PHAC/CIHR Influenza Research Network (PCIRN) Questions & Answers
A: PCIRN is a national network of key influenza vaccine researchers from across Canada. While many of these researchers had previously been working together on pandemic vaccine preparedness, this network solidifies and expands the Canada-wide connections. It is led by the 10-member Management Committee (Principal Investigators).
Q2: What is the purpose of the network?
A: The objective of the network is to develop and test methodologies/methods related to the evaluation of pandemic influenza vaccines as they pertain to safety, immunogenicity and effectiveness, and program implementation and evaluation.
It is further expected to contribute to:
- Consolidating existing expertise in vaccine evaluation.
- Increasing the capacity to rapidly test candidate pandemic vaccines, by developing linkages and methodologies.
- Creating and strengthening links and facilitating two-way knowledge exchange amongst vaccine evaluation researchers and between vaccine evaluation researchers and decision makers.
- Training the next generation of pandemic preparedness and influenza researchers.
Q3: What role does the network play in responding to the H1N1 influenza outbreak?
A: The network is responsible for evaluating and monitoring the H1N1 vaccine when it is rolled out across Canada. The seasonal vaccine program across the country also provides opportunities to test systems such as vaccine safety monitoring, vaccine coverage, data management, and immunization programming.
Q4: Was this network created to respond to H1N1?
A: The network was created to connect research on any pandemic vaccine. The H1N1 pandemic was declared shortly after the original research grant was awarded, and immediately provided the opportunity for real time evaluation.
Q5: How is the network funded?
A: The network was created by a partnership between the Public Health Agency of Canada (PHAC) and the Canadian Institutes of Health Research (CIHR). Original funding of $10.8 million over three years was announced June 5, 2009. An additional $2.7 million over three years was announced August 27, 2009, to accelerate planning and have procedures in place to evaluate the H1N1 vaccine within the context of the declared pandemic.
Q6: What makes the network unique?
A: Rather than researchers working in isolation and possibly duplicating efforts, this network organizes the researchers to focus expertise and communications. It also provides a mechanism to rapidly change research priorities related to pandemic vaccine evaluation when faced with changing conditions.
Q7: How will the network operate?
A: There are five theme groups and three support groups, overseen by the Management Committee (Principal Investigators) and the Scientific Advisory Committee. The themes are:
- Rapid Vaccine Trials – led by Dr. David Scheifele at the BC Center for Disease Control
- Rapid Program Implementation – led by Drs. Marcia Johnson and Bob McKim at the University of Alberta
- Vaccine Coverage – led by Dr. Jeff Kwong at the Institute for Clinical Evaluative Sciences in Toronto
- Vaccine Safety – led by Dr. Gaston De Serres at l'université Laval
- Vaccine Effectiveness – led by Dr. Shelly McNeil at Dalhousie University
- Laboratory Support – led by Dr. Brian Ward at McGill University
- Information Technology Support – led by Dr. Jean Paul Collet at the University of British Columbia
- Curriculum and Knowledge Translation – led by Dr. Robert Bortolussi at Dalhousie University
- Network Management – centered at Dalhousie University and led by Dr. Scott Halperin.
Each of these themes and support groups has its own sub-network of researchers, resulting in a 'network of networks' to investigate pandemic influenza vaccine use.
Q8: When will PCIRN research on the H1N1 vaccine start?
A: PCIRN researchers will receive the vaccine for evaluation purposes at the same time as everyone else. Distribution of the H1N1 vaccine for public consumption is determined by the Public Health Agency of Canada and the vaccine manufacturer. Provincial and territorial governments distribute the vaccine within their respective jurisdictions.
Q9: What clinical trials will be conducted within PCIRN research?
A: PCIRN research will focus on rapid testing for safety and effectiveness of the H1N1 vaccine in aboriginal children and adults, adults with chronic illness, infants 6 – 35 months and adults diagnosed with HIV. The trials will take many months. The findings from this research will be submitted to scientific journals for peer review and eventual publication.
Q10: Will there be H1N1 clinical trials on pregnant women?
A: No. PCIRN research will focus on rapid testing for safety and effectiveness of the H1N1 vaccine in aboriginal children and adults, adults with chronic illness, infants 6 – 35 months and adults diagnosed with HIV.
Q11: Has vaccine evaluation of this magnitude been tried before?
A: All vaccines are continually monitored across Canada for safety and effectiveness. Since most vaccines are received in childhood, the surveillance system for predominantly paediatric diseases and vaccines is currently more developed than for adults. The IMPACT active surveillance program connects children's hospitals across the country to quickly collect data on vaccine-preventable disease cases and possible adverse events following immunization. PCIRN will initiate a similar cross-Canada network of seven adult hospitals to collect data on serious outcomes from influenza (e.g. hospitalization) in adults and possible adverse events following immunization.
Q12: Are there other H1N1 clinical trials currently underway?
A: Clinical trials on the H1N1 vaccine have already been conducted by the manufacturer. PCIRN research will examine the licensed H1N1 vaccine for safety and effectiveness in selected populations only.
Q13: How will PCIRN research be published?
A: Investigators working on PCIRN-funded activities will submit their findings to scientific journals for peer review and eventual publication. A final report will be submitted to the funders at the end of the three-year project.
Q14: How can the media contact PCIRN researchers?
A: Media requests regarding PCIRN research should go through Public Relations at the IWK Health Centre in Halifax, telephone 902-470-6740.