Research Roundup: Hantavirus vaccine research, mRNA flu vaccine trial, HIV biology discovery

A new US National Institutes of Health-funded study conducted in seven high tuberculosis (TB)-burden countries found that a new and improved near point-of-care TB test platform was highly accurate, effective, and scaleable. Pluslife Biotech’s MiniDock MTB test platform is battery operated, low-cost, provides results in 30 minutes, and can be used with tongue swabs in addition to sputum samples, which certain groups, including babies and people living with HIV, cannot produce. The new test is well-suited for low-resource, smaller, or more rural health clinics, which may not have access to current resource-intensive, expensive molecular testing options. The University of Oxford and the Serum Institute of India have signed a license agreement to support the development, large-scale manufacturing, and potential future commercialization of the malaria vaccine candidate R78C for use in clinical settings. R78C combines two Plasmodium falciparum blood-stage antigens, designed to target the malaria parasite at multiple points in its lifecycle, offering longer and more effective protection. This new license, which builds on a long-standing collaboration between the partners on malaria vaccine work, will initially help accelerate the candidate into clinical evaluation. The Serum Institute of India’s global manufacturing capabilities will also help ensure that resulting successful malaria vaccines can be manufactured at scale and deployed affordably to malaria-endemic countries. The Medicines for Malaria Venture (MMV) and Novartis recently announced that the World Health Organization (WHO) has prequalified Coartem® Baby, the first and only antimalarial drug developed specifically for newborns and young infants weighing between 2 and 5 kilograms. This treatment will help address a long-standing gap in malaria care for this group, who are often treated with antimalarial formulations intended for use in older children, which can increase the risk of toxicity or underdosing. The prequalification designation enables countries and global procurers to start purchasing and deploying the treatment in malaria-endemic countries; Novartis is making the treatment available on a largely nonprofit basis in malaria-endemic regions. 

Last week, the Medicines for Malaria Venture (MMV) and GSK announced the world’s first deployment of a novel cure for Plasmodium vivax malaria, the predominant malaria species in Latin America. Pediatric tafenoquine, codeveloped by MMV and GSK, replaces a multiday regimen with a single-dose, child-friendly formulation, improving treatment completion and preventing relapse. P. vivax can remain dormant in the liver, so if patients don’t receive combination treatment for both the blood and liver stages of the disease, they could have multiple malaria relapses. Up until now, the lack of child-friendly tafenoquine formulation left younger kids at risk of the disease, which is associated with long-lasting cognitive impairment. The rollout is taking place among the Yanomami people, an Indigenous population living in the Yanomami Indigenous Territory in northern Brazil. Last Tuesday, Moderna announced the start of a late-stage study of its experimental mRNA vaccine candidate for bird flu, marking the first time a mRNA pandemic bird flu vaccine has reached late-stage trials. The trial is being supported by a $54 million investment by the Coalition for Epidemic Preparedness Innovations (CEPI) following last year’s cancellation by the US government of more than $700 million in contracts with Moderna supporting the late-stage development of the vaccine candidate. Moderna’s trial will evaluate the candidate, mRNA-1018, in 4,000 healthy adults in the United States and the United Kingdom. Under the agreement, Moderna also committed to, if the vaccine is approved and a flu pandemic is declared, setting aside 20 percent of its manufacturing capacity for supplying the vaccine to low- and middle-income countries at affordable prices. The US Food and Drug Administration recently approved Merck’s once-daily, oral combination treatment for HIV, offering patients another treatment option. The combination of doravirine and islatravir is being branded as Idvynso. In two large late-stage studies, the treatment combination demonstrated its ability to significantly suppress replication of HIV-1 in adults receiving another HIV treatment. While another late-stage study in adults living with HIV who had previously received treatment found that Idvynso was not inferior to Gilead’s HIV drug Biktarvy, the approval still provides another treatment option for patients. It is also currently being tested in multiple trials in combination with other antiretrovirals for potential daily and once-weekly HIV treatments.