Pediatric Infectious Diseases and Vaccinology

Study goal: This study aims to measure IgG anti-PT in Asian children aged 10-18 years. This will enable us to identify how many children have evidence of a recent pertussis infection defined by IgG anti-PT above 125 IU/mL and how many children are potentially susceptible to pertussis infection when exposed.

Collaborators

• Timelines: Start: Q3 or 4/2013; Duration: 24 months
• Financial support: SPMSD, Lyon, France

• Study goal: To monitor the effect of new pertussis immunization recommendations in Switzerland (adolescents, young adults, and pregnant women) on the epidemiology of pertussis in children. This will be done using assessment of hospitalizations due to pertussis in children (0-15 years of age) within the framework of the Swiss Pediatric Surveillance Unit (SPSU).
• Collaborators: Co-prinicipal investigators: Ulrich Heininger (UKBB) and Jean-Luc Richard (BAG); Further collaborators: all Swiss pediatric hospitals and units (SPSU); Laboratory analyses: IMM; Univ. of Basel
• Timelines: 01/2013 - 12/2016.
• Financial support: BAG

New Innovative Medicine Initiative (IMI) 2 project on the trail of next generation vaccines against pertussis (whooping cough) 

Despite the availability of effective prophylactic vaccines against pertussis, there has been a rise in the incidence of pertussis, with epidemics in Europe, Australia and the US in the last decade. As well as being a particular problem in vulnerable infants, with devastating consequences in developing countries, the incidence of pertussis is also increasing in adolescents and adults, particularly in industrialized countries. Hence, pertussis continues to be a major public health concern worldwide.

The pan-European initiative PERISCOPE sets out to accelerate improvement of prophylactic vaccines and vaccination strategies for pertussis. The project is funded with a total budget of €28mio over the next five years by the Innovative Medicines Initiative (IMI), a joint undertaking of the European Commission and the European Federation of Pharmaceutical Industries and Associations (EFPIA). Additionally, PERISCOPE is the first IMI project to receive funding from the Bill & Melinda Gates Foundation.

"Given the resurgence and changing epidemiology of pertussis in industrialized countries and the persistent low level of vaccination coverage and high infant mortality caused by pertussis in low income countries, PERISCOPE represents a concerted effort aiming to accelerate the development of improved vaccination strategies that ensure solid, long-lasting protection against infection", says Prof. Ronald de Groot from Radboud University Medical Center and coordinator of PERISCOPE. "This implies, first and foremost, that we need to gain a better understanding of the pathogenesis and underlying mechanisms of the infection to be able to identify novel vaccine candidates. However, it is equally important to rebuild the ecosystem for pertussis research and the technical infrastructure needed in Europe to successfully evaluate those novel candidates".

PERISCOPE will focus on three major areas:

1) Setting up a comprehensive clinical research programme to study the immune response of individuals of all ages to pertussis infection and vaccination; 2) the establishment of parallel clinical and pre-clinical models of pertussis infection, and 3) the development of a comprehensive battery of state-of-the-art bioassays, to help reveal  the markers of an effective and long-lasting immune response to pertussis infection in both clinical and preclinical study subjects. PERISCOPE will also seek to study immunization in pregnancy to gain a better understanding of the impact of maternal antibodies on the infant’s immune responses to pertussis.

In the frame of this ambitious project, Prof. Ulrich Heininger will lead workpackage 4 with the goal to facilitate interaction with experts from regulatory and public health agencies to ensure acceptance of novel and existing biomarkers and facilitate improved design of small-scale Phase II/III trials.

PERISCOPE assembles a multi-national team of leading experts from 22 partnering institutions with long-standing experience in pertussis research, clinical trials, bioinformatics, immunology and public health. The consortium also includes Sanofi Pasteur and GlaxoSmithKline, two of the world’s largest and most experienced vaccine manufacturers, as industrial partners.

Belgium

• GlaxoSmithKline
• Q-Biologicals NV
• Université libre de Bruxelles
  

Czech Republic

• Mikrobiologicky USTAV - AVCR, V.V.I.
  

Finland

• Turun Yliopisto
  

France

• Commissariat à l’énergie atomique et aux energies alternatives
• Institut Pasteur de Lille Fondation
• Sanofi Pasteur SA
  

The Gambia

• Medical Research Council
  

Germany

• Eurice GmbH
  

Ireland

• Trinity College Dublin
  

Netherlands

• Leids Universiteir Medisch Centrum
• Radboud university medical center
• Rijksinstituut voor Volksgezondheid en Milieu part of the Dutch State
  

Spain

• Universidad de Salamanca
  

Switzerland

• Universität Basel
• Hospices Cantonaux CHUV
  

UK

• The Chancellor, Masters and Scholars of the University of Oxford
• Department of Health (Public Health England)
• Imperial College of Science Technology and Medicine
• University of Bath
• University of Southampton

Name: PERISCOPE – PERtussIS COrrelates of Protection Europe
Start date: 2016-03-01
Duration: 60 months
Budget: €28mio
Coordination: Stichting Katholieke Universiteit, Radboud university medical center

Coordinator

• Radboud university medical center
• Prof. Ronald de Groot
• Email
• Phone: +31 24 366 73 47

Project Management

• Eurice - European Research and Project Office GmbH
• Dr. Claudia Schacht
• Email
• Phone: +49 30 370 44 15 831

EFPIA Coordinator

• Sanofi Pasteur
• Dr. Patricia Londoño-Hayes

More information about the project