Vaccines for the Future: News from PATH’s Vaccine Development Program

October 2010

In this issue:

 
 

Welcome to the latest edition of Vaccines for the Future, which is packed with updates from PATH’s vaccine development program. In this issue, you’ll find announcements about several new partnerships related to vaccines against influenza, Shigella, enterotoxigenic Escherichia coli (ETEC), and pneumococcus. Additionally, we report on our involvement in a major influenza conference, recent progress with two ETEC vaccine trials, and manufacturing of a rotavirus vaccine candidate. This issue also features a look at plans for World Pneumonia Day and highlights a new scientific publication co-authored by our staff.

We also include articles on our participation in an international vaccine technology workshop in India, a new PATH project focused on stabilizing influenza vaccines, and a new blog from PATH on defeating diarrheal disease, as well as our usual updates on upcoming conferences and events and job opportunities. We hope you continue to find this newsletter useful and informative and, as always, we welcome your feedback.

Sincerely,
John W. Boslego, MD
Director,Vaccine Development Global Program
PATH

 

Agreements signed to advance research for broad-coverage influenza vaccines

PATH recently entered into new partnerships with Medicago, Inc., a Canadian biotechnology company, and the University of Pittsburgh to initiate research on influenza vaccines that can elicit broad coverage across strains. These partnerships support PATH’s influenza vaccine project in its efforts to advance the development of promising new vaccine technologies that the global population, including people in low-resource countries, can access and afford in influenza outbreaks. PATH and Medicago will collaborate on new influenza vaccine research based on their cost-effective, proprietary plant-based virus-like particle (VLP) technologies. The approach with the University of Pittsburgh will use computationally optimized broadly reactive antigen hemagglutinin immunogens on the surface of VLPs to support the development of relatively simple and affordable influenza vaccines.

In other news, the Archives of Pediatrics & Adolescent Medicine recently published “The promise of maternal vaccination to prevent influenza in young infants” (abstract only), an editorial that accompanies an original research article (abstract only) on the benefits of maternal influenza vaccine on the health of newborn infants. This invited commentary was co-authored by Drs. Justin Ortiz, a clinical research scientist at PATH and acting instructor in the Division of Pulmonary and Critical Care Medicine at the University of Washington, and Kathleen Neuzil, director of PATH’s influenza vaccine project. The authors write in support of recommendations for all pregnant women to receive influenza vaccine in order to protect mother and infant from influenza-related health complications during pregnancy and to reduce disease from influenza in newborn infants.

PATH co-sponsors premier influenza conference, puts spotlight on developing-world needs

Staff from PATH’s influenza projects joined experts from around the world at Options for the Control of Influenza VII—the world’s largest international conference focused entirely on influenza—from September 3 to 7 in Hong Kong, China. As a conference co-sponsor, PATH helped bring the needs of low-resource countries into focus as participants examined advancements in influenza prevention, control, and treatment, as well as seasonal and pandemic planning strategies. To support underserved research communities, PATH awarded scholarships that enabled five researchers from low-income countries to attend the conference and showcase their work. The participation of several PATH staff in conference presentations also helped enhance visibility of needs in the developing world. Dr. Kathleen Neuzil, director of PATH’s influenza vaccine project, chaired a workshop on influenza epidemiology, disease burden, and health economics addressing both high- and low-resource settings. Dr. Rick Bright, scientific director of PATH’s influenza vaccine project, co-chaired two workshops on influenza vaccines, and delivered an overview of PATH’s support for influenza vaccine development tailored to the themes of affordable and accessible vaccines for all. Finally, Dr. Anton Luchitsky, program officer for PATH’s maternal and child health/nutrition program, presented two posters highlighting PATH’s influenza sentinel surveillance work in Ukraine. In addition, presentations from several PATH partners offered further snapshots of its influenza vaccine collaborations.

