I’m pleased to share the latest issue of Vaccines for the Future,
which highlights a number of exciting updates from PATH’s vaccine development program. We highlight new funding to assess non-replicating rotavirus vaccine candidates, as well as new results from a Phase 2b study of an enterotoxigenic Escherichia coli vaccine candidate. In addition, we are pleased to announce new partnerships for our pneumococcal and influenza vaccine projects, along with updates from our diarrhea advocacy work in Asia and our projects’ scientific advisory boards. Finally, we include a new section devoted to recent scientific articles that our staff members have contributed to, as well as our usual updates on PATH’s Vaccine Resource Library, upcoming conferences and events, and current job opportunities.
I would also like to take this opportunity to congratulate the Meningitis Vaccine Project, a partnership between PATH and the World Health Organization, on their recent successful introduction of MenAfriVac™,
the first vaccine designed specifically for Africa. Developed at less than one-tenth the cost of a typical new vaccine and priced at less than US$0.50 per dose, MenAfriVac™ is a highly affordable solution to one of the region’s biggest health problems, epidemic meningococcal A meningitis. The vaccine was developed through a groundbreaking partnership that included the Indian vaccine manufacturer, Serum Institute of India, Ltd., who is also one of our partners on the pneumococcal vaccine project.
We hope you continue to find this newsletter useful and informative and, as always, we welcome your feedback.
John W. Boslego, MD
Director,Vaccine Development Global Program
PATH receives funding to assess new rotavirus vaccine candidates
PATH’s vaccine development program recently broadened its scope with a new grant from the Bill & Melinda Gates Foundation for US$989,356 over two years to assess non-replicating rotavirus vaccine (NRRV) candidates. Several organizations have been developing NRRVs, but none have been evaluated in humans yet. Last year, PATH conducted a landscape analysis of NRRV approaches currently in development and convened an expert discussion to review the results. Based on this research, two candidates (virus-like particles and inactivated rotavirus) were initially identified for possible advancement to proof-of-concept clinical studies. Recently, additional candidates have also been identified. This project will serve as a planning step to confirm that process development, manufacture under current Good Manufacturing Practices, and early clinical development are warranted and
feasible for selected NRRV candidates. If so, PATH will also begin preparatory activities for the advancement of one or more candidates into preclinical and clinical development.
Encouraging trial results for a vaccine candidate against a leading cause of diarrhea
The initial findings from a Phase 2b challenge study of an oral enterotoxigenic Escherichia coli
(ETEC) vaccine candidate, ACE527, indicate that it had an overall positive impact on the reduction of disease incidence and severity as well as shedding of the challenge organism. However, the primary endpoint for the study, to significantly reduce the incidence of moderate to severe diarrhea, was not met. This live, attenuated whole cell vaccine candidate, developed by the Danish biotechnology company TD Vaccines, is comprised of three ETEC strains and was tested in 56 adult volunteers at Johns Hopkins University’s Center for Immunization Research in Baltimore, Maryland. PATH’s enteric vaccine project
funded the trial, and the complete data analysis is expected to be available in February 2011.
Mekong regional health leaders convene to discuss diarrhea control
In partnership with the Vietnam Ministry of Health and the National Pediatric Hospital of Vietnam, PATH hosted a regional workshop
to highlight solutions available for defeating diarrheal disease. Policymakers and health officials shared evidence and lessons learned from projects that are bringing proven interventions to vulnerable communities, including PATH’s work in Vietnam to implement an integrated approach to diarrheal disease control. The workshop was funded in part by PATH’s enteric vaccine project
and featured robust discussions on the role of vaccines within diarrhea control programming, including vaccines against cholera and rotavirus.
New partnership to advance research on pneumococcal protein vaccines
PATH’s pneumococcal vaccine project
recently entered into a preclinical research agreement with University College London to prioritize antigens for inclusion in pneumococcal protein vaccines. Under the agreement, the partners will evaluate the antibody response to pneumococcal proteins in human sera from diverse geographical regions. Data generated through the characterization of immunodominant antibody responses as part of this project could help advance the pneumococcal vaccine field and provide valuable insights into the design of future pneumococcal protein vaccines to meet needs in the developing world.
Vietnamese vaccine manufacturer and PATH collaborate to expand influenza vaccine resources
PATH recently formed a new partnership with the Institute of Vaccines and Medical Biologicals
(IVAC) of Vietnam to help enhance sustainable influenza vaccine production in the country as part of a US$7.9 million project
funded in full by the US Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA). IVAC, a state-run developer and producer of vaccines and other biological products, recently completed construction of a new influenza vaccine manufacturing facility with support from the World Health Organization (WHO) and other international partners prior to this project. Under the new collaboration agreement, PATH and IVAC are working together to prepare this facility for the production of influenza vaccines that meet international quality standards. Ultimately, the partners aim to advance an influenza vaccine candidate into clinical evaluation as part of a larger effort to increase local and regional vaccine supplies and to improve real-time response capacity in influenza outbreaks. The collaboration builds upon support that BARDA is providing to
the WHO to help vaccine manufacturers in low- and middle-resource countries prepare for eventual licensure and commercial-scale manufacturing of influenza vaccines.
