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. A phase 3 trial testing a new malaria drug could offer hope for addressing the burden of malaria in babies, which despite being a leading cause of death across Africa, is often underdiagnosed, mistreated, and not studied in this population. There are no malaria treatments for babies weighing under 11 pounds (about three months old or younger), whose cases also often go undiagnosed because malaria presents differently and can easily be mistaken for common childhood illnesses in children this young or they have not even been tested due to resource shortages. Clinical trials, including those for the RTS,S and R21 malaria vaccines, often exclude children under five months because of the assumption that mothers confer immunity. The ongoing trial, which is supported by the PAMAfrica Consortium and co-funded by the European & Developing Countries Clinical Trials Partnership and Medicines for Malaria Venture, is expected to publish results early next year.The Novo Nordisk Foundation has announced a new initiative, developed with the University of Copenhagen, that will invest up to $260 million to create new or improved vaccines for serious respiratory diseases. It is the first global vaccines initiative to solely focus on how to produce immunity in the airway itself as a way to prevent airborne disease infection. The initiative will initially focus on candidates for tuberculosis, the flu, and Group A Streptococcus. The partners hope that the new project can help to address the rise of antimicrobial resistance, which is driven, in part, by the overuse or misuse of antibiotics to treat airway infections, as well as to address the high death toll globally from these diseases.The European Medicines Agency Committee for Medicinal Products for Human Use recently adopted a positive scientific opinion for the investigational drug arpraziquantel for schistosomiasis, a neglected tropical disease that affects more than 240 million people globally, including 50 million preschool-aged children. There is no child-friendly schistosomiasis medication for preschool-aged children, despite safe and effective treatments available for both adults and school-aged children. The Global Health Innovative Technology (GHIT) Fund has supported the Pediatric Praziquantel Consortium’s development of the drug since 2013 and is now working with the consortium’s implementation research program to prepare for the introduction of the drug in endemic African countries to ensure equitable and sustainable access in the countries where it is most needed.

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 from scientists at the National Institute of Allergy and Infectious Diseases that builds on decades of research offers promising findings about the immune response to HIV, which could help guide further research into HIV vaccine design and development. The researchers compared the immune system activity of past HIV vaccine study participants to people with HIV who naturally keep the virus from replicating even without antiretroviral therapy, finding that future HIV vaccine candidates may be more successful if they include additional doses or persist longer in the body to continue to stimulate the immune system to deliver the proteins necessary to destroy HIV-infected cells. The research is especially encouraging given the recently halted HIV vaccine trial and hopefully can lead to further advances in the field.Last week, the Global Health Innovative Technology (GHIT) Fund announced that it will invest approximately $8.8 million to accelerate the further development and commercialization of a triple artemisinin combination drug against malaria. Specifically, the investment will support a global, multicenter phase 3 clinical trial project in Africa and Southeast Asia led by Fosum Pharma. The project also includes the development of a co-formulated child-friendly version of the drug, given the high proportion of malaria deaths that occur in children under five. The new drug could also play a role in addressing the rising threat of malaria drug resistance. Recent findings suggest that an inhaled vaccine for COVID-19 delivered directly to the respiratory tract where the virus infects the body could improve protection against infection. The researchers tested COVID-19 vaccine boosters delivered via nasal spray, inhaler, and a shot in the arm in adult rhesus macaques, finding that the inhaled vaccine provided greater mucosal immunity than the other two methods. The promising findings will hopefully further research toward more effective vaccines against COVID-19 and other respiratory viral infections.

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 Thursday, Gavi, the Vaccine Alliance, announced the African Vaccine Manufacturing Accelerator, which will invest up to $1 billion in boosting African manufacturing to address the inequality in vaccine access faced by Africans during the COVID-19 pandemic, as well as to produce vaccines to tackle diseases with a high burden on the continent, including cholera and malaria. The funding for the new scheme comes from leftover money from the COVAX initiative, which aimed to help the world’s poorest countries access COVID-19 vaccines during the pandemic. The accelerator is expected to launch in June of next year and hopes to ensure African manufacturers can offer competitive prices, even for new technologies like viral vector and mRNA vaccines.The startup NanoPin Technologies has developed an ultra-sensitive, blood-based test for difficult-to-detect tuberculosis (TB) cases now on the market, which is also the foundation for a multiplex TB and HIV test the company is developing. Both the NanoDetect-TB blood test, which is supposed to ease and speed up the detection of active TB, and the NanoDetect-TB/HIV multiplex assay, which uses quantitation of viral and bacterial loads to simultaneously detect HIV and TB, offer potential advantages over existing tools. Currently available tests, including the gold standard sputum-based methods for TB detection, can have low sensitivity to samples from patients with HIV and TB coinfection. Further research will be necessary to demonstrate that the multiplex test maintains efficacy in the field and that it can continue to be sensitive while reducing cost, complexity, and instrument requirements as much as possible.Last week at the International Conference on AIDS and STIs in Africa, researchers from the PrEPVacc trial that was testing two different vaccine regimens in Africa announced that the study has been shut down, leaving no HIV efficacy trials underway globally. The trial was halted after an independent data monitoring committee concluded there was little or no chance the study would demonstrate efficacy. The study had previously been dubbed the last chance for an HIV vaccine until the 2030s. PrEPVacc was a pioneering study as one of the first large, African-led HIV vaccine trials and one of the first trials to incorporate PrEP. However, the trial did use older vaccine designs that some scientists doubted would demonstrate adequate efficacy. The hope is that data from the halted trial can eventually inform future trials for new and innovative HIV tools.

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. This month, with support from the local government, German biotechnology company BioNtech is opening an mRNA vaccine factory in Rwanda, which is expected to become the first of what the company says will be a decentralized and robust end-to-end mRNA vaccine manufacturing network in Africa that will manufacture novel vaccines for Africans across the continent. The plant is expected to start by producing 50 million vaccines and will increase production based on demand. BioNTech is currently advancing vaccine candidates to address malaria and tuberculosis based on its mRNA vaccine platform.Last week, Population Council announced that South African company Kiara Health will start producing vaginal rings for HIV prevention in the next few years, which could make the innovative tool cheaper and more readily available to women in Africa. The dapivirine ring, which has been authorized by nearly a dozen countries and the World Health Organization, offers women an alternative HIV prevention method that can be taken without anyone else’s knowledge or consent. Population Council owns the rights to the ring, which is currently produced by a Swedish company. About a half million rings have been made available freely in Africa through donor support. Population Council and Kiara estimate that the company will be able to produce double the currently available supply annually.The Coalition for Epidemic Preparedness Innovations (CEPI), the International Vaccine Institute (IVI), and Medical Research Council Unit The Gambia last week announced the launch of the Research Preparedness Program West Africa, which will support a consortium of regional stakeholders to bolster the growing clinical research sector across the region. Specifically, the partners will work toward building up clinical trial capacity to conduct the first-ever large-scale phase 2b and 3 clinical trials of Lassa fever vaccines in the region. The program also aims to improve general preparedness to ensure the capacity to generate high-quality clinical trial data during future outbreaks of other diseases in the region in as little as 100 days.