New progress in developing enterotoxigenic Escherichia coli vaccine candidates

In September, the US National Institutes of Health’s National Institute of Allergy and Infectious Diseases launched a Phase 1 trial of the double mutant heat-labile toxin (dmLT) adjuvant/vaccine. The dmLT is an enterotoxigenic Escherichia coli (ETEC) antigen that when incorporated into a vaccine may offer protection against disease caused by these bacteria. The trial, which is taking place at two US sites, Cincinnati Children’s Hospital Medical Center and the University of Maryland’s Center for Vaccine Development in Baltimore, is assessing the safety of one oral dose of dmLT adjuvant/vaccine over a range of dose levels in 32 healthy adults. The study will also gather long-term safety data over a six-month period. The trial is expected to finish in mid-2011 with complete results available by the end of the year. PATH’s enteric vaccine project provided manufacturing support for this trial.

In related news, PATH recently signed a new agreement with Dutch biotechnology company, Mucosis B.V., to explore the use of their Mimopath™ technology in oral vaccines against Shigella and ETEC. In addition, PATH has begun a new project (PDF) with Advanced BioScience Laboratories, Inc., in Kensington, Maryland, to perform a toxicology program in support of the development of a new adhesin-based ETEC vaccine candidate that could lead to a potential Investigational New Drug filing.

PATH supports new protein research to broaden protection of pneumococcal vaccines

The University of Oklahoma and PATH recently entered into a new research collaboration agreement to advance the development of a recombinant pneumolysin toxoid, or pneumolysoid—a core antigen that could be a potential component in vaccines against Streptococcus pneumoniae. The inclusion of a protein such as pneumolysoid in pneumococcal vaccines could be an important factor in enhancing the ability of these vaccines to provide broad, affordable protection across pneumococcal serotypes—a major goal of PATH’s pneumococcal vaccine project. The partners will study the immune response against the pneumolysoid—developed by Dr. Rodney Tweten of the University of Oklahoma prior to this collaboration—to define antigenic properties that could help increase the success of PATH-supported pneumococcal vaccine candidates.

World Pneumonia Day puts spotlight on the number-one killer of children

Join PATH in supporting World Pneumonia Day on November 12 and take action in the fight against pneumonia—the leading killer of children under five years of age worldwide. PATH is doing its part to build awareness about pneumonia and the importance of vaccines in preventing the estimated 1.6 million unnecessary child deaths caused by the disease each year, mostly in the developing world. As a member of the Global Coalition on Child Pneumonia, PATH has signed on to a letter urging US President Barack Obama to provide support and resources for pneumonia prevention and treatment. PATH is also co-sponsoring a press event in Washington, DC, and spreading the word about pneumonia on Facebook and Twitter. On the heels of the recent World Health Assembly resolution to prioritize the prevention and treatment of childhood pneumonia, World Pneumonia Day and its associated activities all over the globe are important opportunities for generating momentum and action against this devastating disease.

Second clinical lot of rotavirus vaccine candidate completed

Meridian Life Science, Inc., (MLS) in Memphis, Tennessee, recently completed and released a second clinical production lot under current Good Manufacturing Practices (cGMP) of the live oral RV3 rotavirus vaccine candidate for the Murdoch Childrens Research Institute (MCRI) in Australia. The cGMP vaccine manufacturing process at MLS was observed by representatives from MCRI, PATH, and Indonesian manufacturer BioFarma. MLS also provided onsite training to representatives of BioFarma in the manufacture and analysis of RV3 for transferring the technology to them. This batch of lots produced at MLS will be used by MCRI in a Phase 2 clinical trial in Indonesia. PATH’s rotavirus vaccine development project had supported an initial clinical cGMP batch of the RV3 vaccine candidate manufactured at MLS in 2009, which is currently undergoing evaluation in a Phase 1 descending-age study in Australia.

