Rotavirus Vaccine Clinical Trial
Underway
The Rotavirus
Vaccine Program (RVP) is pleased to announce that our collaborators,
International Center for Diarrhoeal Disease Research, Bangladesh
(ICDDR,B) and GlaxoSmithKline Biologicals (GSK), have initiated a
Phase II immunogenicity trial of GSK's Rotarix™ in Bangladesh. With
financial support from RVP, ICDDR,B has initiated recruitment for
this 300-subject trial to evaluate the immunogenicity,
reactogenicity, and safety of two doses of Rotarix™ vaccine when
given concomitantly with OPV versus when given alone in healthy
infants in Bangladesh. This is a one-year study, with results
expected in mid-2006.
Rotavirus Surveillance Activities
Expanding Worldwide
Concern about
rotavirus and interest in rotavirus vaccines are growing rapidly
around the world. In recent months RVP, in partnership with the
World Health Organization (WHO) and the US Centers for Disease
Control and Prevention (CDC), has been sponsoring workshops that
will lead to a greater number of countries conducting rotavirus
surveillance. These expanded surveillance networks will contribute
vital information to assist countries, donors, and manufacturers in
the vaccine decision-making process.
- Africa – In May, representatives from 14 countries
attended a workshop in Accra, Ghana, to learn more about setting
up surveillance systems. Already a number of countries are
conducting rotavirus surveillance in Africa, and more are
expected.
- Newly Independent States/Eastern European Region –
Approximately 80 participants from Armenia, Azerbaijan,
Kazakhstan, Tajikistan, Ukraine, and Uzbekistan attended a meeting
on rotavirus surveillance in Tashkent, Uzbekistan. Since then
several countries in the region have submitted surveillance
proposals.
- Eastern Mediterranean – The first meeting of the
Eastern Mediterranean Regional Working Group (EMRWG) for rotavirus
surveillance was held in Cairo on April 25-26 to review country
proposals for establishing sentinel site rotavirus surveillance
and to agree on technical and financial issues related to
establishing the regional rotavirus surveillance network. As a
result of this meeting, proposals are moving forward to initiate
surveillance projects in Egypt, Iran, Morocco, Pakistan, and
Tunisia.
These new surveillance sites join existing
rotavirus networks in Asia and Latin America. RVP is excited by all
of this interest and activity and looks forward to a prosperous
relationship with all of the countries and participants.
Rotavirus Outbreak in Central
America Leads to Collaboration
As reported
previously, several Central American countries faced significant
outbreaks of rotavirus earlier this year. In May, PATH staff visited
Nicaragua and met with several organizations to exchange information
about rotavirus in Nicaragua and the region, discuss approaches to
management, and gauge receptiveness to rotavirus vaccines.
The team met with officials from the Nicaraguan Ministry of
Health; PAHO; UNICEF; the University in Leon; and NICASALUD, a large
nongovernmental organization in Managua. A strong sense of
collaboration emerged from these meetings, and RVP hopes to be
working with several of these organizations to build awareness of
the disease, the vaccine, and approaches to management of diarrheal
disease.
Similar meetings will be held in other Latin
American countries in the coming months.
2005: Already a Very Busy
Year
Since its
establishment two years ago, RVP has established vital partnerships
with institutions around the world to conduct rotavirus
surveillance, cost-effectiveness studies, and other relevant
research. So far, more than 50 contracts have been signed with
collaborators. Through these arrangements, RVP is developing
information resources that will assist decision-makers in
effectively prioritizing rotavirus vaccines. The following are just
a few of the partnerships established in 2005:
- Aga Khan University, Pakistan – The University will be
conducting hospital-based surveillance of rotavirus among children
in Pakistan, demonstrating the economic impact of the rotavirus
illness, and comparing existing interventions for control of
diarrhea with rotavirus immunization.
- Chinese Center for Disease Control, China – RVP is
supporting the 2nd annual Chinese CDC rotavirus workshop to be
held in Beijing on July 11-12, 2005. The agenda includes
discussion of rotavirus burden in China and vaccine development
and use.
- Emory University, USA – Emory is developing
cost-effectiveness (CE) models, evaluating the impact of
vaccination on mortality reduction, collecting data on costs of
disease, harmonizing rotavirus and pneumococcal CE models, and
comparing CE of three diarrheal interventions.
- International Center for Diarrhoeal Disease Research
(ICDDR,B), Bangladesh – In addition to the clinical trial
mentioned above, ICDDR,B will be conducting hospital-based
surveillance of rotavirus among children and cost analysis in
Bangladesh.
- Ministry of Public Health, Thailand – The Thailand
Ministry is conducting hospital-based surveillance of rotavirus
among children under five years of age in Thailand.
- University of Malawi, Malawi – The University of Malawi
is working with collaborating institutions to implement a national
survey on health care utilization patterns and the cost of
childhood diarrhea and pneumonia in Malawi.
- TNS India Pvt. Ltd., India – TNS India is gathering
information in India on current public health provider knowledge
and attitudes about diarrheal disease and vaccines, which will
contribute to appropriate and effective strategies for rotavirus
advocacy and training interventions.
Rotavirus Audience Research
Underway
Critical to the
introduction of rotavirus vaccines is the development of social
mobilization, advocacy, and communication tools that will reach,
resonate with, and motivate key audiences in various countries and
regions around the world. To do so, these tools need to accurately
reflect local perceptions, knowledge, practices, and culture.
RVP is conducting audience research in select
countries—India, Indonesia, Thailand, Nicaragua, and Ukraine—through
focus groups and key informant interviews with local health workers
and ministry of health officials. The research focuses on knowledge,
attitudes, and practices regarding diarrheal disease management in
general and awareness of rotavirus specifically. RVP will use the
results of this research to create effective and appropriate
messages and communication strategies for developing disease
awareness and vaccine introduction efforts. Results should be
available by October.
© 2004-2005, Rotavirus Vaccine Program.
The Rotavirus Vaccine Program is a limited liability company
of PATH.
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