TY - JOUR
T1 - Randomized trial of HPV4 vaccine assessing the response to HPV4 vaccine in two schedules among Peruvian female sex workers
AU - Brown, Brandon
AU - Blas, Magaly
AU - Cabral, Alejandra
AU - Carcamo, Cesar
AU - Gravitt, Patti
AU - Halsey, Neal
N1 - Funding Information:
Contributors: BB created the study materials, carried out the data cleaning and data analysis, supervised all study activities, and wrote the first draft of the text. NH is the Principal Investigator of the study, provided guidance in all aspects of the study, and helped to obtain funding; CC is the local Principal Investigator of the study and provided guidance during the study; MB is the local Co-Investigator, collaborated in the elaboration of study materials, training of health personnel, and helped complete the IRB processes in Peru. AC is the local study coordinator, trained the team in sample collection, helped translate all materials, and processed the samples. PG is the Co-Investigator and conducted the reported HPV DNA testing; all authors contributed to the final manuscript. Competing interests: Neal Halsey received financial compensation for serving on Safety Monitoring Boards for the post-licensure safety assessment evaluation of Gardasil and other vaccines within the past two years. He received no financial support for participation in this study. Other authors: None declared. Funding: Supported in part by a research grant from the Merck Investigator-Initiated Studies Program of Merck & Co., Inc. The opinions expressed in this paper are those of the authors and do not necessarily represent those of Merck & Co., Inc. This research was funded, in part, by the Department of International Health Global Disease Epidemiology Program , Delta Omega Scholarship , Dan David Prize Scholarship , Carol Eliasberg Martin Scholarship in Cancer Prevention , NIH Postdoctoral training grant # T32 MH080634 , NIH Predoctoral National Research Service Award F31AI080187 , Fogarty International Clinical (FIC) Research Fellows Program , and FIC/NIH grant 1R01TW008398 .
PY - 2012/3/16
Y1 - 2012/3/16
N2 - Two hundred female sex workers (FSWs) in Lima, Peru were randomized to receive HPV4 vaccine in the standard (0, 2, 6 months) or a modified schedule (0, 3, 6 months). One hundred and eighty four (92%) participants completed 3 doses of vaccine. Baseline seropositive rates were 58% for HPV6, 22.5% for HPV11, 41.5% for HPV16, and 13% for HPV18. The final geometric mean antibody titer (GMT) following vaccination was significantly greater for women who were seropositive at baseline compared to seronegative women: HPV6 (GMT ratio = 2.3, p< 0.01), HPV11 (GMT ratio = 2.7, p< 0.01), HPV16 (GMT ratio = 1.3, p= 0.04), and HPV18 (GMT ratio = 2.4, p< 0.01). Antibody titers in the modified schedule were not inferior to those in the standard schedule, suggesting the modified schedule may be paired with required STD visits. Although all women benefit from vaccination, administration at a younger age and before sexual debut is needed to achieve maximum protection from vaccine.
AB - Two hundred female sex workers (FSWs) in Lima, Peru were randomized to receive HPV4 vaccine in the standard (0, 2, 6 months) or a modified schedule (0, 3, 6 months). One hundred and eighty four (92%) participants completed 3 doses of vaccine. Baseline seropositive rates were 58% for HPV6, 22.5% for HPV11, 41.5% for HPV16, and 13% for HPV18. The final geometric mean antibody titer (GMT) following vaccination was significantly greater for women who were seropositive at baseline compared to seronegative women: HPV6 (GMT ratio = 2.3, p< 0.01), HPV11 (GMT ratio = 2.7, p< 0.01), HPV16 (GMT ratio = 1.3, p= 0.04), and HPV18 (GMT ratio = 2.4, p< 0.01). Antibody titers in the modified schedule were not inferior to those in the standard schedule, suggesting the modified schedule may be paired with required STD visits. Although all women benefit from vaccination, administration at a younger age and before sexual debut is needed to achieve maximum protection from vaccine.
KW - Adherence
KW - Female sex workers
KW - HPV vaccine
KW - Human papillomavirus
KW - Immune response
KW - Peru
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U2 - 10.1016/j.vaccine.2012.01.058
DO - 10.1016/j.vaccine.2012.01.058
M3 - Article
C2 - 22306855
AN - SCOPUS:84857785393
SN - 0264-410X
VL - 30
SP - 2309
EP - 2314
JO - Vaccine
JF - Vaccine
IS - 13
ER -