PATH participates in the International Vaccine Technology Workshop in India

This September, PATH staff joined experts from the World Health Organization, the US Department of Health and Human Services, and ministries of health from several countries for the International Vaccine Technology Workshop in Hyderabad, India. The workshop aimed to assist with the creation of regionally based, independent vaccine production centers in emerging economies through capacity building and technology transfer. Workshop participants from a variety of companies, government agencies, academic institutions, developing-country vaccine manufacturers, and nongovernmental organizations identified gaps in current vaccine manufacturing, generated ideas to leverage existing resources, and explored policy options to address shortfalls. The workshop was organized in conjunction with the Developing Countries Vaccine Manufacturers Network, but differed in scope through its focus on sharing technology. Several PATH staff members presented at the workshop. Dr. John Boslego, director of PATH’s vaccine development program, co-chaired the introductory session on the challenge of sustainable vaccine manufacturing, presented at another session on providing technical support to implement new vaccine technologies, and moderated a session on models for technology transfer. Dr. Rick Bright, scientific director of PATH’s influenza vaccine project, also presented on the issues and challenges in selecting a manufacturing platform. Finally, Drs. Dexiang Chen, senior technical officer for PATH’s technology solutions program, and Jean-Marie Preaud, senior technical officer for PATH’s rotavirus vaccine development project, presented separately on transferring specific vaccine technologies to developing countries.

Head of Serum Institute of India, Ltd., receives prestigious award

On September 28, the Pan American Health Organization (PAHO, a regional office of the World Health Organization) presented Dr. Cyrus Poonawalla, chief executive officer of the Serum Institute of India, Ltd. (SIIL), with an award for his role in eliminating rubella and congenital rubella syndrome (CRS) in the Americas. Rubella, also known as the German measles, spreads through the respiratory route and causes influenza-like symptoms in adults. CRS can be particularly devastating when contracted by pregnant women in their first trimester, potentially causing severe health disorders or even death of the infant. PATH works in partnership with SIIL on the Meningitis Vaccine Project and its pneumococcal vaccine project. Dr. John Boslego, director of PATH’s vaccine development program, was honored to participate in the award presentation event at PAHO’s office in Washington, DC.

Also@PATH: New project to stabilize influenza vaccines for pandemic preparedness

The Biomedical Advanced Research and Development Authority within the US Department of Health and Human Services recently awarded the vaccine stabilization team in PATH’s Technology Solutions Global Program a US$5.2 million contract to stabilize the formulations of live and subunit influenza vaccines. In collaboration with Arecor Limited and Aridis Pharmaceuticals, PATH’s work under the contract will focus on extending the product shelf life of pandemic influenza vaccines to facilitate vaccine stockpiling and the rapid deployment of fully potent vaccines beyond the margins of the cold chain—activities that could significantly help to contain future outbreaks, especially in remote regions of the developing world. In addition to liquid-stable formulations, the project team will explore glassy solid formulations using freeze-drying, modified freeze-drying (foam drying), and spray-drying process technologies. PATH will also investigate the manufacturability of selected stable vaccine formulations as well as the regulatory pathways and economic benefits of improved formulations when adopted and used at large scale.

Upcoming conferences and events

  • 59th Annual Meeting of the American Society of Tropical Medicine and Hygiene, Atlanta, Georgia, November 3 to 7, 2010. This meeting brings together scientists, clinicians, and program professionals for topical symposia, oral presentations, scientific posters, and lectures revolving around scientific advances in tropical medicine and global health.
  • International Symposium on Gene-Based Vaccines 2010, Cannes, France, November 8 to 10, 2010. Gene-based vaccines use various biological expression vectors, ranging from simple plasmids to modified viral or bacterial vectors, to deliver the genes of protective antigens to the targeted recipients. This symposium will assemble the world’s experts to review progress in the field and map out the future direction of this new area of modern vaccinology.
  • Phacilitate’s 9th Annual North American Vaccine Forum, Washington, DC, January 24 to 26, 2011. Running concurrently with Phacilitate’s Annual Cell and Gene Therapy Forum, this event will provide a meeting place for senior-level industry and public-sector figures driving the development of novel prophylactic and therapeutic vaccines. Dr. John Boslego, director of PATH’s vaccine development program, will serve as a chair and a panelist for two separate sessions on new pneumococcal vaccines.

New blog from PATH covers vaccines and other interventions to defeat diarrheal disease

Keep up with the latest advances on interventions to fight diarrheal disease, including new vaccines, proven rehydration therapies, and more. The defeatDD.org blog publishes a new post at least once a week, featuring expert perspectives that offer global and local insight to raise awareness about this neglected but resilient threat to child survival. You can also subscribe to the site’s RSS feed to receive the latest blog posts via email.

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.

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 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 Centers for Disease Control and Prevention, 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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