Safety, immunogenicity, and efficacy of quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 virus-like-particle vaccine in Latin American women.
The prevalence of HPV infection in Latin America is among the highest in the world. A quadrivalent (types 6/11/16/18) human papillomavirus L1 virus-like-particle vaccine has been shown to be 95-100% effective in preventing HPV 6/11/16/18-related cervical and genital disease in women naive to vaccine HPV types. A total of 6,004 female subjects aged 9-24 were recruited from Brazil, Mexico, Colombia, Costa Rica, Guatemala and Peru. Subjects were randomized to immunization with intramuscular (deltoid) injections of HPV vaccine or placebo at enrollment (day 1), month 2 and month 6. Among vaccinated subjects in the per-protocol population from Latin America, quadrivalent HPV vaccine was 92.8 and 100% effective in preventing cervical intraepithelial neoplasia and external genital lesions related to vaccine HPV types, respectively. These data support vaccination of adolescents and young adults in the region, which is expected to greatly reduce the burden of cervical and genital cancers, precancers and genital warts.
Perez
Gonzalo
G
National Research Center, Group Saludcoop, Bogotá, Colombia. gperez@interred.net.co
Lazcano-Ponce
Eduardo
E
Hernandez-Avila
Mauricio
M
García
Patricia J
PJ
Muñoz
Nubia
N
Villa
Luisa L
LL
Bryan
Janine
J
Taddeo
Frank J
FJ
Lu
Shuang
S
Esser
Mark T
MT
Vuocolo
Scott
S
Sattler
Carlos
C
Barr
Eliav
E
D000293:Adolescent; D000328:Adult; D052685:Alphapapillomavirus / Q000276:immunology; D002648:Child; D005260:Female; D000068857:Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18; D006801:Humans; D007843:Latin America; D053918:Papillomavirus Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology; D010919:Placebos; D013045:Species Specificity; D002583:Uterine Cervical Neoplasms / Q000517:prevention & control
D000068857:Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18; D053918:Papillomavirus Vaccines; D010919:Placebos