TY - JOUR
T1 - Two-dose recommendation for Human Papillomavirus vaccine can be extended up to 18 years – updated evidence from Indian follow-up cohort study
AU - for the Indian HPV vaccine study group
AU - Basu, Partha
AU - Muwonge, Richard
AU - Bhatla, Neerja
AU - Nene, Bhagwan M.
AU - Joshi, Smita
AU - Esmy, Pulikottil O.
AU - Poli, Usha Rani Reddy
AU - Joshi, Geeta
AU - Verma, Yogesh
AU - Zomawia, Eric
AU - Shastri, Surendra S.
AU - Pimple, Sharmila
AU - Anantharaman, Devasena
AU - Prabhu, Priya R.
AU - Hingmire, Sanjay
AU - Sauvaget, Catherine
AU - Lucas, Eric
AU - Pawlita, Michael
AU - Gheit, Tarik
AU - Jayant, Kasturi
AU - Malvi, Sylla G.
AU - Siddiqi, Maqsood
AU - Michel, Angelika
AU - Butt, Julia
AU - Sankaran, Subha
AU - Rameshwari Ammal Kannan, Thiraviam Pillai
AU - Varghese, Rintu
AU - Divate, Uma
AU - Willhauck-Fleckenstein, Martina
AU - Waterboer, Tim
AU - Müller, Martin
AU - Sehr, Peter
AU - Vashist, Shachi
AU - Mishra, Gauravi
AU - Jadhav, Radhika
AU - Thorat, Ranjit
AU - Tommasino, Massimo
AU - Pillai, M. Radhakrishna
AU - Sankaranarayanan, Rengaswamy
N1 - Funding Information:
Neerja Bhatla has received research funding through her institute from GlaxoSmithKline and Merck. Smita Joshi has received funds from GlaxoSmithKline through the Jehangir Clinical Development Center to do an HPV vaccine study. Partha Basu received research funding from GlaxoSmithKline through Chittaranjan National Cancer Institute, India during his previous position at the institute. The other authors declare no competing interests. Michael Pawlita is an inventor on a patent application by DKFZ on the high-throughput pseudovirion-based neutralisation assay. Peter Sehr is co-inventor on a patent application by DKFZ on the high-throughput pseudovirion-based neutralisation assay.
Funding Information:
We are very grateful to the Bill & Melinda Gates Foundation for their generous financial support and to Merck Sharp Dohme for the donation of the quadrivalent vaccine; European Commission Seventh Framework Programme grant HPV-AHEAD ( FP7-HEALTH-2011–282562 ) for partial support for the establishment of the Luminex-based assays at the RGCB; Peter Dull (Integrated Clinical Vaccine Development, Bill & Melinda Gates Foundation) for his valuable support, encouragement, and advice; current and past members of the data safety monitoring board: Lynette Denny, Lutz Gissmann, Peter Sasieni, Thangarajan Rajkumar, Doreen Ramogola-Masire, Raul Murillo, the late Arun P Kurkure, and Rolando Herrero for their valuable advice and monitoring of the study safety and outcomes; Jan Agosti (formerly at Bill & Melinda Gates Foundation and now at the University of Seattle) for her valuable support, encouragement, and advice; Union for International Cancer Control for the award of International Cancer Technology Transfer fellowships that helped technology transfer and quality assurance for immunogenicity and HPV genotyping studies at the RGCB; the district administrative, civic, education, and health authorities, and medical practitioners in the districts of India where the studies are located for their cooperation, facilitation, and assistance in implementing the study; the study participants, their parents, families, and legal guardians for their understanding, cooperation, excellent and continuing participation in the study, and follow-up procedures despite the challenges and misinformation after suspension of HPV vaccination; Mrs Krittika Guinot, Screening Group, IARC, for help in the preparation of the manuscript; Dr Christopher P. Wild, former Director, IARC, Lyon, France, for his valuable support and advice. The vaccines used in the study were provided by Merck through a memorandum of understanding (MoU) signed with the World Health Organization (WHO). IARC is the autonomous cancer research agency of the WHO. Merck did not have any other role in the study and thus the study is independent of the pharmaceutical industry.
Publisher Copyright:
© 2019
PY - 2019/6
Y1 - 2019/6
N2 - Earlier publication from the ongoing multi-centric study of the International Agency for Research on Cancer to evaluate less than three doses of the quadrivalent Human Papillomavirus (HPV) vaccine in India amongst unmarried girls demonstrated non-inferior total antibody titres, neutralizing antibody titres and antibody avidity in 2-dose recipients compared to 3-dose recipients at 15–18 years of age (Bhatla et al., 2018) [7]. The number of participants recruited at 15–18 years of age was 1515 and 1795 in the 3-dose and the 2-dose groups respectively. At a median follow-up of 7 years, incident HPV 16/18 infections were detected in 1.6% women receiving two doses and 0.8% women receiving three doses at 15–18 years. Frequency of incident infection was 7.0% in the age- and site-matched unvaccinated women (N = 1484). No persistent infection from HPV 16 was observed in the 2- or 3-dose recipients and one (0.2%) persistent HPV 18 infection was documented, each in the 3-dose and 2-dose cohorts. Among the unvaccinated women, the frequency of HPV 16/18 persistent infection was 1.7%. The protection offered by two doses of quadrivalent HPV vaccine against incident and persistent infections in recipients at 15–18 years is comparable to that seen in 3-dose recipients at 15–18 years.
AB - Earlier publication from the ongoing multi-centric study of the International Agency for Research on Cancer to evaluate less than three doses of the quadrivalent Human Papillomavirus (HPV) vaccine in India amongst unmarried girls demonstrated non-inferior total antibody titres, neutralizing antibody titres and antibody avidity in 2-dose recipients compared to 3-dose recipients at 15–18 years of age (Bhatla et al., 2018) [7]. The number of participants recruited at 15–18 years of age was 1515 and 1795 in the 3-dose and the 2-dose groups respectively. At a median follow-up of 7 years, incident HPV 16/18 infections were detected in 1.6% women receiving two doses and 0.8% women receiving three doses at 15–18 years. Frequency of incident infection was 7.0% in the age- and site-matched unvaccinated women (N = 1484). No persistent infection from HPV 16 was observed in the 2- or 3-dose recipients and one (0.2%) persistent HPV 18 infection was documented, each in the 3-dose and 2-dose cohorts. Among the unvaccinated women, the frequency of HPV 16/18 persistent infection was 1.7%. The protection offered by two doses of quadrivalent HPV vaccine against incident and persistent infections in recipients at 15–18 years is comparable to that seen in 3-dose recipients at 15–18 years.
KW - Age 15–18 years
KW - Human papillomavirus
KW - Immunogenicity
KW - Incident infections
KW - Persistent infections
KW - Quadrivalent vaccine
KW - Two doses
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U2 - 10.1016/j.pvr.2019.01.004
DO - 10.1016/j.pvr.2019.01.004
M3 - Article
C2 - 30711698
AN - SCOPUS:85061570913
SN - 2405-8521
VL - 7
SP - 75
EP - 81
JO - Papillomavirus Research
JF - Papillomavirus Research
ER -