October 2008

In this issue:


This edition of Vaccines for the Future highlights a number of new PATH partnerships to advance the development of new vaccines against rotavirus, pneumococcus, enterotoxigenic Escherichia coli, and Shigella. In addition to adding two new vaccine candidates to our portfolio, these agreements will provide valuable research to support our work as well as access to a promising new adjuvant that may apply to many of our projects. This issue also highlights recent discussions that our influenza staff have had with key stakeholders on critical issues, including the importance of open communication around pandemic preparedness and new discoveries in the field of influenza immunity.


Additionally, we are delighted to announce the launch of an updated and redesigned Vaccine Resource Library. This online database provides access to hundreds of essential resources on vaccines, diseases, and immunization topics. As always, we welcome your feedback on our work in the vaccine development program.



John W. Boslego, MD

Director, Vaccine Development Program



PATH forms new partnership to support development of rotavirus vaccine candidate

PATH recently established a new partnership with Murdoch Childrens Research Institute (MCRI) in Australia to support the development of their rotavirus vaccine candidate, RV3. The monovalent RV3 was developed from a strain of rotavirus that was discovered in infants at a newborn nursery in Melbourne, Australia. Infants who were naturally infected with the RV3 strain had no symptoms and were protected from contracting rotavirus disease in the first three years of life. PATH is assisting MCRI in the production of clinical trial lots of RV3 under Good Manufacturing Practices (GMP) at Meridian Life Science in Memphis, Tennessee, in preparation for Phase 1 and 2 clinical trials to be conducted by MCRI. This agreement is part of PATH’s rotavirus vaccine development project.


New research to support vaccines against childhood pneumonia

New insights into how the body recognizes and fights infection may lead to better ways to protect children from pneumococcal disease, the leading cause of childhood pneumonia. In a recent study funded by PATH and the US National Institutes of Health, Drs. Richard Malley of Children’s Hospital Boston and Marc Lipsitch of the Harvard School of Public Health identified T-cells that protect against pneumococcal infection in the nose—where the bacteria first enter the body. This discovery could lead researchers to identify more promising new vaccine candidates by measuring the level of T-cell immunity they cause, which may be more effective than protective antibodies alone. PATH’s pneumococcal vaccine project is also working with Children’s Hospital Boston to develop an inactivated whole cell vaccine against pneumococcal bacteria, which induces a strong T-cell response in preclinical studies in mice. If successful, the vaccine could provide broad protection for children throughout the developing world.


In addition, PATH recently signed two new research agreements to support its work on pneumococcal vaccine development. PATH is partnering with the University of Alabama at Birmingham to develop new technologies for identifying pneumococcal disease in patients. The project will focus on identifying a pneumococcal surface antigen, PcpA, in body fluids—first in mice and then in humans. More efficient diagnostic tests will lead to faster and more effective treatment of patients. PATH is also working in collaboration with Emory University, the US Centers for Disease Control and Prevention, the University of Alabama at Birmingham, and New York University to establish a comprehensive, geographically diverse collection of pneumococcal strains that cause disease in children. This strain bank will aid laboratory testing of vaccine candidates by the pneumococcal research community.


PATH joins discussion with Indonesian delegation on avian influenza

Staff from PATH’s influenza vaccine project recently met with Indonesian government officials to discuss avian influenza and learn about their efforts to prevent and control the spread of the virus. Since 2005, Indonesia has reported 135 human cases of avian influenza. With the ongoing spread of the H5N1 virus strain among avian species and the continued recognition of human cases, it is vital to communicate openly about efforts to combat avian influenza in order to prepare for a possible pandemic. Drs. Kathy Neuzil and Anton Luchitsky of PATH and Dr. Justin Ortiz of the University of Washington updated the delegation on PATH’s work in pandemic preparedness, including the development of new vaccines against avian influenza. The Indonesian delegation, which included members of the Ministry of Health and Department of Agriculture, provided the US participants with information on their pandemic preparedness strategy and answered questions on H5N1 in Indonesia.


New collaborations to develop and support vaccine candidates against diarrheal disease

PATH’s enteric vaccine project recently formed a variety of new partnerships to expand its work on vaccines against the leading bacterial causes of diarrheal disease, Shigella and enterotoxigenic Escherichia coli (ETEC). PATH and EndoBiologics, Inc. in Missoula, Montana, are collaborating on novel conjugate vaccine candidates against Shigella that may provide broad-spectrum protection against the bacteria. The partnership will advance EndoBiologics’s preclinical research on process development, mucosal immunization, and evaluation of novel antigens for potential protection in animal models. PATH also entered into a license agreement with Tulane University in New Orleans, Louisiana, to develop the double mutant heat-labile toxin (dmLT) adjuvant, LTR192G/L211A. This is an ETEC antigen that may offer protection against both diarrhea and intestinal infection. LT is also one of the most effective mucosal adjuvants known. Due to its improved attenuation, the dmLT could provide a breakthrough in mucosal adjuvants and may be tested in conjunction with a number of candidates in PATH’s vaccine portfolio.


In addition, PATH has signed new research agreements to support the development of enteric vaccines for the developing world. In partnership with Johns Hopkins University in Baltimore, Maryland, PATH will conduct studies to refine an ETEC challenge model for assessing the protective efficacy of candidate vaccines. These studies should provide more information about protective immune responses and enable the use of a lower ETEC challenge dose in future clinical studies. In addition, PATH is collaborating with the Bioproduction Facility at Walter Reed Army Institute of Research in Silver Spring, Maryland, on the provision of antigens, vaccine and adjuvant pilot lots, and bacterial challenge organisms.


