Helsinki Carriage Workshop Kirkkonummi, Finland, June 27 th -29 th, 2007

Transcription

1 Helsinki Carriage Workshop Kirkkonummi, Finland, June 27 th -29 th, 2007 Program Overview Wednesday (June 27 th ) Breakfast (7:00 a.m. 9:00 a.m.) A. Opening session (9:00 a.m. 9:30 a.m.) B. Biology of colonization (9:30 a.m. 10:30 a.m.) (10:30 a.m. 11:00 a.m.) C. Detection of multiple colonization (11:00 a.m. 12:30 p.m.) Lunch break (12:30 p.m. 2:00 p.m.) D. Problems in the analysis of pneumococcal carriage data (2:00 p.m. 5:00 p.m.) (3:30 p.m p.m.) Thursday (June 28 th ) Breakfast (7:00 a.m. 9:00 a.m.) E. Measuring the vaccine effect on colonization (part I) (9:00 a.m. 10:30 a.m.) (10:30 a.m a.m.) F. Immunology of colonization and serological correlates (11:00 a.m. 2:30 p.m.) Lunch break (12:30 p.m. 2:00 p.m.) G. Epidemiological models of pneumococcal colonization (2:30 p.m. 5:00 p.m.) (3:30 p.m p.m.) Friday (June 29 th ) Breakfast (7:00 a.m. 9:00 a.m.) H. Measuring the vaccine effect on colonization (part II) (9:00 a.m. 10:30 a.m.) (10:30 a.m a.m.) I. Using colonization and an endpoint in vaccine trials (11:00 a.m. 12:30 p.m.) Lunch break (12:30 p.m. 1:15 p.m.) J. Closing discussion (1:15 p.m. 2:00 p.m.)

2 Session A Opening sesssion Wednesday, June 27 th, 9:00 a.m. 9:30 a.m. 9:00 9:10 a.m. Opening and the PneumoCarr Overview Helena Käyhty 9:10 9:30 a.m. The Bill and Melinda Gates Foundation strategy against pneumonia Doug Holtzman Session B Biology of colonization Wednesday, June 27 th, 9:30 a.m. 10:30 p.m. Jeffrey Weiser Discussion (moderated by David Goldblatt) 10:30 11:00 a.m. Session C - Detection of multiple colonization Wednesday, June 27 th, 11:00 a.m. 12:30 p.m. Kim Mulholland During the 1930s microbiologists in Germany, using highly sensitive methods not in use today, described in great detail the patterns of pneumococcal carriage in children and adults. They described how several serotypes of pneumococci are often carried at the same time with one serotype usually being dominant. This work remained largely forgotten until recently, when the combined effects of antibiotic use, antibiotic resistance and conjugate pneumococcal vaccines have had a dramatic impact on the population biology of the pneumococcus. Now, as the impact of the vaccines on carriage emerges as a key determinant of the indirect effects of pneumococcal immunization, we are rediscovering the principles that were laid out in the work of the old microbiologists. This session will examine the possible mechanisms by which vaccines may affect pneumococcal carriage and the importance of these mechanisms on the modelling exercises being undertaken by the PneumoCarr project. Finally it will present a project that is underway to examine these effects using modern samples. (1) Worrying about multiple carriage: why and how? Marc Lipsitch (2) New methods for detection of multiple carriage Martin Antonio (3) The PneumoCarr microbiology project Catherine Satzke

