Finnish Vaccine Trial Network Collaboration with NordicPedMed?

Transcription

1 2nd Nordic Conference on Pediatric Medicines Helsinki 21 May 2018 Finland Finnish Vaccine Trial Network Collaboration with NordicPedMed? Tampere Prof. Timo Vesikari Vaccine Research Center University of Tampere Finland Europe Finland

2 Vaccine Research Center Semiautonomous unit within the University of Tampere University of Tampere is the legal subject University gives its name added value for the operations

3 University of Tampere, Finland Vaccine Research Center Timo Vesikari, M.D., Ph.D. Professor of Virology and Pediatrics Director of Vaccine Research Center Lead Investigator Main office Biokatu Tampere, Finland Laboratory Arvo Ylpön katu 34, Arvo Building Tampere

4 University of Tampere, Finland Vaccine Research Center 10 vaccine study clinics Northern area Oulu, Kokkola, Seinäjoki Western area Tampere, Turku, Pori Helsinki area Helsinki South, Helsinki East, Espoo, Järvenpää,

5 Vaccine Research Center - Concept All operations within the framework of University of Tampere Public institution but not connected with vaccine recommendations or purchases in Finland 1. Clinical trials (sponsored by industry) Medically and scientifically justified Ethically approved 2. Basic (academic) research Main target development of nonlive norovirus-rotavirus vaccine

6 University of Tampere, Finland Vaccine Research Center Features Study clinics owned and operated by University of Tampere All staff employed by U. Tampere Study clinics are not part of any other healthcare structure, but only conduct clinical trials

7 University of Tampere, Finland Vaccine Research Center Permanent infrastructure and experienced staff Study clinics well integrated in the community and working together with well-baby clinics Friendly atmosphere, good service, high rating among customers

8 Vaccine Research Center Summer Party 2017

9 Baby No History of Vaccine Research Center REST (Merck) recruitment USA 33,998 Jamaica 1,805 Finland 23,429 Costa Rica 1,641 Germany 4,661 Mexico 1,121 Belgium 1,794 Puerto Rico 640 Sweden 625 Guatemala 350 Italy 48 Taiwan 189 Vesikari T, et al. N Engl J Med 2006;354:23-33.

10 Vaccine Research Center Number of Study Protocols

11 University of Tampere, Finland Vaccine Research Center Vaccine Portfolio o Rotavirus vaccines o MMR-V vaccines o Zoster vaccines o Hepatitis B vaccines o HPV vaccines o Pneumococcal conjugate vaccines o Meningococcal conjugate vaccines o Meningococcal B vaccines o Seasonal influenza vaccines o Pandemic H1N1 influenza vaccine o Prepandemic H5N1 vaccines o Pediatric combination vaccines o C.difficile vaccine o RSV vaccine o Maternal immunization o CMV vaccine

12 University of Tampere, Finland Vaccine Research Center Spectrum of studies Phase I adult volunteers Phase II adults and children Phase III efficacy trials in children Phase IV postlicensure studies in adults

13 Vaccine Research Center Age spectrum of the studies

14 University of Tampere, Finland Vaccine Research Center and Vaccine Trial Network Collaboration with CROs SMERUD

15 University of Tampere, Finland Vaccine Research Center Collaboration with Industry

16 Achievements of vaccine trials Clinical trials of vaccines has been a successful operation within the University framework Vaccine Research Center of U.Tampere has made significant contributions to the licensure of several important vaccines Live oral rotavirus vaccine Live intranasal influenza vaccine Adjuvanted non-live influenza vaccine Meningococcal vaccines, particularly MenB Herpes zoster vaccines

17 Licensure of RotaTeq (Merck) N Engl J Med 2006;354: REST study Paper of the Year Lancet 2007

18 Licensure of Rotarix (GSK) Lancet 2007;370:

19 Licensure of Flumist/Fluenz (MedImmune) N Engl J Med 2007;356(7):

20 Licensure of Fluad (Novartis) N Engl J Med 2011;365:

21 Licensure of Bexsero (Novartis GSK) Lancet 2013;381:

22 Licensure of VZV glycoprotein E (ge) vaccine Shingrix (GSK)

23 Vaccine Research Center Laboratory Follow-up of RV vaccination studies on gastroenteritis viruses

24 Vaccine Research Center (VRC) University of Tampere Tampere, Finland Director Timo Vesikari, MD, Prof. Vaccine Development Unit (2009) Laboratory Head: Vesna Blazevic, Ph.D. Researches: M Malm Ph.D., S Heinimäki Ph.D., K Tamminen Ph.D., (L Huhti Ph.D) Technical personnel: E Jokela, S Kaven, N Koivisto, (M Karlsberg) Main target of the research laboratory is development of a combination norovirus (NoV) + rotavirus (RV) vaccine

25 Vaccine Research Center University of Tampere We vaccinate healthy subjects, not patients What we do not do? Vaccination of pediatrics patients (children) that need expert care Possibility for collaboration with NordicPedMed

26 Vaccine Research Center University of Tampere Studies in patients/special groups Collaboration with hospitals Asthmatic children - Influenza vaccine Premature infants - RSV immunoglobulin Pregnant women (and their newborn infants) - Pertussis vaccine Influenza vaccine

27 Varicella vaccine in Europe Licensed in 1984 for high risk groups Total use in Europe 700 doses in 10 years Licensed in 1994 for healthy children Much better to vaccinate healthy children (before any serious disease)

28 Rotavirus vaccine licensed for healthy children in 2006 Studies after licensure - Premature infants - HIV infected infants - Short bowel syndrome (Severe immunodeficiency not studied)

29 Vaccine trials in special patient groups Primarily the responsibility of the hospital/physicians in charge What can Vaccine Research Center contribute - Frequent clinic visits at VRC - Blood sampling - Monitoring of side effects

30 Thank you!