Durability of single-dose HPV vaccination in young Kenyan women: randomized controlled trial 3-year results

被引：34

作者：

Barnabas, Ruanne V. ^{[1
,2
,3
]}

Brown, Elizabeth R. ^{[4
,5
,6
]}

Onono, Maricianah A. ^{[7
]}

Bukusi, Elizabeth A. ^{[7
,8
,9
]}

Njoroge, Betty ^{[10
]}

Winer, Rachel L. ^{[11
]}

Galloway, Denise A. ^{[12
]}

Pinder, Leeya F. ^{[8
,13
]}

Donnell, Deborah ^{[4
,8
]}

Wakhungu, Imelda N. ^{[7
]}

Biwott, Charlene ^{[10
]}

Kimanthi, Syovata ^{[10
]}

Heller, Kate B. ^{[1
,8
]}

Kanjilal, Diane G. ^{[1
]}

Pacella, Daniel ^{[1
]}

Morrison, Susan ^{[8
]}

Rechkina, Elena A. ^{[8
]}

Cherne, Stephen L. ^{[14
,15
]}

Schaafsma, Torin T. ^{[8
]}

McClelland, R. Scott ^{[8
,11
,16
,17
]}

Celum, Connie ^{[8
,11
,16
]}

Baeten, Jared M. ^{[8
,16
]}

Mugo, Nelly R. ^{[8
,10
]}

Dull, Peter ^{[18
]}

Gulati, Reena ^{[18
]}

Vernam, Sara ^{[18
]}

Yousufzay, Abdul Rawuf ^{[18
]}

Gunderson, Krissa ^{[19
]}

Hercinovic, Amra ^{[19
]}

Ondrejcek, Lisa ^{[19
]}

Robertson, Gavin ^{[19
]}

Williams, Angela ^{[19
]}

Brown, Elizabeth ^{[4
,5
,6
,12
]}

Carter, Jody ^{[12
]}

Donnell, Deborah ^{[4
,8
]}

Galloway, Denise ^{[12
]}

Pinder, Leeya ^{[8
,13
]}

Prabhu, Priya R. ^{[12
]}

Smith, Robin ^{[12
]}

Wright, Marci ^{[12
]}

Abiero, Stephen O. ^{[7
]}

Achola, Maqline A. ^{[7
]}

Adipo, Meldah O. ^{[7
]}

Amukonyi, Katherine L. ^{[7
]}

Akinyi, Cynthia ^{[7
]}

Akinyi, Teresia O. ^{[7
]}

Amboka, Penina N. ^{[7
]}

Arum, Karl D. ^{[7
]}

Atogo, Veronica O. ^{[7
]}

Atonga, Pius O. ^{[7
]}

机构：

[1] Massachusetts Gen Hosp, Dept Med, Div Infect Dis, Boston, MA 02114 USA

[2] Harvard Med Sch, Sch Med, Boston, MA 02115 USA

[3] Harvard TH Chan Sch Publ Hlth, Dept Epidemiol, Boston, MA 02115 USA

[4] Fred Hutchinson Canc Ctr, Vaccine & Infect Dis Div, Seattle, WA USA

[5] Fred Hutchinson Canc Ctr, Publ Hlth Sci, Seattle, WA USA

[6] Univ Washington, Dept Biostat, Seattle, WA USA

[7] Kenya Govt Med Res Ctr, Ctr Microbiol Res, Kisumu, Kenya

[8] Univ Washington, Dept Global Hlth, Seattle, WA USA

[9] Univ Washington, Dept Obstet & Gynecol, Seattle, WA USA

[10] Kenya Govt Med Res Ctr, Ctr Clin Res, Nairobi, Kenya

[11] Univ Washington, Dept Epidemiol, Seattle, WA USA

[12] Fred Hutchinson Canc Ctr, Human Biol Div, Seattle, WA 98109 USA

[13] Univ Cincinnati, Dept Obstet & Gynecol, Cincinnati, OH USA

[14] Univ Washington, Dept Lab Med, Seattle, WA USA

[15] Univ Washington, Dept Pathol, Seattle, WA USA

[16] Univ Washington, Dept Med, Div Allergy & Infect Dis, Seattle, WA USA

[17] Univ Washington, East Africa STI Lab, Mombasa, Kenya

[18] Bill & Melinda Gates Fdn, Seattle, WA USA

