FORM RESPONSES - EXPRESSION OF INTEREST, December 10, 2014
1.1. Introduction
The Canadian Immunization Research Network (CIRN) has assembled a team of Canadian researchers to respond
to this initiative. The team provides a range of experience and expertise, including clinical trials, modeling,
epidemiology, social science and policy, and laboratory. As an established network with existing infrastructures,
CIRN has both the scientific and administrative capabilities for a rapid research response.
1.2. Experience and expertise conducting international vaccine clinical trials
The CIRN team, and specifically the CIRN Clinical Trials Network (CTN) has extensive expertise in clinical trial
design, methodology and performance including the PI for Clinical Trials (Joanne Langley) and members Dr. Shelly
McNeil, Dr. Allison McGeer, Dr. Scott Halperin, Dr. Brian Ward and Dr. Caroline Quach, each of whom lead active
clinical trial sites within their own institution. The CTN, which comprises 10 clinical trial sites in six provinces, has
designed and performed eight trials in its first four years, including rapid trials the provided data for public health
decision makers. Drs. Langley, Halperin, McGeer, and McNeil have actively participated in multiple international
clinical trials in developed countries. Between between1989-2009, Dr. Ward contributed to high and standardtiter measles-containing vaccine trials in Haiti, Peru, and Sudan.
As Principal Investigator of the mathematical modeling component of the NIH funded HIV Prevention Trial (HPTN),
Dr. Marie-Claude Boily lends practical expertise using models to support the design and analyses of randomized
and non-randomized evaluation of prevention interventions. Similarly, Dr. Benoît R Mâsse, is a collaborator on the
research agenda of the HIV Vaccine Trials Network (HVTN) as well as the aforementioned HPTN, working closely
with the investigators of each network as well as acting as lead biostatistician on many of the vaccine and
prevention clinical trials. Currently, Dr. Mâsse is developing a mathematical model for the assessment of immune
correlates of protection in the HVTN HIV vaccine efficacy trials to be initiated soon in South Africa.
Dr. Cécile Tremblay is involved with Ebola preparedness and is also the University of Montréal Chair on HIV
translational research. She brings with her an expertise in virology capacity building in West Africa, and
conducting clinical trials, having recently conducted an influenza vaccine trial among HIV-infected individuals
during the H1N1 pandemic.
1.3. Experience carrying out clinical research in resource-limited areas
In addition to the international clinical trial experience described above, CIRN applicants have undertaken
additional clinical research in resource-limited areas. Most of the aforementioned work carried out by Dr. Mâsse
focuses on developing countries and is carried out through international collaborations. Dr. Mâsse has worked on
large interdisciplinary projects with clinicians, epidemiologists, and social scientists in India, Zimbabwe, South
Africa, Benin, and Senegal.
Dr. Shelly Bolotin has carried out several studies related to HIV and tuberculosis in Zimbabwe, and studies relating
to quinolone resistance and yaws in Guyana. While working on these studies Dr. Bolotin lived in the local
communities and was the primary researcher in charge of data collection. Dr. Peter Daley conducted research full
time in India for over three years at a tertiary care center (CMC Vellore). Dr. Daley’s many roles included design,
granting, staff appointment, consent design, lab protocols, ethics, ethics compliance, analysis, and manuscript
writing.
Dr. Natasha Crowcroft is an epidemiologist who has worked with the World Health Organization in determining
methods to assess mortality from vaccine preventable diseases in developing countries. Her PhD student and
member of the team, Jordan Tustin, just left for Guinea when the RFA was announced and was unable to provide
her curriculum vitae for the application because of lack of internet access.
Dr. Soren Gantt has over fifteen years experience working in sub-Saharan Africa. Dr. Gantt has led numerous
prospective cohort studies in Zimbabwe, Mozambique, and Uganda, all of which involved blood and case report
form data collection, as well as laboratory testing both in-country and in North America.
Dr. Janice Graham has been working in West Africa on vaccine issues with the Ministry of Health in Burkina Faso
for the past eight years and is currently working as a medical anthropologist with a clinical research team there.
Dr. Allison McGeer has worked on the outbreak investigation of MERS in eastern Saudi Arabia and is currently
working with two groups in Liberia on research projects related to the Ebola outbreak.
Dr. Salah Mahmud, Canada has participated in randomized controlled trials in several developing countries. His
study in Kenya focused on aspirin among HIV patients, and in India he developed interventions working to reduce
HIV transmissions among female sex workers. Dr. Mahmud also worked on a randomized, controlled trial in the
Congo involving HPV screening using visual methods.
Dr. Tremblay has had involvement in several studies conducted in West Africa, including cohort studies of female
sex workers and antiretroviral therapy, and Dr. Ward has more than thirty years of translational research
experience (including setting up laboratory capacity) in Peru, Haiti, Sudan, Zimbawe, and Venezuela.
