Article ; Online: 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.
The Lancet. Infectious diseases
2023 Volume 23, Issue 8, Page(s) 965–973
Abstract: 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 ... ...
| Abstract | 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. |
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| MeSH term(s) | Child, Preschool ; Humans ; Infant ; Antibodies, Viral ; COVID-19 ; Double-Blind Method ; Immunogenicity, Vaccine ; Uganda ; Vaccination/methods ; Yellow Fever/prevention & control ; Yellow Fever Vaccine/adverse effects |
| Chemical Substances | Antibodies, Viral ; Yellow Fever Vaccine |
| Language | English |
| Publishing date | 2023-04-28 |
| Publishing country | United States |
| Document type | Randomized Controlled Trial ; Clinical Trial, Phase IV ; Journal Article ; Research Support, Non-U.S. Gov't |
| ZDB-ID | 2061641-7 |
| ISSN | 1474-4457 ; 1473-3099 |
| ISSN (online) | 1474-4457 |
| ISSN | 1473-3099 |
| DOI | 10.1016/S1473-3099(23)00131-7 |
| Database | MEDical Literature Analysis and Retrieval System OnLINE |
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