Durability of single-dose HPV vaccination in young Kenyan women: randomized controlled trial 3-year results
Authors: Ruanne V. Barnabas, Elizabeth R. Brown, Maricianah A. Onono, Elizabeth A. Bukusi, Betty Njoroge, Rachel L. Winer, Denise A. Galloway, Leeya F. Pinder, Deborah Donnell, Imelda N. Wakhungu, Charlene Biwott, Syovata Kimanthi, Kate B. Heller, Diane G. Kanjilal, Daniel Pacella, Susan Morrison, Elena A. Rechkina, Stephen L. Cherne, Torin T. Schaafsma, R. Scott McClelland, Connie Celum, Jared M. Baeten, Nelly R. Mugo, Peter Dull, Reena Gulati, Sara Vernam, Abdul Rawuf Yousufzay, Krissa Gunderson, Amra Hercinovic, Lisa Ondrejcek, Gavin Robertson, Angela Williams, Elizabeth Brown, Jody Carter, Denise Galloway, Leeya Pinder, Priya R. Prabhu, Robin Smith, Marci 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, Adero J. 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, Peter O. Mboya, Elijah Mbuya, Lyna A. 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, Lydiah A. Okumu, Christine A. Olweny, Hellen A. Olweyo, George O. Omondi, Donnavane A. Ondego, Florence A. Ondiek, Joan A. Ongere, Maricianah Onono, Kevin O. Onyango, Annette A. Opondo, Millicent A. Oronje, Beryl A. Osoga, Rebecca A. Otieno, Job A. Ouma, Mildred A. Owenga, Samya S. Rashid, Vincent K. Salano, Moses O. Siaji, Roseline Sikolia, Imelda N. Wakhungu, Nicholas Walukana, Nobert B. Walusala, Caren A. Wemali, Faith Ambiyo, Emily Anyango, Esther K. Charles, David Chege, Jane Gacheru, Anne Gaitho, Stephen Gakuo, Zachary Gathu, Mathew Irungu, Vincent Juma, Irene Kamau, Mary Kibatha, Dorcas Kiboi, Francis Khaemba, Hellen W. Kimani, Catherine Kiptinness, Caren Koli, Erick Koome, Solomon Maina, Linet Makena, Sarah Mbaire, Veronica Muchoki, Victor Munene, Edwin Mugo, Nelly R. Mugo, Umi W. Mugo, Faith Munyaka, Paul Mutunga, Margaret Mwangi, Stanley Mwangi, Peter Mwenda, Gladys Namboka, Grace Ndung’u, Rispa Nduuru, Esther Neema, Sammy Ng’ang’a, Josephine Njeri, Irene Njeru, Alice Njoki, John Njoroge, Sarah Njoroge, Peter Nzuve, Fridah Nkatha, Jemimah Nyakio, Edna Nyandiga, Jacinta Nyokabi, Rose Odera, John Okumu, Lynda Oluoch, Linda Orwa, Nina Ouko, Matilda Saina, Agata Thumi, Innes Wambui, Victoria Wambui, Virginia Wangechi, Scholastica Wanjiku, Ruanne Barnabas, Francesca Caramazza, Kate Heller, Diane Kanjilal, Kyle Kennedy, Odunayo Kolawole Talabi, Rukiya Hassan, Emmanuel Kabare, Fatma H. Mwidadi, Khamis Mwinyikai, Salwa Mustafa, Juma Shafi, Stephen L. Cherne, Daphne Hamilton, Rachel Johnson, John Lin, Justice Quame-Amaglo, Elena A. Rechkina, Torin T. Schaafsma
Journal: Nature Medicine (2023)

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 .