Breakthroughs Blog: NTDs

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign up now to receive our weekly R&D News Roundup email. As the dengue outbreak in Latin America has continued to grow and the threat of dengue continues to rise globally due to climate change, better and cheaper vaccines are on the horizon but are unlikely to be available soon enough to address the current crises. Currently approved vaccines for dengue include one expensive two-shot regimen and one that can only be given to people who have already been infected. A new, single-dose vaccine designed to target all four strains of the dengue virus, which was created by the US National Institutes of Health and licensed for development by the Brazilian Instituto Butantan, provided strong protection in a Phase 3 trial. The institute plans to submit the vaccine to Brazil’s regulatory agency for approval within the next few months, and if approved, the institute could start producing tens of million doses next year. Merck also licensed the vaccine technology and is developing a related vaccine for the rest of the world but has yet to test it in a clinical trial. In the meantime, the Brazilian government bought global supply of Takeda’s Qdenga vaccine, which, at a steep per-dose price, will provide some protection during the current outbreak. Takeda’s vaccine has also been licensed to an Indian generic drugmaker, but a slow start-up process means that is unlikely to be available before 2030.Pfizer recently announced that its RSV vaccine demonstrated the potential to protect adults between 18 and 50 at high risk of severe illness in a late-stage clinical trial, offering the promise of a tool to protect a far broader population against the virus that not only causes thousands of hospitalizations and deaths among older Americans and hundreds among infants every year but also can also cause severe illness in younger adults with weakened immune systems or underlying chronic conditions. Abrysvo is currently approved in the United States and elsewhere for adults 60 and older and expectant mothers. Pfizer announced plans to submit the final results from the trial for expanded approval of Abrysvo, although a timeline for submission has not yet been disclosed. Last fall, GSK released late-stage trial data demonstrating that its RSV vaccine could protect adults between 50 and 59 years old, and the US Food and Drug Administration is expected to make its decision on that vaccine in June.A research team from the Centre for Clinical Microbiology at University College London has developed a new method for testing tuberculosis (TB) that would allow lower-resourced laboratories in low- and middle-income countries (LMICs) to process samples safely, with the method primarily aimed at use for monitoring drug treatment response and clinical trials. The World Health Organization recommends monthly treatment monitoring with sputum culture to ensure patients are adhering to treatment to reduce the emergence of multidrug- or rifampicin-resistant TB, but monitoring with culture is often unavailable or incredibly slow in LMICs. The new method cuts out the need for a culture; uses common instrumentation available in most laboratories, even in LMICS; does not have high energy requirements; and takes only three or four hours to return a result. The method is already being used in clinical studies.

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign up now to receive our weekly R&D News Roundup email. The first participants have been vaccinated in a Phase 2 clinical trial of a vaccine candidate for Lassa fever virus, which is being led by an international collaboration between IAVI, the Coalition for Epidemic Preparedness Innovations (CEPI), and in-country partners in Nigeria. Lassa fever is recognized by the World Health Organization (WHO) as a priority pathogen requiring accelerated research and causes an estimated 5,000 deaths each year, with the disease primarily affecting West Africa. There are no approved vaccines for Lassa currently. The hope is that this trial, which is the most advanced Lassa vaccine trial to date, will lead to the availability of a vaccine candidate for evaluation and use in future Lassa outbreaks and eventually an approved vaccine for routine immunization, as well as foster sustainable in-country research capacity and partnerships through engagement with Nigerian partners.Last week, FIND and LifeArc announced a new project in Kenya aimed at improving the detection and treatment of visceral leishmaniasis, a neglected tropical disease that mainly affects children and is fatal in more than 95 percent of cases if untreated. The project, which will run from 2024 to 2027, aims to increase early diagnosis and treatment to prevent disability and death from the disease in part by accelerating the development of new and improved diagnostic tests that are more sensitive than those currently available. The project will also build on ongoing efforts to improve community awareness, boost local and national testing capacity, and strengthen overall health system capacity.Last week, Cepheid announced that its point-of-care HIV test has received prequalification status from WHO. The decision will lead to the inclusion of the company’s HIV-1 PCR assay with extended coverage on a list of tests that meet WHO’s standards for global use, boosting access in low- and middle-income countries without designated or stringent regulatory authorities. The test can be used to detect HIV infection in infants and people who were recently infected and provides rapid results, enabling improved linkage to further care and treatment initiation.

