Pregnancy and Infant PrEparedness pLatform IN Europe (PIPELINE)-RSV International immunisation adaptive platform trial

Research summary

Phase 3 open-label adaptive platform trial for the prevention of RSV in infants. Sites will define locally relevant interventions and questions,likely to depend on standard of care and drug availability in country. Interventions include: • Seasonal mAb: monoclonal antibody administered to infants entering their first RSV season (nirsevimab (Beyfortus)) • MV: maternal vaccine administered between 24+0 and 36+6 weeks of gestation (bivalent RSV prefusion F protein-based vaccine (Abrysvo)) • MV + 4m mAb: MV administered between 24+0 and 36+6 weeks of gestation plus infant mAb at 4 months of age Randomisation options include: 1. Seasonal mAb vs. MV + 4m mAb 2. MV vs. MV + 4m mAb 3. MV vs. Seasonal mAb vs. MV + 4m mAb 4. MV vs. Seasonal mAb Randomisation will allocate equally between defined interventions (i.e. 1:1 or 1:1:1). Where the mAb is given alone it will be given at the entry into the first RSV season; where it is given following the MV,it will be given when the infant is 4 months old (± 1 month). Follow-up will be up to 12 months (± 1 month) after delivery. The planned study duration is 40 months: - We aim to complete recruitment in around 21-24 months. - Mothers and infants will be followed-up from enrolment until the infant reaches 12 months of age. - We then expect to perform database lock within 4 months of last patient last visit. The trial database is provided through a REDCap Web-based platform comprising data collected directly from participants through participant-facing surveys (eHealth questionnaire,Vaccine Hesitancy questionnaire,Participant Trial Experience questionnaire and Questionnaire on motivations for joining the trial) and data collected through the clinical database including data entered into eCRFs at clinical sites and laboratory data. The clinical database includes the randomisation module.

Principal Investigator

Prof Manu Vatish

Contact us

Email: osprea@wrh.ox.ac.uk

IRAS number

1012051