3 Lunch break 12:30 2:00 p.m. Session D Problems in the analysis of pneumococcal carriage data Wednesday, June 27 th, 2:00 p.m. 5:00 p.m. Anthony Scott 2: p.m. Scene setting talks - modeling carriage and transmission from longitudinal studies 2: p.m. How to define an episode of carriage Tom Smith (20/30 min) 2: p.m. Analyses of transmission Elizabeth Halloran (20/30 min) 3:00 3:45 p.m. Presentations of new/in-process data and discussion by panel/floor (each 5/15 min) (1) Serotype competition and vaccine efficacy against colonisation Kari Auranen (2) The prevalence, duration and incidence of pneumococcal carriage by serotype in children in Kilifi District Osman Abdullahi (3) Statistical analysis of risk factors for carriage in a longitudinal study Nick Andrews (4) How can non-random cross-sectional samples of nasopharyngeal carriage be used to understand carriage dynamics in a community? Dana Bruden Panel: Marc Lipsitch 1 Deborah Lehmann 2 Christophe Fraser 3 Terhi Kilpi 4 3:45 4:00 p.m.

4 4:00 5:00 p.m. Discussion of specific issues in longitudinal data analysis (each 10/20 min) (1) Modeling competition of pneumococci between, and replacement of, serotypes within longitudinal studies of carriage Alessia Melegaro (2) How to explore and model the effect of family on pneumococcal transmission a study of Bangladeshi families Panu Erästö (3) Group-based modelling of longitudinal data Peter Jacoby Panel: Bruce Levin 1 John Mathews 2 Juhani Eskola 3 Session E Measuring the vaccine effect on colonization (part I) Thursday, June 28 th, 9:00 a.m. 10:30 p.m. Hanna Nohynek 9:00 9:30 a.m. What do we know and what do we not know of the effect pneumococcal conjugate vaccine on upper respiratory tract colonization by Streptococcus pneumoniae Kate O Brien Discussion (moderated by Hanna Nohynek) 9:30 10:30 a.m. Short presentations of new data arising from work by participants (each 5/12 min) (1) Increase in importance of Streptococcus pneumoniae serotype 19A in AOM in the absence of vaccination with PCV7 Ron Dagan (2) Absence of replacement in the presence of marked reduction in VT serotypes after primary immunization schedule with PCV7 in infants Ron Dagan (3) The impact of 11-valent pneumococcal conjugate vaccine (PCV) on nasopharyngeal carriage of Streptococcus pneumoniae in Filipino children P.Helen Mäkelä (4) PCV7 reduces total pneumococcal and PCV7-type carriage but does not affect carriage of S. aureus and H. influenzae during the 1 st year of life Ron Dagan

5 (5) Association between upper respiratory tract carriage of Staphylococcus aureus and Streptococcus pneumoniae in a cohort study of Aboriginal and non-aboriginal children in Western Australia Deborah Lehmann 10:30 11:00 a.m. Session F Immunology of colonization and serological correlates Thursday, June 28 th, 11:00 a.m. 2:30 p.m. Jukka Jokinen 11:00 11:05 a.m. Introduction to the session 11:05 11:30 a.m. Immunology of colonization David Goldblatt 11:30 12:00 a.m. Serological correlates of protection against carriage Robert Kohberger 12:00 12:15 p.m. Evidence for Non-Antibody-Mediated Protection against Pneumococcal Colonization and Disease Marc Lipsitch 12:15 12:30 p.m. Does previous pneumococcal colonization protect from new colonization in human infants? Simo Granat 12:30 2:00 p.m. Lunch Session F continues 2:00 p.m. 2:30 p.m. Panel discussion (moderated by Jukka Jokinen)

