Freya Davies, Michelle Edwards, Delyth Price, Pippa Anderson, Andrew Carson-Stevens, Mazhar Choudhry, Matthew Cooke, Jeremy Dale, Liam Donaldson, Bridie Angela Evans, Barbara Harrington, Shaun Harris, Julie Hepburn, Peter Hibbert, Thomas Hughes, Faris Hussain, Saiful Islam, Rhys Pockett, Alison Porter, Aloysius Niroshan Siriwardena, Helen Snooks, Alan Watkins, Adrian Edwards, Alison Cooper
Evaluation of different models of general practitioners working in or alongside emergency departments: a mixed-methods realist evaluation
Health and social care delivery research
microneedle patches mnps ranked highest global priority innovation overcoming immunisation barriers lowincome middleincome countries trial aimed provide first data tolerability safety immunogenicity measles rubella vaccine mrvmnp children singlecentre phase 12 doubleblind doubledummy randomised activecontrolled age deescalation trial conducted gambia eligible participants healthy according prespecified criteria aged 1840 years adult cohort 1518 months toddlers 910 months infants available visits throughout followup period three age cohorts randomly assigned 21 ratio adults 11 ratio toddlers infants receive either mrvmnp micron biomedical atlanta ga usa placebo 09 sodium chloride subcutaneous injection placebomnp mrv subcutaneous injection mrvsc serum institute india pune india unmasked staff ransomly assigned participants using online application prepared visually identical preparations mrvmnp placebomnp mrvsc placebosc involved collecting endpoint data staff administering study interventions participants parents study staff assessing trial endpoints masked treatment allocation safety population consists vaccinated participants analysis conducted according route mrv administration irrespective subsequent protocol deviations immunogenicity population consisted vaccinated participants baseline day 42 visit result available protocol deviations considered substantially affect immunogenicity endpoints solicited local systemic adverse events collected 14 days following vaccination unsolicited adverse events collected day 180 age deescalation cohorts based review safety data day 14 independent data monitoring committee serum neutralising antibodies measles rubella measured baseline day 42 day 180 analysis descriptive included safety events seroprotection seroconversion rates geometric mean antibody concentrations trial registered pan african clinical trials registry pactr202008836432905 complete recruitment took place may 18 2021 may 27 2022 45 adults 120 toddlers 120 infants randomly allocated vaccinated safety concerns first 14 days following vaccination either adults toddlers age deescalation proceeded accordingly infants 93 5256 95 ci 830972 seroconverted measles 100 5858 938100 seroconverted rubella following mrvmnp administration 90 5258 792952 100 5959 939100 seroconverted measles rubella respectively following mrvsc induration mrvmnp application site frequent local reaction occurring 46 77 60 toddlers 39 65 60 infants related unsolicited adverse events commonly discolouration application site reported 35 58 60 toddlers 57 95 60 infants received mrvmnp local reactions mild related severe serious adverse events safety immunogenicity data support accelerated development mrvmnp bill melinda gates foundation