Durability of single-dose HPV vaccination in young Kenyan women: randomized controlled trial 3-year results
Ruanne V. Barnabas, Elizabeth R. Brown, Maricianah Onono, Elizabeth A. Bukusi, Betty Njoroge, Rachel L. Winer, Denise A. Galloway, Leeya F. Pinder, Deborah Donnell, Imelda Wakhungu, Charlene Biwott, Syovata Kimanthi, Kate B. Heller, Diane G. Kanjilal, Daniel Pacella, Susan Morrison, Elena A. Rechkina, Stephen Cherne, Torin Schaafsma, R. Scott McClelland, Connie Celum, Jared M. Baeten, Nelly Mugo, the KEN SHE Study Team, Peter Dull, Reena Gulati, Sara Vernam, Abdul Rawuf Yousufzay, Krissa Gunderson, Amra Hercinovic, Lisa Ondrejcek, G.W. Robertson, Angela Williams, Elizabeth R. Brown, Jody Carter, Denise A. Galloway, Leeya F. Pinder, Priya R. Prabhu, Robin A.J. Smith, M. Wright, Stephen O. Abiero, Maqline A. Achola, Meldah O. Adipo, Katherine L. Amukonyi, Cynthia Akinyi, Teresia O. Akinyi, Penina N. Amboka, Karl D. Arum, Veronica O. Atogo, Pius O. Atonga, A.J. ten Cate, Daisy Chepkoros, Oyamo O. Christopher, Imelda N. Imali, Mildred Imbayi, Lizzie N. Kabete, Enericah K. Kanampiu, Geoffrey Kebaso, Dennis Kegode, Timothy Kwena, Reina Lenturkana, Celestine Lihavi, David N. Marwa, Patricia Matti, P. Mboya, Elijah Mbuya, L. Memo, Robai M. Mituyi, Benard M. Muga, David E. Muhoma, Elizabeth L. Musi, Gilbert C. Mutai, Simon M. Muthusi, Ivy M. Mutuiri, Catherine W. Mwakio, Bill Nyongesa, Maureen A. Ochieng, Vincent R. Ochuka, Belder A. Odedo, Esther A. Odeny, Vincent O. Odera, Debora A. Odhiambo, Perez O. Odhiambo, Janet A. Okeyo, Linet A. Okode, Nollyne A. Okuku, Irene Okumu, L A Okumu, Christine A. Olweny, Hellen A. Olweyo, G. Omondi, Donnavane A. Ondego, Florence A. Ondiek, Joan A. Ongere, Maricianah Onono, Kevin Onyango, Annette A. Opondo, Millicent A. Oronje, Beryl A. Osoga, Rebecca A. Otieno
Abstract
Cervical cancer burden is high where prophylactic vaccination and screening coverage are low. We demonstrated in a multicenter randomized, double-blind, controlled trial that single-dose human papillomavirus (HPV) vaccination had high vaccine efficacy (VE) against persistent infection at 18 months in Kenyan women. Here, we report findings of this trial through 3 years of follow-up. Overall, 2,275 healthy women aged 15-20 years were recruited and randomly assigned to receive bivalent (n = 760), nonavalent (n = 758) or control (n = 757) vaccine. The primary outcome was incident-persistent vaccine type-specific cervical HPV infection. The primary evaluation was superiority analysis in the modified intention-to-treat (mITT) HPV 16/18 and HPV 16/18/31/33/45/52/58 cohorts. The trial met its prespecified end points of vaccine type-specific persistent HPV infection. A total of 75 incident-persistent infections were detected in the HPV 16/18 mITT cohort: 2 in the bivalent group, 1 in the nonavalent group and 72 in the control group. Nonavalent VE was 98.8% (95% CI 91.3-99.8%, P < 0.0001) and bivalent VE was 97.5% (95% CI 90.0-99.4%, P < 0.0001). Overall, 89 persistent infections were detected in the HPV 16/18/31/33/45/52/58 mITT cohort: 5 in the nonavalent group and 84 in the control group; nonavalent VE was 95.5% (95% CI 89.0-98.2%, P < 0.0001). There were no vaccine-related severe adverse events. Three years after vaccination, single-dose HPV vaccination was highly efficacious, safe and conferred durable protection. ClinicalTrials.gov no. NCT03675256 .