October 2009

In this issue:

 

The latest issue of Vaccines for the Future features news about PATH’s collaborations to advance the development of vaccines against pneumococcus and influenza. We are also excited to share new data that confirms the use of a lower human challenge model dose of enterotoxigenic Escherichia coli, which will help more accurately evaluate vaccine candidates against the disease. Additionally, we highlight new disease burden data for pneumococcus, recent contributions to influenza literature by PATH staff, and meetings in China that featured our work on new rotavirus vaccines.

This edition also spotlights Project Optimize, a PATH and World Health Organization collaboration that aims to help define the ideal characteristics and specifications for future vaccines as well as develop appropriate supply chains. We also include our regular updates on upcoming conferences and events and current employment opportunities at PATH. We hope you continue to find our updates useful and informative, and we always welcome your feedback.

 

Sincerely,

John W. Boslego, MD

Director, Vaccine Development Program

PATH

 

PATH research collaborations support vaccine development against pneumococcal disease

With the help of funding from PATH’s pneumococcal vaccine project, the US National Institute of Standards and Technology (NIST) recently completed the development of new, efficient software that is designed to aid in the development of vaccines against Streptococcus pneumoniae. NIST’s Integrated Colony Enumerator (NICE) software was developed in collaboration with the University of Alabama at Birmingham as a tool for counting pneumococcal bacteria colonies cultured in human serum and white blood cells after vaccination in order to assess the degree to which antibodies kill the bacteria. NICE is open source, automated, standardized, and usable on any common imaging device, making it more precise than current manual counting methods and appropriate for distribution and use in developing countries.

 

PATH’s pneumococcal vaccine project also entered into a new research agreement with Purdue University in West Lafayette, Indiana, to determine the optimal formulation for a chemically inactivated whole cell pneumococcal vaccine candidate. The aim of the project will be to support the advancement of whole cell vaccines that can provide broad protection against S. pneumoniae for children in low-resource countries and that are inexpensive to produce and administer. In addition, PATH is sponsoring a meeting hosted by the Fondation Mérieux in Annecy, France, on October 18 to 20, 2009, that will bring together pneumococcal experts from around the world to exchange information and strategies on pneumococcal disease diagnostics.

 

New data support action on leading childhood killer

A recent study, published in The Lancet, provides new burden of disease data for Streptococcus pneumoniae, a leading cause of bacterial pneumonia, meningitis, and sepsis in children worldwide. The study, supported by the World Health Organization, found that in 2000 the majority (51 percent) of the world’s 14.5 million pneumococcal cases occurred in Asia, but an estimated 54 percent of pneumococcal deaths occurred in Africa. The findings underscore the urgent need for pneumococcal vaccines to be accessible and affordable for low-resource countries where they are not yet widely available, particularly in Africa and Asia. The article also presents first-ever country-level data, which can help inform local and global policy decision-makers on pneumococcal disease prevention and treatment, particularly regarding the introduction of pneumococcal vaccines into national immunization programs.

 

In support of coordinated action against pneumococcal disease, PATH has joined other child health groups as part of the Global Coalition Against Child Pneumonia for World Pneumonia Day in an effort to bring attention to pneumonia as an important public health issue. The call for a World Pneumonia Day on November 2, 2009, seeks to raise awareness and mobilize efforts among policymakers and grassroots organizers to fight against this childhood killer.

 

Study finds that human challenge model dose can be significantly lowered for future trials

New results from a recent clinical trial found that the human challenge model currently being used to test vaccines against enterotoxigenic Escherichia coli (ETEC) is utilizing a higher dose than is necessary to determine effectiveness. Using a challenge dose that is too high may result in premature elimination of promising vaccines that could work in developing-country populations. The ETEC strain H10407 used most frequently in vaccine challenge studies has been administered at a dose of 109 cfu with bicarbonate buffer after a 90-minute fasting period. This study enrolled a total of 45 healthy adult volunteers in three cohorts who were tested with doses of 108 or 107 cfu with bicarbonate or rice-based buffer. In addition, all participants fasted overnight until 90 minutes after the challenge. The study design included retesting of the lowest responsive dose, as well as re-challenge of 10 volunteers. Combined data from the study validate that ETEC H10407 administered at the 107 dose with an overnight fast induces a reproducible attack rate of at least 70 percent and similar disease severity as higher dose models. The results of this study, funded by PATH’s enteric vaccine project and conducted by Johns Hopkins University in Baltimore, Maryland, were presented at the Vaccines for Enteric Diseases conference in Malaga, Spain, in September and the US-Japan Conference on Cholera and Other Bacterial Enteric Infections in San Diego, California, in October.

