April 2009

In this issue:

 

In this edition of Vaccines for the Future, we are pleased to announce that two of our partners have launched the first clinical trials to be supported by our enteric and pneumococcal vaccine development projects. This milestone was marked by the start of a challenge model validation trial for enterotoxigenic Escherichia coli in February and a Phase 1 trial of a common protein pneumococcal vaccine in April. In addition, we highlight how our influenza vaccine staff continues to participate in key meetings on seasonal and pandemic influenza, and the work of our rotavirus vaccine development project getting featured in a prominent medical school magazine. We also share two major accomplishments from the influenza and pneumococcal vaccine fields.

In another first, we are including a new section highlighting other PATH programs working on vaccines and related technologies. In this issue, we spotlight two projects focused on improving vaccine delivery and distribution, making it easier to get vaccines to those who need them most. Finally, we provide links to new publications, upcoming conferences of interest, and job opportunities within our program. As always, we welcome your feedback and hope these updates continue to be useful.

 

Sincerely,

John W. Boslego, MD

Director, Vaccine Development Program

PATH

 

Phase 1 trial begins for “common protein” pneumococcal vaccine candidate

PATH supported the April launch of a first-in-man clinical trial for a “common protein” pneumococcal vaccine candidate with partner Intercell AG, an Austrian biotechnology company. The Phase 1 clinical trial, which is taking place in Germany, will test the safety and immunogenicity of IC47, a recombinant subunit vaccine consisting of three conserved surface proteins from Streptococcus pneumoniae. Researchers are enrolling 32 healthy adult subjects in the study and will administer two different vaccine candidate doses either with or without an adjuvant. Vaccines containing proteins common to all pneumococcus serotypes are promising because they could provide broad protection to children worldwide. This partnership is part of PATH’s project focused on advancing pneumococcal vaccine development.

 

Rwanda launches groundbreaking national immunization program against pneumococcal disease

Rwanda’s Ministry of Health, the GAVI Alliance, Wyeth, PneumoADIP, and UNICEF lent their support as hundreds of infants and children received the first doses of Prevnar®, Wyeth’s 7-valent pneumococcal conjugate vaccine, during a launch event for Rwanda’s new national pneumococcal immunization program in late April. The program is the first of its kind to commence among GAVI-eligible countries and aims to vaccinate nearly all Rwandan infants by the end of 2009. In May, the Gambia will follow suit by adopting the vaccine as part of its national immunization schedule. The introduction of pneumococcal vaccines in Rwanda and the Gambia are important milestones for the broad roll-out of pneumococcal and rotavirus vaccines in GAVI-eligible countries this year.

 

PATH furthers research to support enteric vaccine development

The Center for Immunization Research at Johns Hopkins Bloomberg School of Public Health recently launched a clinical trial to validate a low-dose enterotoxigenic Escherichia coli (ETEC) challenge model. PATH is working in partnership with Johns Hopkins to conduct the trial, which should determine if it is possible to administer a lower ETEC challenge dose than has been used in the past when assessing vaccine candidates. Using a challenge dose that is too high to detect protection could result in premature dismissal of promising vaccines that may work in developing-country populations. If the current trial is successful, a lower ETEC challenge dose can be used in future challenge trials of ETEC vaccine candidates. The trial is expected to be completed by June 2009, with trial results available by the end of the year.

 

In related news, PATH’s enteric vaccine development project recently signed an agreement with BioVentures for Global Health (BVGH) to conduct a business analysis of the market potential and financial models for ETEC vaccines to better inform potential manufacturers and to better understand supply and demand drivers for the development of these vaccines. An ETEC model developed by BVGH and Boston Consulting Group will be used to conduct the market assessment. In addition, PATH plans to adapt this model to conduct an assessment of the Shigella vaccine market.

 

Indian rotavirus vaccine candidate featured in Stanford Medicine magazine

The Spring 2009 issue of Stanford Medicine magazine, published by Stanford University’s School of Medicine, included an article on the development of the 116E rotavirus vaccine candidate. The article outlined the unique history of the vaccine’s development in India and the need for locally produced rotavirus vaccines. Since 2001, PATH has been part of a collaborative effort to develop and evaluate this monovalent vaccine, supporting Bharat Biotech International, Ltd. (BBIL) in India to conduct early-stage clinical trials. PATH’s rotavirus vaccine development project is also currently supporting BBIL to build manufacturing and quality control systems to prepare for a Phase 3 efficacy trial of 116E.

 

PATH co-chairs conference on seasonal and pandemic influenza

Dr. Kathy Neuzil, director of PATH’s influenza vaccine project, recently joined Dr. Arnold Monto of the University of Michigan and Dr. Richard Whitley of the University of Alabama at Birmingham to co-chair the Seasonal & Pandemic Influenza 2009: A Turning Point conference, sponsored by the Infectious Diseases Society of America. The two-day February event brought together key stakeholders from around the world and focused on seasonal and pandemic global impact, new vaccine developments, and the roles of national and local governments and the private sector in control strategies. Dr. Neuzil also gave a presentation on “Changing Landscapes of Vaccines,” which emphasized the need for low-cost, rapid-response technologies with improved immunogenicity, attention to the needs of low-resource countries, and a better understanding of seasonal influenza in many areas of the world.

