دورية أكاديمية
Comparing one dose of HPV vaccine in girls aged 9-14 years in Tanzania (DoRIS) with one dose in young women aged 15-20 years in Kenya (KEN SHE): an immunobridging analysis of randomised controlled trials.
| العنوان: | Comparing one dose of HPV vaccine in girls aged 9-14 years in Tanzania (DoRIS) with one dose in young women aged 15-20 years in Kenya (KEN SHE): an immunobridging analysis of randomised controlled trials. |
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| المؤلفون: | Baisley K; Faculty of Epidemiology and Population Health, London School of Hygiene & Tropical Medicine, London, UK. Electronic address: kathy.baisley@lshtm.ac.uk., Kemp TJ; HPV Serology Laboratory, Frederick National Laboratory for Cancer Research, Frederick, MD, USA., Mugo NR; Department of Global Health, University of Washington, Seattle, WA, USA; Center for Clinical Research, Kenya Medical Research Institute, Nairobi, Kenya., Whitworth H; Faculty of Infectious and Tropical Diseases UK, London School of Hygiene & Tropical Medicine, London, UK; Mwanza Intervention Trials Unit, National Institute for Medical Research, Mwanza, Tanzania., Onono MA; Center for Microbiology Research, Kenya Medical Research Institute, Nairobi, Kenya., Njoroge B; Center for Clinical Research, Kenya Medical Research Institute, Nairobi, Kenya., Indangasi J; Faculty of Infectious and Tropical Diseases UK, London School of Hygiene & Tropical Medicine, London, UK; Mwanza Intervention Trials Unit, National Institute for Medical Research, Mwanza, Tanzania., Bukusi EA; Department of Global Health, University of Washington, Seattle, WA, USA; Center for Microbiology Research, Kenya Medical Research Institute, Nairobi, Kenya., Prabhu PR; Human Biology Division, Fred Hutchinson Cancer Center, Seattle, WA, USA., Mutani P; Mwanza Intervention Trials Unit, National Institute for Medical Research, Mwanza, Tanzania., Galloway DA; Human Biology Division, Fred Hutchinson Cancer Center, Seattle, WA, USA., Mwanzalime D; Mwanza Intervention Trials Unit, National Institute for Medical Research, Mwanza, Tanzania., Kapiga S; Faculty of Epidemiology and Population Health, London School of Hygiene & Tropical Medicine, London, UK; Mwanza Intervention Trials Unit, National Institute for Medical Research, Mwanza, Tanzania., Lacey CJ; York Biomedical Research Institute & Hull York Medical School, University of York, York, UK., Hayes RJ; Faculty of Epidemiology and Population Health, London School of Hygiene & Tropical Medicine, London, UK., Changalucha J; Mwanza Intervention Trials Unit, National Institute for Medical Research, Mwanza, Tanzania., Pinto LA; HPV Serology Laboratory, Frederick National Laboratory for Cancer Research, Frederick, MD, USA., Barnabas RV; Department of Global Health, University of Washington, Seattle, WA, USA; Division of Infectious Diseases, Massachusetts General Hospital, Boston, MA, USA., Watson-Jones D; Faculty of Infectious and Tropical Diseases UK, London School of Hygiene & Tropical Medicine, London, UK; Mwanza Intervention Trials Unit, National Institute for Medical Research, Mwanza, Tanzania. |
| المصدر: | The Lancet. Global health [Lancet Glob Health] 2024 Mar; Vol. 12 (3), pp. e491-e499. |
| نوع المنشور: | Journal Article |
| اللغة: | English |
| بيانات الدورية: | Publisher: Elsevier Ltd Country of Publication: England NLM ID: 101613665 Publication Model: Print Cited Medium: Internet ISSN: 2214-109X (Electronic) Linking ISSN: 2214109X NLM ISO Abbreviation: Lancet Glob Health Subsets: In Process |
| أسماء مطبوعة: | Original Publication: [England] : Elsevier Ltd. 2013- |
| مستخلص: | Background: The first randomised controlled trial of single-dose human papillomavirus (HPV) vaccine efficacy, the Kenya single-dose HPV-vaccine efficacy (KEN SHE) trial, showed greater than 97% efficacy against persistent HPV16 and HPV18 infection at 36 months among women in Kenya. We compared antibody responses after one dose of HPV vaccine in the Dose Reduction Immunobridging and Safety Study (DoRIS), the first randomised trial of the single- dose regimen in girls aged 9-14 years, the target age range for vaccination, with those after one dose of the same vaccine in KEN SHE. Methods: In the DoRIS trial, 930 girls aged 9-14 years in Tanzania were randomly assigned to one, two, or three doses of the 2-valent vaccine (Cervarix) or the 9-valent vaccine (Gardasil-9). The proportion seroconverting and geometric mean concentrations (GMCs) at month 24 after one dose were compared with those in women aged 15-20 years who were randomly assigned to one dose of the same vaccines at the same timepoint in KEN SHE. Batched samples were tested together by virus-like particle ELISA for HPV16 and HPV18 IgG antibodies. Non-inferiority of GMC ratios (DoRIS trial:KEN SHE) was predefined as a lower bound of the 95% CI less than 0·50. Findings: Month 24 HPV16 and HPV18 antibody GMCs in DoRIS were similar or higher than those in KEN SHE. 2-valent GMC ratios were 0·90 (95% CI 0·72-1·14) for HPV16 and 1·02 (0·78-1·33) for HPV18. 