PATH’s influenza vaccine project, the Johns Hopkins Bloomberg School of Public Health, and the US National Institute of Allergy and Infectious Diseases launched an open-label clinical study in October to evaluate the degree to which previous receipt of an avian A/H5N1 live attenuated influenza vaccine (LAIV) enhances immune responses to a 45 µg dose of inactivated, unadjuvanted influenza A/H5N1 vaccine in healthy adults. While the LAIV is only moderately immunogenic by conventional antibody measurements, the partners hypothesize that it may help broaden and/or heighten protection against subsequent infection or vaccination. This could be an important proof-of-concept study that contributes to the understanding of how LAIVs work.

In related news, PATH recently received a new cooperative agreement from the US Centers for Disease Control and Prevention (CDC), which the CDC is funding in full for US$3.75 million over three years. The new agreement extends PATH’s work in Senegal (PDF) to evaluate the effectiveness of influenza vaccines in tropical Africa and to gain a better understanding of influenza disease patterns in this setting.

The start-up phase of PATH’s new respiratory syncytial virus (RSV) vaccine project is underway, kicking off with the establishment of a scientific advisory board comprised of key vaccine experts to provide strategic guidance for the RSV vaccine project. The board, which convened for the first time on September 16, plays a key role in shaping the RSV project portfolio. Going forward, the members will meet periodically to provide input on prioritizing technologies, review data and progress, and provide strategic recommendations. In addition, the RSV project launched new text on PATH’s website to highlight the work being conducted and provide background information on the disease.

PATH sponsored a symposium from October 20 to 21 in Beijing, China, that brought together international experts and scientific staff from potential Chinese pneumococcal conjugate vaccine (PCV) manufacturers to discuss key issues surrounding the development of PCVs in China and other emerging markets. The nearly 50 participants shared knowledge and experience to help advance PCV development in China, clarify a path toward World Health Organization prequalification for Chinese PCVs, and ensure the suitability of these PCVs for markets in the developing world where need is greatest. From PATH’s pneumococcal vaccine project team, Drs. Mark Alderson and Dr. Sheau-Mei Cheng delivered opening remarks, and Dr. Jeff Maisonneuve chaired a round-table discussion on regulatory issues and international marketing for PCVs. Overall, the information exchanged at the symposium helped advance larger efforts by PATH and other global health organizations to foster competitive markets that include emerging-country manufacturers like those in China—a critical strategy for making  lifesaving vaccines such as PCVs sustainably affordable, available, and accessible for low-resource countries.

Join PATH in commemorating World Pneumonia Day on November 12 and raise awareness about the urgent need to prevent infants and young children around the world from dying of pneumonia. Pneumonia is the world’s leading killer of children under five years of age due to infectious disease, causing one in every five child deaths, mainly in the developing world. In honor of World Pneumonia Day, PATH is spreading the word via Facebook, Twitter, and other outlets about the importance of prioritizing pneumonia and making prevention and treatment options affordable and accessible for vulnerable populations. For more information about how to help in the fight against pneumonia, visit the World Pneumonia Day website. Also, check out PATH’s website for updates on its activities for World Pneumonia Day and on its work to advance the development of new, low-cost vaccines against pneumonia’s leading cause, Streptococcus pneumoniae.

Several PATH staff members joined top researchers from around the world at the 6th International Conference on Vaccines for Enteric Diseases from September 14 to 16 in Cannes, France, to discuss advances in the field. PATH was a co-sponsor of the conference, which included eight presentations featuring the work of its enteric vaccine project to develop new, affordable vaccines against enterotoxigenic Escherichia coli and Shigella for young children in resource-poor countries. Three additional speakers also cited PATH’s role in supporting parts of their studies. Numerous partners were represented at the conference, including the Johns Hopkins Bloomberg School of Public Health, Mucosis B.V., Oklahoma State University, TD Vaccines, Tufts University, Tulane University, University of Gothenburg, University of Maryland in Baltimore, the US Naval Medical Research Center, and the Walter Reed Army Institute of Research.

In addition, Dr. Duncan Steele, a senior technical advisor for PATH’s Vaccine Development Global Program at the time of the event, served as the scientific chair and delivered a keynote address at the opening of the conference. Dr. Steele reminded the enteric vaccine experts in attendance to consider the broad impact of diarrheal disease and the role of vaccines within an integrated approach that includes a comprehensive array of interventions, including hygiene and sanitation, safe water, oral rehydration therapy, zinc treatment, and breastfeeding.

In follow-up to an April 2011 article in Vaccines for the Future, PATH has now completed two additional training sessions on the rotavirus vaccine formulation that Aridis Pharmaceuticals and PATH co-developed; one with Brazil’s Instituto Butantan on July 5 to 12 and another with China National Biotec Group’s Wuhan Institute of Biological Products on August 29 to September 2. PATH’s rotavirus vaccine development project supports several emerging-country manufacturers actively developing the bovine-human reassortant vaccine (BRV) through a “shared technology platform,” which includes access to an optimized liquid formulation that they may choose to evaluate further with their BRV candidates. As with the first training, staff from PATH’s Technology Solutions Global Program conducted the sessions at its headquarters in Seattle, Washington. The trainings included a review of the blending procedure, the successful preparation of several batches of formulation (without BRV) along with scale-up, preparation of reagents, stability testing, and formulation troubleshooting. PATH will continue to provide technical support to these manufacturers on using the liquid formulation and may conduct further training sessions for other partners if requested.

In addition to the diseases addressed under PATH’s Vaccine Development Global Program, the PATH Malaria Vaccine Initiative (MVI) is working to accelerate the development of malaria vaccines and to ensure their availability and accessibility in the developing world. Every year there are about 225 million cases of malaria, a parasitic infection transmitted by mosquitoes, and nearly 800,000 deaths, mostly among children in Africa under the age of five. These deaths are due largely to the predominance of Plasmodium falciparum, the malaria parasite deadliest to humans, in the Africa region. While consistent use of effective insecticides, insecticide-treated nets, and malaria drugs saves lives, a malaria vaccine is critical to preventing these deaths.

Established in 1999, MVI was founded on the premise that although promising malaria vaccine approaches existed, they required assistance to get out of the laboratory and into clinical trials. MVI establishes strategic partnerships to identify promising vaccine approaches and systematically move them through the development process. Partners include academic institutions, government agencies, biotechs, and pharmaceutical companies, with MVI providing technical, scientific, financial, and project management expertise as needed. MVI maintains a diverse portfolio of preclinical and clinical products, and currently has one vaccine candidate and two approaches under clinical development. The most advanced is GlaxoSmithKline Biologicals’ RTS,S, which targets the pre-erythrocytic stages of P. falciparum and is now in a large-scale Phase 3 efficacy trial at 11 sites in 7 African countries. Initial results from this trial show that RTS,S reduces the risk of malaria by half in children aged 5 to 17 months. In addition to vaccine approaches that are similar to RTS,S, MVI is also supporting those that seek to block malaria transmission and is increasing its focus on P. vivax, the parasite that causes a less deadly—but more widespread—form of malaria.