6 Session G Epidemiological models of pneumococcal colonization Thursday, June 28 th, 2:30 p.m. 5:00 p.m. Kari Auranen 2:30 3:00 p.m. Putting epidemiological modeling into the context Christophe Fraser (20/30 min) 3:00 3:15 p.m. Dynamic models of pneumococcal carriage and the impact of the Heptavalent Pneumococcal Conjugate Vaccine on invasive pneumococcal disease in England and Wales Yoon Choi (10/15 min) 3:15 3:30 p.m. Modeling drug resistance in pneumococci Ted Cohen (10/15 min) 3:30 3:45 p.m. Micro-epidemics in the carriage of Streptococcus pneumoniae Fabian Hoti (10/15 min) 3:45 4:15 p.m. 4:15 4:30 p.m. Dynamic models for the acquisition and clearance of pneumococcal serotypes in high prevalence populations John Mathews (10/15 min) 4:30 4:45 p.m. Recombination, selection and the molecular epidemiology of Streptococcus pneumoniae Bruce Levin (10/15 min) 4:45 5:00 p.m. Modeling the diversity of pneumococcal serotypes Christophe Fraser (10/15 min) Session H Measuring the vaccine effect on colonization (part II) Friday, June 29 th, 9:00 a.m. 10:30 p.m. Hanna Nohynek 9:00 9:20 a.m. Estimating indirect effects of vaccination on pneumococcal carriage Elizabeth Halloran (15/20 min) 9:20 9:35 a.m. How does the design of a study impact our understanding the vaccine effect on colonization Discussion/a critical appraisal of the pros and cons of different study designs (Moderated by Hanna Nohynek) 9:35 10:20 a.m. Presentations (each 5/12 min)

7 (1) Nasopharyngeal pneumococcal (Pnc) carriage in 1 st year of life following administration of 2 or 3 doses of PCV7 Ron Dagan (2) Inferior Immunogenicity after Primary Immunization with CRM-Conjugated 7- Valent Pneumococcal Vaccine (PCV7) Administered at 2 doses (age 4 and 6m) Compared with 3 Doses (Age 2, 4, and 6m) Noga Givon-Lavi (3) How can cross-sectional carriage studies be used along with population-based laboratory surveillance to understand the impact of vaccine introduction? Thomas Hennessy (4) Serotype replacement, where will it stop? William Hanage (5) Impact of number of doses of 7vPCV on pneumococcal carriage in Aboriginal children in Western Australia Deborah Lehmann 10:20 10:30 a.m. Discussion on the gaps in our knowledge and how we best approach these in future vaccine trials. Intention to produce a gaps list for session I. Moderator Hanna Nohynek 10:30 11:00 a.m. Session I: Using Colonization as an endpoint in vaccine trials Friday, June 29 th, 11:00 a.m. 12:30 p.m. David Goldblatt One of the deliverables for PneumoCarr is the exploration of using changes in nasopharyngeal carriage of pneumococci as an endpoint in pivotal trials of new pneumococcal vaccines. In order to realise this deliverable and in addition to the academic work being undertaken to achieve this goal, it is the desire by PneumoCarr to engage with relevant regulatory authorities and those with experience of regulatory issues related to vaccine development and licensure to develop a strategy in partnership that will lay the foundation for the acceptance of nasopharyngeal carriage as an endpoint in assessment of pneumococcal vaccines. The relevant authorities and stakeholders include the FDA, EMEA, WHO (vaccine prequalification pathway), PATH and representatives of developed and developing country manufacturers. At the Helsinki Carriage Workshop it is planned to bring these groups together as the first in a series of consultation that can put in place a roadmap that will lead to the eventual delivery of a licensing strategy based on carriage.

8 10:30: Introduction of the Pneumocarr rationale for exploring nasopharyngeal carriage as an endpoint: Ron Dagan (Pneumocarr) 11.00: Roundtable discussion starting with short presentations (Chairperson D Goldblatt): Licensing new Pneumococcal Vaccines: Are Alternative Endpoints Required and could Nasopharyngeal Carriage be one of them? Milan Blake, US FDA (15 minutes) William Hausdorff, GSK (15 minutes) Bernard Fritzell, Wyeth (15 minutes) 11.45: Roundtable Questions and Answers with extra panellists Mair Powell (MHRA) Florian Schödel (Merck) Sanjay Gurunathan (Sanofi Pasteur) Carl Frasch (independent Consultant) Ingrid Uhnoo (MPA) Keith Klugman Luciana Leite (DCVMN) 12:30 13:15 p.m. Lunch break Session J: Closing session Friday, June 29 th, 1:15 2:00 p.m Moderated by Kate O Brien