Breakthroughs Blog: Research Roundup

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. Last Tuesday, Valneva announced the launch of a Phase 1 clinical trial to investigate the safety and immunogenicity of a vaccine against the Zika virus, for which there are currently no available preventable vaccines or treatments. The second-generation adjuvanted inactivated vaccine candidate, VLA1601, will be tested in 150 adult participants in the United States, with the first topline data from the trial expected as soon as early next year.  Numerous outbreaks of Zika have occurred around the world, but the virus is currently circulating in Mexico, Central and South America, the Caribbean region, and some areas of the continental United States.Moderna’s next-generation mRNA vaccine for COVID-19 elicited a higher immune response against most strains of omicron BA.4/BA.5 and the original virus than the company’s currently licensed vaccine and has a similar safety profile in Phase 3 trial. The vaccine candidate, mRNA-1283, demonstrated the highest benefits in patients over 65, who are at risk of more severe disease. The trial included over 11,000 patients from across the United States, the United Kingdom, and Canada. These results also point to the future promise of the company’s combination mRNA vaccines for COVID-19 and influenza, which are also currently in development and previously demonstrated a similar immune response to the company’s vaccines for COVID-19.The US Food and Drug Administration (FDA) recently announced the approval of Roche’s Cobas malaria test for screening blood, organ, and tissue donors, which could help reduce the risk of transfusion-transmitted malaria. The test is designed to qualitatively detect in whole-blood samples Plasmodium DNA and RNA from the five main species of Plasmodium parasite species known to cause human infection: P. falciparum, P. malariae, P. vivax, P. ovale, and P. knowlesi. Roche’s technology is now the first FDA-licensed test for screening blood donors for malaria.

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 International Vaccine Institute (IVI) has initiated a technology transfer, first announced last year, of the simplified Oral Cholera Vaccine (OCV-S) to Indian company Biological E. Limited. In the face of an unprecedented rise in cholera outbreaks around the world in recent years, the technology transfer aims to increase the volume of affordable cholera vaccines in the Indian and international markets. IVI is providing technical information, know-how, and materials to support clinical development and regulatory approvals of the vaccine. OCV-s is a simplified formulation of the Oral Cholera Vaccine that can lower production costs while increasing capacity for manufacturers.The Bill & Melinda Gates Medical Research Institute last week announced the launch of a Phase 3 trial evaluating a vaccine for tuberculosis (TB), which researchers hope could become the second licensed vaccine for TB in more than 100 years. The adjuvanted subunit vaccine M72/AS01E was originally developed by GSK, Aeras, and IAVI. The trial, funded by the Bill & Melinda Gates Foundation and the Wellcome Trust, is testing the vaccine’s ability to prevent latent TB from progressing to active pulmonary TB in adults and adolescents. If successful, the pivotal trial could lead to a new tool with the potential to transform TB control globally.A research team from the University of Pittsburgh School of Medicine has identified drug candidates that demonstrate the potential to eliminate the HIV viral reservoir that cannot be expelled completely by existing antiretroviral drugs, preventing people who have undetectable viral load from being completely cured of HIV. The drug candidates, which are called proteolysis targeting chimeras, or PROTACs, can trigger the degradation of the viral protein that prevents the immune system from destroying infected cells by hiding signs of the virus on the surface of the cell. Through this method, the drugs show promise in reversing the ability of HIV to evade detection by the immune system. The PROTAC approach still has significant hurdles to go before it can be used in humans, including preclinical testing in animal models and medical chemistry optimization.

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.