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign up now to receive our weekly R&D News Roundup email. A new study that tested Gilead’s antiviral drug, obeldesivir, in primates given a lethal dose of the Ebola Sudan virus found that the drug may be effective in curing infections from the Sudan strain, for which there are currently no approved vaccines or treatments. The study tested a regimen of once-daily pills for ten days. If proven effective in humans and approved, it would be the first oral treatment for any subspecies of Ebola. Moreover, the drug can be stored at room temperature and is relatively inexpensive to manufacture, especially compared to the monoclonal antibodies approved for Ebola Zaire. Previous work in cell culture also showed that obeldesivir seems to work against all known species of Ebola and the related Marburg virus. Further research could confirm the drug's use as a pan-ebolavirus therapy; however, running clinical trials will prove challenging as there are long stretches between outbreaks of Ebola Sudan, in particular.A new initiative led by Imperial College London and co-funded by the Coalition for Epidemic Preparedness Innovations (CEPI) aims to develop next-generation coronavirus vaccines that not only reduce disease severity but also stop viral transmission, reducing the spread of disease. The project will deliberately infect healthy human volunteers with betacoronaviruses, including the virus that causes COVID-19, to test the efficacy of vaccines that are administered via nasal spray. Experts believe this method could be more effective in triggering the highly specialized mucosal immunity that can stop transmission by directly acting at the cells lining the nose, throat, and lungs—where the viruses enter the body. The human challenge trial design of the project is also unique. Imperial College London last year announced that the world’s first COVID-19 human challenge trial was safe, paving the way for broader use of this approach.A research team has discovered an enzyme in the species of sandfly that is primarily responsible for the spread of leishmaniasis in South America that they hope will lead to the development and commercialization of targeted traps to control the insect population and reduce the spread of the disease. Leishmaniasis can be disfiguring, and the severe form, visceral leishmnasis, which mostly occurs in Brazil, can be lethal if left untreated. The researchers analyzed the genome of the Lutzomyia longipalpis, a species of sandfly native to Brazil and South America, and identified the enzyme, Terpene Synthase, which is responsible for making the pheromone used to attract mates, a discovery that could be leveraged for future control technologies.

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign up now to receive our weekly R&D News Roundup email. The Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) last week announced $467,000 in funding to GlyProVac to develop a maternal vaccine that targets Escherichia coli, the bacteria mainly responsible for neonatal sepsis, which is the leading cause of death among infants and a particular challenge in low- and middle-income countries. The funding will specifically support the development of the vaccine candidate GPV02, which offers protection to newborns through the antibodies passed on by vaccinated expectant mothers in utero and through breast milk after birth. GPV02 uses a unique approach compared to other attempted protein-based bacterial vaccines because it involves previously undiscovered natural sugar modifications and uses BEMAP technology to allow the vaccine to imitate E. coli, preparing the immune system to recognize the bacterium in the case of future infection.Last week, the Advisory Group on Immunization Practices at the US Centers for Disease Control and Prevention (CDC) recommended Valneva’s Ixchiq chikungunya vaccine for some travelers and laboratory researchers at risk of contracting the mosquito-borne virus. The United States records about 100 to 200 chikungunya cases a year in people infected abroad by the virus, which is mainly found in parts of Central and South America, Africa, and Asia. The vaccine was licensed by the Food and Drug Administration last fall for adults—the first vaccine approved for chikungunya. CDC has indicated that it may later expand the recommendation for people living in US territories where the virus may spread.A new extensive, long-term analysis from the Icahn School of Medicine at Mount Sinai found that COVID-19 vaccines induce long-lasting antibody responses, debunking previous claims that mRNA-based vaccine immunity wanes quickly. The researchers examined in over 8,000 samples collected over three years in New York City how antibody responses changed after infections, during the first series of vaccinations, during booster vaccinations, and during breakthrough infections. They concluded that the major reason for breakthrough infections is the virus evolving to evade immunity rather than waning immunity. The results will, hopefully, not only encourage people to continue to get vaccine boosters but also to continue research into new vaccines and viral variants.