January 2008

In this issue:

 

With a new year under way, it’s a good time to renew our commitment to saving lives, especially in the developing world. The recent release of UNICEF’s State of the World’s Children 2008 highlighted the urgent need for more progress against the two major causes of childhood deaths—pneumonia and diarrhea. PATH’s recently expanded work on vaccines against diarrheal disease and our efforts to develop new pneumococcal vaccines are tackling these problems head-on. We are also very excited about the addition of our newest project to develop vaccines against influenza and their potential impact in protecting developing-world populations if a pandemic were to strike.

 

We look forward to sharing more updates on our work through the Vaccines for the Future e-newsletter this year, and we hope they continue to inform and inspire the development of safe, effective, and affordable vaccines for the developing world.

 

Sincerely,

 

John W. Boslego, MD

Director, Vaccine Development Program

PATH

 

Developing new vaccines against influenza

With global health leaders increasingly concerned about the near-term possibility of an influenza pandemic, PATH announced a new program to support rapid development of vaccines to protect against a future outbreak. PATH will collaborate with a number of public- and private-sector partners to advance the development of promising new vaccines, focusing on new technologies that could more easily be used in case of an influenza pandemic. Live attenuated (egg-based or cell-based) technology and recombinant technologies (proteins and virus-like particles) could provide more “real-time access” and be produced more affordably, thereby increasing access for developing-world populations.

 

PATH recently published a report, Influenza Vaccine Strategies for Broad Global Access, which highlights vaccine supply and demand and identifies promising new approaches for the development of new influenza vaccines. The report was published in conjunction with Oliver Wyman, Inc., and the findings informed the focus of PATH’s new project.

 

Rotavirus vaccine trial completes enrollment

PATH’s work on advancing the development of two new rotavirus vaccines is continuing to move forward. The Phase 1/2 clinical trial of the 116E human monovalent vaccine has completed enrollment. The trial is being conducted in healthy infants (8 to 20 weeks old) to evaluate the safety and immunogenicity of the vaccine at two dosage levels (187 infants in the first, 182 infants in the second) and three administrations. The Society for Applied Studies, New Delhi, is conducting the trial in two urban neighborhoods in South Delhi, India, and data is expected in April 2008. PATH’s work on this vaccine candidate has been a collaborative effort with Bharat Biotech International, the Indian Department of Biotechnology, the Indian National Institute of Immunology, and an expert consultative group.

 

PATH also has active partnerships with Shantha Biotech and Wuhan Institute of Biological Products to accelerate the development and clinical trials of a human bovine reassortant vaccine candidate licensed from the US National Institutes of Health. Currently, PATH is working in collaboration with each company to develop and refine their product development plans.

 

New genome data on developing-world pneumococcal strains

Data from a PATH-sponsored study on sequencing the genomes of five geographically diverse Streptococcus pneumoniae isolates are now available. The sequencing was performed by The Institute for Genome Research (TIGR, now known as the J. Craig Venter Institute) and involved an analysis of clinically important strains from Bangladesh, Ghana, Taiwan, Hungary, and Brazil. Included in these strains are serotypes 1 and 5, which are more prevalent in developing countries than in the United States and Europe and are not covered by the current 7-valent pneumococcal conjugate vaccine, PCV7 (Prevnar®).

 

The data will provide valuable information for comparing the genomic sequences of developing-world pneumococcal isolates with those from industrialized nations and help prioritize protein vaccine candidates whose sequences are homogenous with global strains. The entire data set, sequence, and annotation information have been submitted to Genbank for public release. For more information about the sequencing project and the data generated, including comparisons between these five new genomes and previously published S. pneumoniae genomes, please visit the Streptococcus Pneumoniae Comparative System.

 

Promising results from Intercell on pneumococcal vaccine candidate

PATH is partnering with the biotech company Intercell on development of a “common protein” vaccine. A vaccine containing proteins common to all pneumococcal strains could provide broad protection against the disease.