 

New agreement to support global access to influenza vaccines

The World Health Organization (WHO) and Nobilon, Schering-Plough’s human vaccine business unit, recently signed an agreement to provide the rights to seasonal and pandemic live, attenuated influenza vaccines (LAIVs) for developing-country vaccine manufacturers working within the WHO Global Pandemic Influenza Action Plan to Increase Supply framework. This partnership is an important step toward achieving sustainable global access to influenza vaccines. Through the agreement, Nobilon has granted WHO a non-exclusive license to develop, register, manufacture, use, and sell LAIVs produced on embryonated chicken eggs. Manufacturers will receive sub-licenses from WHO and can then provide vaccines royalty-free to public health sectors in the developing world. LAIVs are a promising approach against pandemic influenza because they can provide improved, “real-time” access to vaccines and can be produced more affordably than traditional inactivated vaccines, thereby increasing access for people living in low-resource countries.

 

PATH participates in panel on novel collaborations to improve global health

On April 3, Chris Elias, PATH’s president and CEO, presented on novel collaborative research models and partnerships to accelerate research and development and improve global health. The panel was moderated by Margaret Anderson from FasterCures and also included presentations by Alpheus Bingham of InnoCentive, Elaine K. Gallin of the Doris Duke Foundation, and Rachel Glennerster of the Massachusetts Institute for Technology. The panel was part of a working group meeting organized by the US Institute of Medicine (IOM) that discussed capacity building, knowledge sharing, and innovation in global health. The aim of the meeting was to identify ways in which the public and private sectors could work together to support developing-country research capacity; share information to enable scientific and health progress; and explore innovative ways to develop technologies, interventions, and tools to improve global health. An IOM expert committee is working on recommendations for US policy in a forthcoming report: The US Commitment to Global Health.

 

Also@PATH: Technologies to support vaccine development and delivery

In addition to developing new vaccines, PATH also works on new technologies to improve vaccine delivery and distribution in developing-country populations. One project recently announced the development of a new formulation method that protects vaccines from freeze damage. By adding freeze-protection stabilizers, such as glycerin, polyethylene glycol 300, or propylene glycol, to a number of vaccines containing aluminum adjuvants, vaccines can be effectively protected from the damage often caused by accidental freezing. In addition to ensuring vaccine effectiveness, the prevention of freeze damage also means less vaccine wastage, which often occurs when health workers dispose of vaccines suspected to have been exposed to freezing. To date, the freeze protection technology and analytical assays have been transferred to three vaccine manufacturers and assisted them with validation and incorporation into two children’s vaccines: monovalent hepatitis B and DTP-hepatitis B-Hib.

 

Another PATH project is working to improve the delivery of dry stable vaccines by advancing safe, effective, and affordable prefilled vaccine reconstitution devices. These devices would simplify the current multistep process for reconstitution, which can lead to vaccine ineffectiveness or severe injury if done incorrectly. PATH is currently gathering critical information about these devices, including manufacturing and filing costs, user acceptance, and failure modes, in order to ensure appropriate devices are available for vaccine clinical studies.

 

Upcoming conferences and events

·         Asian Conference on Diarrhoeal Diseases and Nutrition, Yogyakarta, Indonesia, May 25 to 27. This regional conference brings together experts in the fields of diarrhea, infectious diseases, and nutrition. The theme of this year’s conference is Bridging the Differences Between Developed and Developing Countries in Diarrhoeal Disease, Nutrition, and Other Related Issues Through Translational Research From Basic to Clinical and Community. More than 900 participants are expected to attend this year’s conference, including renowned scientists and diarrheal disease experts.

·         Global Health Council’s 36th Annual International Conference, Washington, DC, May 26 to 30. This year’s conference, New Technologies + Proven Strategies = Healthy Communities, will focus on how technologies in combination with best practices and evidence-based policies improve health worldwide. Participants will hear from experts in the fields of HIV/AIDS, child survival, reproductive health, infectious diseases, and many more. In addition to hosting a booth in the exhibition hall, several PATH staff will present and moderate sessions at this year’s conference, and PATH will host two auxiliary events on new technologies for global health and approaches for addressing diarrheal disease.

·         European Society for Paediatric Infectious Diseases Annual Meeting, Brussels, Belgium, June 9 to 13. This conference brings together leaders in the field of pediatric infectious diseases to discuss bacteriology, epidemiology, diagnosis, prevention, and treatment of major pediatric infectious diseases. This year’s conference will focus on serious bacterial infections. PATH’s Dr. Kathy Neuzil will conduct a “poster walk” session on rotavirus entitled “RIX4414 is protective against severe RVGE caused by diverse rotavirus serotypes during the first year of life in African infants.”

·         10th International Symposium on Double Stranded RNA Viruses, Hamilton Island, Great Barrier Reef, Australia, June 21 to 25. This conference brings together top researchers in the field of double-stranded RNA viruses. Participants will have access to workshops on virus structure and assembly, function of virus proteins, epidemiology and emerging virus infection, and vaccines, along with many other topics.

 

New PATH resources

·         Developing New Vaccines Against Diarrheal Disease fact sheet

·         Accelerating the Development of New Rotavirus Vaccines fact sheet

 

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.

·         Graduate-level intern, Enteric Vaccine Initiative

·         Graduate-level intern, Rotavirus Vaccine Development

 

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.

 

Learn more about PATH’s work

PATH is now sending periodic email updates highlighting programmatic activities from throughout the organization. Find out what we’re working on, where we’ll be presenting our work, and what new publications and tools are available. Sign up for PATH’s email updates.