Durability of single-dose HPV vaccination in young Kenyan women: randomized controlled trial 3-year results
Authors: Barnabas Ruanne V. , Brown Elizabeth R. , Onono Maricianah A. , Bukusi Elizabeth A. , Njoroge Betty , Winer Rachel L. , Galloway Denise A. , Pinder Leeya F. , Donnell Deborah , N. Wakhungu Imelda , Biwott Charlene , Kimanthi Syovata , Heller Kate B. , Kanjilal Diane G. , Pacella Daniel , Morrison Susan , A. Rechkina Elena , L. Cherne Stephen , Schaafsma Torin T. , McClelland R. Scott , Celum Connie , Baeten Jared M. , Mugo Nelly R. ,   the KEN SHE Study Team, Dull Peter , Gulati Reena , Vernam Sara , Yousufzay Abdul Rawuf , Gunderson Krissa , Hercinovic Amra , Ondrejcek Lisa , Robertson Gavin , Williams Angela , Brown Elizabeth , Carter Jody , Galloway Denise , Pinder Leeya , Prabhu Priya R. , Smith Robin , Wright Marci , Abiero Stephen O. , Achola Maqline A. , Adipo Meldah O. , Amukonyi Katherine L. , Akinyi Cynthia , Akinyi Teresia O. , Amboka Penina N. , Arum Karl D. , Atogo Veronica O. , Atonga Pius O. , Cate Adero J. , Chepkoros Daisy , Christopher Oyamo O. , Imali Imelda N. , Imbayi Mildred , Kabete Lizzie N. , Kanampiu Enericah K. , Kebaso Geoffrey , Kegode Dennis , Kwena Timothy , Lenturkana Reina , Lihavi Celestine , Marwa David N. , Matti Patricia , Mboya Peter O. , Mbuya Elijah , Memo Lyna A. , Mituyi Robai M. , Muga Benard M. , Muhoma David E. , Musi Elizabeth L. , Mutai Gilbert C. , Muthusi Simon M. , Mutuiri Ivy M. , Mwakio Catherine W. , Nyongesa Bill , Ochieng Maureen A. , Ochuka Vincent R. , Odedo Belder A. , Odeny Esther A. , Odera Vincent O. , Odhiambo Debora A. , Odhiambo Perez O. , Okeyo Janet A. , Okode Linet A. , Okuku Nollyne A. , Okumu Irene , Okumu Lydiah A. , Olweny Christine A. , Olweyo Hellen A. , Omondi George O. , Ondego Donnavane A. , Ondiek Florence A. , Ongere Joan A. , Onono Maricianah , Onyango Kevin O. , Opondo Annette A. , Oronje Millicent A. , Osoga Beryl A. , Otieno Rebecca A. , Ouma Job A. , Owenga Mildred A. , Rashid Samya S. , Salano Vincent K. , Siaji Moses O. , Sikolia Roseline , Wakhungu Imelda N. , Walukana Nicholas , Walusala Nobert B. , Wemali Caren A. , Ambiyo Faith , Anyango Emily , Charles Esther K. , Chege David , Gacheru Jane , Gaitho Anne , Gakuo Stephen , Gathu Zachary , Irungu Mathew , Juma Vincent , Kamau Irene , Kibatha Mary , Kiboi Dorcas , Khaemba Francis , Kimani Hellen W. , Kiptinness Catherine , Koli Caren , Koome Erick , Maina Solomon , Makena Linet , Mbaire Sarah , Muchoki Veronica , Munene Victor , Mugo Edwin , R. Mugo Nelly , Mugo Umi W. , Munyaka Faith , Mutunga Paul , Mwangi Margaret , Mwangi Stanley , Mwenda Peter , Namboka Gladys , Ndung’u Grace , Nduuru Rispa , Neema Esther , Ng’ang’a Sammy , Njeri Josephine , Njeru Irene , Njoki Alice , Njoroge John , Njoroge Sarah , Nzuve Peter , Nkatha Fridah , Nyakio Jemimah , Nyandiga Edna , Nyokabi Jacinta , Odera Rose , Okumu John , Oluoch Lynda , Orwa Linda , Ouko Nina , Saina Matilda , Thumi Agata , Wambui Innes , Wambui Victoria , Wangechi Virginia , Wanjiku Scholastica , Barnabas Ruanne , Caramazza Francesca , Heller Kate , Kanjilal Diane , Kennedy Kyle , Talabi Odunayo Kolawole , Hassan Rukiya , Kabare Emmanuel , Mwidadi Fatma H. , Mwinyikai Khamis , Mustafa Salwa , Shafi Juma , Cherne Stephen L. , Hamilton Daphne , Johnson Rachel , Lin John , Quame-Amaglo Justice , Rechkina Elena A. , T. Schaafsma Torin 
Published: December 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.