 

In other news from the enteric vaccine project, PATH recently signed a master services agreement with Advanced BioScience Laboratories, Inc. (PDF) (ABL), based in Kensington, Maryland, to conduct preclinical research. To date, ABL’s services have already been engaged to execute a pharmacological/toxicological study and to develop an immunological assay.

 

New collaboration formed to advance the development of pandemic influenza vaccines

As part of its influenza vaccine project, PATH recently established a new vaccine development partnership with the Institute of Experimental Medicine (IEM), a vaccine research institution in St. Petersburg, Russia. The aim of the collaboration is to advance live attenuated influenza vaccines (LAIVs) that can be affordable and accessible for low-resource countries in a future pandemic. Under this agreement, PATH will provide financial and technical support to

IEM and third-party contractors for the preclinical development of LAIV candidates against avian influenza subtypes that may emerge as pandemic strains. LAIVs hold particular promise due to their potential to be produced less expensively, quicker, and in larger quantities than conventional inactivated influenza vaccines. Any development plan data coming out of this collaboration will be available for use in developing countries under the World Health Organization’s Global Pandemic Influenza Action Plan to Increase Vaccine Supply.

 

PATH staff contribute to literature on influenza

Two PATH staff members recently authored editorials on pandemic influenza. In one editorial, published in The New England Journal of Medicine, Dr. Kathleen Neuzil, director of PATH’s influenza vaccine project, comments on two articles that describe newly available data on the immunogenicity of the pandemic influenza A(H1N1) 2009 monovalent vaccine. Dr. Neuzil emphasizes that the immunogenicity data are encouraging and supportive of the use of one dose of vaccine, which should facilitate its rapid deployment to reduce morbidity associated with the pandemic. In the second editorial, published in the Journal of Infectious Diseases, Drs. Neuzil and Rick Bright, scientific director of PATH’s influenza vaccine project, comment on current challenges in influenza vaccine manufacturing and how the current pandemic influenza A(H1N1) outbreak highlights these challenges, including the need to ensure a rapid, flexible, and scalable manufacturing response when new influenza antigens are identified. Drs. Neuzil and Bright highlight progress in influenza vaccine manufacturing, but stress the need for further efforts to address the many associated challenges as well.

 

Additionally, Drs. Bright and John Boslego, director of PATH’s vaccine development program, each co-authored a chapter in the 2009 text book Vaccines for Pandemic Influenza on the microbiology and immunology of influenza vaccines currently in use and under development. The chapters focus respectively on virus-like particles as pandemic influenza vaccines and global access strategies for pandemic influenza vaccines.

 

China meetings highlight PATH’s work on rotavirus vaccine development

On September 18, PATH’s rotavirus vaccine development project convened a Vaccine Development Committee meeting in Beijing, China, for the bovine-human reassortant vaccine (BRV) candidate in development by China National Biotec Group’s (CNBG’s) Wuhan Institute of Biological Products (WIBP). The 15 experts that participated in the meeting included representatives from CNBG, WIBP, and PATH. The meeting was held to report on the progress of the project, to review financial, technical, and managerial resources, and to agree on a strategy for the future. WIBP reported on the encouraging progress they have made in the past year, including improvement of the staff’s expertise in Good Manufacturing Practices as well as updated facilities and equipment. Looking ahead, all project milestones are expected to be met for the remainder of 2009 and WIBP is beginning discussions with local regulatory authorities in preparation for its first clinical trial of the BRV.

 

In related news, Dr. John Boslego, director of PATH’s vaccine development program, participated in the Developing Country Vaccine Manufacturers Network Annual Meeting, hosted this year by CNBG in Beijing on September 14 to 18. Dr. Boslego presented on PATH’s work to accelerate the development of new vaccines for populations in low-resource countries, specifically highlighting its work with WIBP on the BRV candidate. Other PATH presenters at the meeting included Mansour Yaïch, a vaccine development advisor who highlighted the Japanese encephalitis vaccine project, and Debra Kristensen, a senior technical officer who featured PATH’s collaboration with the World Health Organization on Project Optimize (see article below).

 

Also@PATH: Working with the vaccine industry to develop more practical products

PATH’s work on vaccines isn’t limited to development. Project Optimize, a collaboration between PATH and the World Health Organization (WHO), is helping define the ideal characteristics and specifications for future vaccines as well as develop supply chains flexible and robust enough to handle an increasingly large and costly vaccine portfolio. As part of its work, Optimize supports the Vaccine Presentation and Packaging Advisory Group (VPPAG), established in 2007 by the GAVI Alliance and hosted at WHO. The VPPAG released version 2.1 of their Generic Preferred Product Profile (gPPP) for future vaccines in September after a public consultation process. VPPAG is the only formal forum where vaccine industry and public-sector immunization program stakeholders interact to discuss details regarding vaccine product characteristics and their impact on immunization programs.

