Immunologic responses following administration of a vaccine targeting human papillomavirus Types 6, 11, 16, and 18.
Human papillomavirus (HPV) infection causes cervical cancer and genital warts. Young women (1106) were randomized to receive one of three formulations of a quadrivalent HPV (Types 6/11/16/18) L1 virus-like particle (VLP) vaccine or one of two placebo formulations. The goal was to assess vaccine safety and immunogenicity in baseline HPV 6/11/16 or 18-naïve and previously infected subjects. All three formulations were highly immunogenic. At Month 2 (postdose 1), among women with vaccine-type antibodies at baseline, vaccine-induced anti-HPV responses were approximately 12- to 26-fold higher than those observed in baseline-naïve women, suggesting an anamnestic response. Following an initial, similar sized decline, anti-HPV responses plateaued and remained stable through end-of-study (3.0 years). No vaccine-related serious adverse experiences were reported.
Villa
Luisa L
LL
Department of Virology, Ludwig Institute for Cancer Research, R. Prof. Antonio Prudente 109, 4th floor, 01509-010 Sao Paulo, SP, Brazil. llvilla@ludwig.org.br
Ault
Kevin A
KA
Giuliano
Anna R
AR
Costa
Ronaldo L R
RL
Petta
Carlos A
CA
Andrade
Rosires P
RP
Brown
Darron R
DR
Ferenczy
Alex
A
Harper
Diane M
DM
Koutsky
Laura A
LA
Kurman
Robert J
RJ
Lehtinen
Matti
M
Malm
Christian
C
Olsson
Sven-Eric
SE
Ronnett
Brigitte M
BM
Skjeldestad
Finn Egil
FE
Steinwall
Margareta
M
Stoler
Mark H
MH
Wheeler
Cosette M
CM
Taddeo
Frank J
FJ
Yu
Jimmy
J
Lupinacci
Lisa
L
Railkar
Radha
R
Marchese
Rocio
R
Esser
Mark T
MT
Bryan
Janine
J
Jansen
Kathrin U
KU
Sings
Heather L
HL
Tamms
Gretchen M
GM
Saah
Alfred J
AJ
Barr
Eliav
E
D000293:Adolescent; D000328:Adult; D000914:Antibodies, Viral / Q000096:biosynthesis / Q000276:immunology; D004311:Double-Blind Method; D005260:Female; D052140:Human papillomavirus 11 / Q000276:immunology; D052162:Human papillomavirus 16 / Q000276:immunology; D052161:Human papillomavirus 18 / Q000276:immunology; D052163:Human papillomavirus 6 / Q000276:immunology; D006801:Humans; D027383:Papillomaviridae / Q000145:classification / Q000276:immunology*; D030361:Papillomavirus Infections / Q000276:immunology / Q000821:virology; D053918:Papillomavirus Vaccines; D014765:Viral Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology*
D000914:Antibodies, Viral; D053918:Papillomavirus Vaccines; D014765:Viral Vaccines