9-valent GMC ratios were 1·44 (95% CI 1·14-1·82) and 1·47 (1·13-1·90), respectively. Non-inferiority of antibody GMCs and seropositivity was met for HPV16 and HPV18 for both vaccines. Interpretation: HPV16 and HPV18 immune responses in young girls 24 months after a single dose of 2-valent or 9-valent HPV vaccine were comparable to those in young women who were randomly assigned to a single dose of the same vaccines and in whom efficacy had been shown. A single dose of HPV vaccine, when given to girls in the target age range for vaccination, induces immune responses that could be effective against persistent HPV16 and HPV18 infection at least two years after vaccination. Funding: The UK Department of Health and Social Care, the Foreign, Commonwealth, & Development Office, the Global Challenges Research Fund, the UK Medical Research Council and Wellcome Trust Joint Global Health Trials scheme, the Bill and Melinda Gates Foundation, the US National Cancer Institute; the US National Institutes of Health, and the Francis and Dorothea Reed Endowed Chair in Infectious Diseases. Translation: For the KiSwahili translation of the abstract see Supplementary Materials section. Competing Interests: Declaration of interests KB reports grants from the Bill & Melinda Gates Foundation during the conduct of the DoRIS trial, and a grant and vaccine donations from Merck Pharmaceuticals outside the submitted work. DW-J reports grants from the Gates Foundation and the UK Research and Innovation Medical Research Council during the DoRIS trial, and a grant and vaccine donations from Merck outside the submitted work. HW reports grants from the Gates Foundation and the UK Research and Innovation Medical Research Council during the DoRIS trial, and vaccine donations from Merck outside the submitted work. JC reports grant support from the Gates Foundation and the UK Research and Innovation Medical Research Council during the DoRIS trial. RJH reports a grant from the UK Research and Innovation Medical Research Council during the DoRIS trial. RVB reports grants from the Gates Foundation during the conduct of the KEN SHE trial, and data monitoring committee honorarium from Gilead Sciences and manuscript and abstract writing support from Regeneron Pharmaceuticals outside the submitted work. NRM reports grant support from Merck Pharmaceuticals outside the submitted work. DAG reports grants from the Gates Foundation during the conduct of the KEN SHE trial, and grants and personal fees from Merck outside the submitted work. EAB reports grants from the National Institutes of Health, the Centers for Disease Control and Prevention, and the European and Developing Countries Clinical Trials Partnership during the conduct of the KEN SHE trial; and personal fees from Gilead Sciences and personal fees from Merck outside the submitted work. All other authors declare no competing interests. (Copyright © 2024 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.) |
| References: | Vaccine. 2023 Jan 4;41(1):236-245. (PMID: 36446654) Vaccine. 2018 Aug 6;36(32 Pt A):4768-4773. (PMID: 29325819) Contemp Clin Trials. 2021 Feb;101:106266. (PMID: 33421649) Lancet Glob Health. 2022 Oct;10(10):e1473-e1484. (PMID: 36113531) Lancet Glob Health. 2022 Oct;10(10):e1485-e1493. (PMID: 36113532) Hum Vaccin Immunother. 2014;10(12):3435-45. (PMID: 25483701) JAMA. 2013 May 1;309(17):1793-802. (PMID: 23632723) Lancet Oncol. 2015 May;16(5):e226-33. (PMID: 25943067) Vaccine. 2020 Aug 27;38(38):5997-6006. (PMID: 32713678) Saudi Med J. 2022 May;43(5):538. (PMID: 35537734) J Natl Cancer Inst. 2020 Oct 1;112(10):1038-1046. (PMID: 32091594) Vaccine. 2008 Dec 9;26(52):6844-51. (PMID: 18930097) Cochrane Database Syst Rev. 2019 Nov 22;2019(11):. (PMID: 31755549) Vaccine. 2015 Aug 26;33(36):4383-4. (PMID: 25510390) Trials. 2021 Sep 27;22(1):661. (PMID: 34579786) J Biol. 2006;5(2):5. (PMID: 16611373) Vaccine. 2018 Aug 6;36(32 Pt A):4761-4767. (PMID: 29580641) NEJM Evid. 2022 Jun;1(5):EVIDoa2100056. (PMID: 35693874) Vaccine. 2018 Aug 6;36(32 Pt A):4783-4791. (PMID: 29551226) Clin Infect Dis. 2020 Aug 14;71(4):1022-1029. (PMID: 31617568) Biometrics. 1999 Dec;55(4):1202-9. (PMID: 11315068) Pediatr Infect Dis J. 2000 May;19(5):444-9. (PMID: 10819341) Lancet Glob Health. 2023 Jul;11(7):e1096-e1104. (PMID: 37207683) Vaccine. 2014 Jan 23;32(5):611-7. (PMID: 24291193) Lancet Oncol. 2015 Jul;16(7):775-86. (PMID: 26071347) Lancet Infect Dis. 2021 Oct;21(10):1458-1468. (PMID: 34081923) Vaccine. 2022 Sep 2;40(37):5413-5432. (PMID: 35965239) |
| معلومات مُعتمدة: | G0901756 United Kingdom MRC_ Medical Research Council |
| تواريخ الأحداث: | Date Created: 20240216 Latest Revision: 20240722 |
| رمز التحديث: | 20240723 |
| مُعرف محوري في PubMed: | PMC10882205 |
| DOI: | 10.1016/S2214-109X(23)00586-7 |
| PMID: | 38365419 |
| قاعدة البيانات: | MEDLINE |
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Full Text Finder | تدمد: | 2214-109X |
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| DOI: | 10.1016/S2214-109X(23)00586-7 |