 

In The Journal of Experimental Medicine, Intercell reports identifying two antigens that are nearly identical among all pneumococcal strains and generate strong antibody responses and protection against challenge with Streptococcus pneumoniae in animal models. Intercell’s scientists searched for bacterial antigens that would be exposed on the pathogen during disease and found two lead candidates that are cross-protective against different serotypes in sepsis and pneumonia models, and immunogenic in both the elderly and young children. Because the antigens come from proteins that are essential for bacterial growth and survival (that is, unlikely to mutate), they are seen as promising targets. The antigens form the basis of Intercell’s subunit pneumococcal vaccine which is on track for clinical testing.

 

Moving toward vaccines against bacterial causes of diarrhea

PATH’s project focused on developing new vaccines against two of the leading bacterial causes of diarrheal disease, Shigella and enterotoxigenic Escherichia coli, is moving steadily ahead. A scientific advisory board (SAB) was formed and met for the first time in November. The SAB, consisting of nine prominent experts in the field of enteric diseases and vaccines, will play a critical role in guiding PATH’s decisions about which products to support.

 

PATH’s request for letters of intent was closed this month, and a second SAB meeting is scheduled for February to review these and continue working with PATH on making decisions about which proposals and products to move forward. The organizations with the most promising submissions will be asked to generate full product development plans.

 

Funding opportunities for innovative research

The Bill & Melinda Gates Foundation recently announced a new major initiative to support innovative global health research. The Global Health Explorations Initiative awards fast-track grants to individuals and groups working to solve some of the world’s most important health challenges through creative and innovative thinking. Learn more about the Global Health Explorations Initiative and sign up for more information.

 

Upcoming conferences and events

·         Third Regional Pneumococcal Symposium, Istanbul, Turkey, February 13 to 14, 2008. This meeting, sponsored by the Sabin Institute and the Pneumococcal Accelerated Development and Introduction Program at Johns Hopkins, will present the status of pneumococcal vaccine development and implementation, review the estimates of the health and economic burden of the disease, examine the epidemiology of the disease, and identify key actions for the advancement of pneumococcal disease prevention in Eastern Europe and Central Asia. Dr. Mark Alderson will give a presentation on PATH’s pneumococcal vaccine project at the conference.

·         Partnering for Global Health Forum 2008, Washington, DC, USA, March 10 to 12, 2008. This international meeting is focused on accelerating the development of medicines for neglected diseases of the developing world. Leaders from the biopharmaceutical industry, public and private donors, country health officials, academic research institutions, and public-private partnerships will explore new collaborations to advance global health product development.

·         National Foundation for Infectious Diseases’ Annual Conference on Vaccine Research, Baltimore, Maryland, USA, May 5 to 7, 2008. This is the largest scientific meeting devoted exclusively to research on vaccines and associated technologies for disease prevention and treatment through immunization. Attendees will learn about current scientific progress in both human and animal vaccinology and exchange research in the hope of fostering new ideas and collaborations critical to advancing vaccine science and development.

·         Eighth International Rotavirus Symposium, Istanbul, Turkey, June 2 to 3, 2008. This meeting will bring together scientists, policymakers, economists, public health experts, and the donor community to address scientific, social, and economic issues confronting rotavirus prevention and vaccine introduction.

·         Sixth International Symposium on Pneumococci & Pneumococcal Diseases (ISPPD), Reykjavik, Iceland, June 8 to 12, 2008. PATH is pleased to help sponsor the conference and looks forward to sharing updates on our pneumococcal vaccine program. Attendees will learn about the latest scientific achievements, exchange ideas, strengthen ongoing research collaborations, and establish new collaborations on pneumococcal disease.

 

PATH resources

PATH’s Vaccine Resource Library

Developing New Vaccines Against Diarrheal Disease fact sheet

Enhanced Diarrheal Disease Control Resource Center

 

 

PATH’s vaccine development program is working to accelerate development of innovative, safe, effective, and affordable vaccines for the diseases that are the leading causes of childhood deaths in the developing world: pneumococcal disease, diarrheal disease, and influenza. 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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