دورية أكاديمية
Immunogenicity and safety of fractional doses of 17D-213 yellow fever vaccine in children (YEFE): a randomised, double-blind, non-inferiority substudy of a phase 4 trial.
| العنوان: | Immunogenicity and safety of fractional doses of 17D-213 yellow fever vaccine in children (YEFE): a randomised, double-blind, non-inferiority substudy of a phase 4 trial. |
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| المؤلفون: | Juan-Giner A; Epicentre, Paris, France., Namulwana ML; Epicentre Mbarara Research Centre, Mbarara, Uganda., Kimathi D; Kenya Medical Research Institute-Wellcome Trust Research Programme, Kilifi, Kenya; Centre for Tropical Medicine & Global Health, University of Oxford, Oxford, UK., Grantz KH; Department of Biology and Emerging Pathogens Institute, University of Florida, Gainesville, FL, USA; Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA., Fall G; Institut Pasteur Dakar, Dakar, Senegal., Dia M; Institut Pasteur Dakar, Dakar, Senegal., Bob NS; Institut Pasteur Dakar, Dakar, Senegal., Sall AA; Institut Pasteur Dakar, Dakar, Senegal., Nerima C; Epicentre Mbarara Research Centre, Mbarara, Uganda., Sahani MK; Epicentre Mbarara Research Centre, Mbarara, Uganda., Mulogo EM; Department of Community Health, Mbarara University of Science & Technology, Mbarara, Uganda., Ampeire I; Expanded Program on Immunization, Ministry of Health, Kampala, Uganda., Hombach J; Immunization, Vaccines, and Biologicals, World Health Organization, Geneva, Switzerland., Nanjebe D; Epicentre Mbarara Research Centre, Mbarara, Uganda., Mwanga-Amumpaire J; Epicentre Mbarara Research Centre, Mbarara, Uganda., Cummings DAT; Department of Biology and Emerging Pathogens Institute, University of Florida, Gainesville, FL, USA., Bejon P; Kenya Medical Research Institute-Wellcome Trust Research Programme, Kilifi, Kenya; Centre for Tropical Medicine & Global Health, University of Oxford, Oxford, UK., Warimwe GM; Kenya Medical Research Institute-Wellcome Trust Research Programme, Kilifi, Kenya; Centre for Tropical Medicine & Global Health, University of Oxford, Oxford, UK., Grais RF; Epicentre, Paris, France. Electronic address: rebecca.grais@epicentre.msf.org. |
| المصدر: | The Lancet. Infectious diseases [Lancet Infect Dis] 2023 Aug; Vol. 23 (8), pp. 965-973. Date of Electronic Publication: 2023 Apr 28. |
| نوع المنشور: | Randomized Controlled Trial; Clinical Trial, Phase IV; Journal Article; Research Support, Non-U.S. Gov't |
| اللغة: | English |
| بيانات الدورية: | Publisher: Elsevier Science Country of Publication: United States NLM ID: 101130150 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1474-4457 (Electronic) Linking ISSN: 14733099 NLM ISO Abbreviation: Lancet Infect Dis Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: New York, NY : Elsevier Science ; The Lancet Pub. Group, 2001- |
| مواضيع طبية MeSH: | COVID-19* , Yellow Fever*/prevention & control , Yellow Fever Vaccine*/adverse effects, Child, Preschool ; Humans ; Infant ; Antibodies, Viral ; Double-Blind Method ; Immunogenicity, Vaccine ; Uganda ; Vaccination/methods |
| مستخلص: | Background: Current supply shortages constrain yellow fever vaccination activities, particularly outbreak response. Although fractional doses of all WHO-prequalified yellow fever vaccines have been shown to be safe and immunogenic in a randomised controlled trial in adults, they have not been evaluated in a randomised controlled trial in young children (9-59 months old). We aimed to assess the immunogenicity and safety of fractional doses compared with standard doses of the WHO-prequalified 17D-213 vaccine in young children. Methods: This substudy of the YEFE phase 4 study was conducted at the Epicentre Mbarara Research Centre (Mbarara, Uganda). Eligible children were aged 9-59 months without contraindications for vaccination, without history of previous yellow fever vaccination or infection and not requiring yellow fever vaccination for travelling. Participants were randomly assigned, using block randomisation, 1:1 to standard or fractional (one-fifth) dose of yellow fever vaccine. Investigators, participants, and laboratory personnel were blinded to group allocation. Participants were followed for immunogenicity and safety at 10 days, 28 days, and 1 year after vaccination. The primary outcome was non-inferiority in seroconversion (-10 percentage point margin) 28 days after vaccination measured by 50% plaque reduction neutralisation test (PRNT Findings: Between Feb 20, 2019, and Sept 9, 2019, 433 children were assessed, and 420 were randomly assigned to fractional dose (n=210) and to standard dose (n=210) 17D-213 vaccination. 28 days after vaccination, 202 (97%, 95% CI 95-99) of 207 participants in the fractional dose group and 191 (100%, 98-100) of 191 in the standard dose group seroconverted. The absolute difference in seroconversion between the study groups in the per-protocol population was -2 percentage points (95% CI -5 to 1). 154 (73%) of 210 participants in the fractional dose group and 168 (80%) of 210 in the standard dose group reported at least one adverse event 28 days after vaccination. At 10 days follow-up, seroconversion was lower in the fractional dose group than in the standard dose group. The most common adverse events were upper respiratory tract infections (n=221 [53%]), diarrhoea (n=68 [16%]), rhinorrhoea (n=49 [12%]), and conjunctivitis (n=28 [7%]). No difference was observed in incidence of adverse events and serious adverse events between study groups. Conclusions: Fractional doses of the 17D-213 vaccine were non-inferior to standard doses in inducing seroconversion 28 days after vaccination in children aged 9-59 months when assessed with PRNT Funding: Médecins Sans Frontières Foundation. Competing Interests: Declaration of interests We declare no competing interests. (Copyright © 2023 Elsevier Ltd. All rights reserved.) |
| التعليقات: | Comment in: Lancet Infect Dis. 2023 Aug;23(8):889-890. (PMID: 37127046) |
| معلومات مُعتمدة: | 001 International WHO_ World Health Organization |
| سلسلة جزيئية: | ClinicalTrials.gov NCT02991495 |
| المشرفين على المادة: | 0 (Antibodies, Viral) 0 (Yellow Fever Vaccine) |
| تواريخ الأحداث: | Date Created: 20230501 Date Completed: 20230801 Latest Revision: 20230903 |
| رمز التحديث: | 20230903 |
| DOI: | 10.1016/S1473-3099(23)00131-7 |
| PMID: | 37127047 |
| قاعدة البيانات: | MEDLINE |
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Full Text Finder | تدمد: | 1474-4457 |
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| DOI: | 10.1016/S1473-3099(23)00131-7 |