Extended follow-up of the participants of the HPV vaccine trial to evaluate the effectiveness of one, two, and three doses of quadrivalent HPV vaccine in preventing cervical neoplasia

Study sites:	India: Ahmedabad, Aizawl, Ambilikkai, Barshi, Hyderabad, Kolkata, Mumbai, New Delhi, Pune, Sikkim, Thiruvananthapuram
Principal investigator (PI) from IARC:	P. Basu
PIs from collaborating institutions:	Geeta Joshi, Gujarat Cancer & Research Institute (GCRI), Ahmedabad Eric Zomawia, Civil Hospital, Aizawl, Mizoram Pulikattil Okkaru Esmy, Christian Fellowship Community Health Centre (CFCHC), Ambilikkai S. Malvi, Nargis Dutt Memorial Cancer Hospital (NDMCH), Barshi P. Usha Rani Reddy Poli, Mehdi Nawaj Jung Cancer Institute (MNJCI), Hyderabad Maqsood Siddiqi, Cancer Foundation of India (CFI), Kolkata Sharmila Pimple, Tata Memorial Centre (TMC), Mumbai Neerja Bhatla, All India Institute of Medical Science (AIIMS), New Delhi Smita Joshi, Jehangir Clinical Development Centre (JCDC), Pune Yogesh Verma, Sir Thodup Namgyal Memorial Hospital (STNM), Gangtok, Sikkim M. Radhakrishna Pillai, Rajiv Gandhi Centre for Biotechnology (RGCB), Thiruvananthapuram
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Start date:	2016
Closure date:	Ongoing
Objectives:	To conduct long-term follow-up of the vaccinated cohorts to document medically significant events occurring 5–10 years after HPV vaccination To carry out annual HPV detection and genotyping in the vaccinated and unvaccinated cohorts to assess the protection offered by the vaccine against incident and persistent infections To evaluate the protection provided by the vaccine against the development of high-grade cervical premalignant lesions To evaluate memory B-cell and adaptive T-cell response against target HPV types in the vaccinated cohorts To study the immune correlate of protection for the HPV vaccine
Publications:	Ringborg U., Berns A., Celis J.E., Heitor M., Tabernero J., Schüz J., Baumann M., Henrique R., Aapro M., Basu P., Beets-Tan R., Besse B., Cardoso F., Carneiro F., van den Eede G., Eggermont A., Fröhling S., Galbraith S., Garralda E., Hanahan D., Hofmarcher T., Jönsson B., Kallioniemi O., Kásler M., Kondorosi E., Korbel J., Lacombe D., Carlos Machado J., Martin-Moreno J.M., Meunier F., Nagy P., Nuciforo P., Oberst S., Oliveiera J., Papatriantafyllou M., Ricciardi W., Roediger A., Ryll B., Schilsky R., Scocca G., Seruca R., Soares M., Steindorf K., Valentini V., Voest E., Weiderpass E., Wilking N., Wren A., Zitvogel L. The Porto European Cancer Research Summit 2021. Mol Oncol. 2021 Sep 13. doi: 10.1002/1878-0261.13078. PMID: 34515408 Bhatla N., Nene B.M., Joshi S., Esmy P.O., Poli U.R.R., Joshi G., Verma Y., Zomawia E., Pimple S., Prabhu P.R., Basu P., Muwonge R., Hingmire S., Sauvaget C., Lucas E., Pawlita M., Gheit T., Jayant K., Malvi S.G., Siddiqi M., Michel A., Butt J., Sankaran S., Kannan T.P.R.A., Varghese R., Divate U., Willhauck-Fleckenstein M., Waterboer T., Müller M., Sehr P., Kriplani A., Mishra G., Jadhav R., Thorat R., Tommasino M., Pillai M.R., Sankaranarayanan R.; Indian HPV vaccine study group. Are two doses of human papillomavirus vaccine sufficient for girls aged 15-18 years? Results from a cohort study in India. Papillomavirus Res. 2018 Jun;5:163-171. PMID: 29578097 Sankaranarayanan R., Joshi S., Muwonge R., Esmy P.O., Basu P., Prabhu P., Bhatla N., Nene B.M., Shaw J., Poli U.R.R., Verma Y., Zomawia E., Pimple S., Tommasino M., Pawlita M., Gheit T., Waterboer T., Sehr P., Pillai M.R.; Indian HPV vaccine study group. Can a single dose of human papillomavirus (HPV) vaccine prevent cervical cancer? Early findings from an Indian study. Vaccine. 2018 Aug 6;36(32 Pt A):4783-4791. PMID: 29551226 Two-dose recommendation for Human Papillomavirus vaccine can be extended up to 18 years - updated evidence from Indian follow up cohort study. Basu P., Muwonge R., Bhatla N., Nene B.M., Joshi S., Esmy P.O., Poli U.R.R., Joshi G., Verma Y., Zomawia E., Shastri S.S., Pimple S., Anantharaman D., Prabhu P.R., Hingmire S., Sauvaget C., Lucas E., Pawlita M., Gheit T., Jayant K., Malvi S.G., Siddiqi M., Michel A., Butt J., Sankaran S., Rameshwari Ammal Kannan T.P., Varghese R., Divate U., Willhauck-Fleckenstein M., Waterboer T., Müller M., Sehr P., Vashist S., Mishra G., Jadhav R., Thorat R., Tommasino M., Pillai M.R., Sankaranarayanan R.; Indian HPV vaccine study group. Papillomavirus Res. 2019 Jan 31. pii: S2405-8521(18)30133-2. PMID: 30711698
Funding:	Bill & Melinda Gates Foundation