PATH’s vaccine development projects add new members to their scientific advisory boards
Scientific advisory boards, comprised of key experts in their fields, provide strategic guidance to several of PATH’s vaccine development projects. Board members play a key role in shaping project portfolios, meeting regularly to provide input on prioritizing technologies, reviewing data and progress, and providing strategic recommendations. PATH greatly appreciates the support provided by these experts and recently welcomed new members to the scientific advisory boards for its pneumococcal vaccine project,
enteric vaccine project, and influenza vaccine project.
Recent scientific publications
A number of staff from PATH’s vaccine development program recently contributed to new scientific publications, including the following articles:
- Development of strategies to overcome barriers to effective mucosal immunization of infants in developing countries
(PDF) provides a summary of the discussions at a workshop hosted by the Old Herborn University Foundation in June 2010 to examine the mechanisms that may contribute to the poor response of infants in developing countries to oral vaccines. Drs. Richard Walker, A. Louis Bourgeois, and Lillian Van De Verg authored this article that appeared in the Old Herborn University Seminar Monograph (PDF), which includes several papers focused on specific workshop topics.
- GMP-grade pneumococcal whole-cell vaccine injected subcutaneously protects mice from nasopharyngeal colonization and fatal aspiration-sepsis
details research conducted at Children’s Hospital Boston with support from PATH to determine the performance of subcutaneous injection of pneumococcal whole-cell vaccine in preclinical studies. Dr. Mark Alderson, Andi Tate, Dr. Jean-Francois Maisonneuve, and Dr. George Robertson co-authored this article, which appeared in Vaccine.
Options for inactivation, adjuvant, and route of topical administration of a killed, unencapsulated pneumococcal whole-cell vaccine describes research conducted at Children’s Hospital Boston with support from PATH showing that killing cells of a noncapsulated strain of Streptococcus pneumoniae with chloroform, tricholorethylene, or beta-propiolactone contributed to the protectiveness of a pneumococcal whole-cell vaccine candidate in preclinical studies. Dr. Mark Alderson, Andi Tate, Dr. Jean-Francois Maisonneuve, and Dr. George Robertson co-authored this article, published in
Clinical and Vaccine Immunology.
- Outpatient upper respiratory tract viral infections in children with malaria symptoms in Western Kenya
describes a cross-sectional study conducted in Kenya’s Nyanza Province to investigate the burden of viral respiratory disease, including influenza, in malaria-endemic populations, specifically in children five through ten years of age. Dr. Kathleen Neuzil was among the co-authors for this article, which appeared in the American Journal of Tropical Medicine and Hygiene.
- PATH pneumococcal vaccine project
provides an overview of this project’s work partnering with public- and private-sector collaborators to accelerate the development of pneumococcal vaccines that can be effective, affordable, and accessible for children in low-resource countries. Dr. Mark Alderson, Dr. Jean-Francois Maisonneuve, Lauren Newhouse, and Dr. John Boslego authored this article, which appeared in Pediatric Health.
New on PATH’s Vaccine Resource Library
Recent additions to PATH’s Vaccine Resource Library include:
Upcoming conferences and events
- Vaccine World Summit India, New Delhi, India, March 1 to 3.
This conference aims to bring together the Indian vaccine community in order to provide a platform to showcase new innovations, exchange ideas, and form partnerships to create next-generation technologies. The key topics at the conference will include novel adjuvants and delivery systems, vaccine regulations in India, and technology transfer opportunities among leading vaccine institutions.
- BIT Life Sciences’ 3rd Annual World Vaccine Congress, Beijing, China, March 23 to 25.
This event will include more than 400 sessions in 12 tracks covering a range of topics in science, technology, business, economics, and policy related to vaccines. Dr. Richard Walker, director of PATH’s enteric vaccine project, will present on “Recent progress in developing vaccines against diarrhea caused by ETEC,” and Dr. Mark Alderson, director of PATH’s pneumococcal vaccine project, will present on “New pneumococcal vaccines: protein, conjugate, and hybrid vaccine strategies.”
- Immunopotentiators in Modern Vaccines, Porto, Portugal, April 6 to 8.
Bringing together researchers and manufacturers, this conference will provide an international forum to review the current state of research and development of immunopotentiators and adjuvants for modern vaccines. Topics for the conference sessions include immunological mechanisms underlying adjuvant activity, host-derived immunopotentiators, and mucosal adjuvants, as well as pharmaceutical topics and regulatory issues.
PATH’s vaccine development program has several open positions listed below. Please visit the employment opportunity web page for all open PATH positions.
View past issues of Vaccines for the Future
PATH’s vaccine development program is working to accelerate the development of innovative, safe, effective, and affordable vaccines against the leading causes of childhood deaths in the developing world, pneumonia (pneumococcal disease) and diarrheal disease (rotavirus, Shigella, and enterotoxigenic
), as well as new influenza vaccines for the global population. PATH is also partnering on vaccine development through its Malaria Vaccine Initiative and the Meningitis Vaccine Project. Additionally, PATH works to ensure the worldwide availability of vaccines through its vaccine access and delivery program. The work of the vaccine development program is currently supported by grants from the Bill & Melinda Gates Foundation, the US Department of Health and Human Services, and the United Kingdom’s Department for International Development. Some projects within the vaccine development program are funded by PATH Vaccine Solutions.
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