PATH chairs meeting on immune responses to influenza virus

Dr. Rick Bright, scientific director for PATH’s influenza vaccine project, recently served as chairman of a World Health Organization (WHO) meeting on the role immunity to neuraminidase (NA) has in preventing influenza infection. In recent studies, antibodies to NA from seasonal H1N1 influenza viruses have been found to elicit immune responses that cross-react against avian influenza H5N1 strains. Dr. Bright led the participants in a discussion about the current status of research on immune responses elicited by NA, as well as new approaches in the development of simpler and reproducible assays for detecting anti-NA immunity. The participants also prioritized activities for the standardization of immunological assays.


The meeting, sponsored by WHO’s Initiative for Vaccine Research, was held on September 14 in conjunction with the 3rd European Influenza Conference in Vilamoura, Portugal. Dr. Kathy Neuzil, director of PATH’s influenza vaccine project, served as rapporteur for the meeting. Drs. Neuzil and Bright will summarize the discussion in an upcoming manuscript to be submitted for publication in a peer-reviewed journal.


Immunization resources at your fingertips

PATH recently launched an updated and redesigned Vaccine Resource Library (VRL) that provides users with a one-stop shop for essential resources on vaccines and immunization. The VRL offers a comprehensive online database of high-quality, scientifically accurate documents for many different audiences—from public health officials in developing countries wondering how best to introduce new vaccines, to parents with questions about immunization schedules. With content from the World Health Organization, the US Centers for Disease Control and Prevention, UNICEF, PATH, and many others, the VRL is a user-friendly site that makes it easy to find for a variety of vaccine-related resources. The library contains information on general immunization topics, such as injection safety and immunization financing, as well as an in depth look at a range of specific diseases, such as rotavirus, pneumococcus, influenza, and more.


Experts gather to discuss investing in global health

PATH co-sponsored an event in September with the Institute of Medicine (IOM) of the National Academies on US Interests and Investments in Global Health which explored key topics in global health today. The lively panel discussion covered a range of issues, including global health spending and how it contributes to security and economic growth, how investments in research will generate new tools for saving lives, the importance of wise policy choices to ensure investments have optimal public health impact, and how the rapid urbanization of communities in sub-Saharan Africa affects delivery of health services. The panel was moderated by Ambassador Thomas Pickering (retired), co-chair of an IOM committee on the US commitment to global health. Panelists included Dr. Alex Ezeh of the African Population and Health Research Center (also a member of PATH’s Board of Directors), Dr. Christopher Elias of PATH, Dr. Harvey Fineberg of the US Institute of Medicine, and US Congresswoman Nita Lowey. During the discussion period, the audience raised several important points, including whether economic challenges in the US will affect global health investments, if enough attention is focused on mental health and chronic health conditions, and how the US can better support research capacity in low-income countries. The event was held at the Marian Koshland Science Museum in Washington, DC, which features a special exhibit called Infectious Disease: Evolving Challenges to Human Health.


Upcoming conferences and events

·         6th Annual Vaccines: “All Things Considered” Conference, Washington, DC, November 13 to 14, 2008. This conference is a key gathering for updates on all aspects of vaccine research, development, regulations, and policy. Leaders in government, industry, and nongovernmental organizations will cover topics ranging from new vaccine technologies to regulatory policies.

·         Developing Country Vaccine Manufacturers Network Meeting, Cape Town, South Africa, November 17 to 19, 2008. This conference brings together vaccine manufacturers from developing countries that are currently involved in vaccine development. Participating manufacturers will learn about new vaccine-development efforts, advances in the field, and potential collaboration efforts, among other important topics. Dr. Richard Walker, director of PATH’s enteric vaccine project, will present on PATH’s vaccine development program and potential areas for collaboration with developing-country manufacturers.

·         24th International Federation of Pharmaceutical Manufacturers and Associations Assembly, Washington, DC, November 18 to 19, 2008. This biennial meeting is a premier event for the research-based pharmaceutical industry, bringing together company chief executives, senior industry executives and the heads of national pharmaceutical industry associations around the world. This year’s event will address the theme “Improving Global Health Outcomes through Innovation and Better Access.” Dr. John Boslego, director of PATH’s vaccine development program, will represent PATH at the meeting.

·         Vaccine 2nd Global Congress, Boston, MA, December 7 to 9, 2008. This international congress, organized by the journal Vaccine, serves as an interface between academics, regulatory and governmental agencies, nonprofits, and health and industry professionals working in the field of vaccinology. The congress aims to move forward the development of vaccines by providing participants with access to high-quality speakers and topics, as well as the ability to network with delegates from more than 30 countries.

·         Phacilitate Vaccine Forum, Washington, DC, January 26 to 28, 2009. This conference features a mix of business, regulatory, investment, and public policy topics. The forum provides an opportunity to hear from vaccine-development companies, government agencies, and nongovernmental organizations (NGOs), as well as network with key stakeholders in the vaccine industry. Dr. John Boslego will participate in the joint NGO-industry-regulator presentation and panel discussion that will analyze how these groups can work together to successfully produce vaccines for the developing world.


Job opportunities

PATH’s vaccine development program has several open positions listed below. Please visit the employment opportunity web page for all open PATH positions.

·         Senior scientist/project manager

·         Communications associate


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 Escherichia coli), 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 Program. Additionally, PATH works to ensure the worldwide availability of vaccines through its Immunization Solutions program. The work of the vaccine development program is currently supported by grants from the Bill & Melinda Gates Foundation.


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