1.4. Experience in building capacity in resource-limited areas
CIRN applicants have been involved in capacity building associated with many of the projects they have
undertaken in resource-limited areas, including education of local health care providers and researchers,
establishing laboratories that remain after completion of the trial and technology transfer.
Dr. Boily has organized and delivered workshops in India and Africa in mathematical modeling.
Dr. Marc Brisson is a member of the WHO Advisory Committee on Immunization and Vaccines-related
Implementation Research, and has worked on mathematical models of vaccination impact in low-income
countries for the organization.
Dr. Joanne Langley has taught pediatric infectious diseases clinical skills in China as part of a project through the
University of British Columbia. She has also contributed to local non-medical work in subsidized housing
communities in Halifax, Nova Scotia.
In Zimbabwe, Dr. Bolotin worked extensively to develop local capacity, which involved basic epidemiology training
for the local staff, as well as developing a database for HIV patients at the Howard Hospital. Dr. Bolotin also led a
CIDA application aimed at improving tuberculosis diagnostics at the hospital. Dr. Daley was part of an initiative in
India for the Infectious Diseases Training and Research Center, which was developed with Norwegian funding and
collaboration. Dr. Gantt helped to establish all of the research sites in Africa where he has conducted work.
Dr. Mahmud has assembled and trained several research teams in Libya and Egypt and built computer systems for
use in low-resources areas. Dr. Tremblay has been involved as a consultant for President's Emergency Plan for
AIDS Relief (PEPFAR) in capacity building in Tanzania and Uganda, as well as contributing to the development of
an STI laboratory in Cotonou, Bénin. Dr. Halperin has been involved in onsite vaccine education activities and
providing programmatic advice to Ministries of Health in a number of middle income countries in South and
Central America.
1.4. Capacity and plans for the team to understand and examine public health, cultural and social issues tied to
the setup and implementation of their Ebola clinical trial in West Africa
Currently CIRN's Social Sciences and Humanities Network (SSH) is actively conducting research in the areas of
public health and cultural and social issues. Dr. Eve Dubé is an anthropologist and the lead investigator for the SSH
and has expertise in ethical issues in public health. Dr. Janice Graham, also an investigator in the SSH, currently
works as a medical anthropologist with a clinical research team in Burkina Faso. The named CIRN anthropologists
and other CIRN social scientists who will be included at the time of the full application will examine and
understand the role of Canadian technology in response to this emerging pathogen, the regional crisis that it has
caused and the global response to that crisis. The urgent nature of this vaccine’s clinical trial research in light of
the current Ebola crisis in West Africa requires anthropological expertise and a high level sensitivity to West
African socio-cultural, environmental and political circumstances as well as coordination and integration with the
other countries carrying out clinical trials. This is a unique opportunity to study a Canadian vaccine innovation
through to its implementation and explore its humanitarian contribution to global health. Of additional interest is
whether expertise and infrastructure brought to countries with limited health care resources by these trials might
serve to build a platform for capacity and capabilities for more sustainable health systems. A number of potential
social science questions could be addressed including: how will criteria for AEFIs be developed, reported and
monitored in such an emergency; how does the Phase 1 trial conducted in Canada compare to the Phase 2/3 trials
in West Africa in terms of exclusion/inclusion criteria; how will ethical issues concerning clinical equipoise play out
on the ground in such an emergency; how will the clinical trials be perceived by communities when resources are
focused on Ebola related priorities to the exclusion of other local health priorities; will the ability to participate in
the clinical trial be perceived as a benefit not available to all, and how will communities be engaged to determine
enrollment priorities; how will traditional and local healers be engaged; how will community priorities for capacity
building and legacies from the trial be considered. The specifics of the social science issues to be addressed will
require engagement of the local teams and communities and must be a priority as the Canadian team integrates
with its international partners.
1.5. Ability of the team to conduct research in a French environment
Of the twenty seven members listed on this team, six applicants are Francophone (primary language French) and
bilingual (English). Three additional investigators are Anglophone but full bilingual in French. An additional 4
investigators have a working ability in French and 5 more have some limited capacity to speak/read/understand
French. Only 8 members of the team have no French capability.
1.6. Ability to develop communication plans to effectively inform relevant stakeholders
CIRN currently has an operating communications plan which will be leveraged to include any requirements
associated with this additional project. The current communications plan encompasses requirements for all
stakeholder communications including network investigators and trainees, public health, institutions, industry,
media, and the public. Since CIRN was designed to be open and inclusive, most of the communications methods
have been designed (and are required) to work for multiple audiences. CIRN conducts Knowledge Translation in a
variety of media tools, including our network website, social media accounts (Twitter, Facebook), monthly
newsletters, annual report, and an annual meeting.