6540 Model of a paediatric vaccine-based trial in a district general hospital

Objectives Harmonie Trial is a Phase IIIb randomized open label multi-centre study of nirsevimab (versus no intervention) in reducing hospitalizations from Respiratory syncytial virus infection among infants. Surrey and Sussex NHS Healthcare Trust (SaSH) was a study centre for this trial. Results are awaited. Methods MULTI MODEL PATIENT RECRUITMENT Posters and flyers around paediatrics and neonatal department, antenatal clinic and Obstetric Ultrasound. Trial website self-referral portal Via Maternity Research Instagram Letters sent to mothers delivering at SaSH Information sheets emailed to interested families IMPLEMENTATION Multidisciplinary teams (MDT) included research team, paediatric doctors and nurses, midwives and pharmacists. Vaccination Clinics conducted weekly in paediatrics OPD Recruitment steps involved – patient eligibility confirmation, informed consent, randomization, trial drug prescription, study drug administration, observation for any immediate adverse events. 140 women listed on screening log, 55% didn't respond following the initial expression of interest and receipt of the information sheet; 17% either declined or subsequently weren't eligible. 6% were yet to deliver by the end of the trial. 31 participants (target was 30) were recruited. CHALLENGES & HOW WE SUCCEEDED This is the first paediatric vaccine-based trial at Surrey and Sussex Healthcare NHS Trust. Hence implementation itself was a challenge. However, we achieved recruitment target. Limited space: 2 clinic rooms and the waiting area were used to increase efficiency and to minimize waiting times Staff availability due to clinical pressures: Minimum of one doctor present always with consultant supervision Communication between MDT: Email and a WhatsApp group Cold chain maintenance: Pharmacy run in the middle of the clinic Results Recruited to contracted target (follow-up ongoing in all centres in UK & Europe till 2024; in UK till 2025). Identified challenges for resources in a DGH setting. Good Paediatric trainee and MDT interdisciplinary working. Conclusion It laid a successful model for future vaccine-based trials. We can aim higher participation through broader marketing/more clinicians and space and consider MDT involvement and better inter-team coordination for future projects.