[19] DF Net Res, Seattle, WA USA

来源：

NATURE MEDICINE | 2023年 / 29卷 / 12期

关键词：

HUMAN-PAPILLOMAVIRUS VACCINE; CLINICAL VALIDATION; CERVICAL-CANCER; IMMUNOGENICITY; EFFICACY; SAFETY; DORIS; DNA;

D O I：

10.1038/s41591-023-02658-0

中图分类号：

Q5 [生物化学]; Q7 [分子生物学];

学科分类号：

071010 ; 081704 ;

摘要：

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.

引用

页码：3224 / 3232

页数：23

共 34 条

[1]

Baisley K, 2022, LANCET GLOB HEALTH, V10, pE1485, DOI 10.1016/S2214-109X(22)00306-0

[2]

Barnabas Ruanne V, 2022, NEJM Evid, V1, pEVIDoa2100056, DOI 10.1056/EVIDoa2100056

[3] Single-dose HPV vaccination efficacy among adolescent girls and young women in Kenya (the KEN SHE Study): study protocol for a randomized controlled trial [J].

Barnabas, Ruanne, V ;

Brown, Elizabeth R. ;

Onono, Maricianah ;

Bukusi, Elizabeth A. ;

Njoroge, Betty ;

Winer, Rachel L. ;

Donnell, Deborah ;

Galloway, Denise ;

Cherne, Stephen ;

Heller, Kate ;

Leingang, Hannah ;

Morrison, Susan ;

Rechkina, Elena ;

McClelland, R. Scott ;

Baeten, Jared M. ;

Celum, Connie ;

Mugo, Nelly .

TRIALS, 2021, 22 (01)

[4] Vaccine efficacy against persistent human papillomavirus (HPV) 16/18 infection at 10 years after one, two, and three doses of quadrivalent HPV vaccine in girls in India: a multicentre, prospective, cohort study [J].

Basu, Partha ;

Malvi, Sylla G. ;

Joshi, Smita ;

Bhatla, Neerja ;

Muwonge, Richard ;

Lucas, Eric ;

Verma, Yogesh ;

Esmy, Pulikkottil O. ;

Poli, Usha Rani Reddy ;

Shah, Anand ;

Zomawia, Eric ;

Pimple, Sharmila ;

Jayant, Kasturi ;

Hingmire, Sanjay ;

Chiwate, Aruna ;

Divate, Uma ;

Vashist, Shachi ;

Mishra, Gauravi ;

Jadhav, Radhika ;

Siddiqi, Maqsood ;

Sankaran, Subha ;

Prabhu, Priya Ramesh ;

Kannan, Thiraviam Pillai Rameshwari Ammal ;

Varghese, Rintu ;

Shastri, Surendra S. ;

Anantharaman, Devasena ;

Gheit, Tarik ;

Tommasino, Massimo ;

Sauvaget, Catherine ;

Pillai, M. Radhakrishna ;

Sankaranarayanan, Rengaswamy .

LANCET ONCOLOGY, 2021, 22 (11) :1518-1529

[5] Potential population-level effectiveness of one-dose HPV vaccination in low-income and middle-income countries: a mathematical modelling analysis [J].

Benard, Elodie ;

Drolet, Melanie ;

Laprise, Jean-Francois ;

Gingras, Guillaume ;

Jit, Mark ;

Boily, Marie-Claude ;

Bloem, Paul ;

Brisson, Marc .

LANCET PUBLIC HEALTH, 2023, 8 (10) :E788-E799

[6] Global estimates of expected and preventable cervical cancers among girls born between 2005 and 2014: a birth cohort analysis [J].

Bonjour, Maxime ;

Charvat, Hadrien ;

Franco, Eduardo L. ;

Pineros, Marion ;

Clifford, Gary M. ;

Bray, Freddie ;

Baussano, Iacopo .

