: Li
authors.forename: Yanping
authors.initials: Y
authors.lastname: Li
authors.forename: David
authors.initials: D
authors.lastname: Radley
authors.forename: Youping
authors.initials: Y
authors.lastname: Liu
authors.forename: Teng
authors.initials: T
authors.lastname: Huang
authors.forename: Heather L
authors.initials: HL
authors.lastname: Sings
authors.forename: Lingling
authors.initials: L
authors.lastname: Zhang
authors.forename: Wei
authors.initials: W
authors.lastname: Wang
authors.forename: Xiang
authors.initials: X
authors.lastname: Zhong
authors.forename: Alfred J
authors.initials: AJ
authors.lastname: Saah
mesh_terms: D000293:Adolescent; D000328:Adult; D000914:Antibodies, Viral / Q000097:blood; D002648:Child; D002681:China; D004311:Double-Blind Method; D005260:Female; D000068857:Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18; D006801:Humans; D008297:Male; D008875:Middle Aged; D027383:Papillomaviridae / Q000276:immunology*; D030361:Papillomavirus Infections / Q000517:prevention & control* / Q000821:virology*; D053918:Papillomavirus Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D010919:Placebos / Q000008:administration & dosage; D055815:Young Adult
chemical_list: D000914:Antibodies, Viral; D000068857:Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18; D053918:Papillomavirus Vaccines; D010919:Placebos