 

The gPPP is designed to be a reference for vaccines in the early stages of development, providing recommendations on formulation, presentation, labeling, and packaging to vaccine developers. As such, it is a starting point for discussion between industry and public health agencies, and does not replace preferred product profiles for specific vaccines. The VPPAG is also available as a resource to work on specific vaccine profiles and is currently advancing a profile for second-generation human papillomavirus vaccines. While the current version of the gPPP has benefited from the input of a wide range of partners and stakeholders, there is still work to be done. The VPPAG is now focusing its efforts on gathering the necessary data to add specificity to its recommendations. As such, the gPPP remains a “living document” in draft form, with a new version expected in 2010. PATH’s vaccine development program also aims to integrate VPPAG recommendations into their work to ensure that future vaccine products meet the needs of developing countries.

 

Upcoming conferences and events

  • Global Vaccine Development for World Health Symposium, Bethesda, MD, November 3 to 4. This meeting will address the expanding need for discussion on regulatory guidelines for the development of vaccines for infectious diseases. Industry professionals and worldwide regulatory agencies will present current challenges and solutions, with a focus on the World Health Organization prequalification process and the US Food and Drug Administration voucher program as they relate to vaccine development for global health.
  • 2009 GAVI Partners’ Forum, Hanoi, Vietnam, November 18 to 20. This meeting allows partners of the GAVI Alliance to exchange ideas about opportunities and challenges ahead, and to provide feedback on GAVI’s policies and strategy through 2015. This year’s forum will feature topics including challenges presented by the current economic crisis and lessons learned from developing-country experiences in fighting infectious disease. Participants include global health leaders, delegates from GAVI-eligible and donor countries, civil society representatives, and private-sector partners.
  • Influenza Congress USA 2009, Washington, DC, November 18 to 20. This conference brings together leaders in industry, government, and healthcare organizations to discuss key topics in prevention and treatment of influenza. This year’s event will include sessions on the current influenza A(H1N1) pandemic; vaccine development and commercialization strategies for pandemic, universal, and seasonal vaccines; adjuvants; and vaccine production, manufacturing, and capacity.
  • American Society of Tropical Medicine and Hygiene 58th Annual Meeting, Washington, DC, November 18 to 22. This annual meeting provides a forum for sharing scientific advances in tropical medicine and global health. This year’s conference will feature a new subsection on global heath, including topics such as cost-effective prevention of disease in the developing world, rapid diagnostics and drug delivery for low-resource settings, and water and sanitation in the developing world. PATH is co-hosting a symposium on vaccination against bacterial causes of diarrheal disease, as well as organizing a session on rotavirus vaccines.
  • Global Vaccine Research Forum 2009, Bamako, Mali, December 6 to 9. This annual meeting, organized by the World Health Organization, brings together top researchers and scientists from around the world to discuss vaccine research and development issues and to update research agendas. The conference also provides an opportunity for discussion about the broader issues of vaccine policy and implementation. Dr. Kathleen Neuzil, director of PATH’s influenza vaccine project, will co-moderate a session on influenza vaccine research and development, as well as present on rotavirus vaccine clinical trial results. Additionally, Dr. Rick Bright, scientific director of PATH’s influenza vaccine project, will present on the feasibility of universal seasonal influenza vaccination.
  • World Influenza Congress Europe 2009, Brussels, Belgium, December 7 to 9. This annual conference addresses aspects of influenza policy and planning, research and development, and partnerships. Participants will hear from both industry and government speakers. Featured topics include pandemic regulatory response, early-stage influenza vaccines, vaccine delivery technologies, and enhancing vaccine immunogenicity.
  • Phacilitate Vaccine Forum Washington 2010, Washington, DC, January 25 to 27. This yearly meeting brings together participants from industry, regulatory agencies, and vaccine manufacturers to discuss business, regulatory, and scientific topics related to vaccines. This year’s featured sessions include pandemic preparedness, business models for vaccine delivery, and the impact of the US administration’s healthcare regime on vaccine prioritization. Dr. John Boslego, director of PATH’s vaccine development program, will deliver a keynote address at the conference on Innovative approaches to accelerate vaccine development for low-resource countries.

 

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.

·         Technical officer, Influenza Vaccine Project

·         Program assistant

 

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 Vaccine Access and Delivery Program. The work of the vaccine development program is currently supported by grants from the Bill & Melinda Gates Foundation and the US Centers for Disease Control and Prevention. Some projects within the vaccine development program are funded by PATH Vaccine Solutions.

 

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