EP456 - CAPACITY MAPPING AND BUILDING FOR PEDIATRIC VACCINE TRIALS ACROSS EUROPE WITH VACCELERATE’S HARMONIZED ASSESSMENT TOOL (ID 1429)
- Ioannis Kopsidas (Greece)
- Sanne Hofstraat (Netherlands)
- Jon Salmanton-García (Germany)
- Dimitra Kousi (Greece)
- Christos Argyropoulos (Cyprus)
- Margot Hellemans (Belgium)
- Greet Hendrickx (Belgium)
- Catherine Isitt (Sweden)
- Lotte Jonker (Netherlands)
- Salma Malik (France)
- Christina Merakou (Greece)
- Paula Valle Simon (Spain)
- Sophia Themistocleus (Cyprus)
- Camilla Tøndel (Norway)
- Theoklis Zaoutis (Greece)
- Oliver Cornely (Germany)
- Patricia C. Bruijning-Verhagen (Netherlands)
- Zoi Dorothea Pana (Cyprus)
Abstract
Backgrounds:
VACCELERATE a clinical research network for the coordination and conduct of COVID-19 vaccine trials, funded by the European Commission for future pandemic preparedness (HERA Incubator). In this framework, the European Vaccine Trial Accelerator Platform (EUVAP) is providing a continuous Europe-wide harmonized mapping of clinical trial sites for conducting COVID-19 vaccine trials. Herewith, we focus on the current readiness status of the pediatric vaccine trial sites across Europe aiming to identify future targets for capacity building.
Methods
EUVAP provides an online accessible survey at www.euvap.eu . Participating sites were sent a feasibility questionnaire (July 2021) providing information about available infrastructure and resources, previous clinical trial experience, and regulatory approval conditions. A harmonized assessment tool was developed which evaluates pediatric site readiness. Answers are scored 1-4 points and are presented using a traffic light approach.
Results:
In total 95 pediatric sites participated from 22 countries. The majority included University Hospitals (72, 75.8%). Seventy sites (73.7%) reported previous experience with pediatric clinical (non-vaccine) trials, of which most in Phase III (53, 79.1%), while only 16 (23.9%) in Phase I. Even less (48, 50.5%) reported experience with pediatric vaccine trials over the last 5 years, most of which were in Phase III (37, 77.1%) and only 6 (12.2%) in Phase I. Average readiness scores are shown in Figure1. Fast track approval for COVID-19 vaccine studies was available in 56 (58.9%) sites. In almost 1/3 of the sites(30, 31.6%) institutional review board approval takes 30 days or less.
Conclusions/Learning Points:
A significant variability in the current site readiness for pediatric vaccine trials across 22 countries was observed. EUVAP provides continuous identification of existing gaps with a standardized and harmonized assessment tool, and supports future improvement within the aims of VACCELERATE.
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