LANCET PUBLIC HEALTH, 2021, 6 (07) :E510-E521

[7] HPV vaccination introduction worldwide and WHO and UNICEF estimates of national HPV immunization coverage 2010-2019 [J].

Bruni, Laia ;

Saura-Lazaro, Anna ;

Montoliu, Alexandra ;

Brotons, Maria ;

Alemany, Laia ;

Diallo, Mamadou Saliou ;

Afsar, Oya Zeren ;

LaMontagne, D. Scott ;

Mosina, Liudmila ;

Contreras, Marcela ;

Velandia-Gonzalez, Martha ;

Pastore, Roberta ;

Gacic-Dobo, Marta ;

Bloem, Paul .

PREVENTIVE MEDICINE, 2021, 144

[8] Population-level impact and herd effects following the introduction of human papillomavirus vaccination programmes: updated systematic review and meta-analysis [J].

Drolet, Melanie ;

Benard, Elodie ;

Perez, Norma ;

Brisson, Marc ;

Boily, Marie-Claude ;

Ali, Hammad ;

Baldo, Vincenzo ;

Brassard, Paul ;

Brotherton, Julia M. L. ;

Callander, Denton ;

Checchi, Marta ;

Chow, Eric P. F. ;

Cocchio, Silvia ;

Dalianis, Tina ;

Deeks, Shelley L. ;

Dehlendorff, Christian ;

Donovan, Basil ;

Fairley, Christopher K. ;

Flagg, Elaine W. ;

Gargano, Julia W. ;

Garland, Suzanne M. ;

Grun, Nathalie ;

Hansen, Bo T. ;

Harrison, Christopher ;

Herweijer, Eva ;

Imburgia, Teresa M. ;

Johnson, Anne M. ;

Kahn, Jessica A. ;

Kavanagh, Kimberley ;

Kjaer, Susanne K. ;

Kliewer, Erich V. ;

Liu, Bette ;

Machalek, Dorothy A. ;

Markowitz, Lauri ;

Mesher, David ;

Munk, Christian ;

Niccolai, Linda ;

Nygard, Mari ;

Ogilvie, Gina ;

Oliphant, Jeannie ;

Pollock, Kevin G. ;

Purrinos-Hermida, Maria Jesus ;

Smith, Megan A. ;

Steben, Marc ;

Soderlund-Strand, Anna ;

Sonnenberg, Pam ;

Sparen, Par ;

Tanton, Clare ;

Wheeler, Cosette M. ;

Woestenberg, Petra J. .

LANCET, 2019, 394 (10197) :497-509

[9] Continuing global improvement in human papillomavirus DNA genotyping services: The 2013 and 2014 HPV LabNet international proficiency studies [J].

Eklund, Carina ;

Forslund, Ola ;

Wallin, Keng-Ling ;

Dillner, Joakim .

JOURNAL OF CLINICAL VIROLOGY, 2018, 101 :74-85

[10] A Deferred-Vaccination Design to Assess Durability of COVID-19 Vaccine Effect After the Placebo Group Is Vaccinated [J].

Follmann, Dean ;

Fintzi, Jonathan ;

Fay, Michael P. ;

Janes, Holly E. ;

Baden, Lindsey R. ;

El Sahly, Hana M. ;

Fleming, Thomas R. ;

Mehrotra, Devan, V ;

Carpp, Lindsay N. ;

Juraska, Michal ;

Benkeser, David ;

Donnell, Deborah ;

Fong, Youyi ;

Han, Shu ;

Hirsch, Ian ;

Huang, Ying ;

Huang, Yunda ;

Hyrien, Ollivier ;

Luedtke, Alex ;

Carone, Marco ;

Nason, Martha ;

Vandebosch, An ;

Zhou, Honghong ;

Cho, Iksung ;

Gabriel, Erin ;

Kublin, James G. ;

Cohen, Myron S. ;

Corey, Lawrence ;

Gilbert, Peter B. ;

Neuzil, Kathleen M. .

ANNALS OF INTERNAL MEDICINE, 2021, 174 (08) :1118-+

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