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Research Roundup: New gonorrhea treatment, Arenavirus vaccine development, Study sheds light on viral infection

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FDA/Michael J. Ermarth

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week.

November 6, 2023 by Hannah Sachs-Wetstone

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 Wednesday, the Global Antibiotic Research and Development Partnership (GARDP) announced the results of a successful phase 3 trial, conducted in collaboration with Innoviva Specialty Therapeutics and supported by the National Institute of Allergy and Infectious Diseases, which found that a single dose of a first-in-class oral antibiotic, zoliflodacin, was as safe and effective as standard therapy for treating uncomplicated urogenital gonorrhea. The growing resistance of the gonorrhea bacteria to many classes of antibiotics has left only one remaining globally recommended treatment available as an option. Zoliflodacin, if approved, could not only help address those rising cases because studies have shown that it is active against multi-drug resistant gonorrhea strains, but the antibiotic will also simplify treatment because it is one pill rather than an injection and a pill like the current standard therapy. 

Last week, the Coalition for Epidemic Preparedness Innovations (CEPI) and the University of Oxford announced the launch of a new project to develop prototype vaccines against an arenavirus called Junin virus, which causes Argentine hemorrhagic fever. The project is aimed at kickstarting the broader development of vaccines for arenaviruses, which include the virus that causes Lassa fever, one of CEPI’s priority pathogens. CEPI will invest $25 million in the development of early prototypes of viral vector and mRNA vaccines against the Junin virus, as well as the improvement of the ChAdOx viral vector technology, part of the broader partnership between CEPI and Oxford to support vaccine development for a variety of viral families with future epidemic or pandemic potential. 

In a recent study, researchers have identified a new molecule in cells that is necessary for the Ebola and Marburg viruses to infect and spread in the body and that is also involved in SARS-CoV-2 infections. This discovery could eventually lead to new antiviral drugs for Ebola and Marburg, among other viral infections. The molecular, CCZ1, is a protein that regulates the transport of other molecules by cells. Researchers from the Karolinska Institutet and Institute of Molecular Biotechnology used advanced stem cell libraries and lab-grown organs to study how viruses infect the human liver and blood vessels and ultimately demonstrate how CCZ1 operates as a key factor in their spread through the body. 

Categories: Antimicrobial resistance, COVID-19, Ebola, Pandemic preparedness, Research Roundup, Vaccines

About the author

Hannah Sachs-WetstoneGHTC

Hannah supports advocacy and communications activities and member coordination for GHTC. Her role includes developing and disseminating digital communications, tracking member and policy news, engaging coalition members, and organizing meetings and events.Prior to joining GHTC,...read more about this author

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Research Roundup: Chikungunya vaccine approval, Kenyan malaria producer gets WHO approval, TB drug resistance

Written by Hannah Sachs-Wetstone / GHTC
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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, the US Food and Drug Administration (FDA) announced its approval of the first vaccine to prevent the disease caused by the chikungunya virus. The Ixchiq vaccine, developed by Valenva, is approved for adults at increased risk of exposure to the virus. It was previously granted fast-track and breakthrough therapy designations from FDA. Chikungunya is a chronic and debilitating disease that has no specific treatment, which has become an increasing global threat due to climate change. FDA is requiring that Valneva perform a post-market study to continue to monitor the vaccine’s safety and side effects.With support from Medicines for Malaria Venture (MMV), Kenyan manufacturer Universal Corporation Ltd has received prequalification from the World Health Organization (WHO) for sulfadoxine-pyrimethamine plus amodiaquine (SPAQ), an antimalarial drug used to prevent seasonal malaria in children during peak transmission periods. This approval, which makes UCL only the sixth African pharmaceutical company to have a product WHO-prequalified, will allow Africa to reduce reliance on imported generic versions of the drug from India and China. In the face of a myriad of barriers to quality local drug production and a persistently high burden of malaria cases and deaths, the approval will also make it easier for other African companies to enter the market and attract major buyers, as well as ensure the accessibility and availability of the drug where it is most needed and free up national resources to dedicate to other aspects of the malaria response.A new study found that more than half of tuberculosis (TB) patients in South Africa receiving treatment with a bedaquiline-containing regimen had isolates resistant to the drug, which was introduced in South Africa in 2012 and has recently become part of all standard drug-resistant TB regimens globally. The study is one of the first to report individual-level bedaquiline resistance gain over time among patients in a setting with a bedaquiline-containing regimen as the standard treatment. The results highlight the need for drug-susceptibility testing capacity to accompany the scale-up of new drugs like bedaquiline to monitor the emergence of drug resistance.
US Department of State
October 30, 2023

Research Roundup: COVID-19-flu shot, Malaria vaccine results, Zika controlled infection method

Written by Hannah Sachs-Wetstone / GHTC
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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. Pfizer and BioNTech last week reported promising early-phase data on an mRNA combination vaccine against COVID-19 and influenza and announced plans to start a phase 3 trial of the vaccine, following Moderna’s similar announcement for its combination vaccine earlier this month. Moderna’s trial began last week, with Pfizer and BioNTech’s likely to start in the coming months as well. A combination vaccine for COVID-19 and influenza has the potential to greatly reduce the burden of these respiratory viruses on patients, providers, and health care systems, underscoring why these companies and the broader research community have placed a greater focus on combination vaccines coming out of the pandemic.At the annual meeting of the American Society of Tropical Medicine and Hygiene (ASTMH) last week, the World Health Organization reported the results of a major evaluation of a pilot rollout in three African countries of RTS,S, the first approved malaria vaccine, showing positive findings about the lives it has already saved. RTS,S cut deaths among young children by 13 percent over nearly four years and cut cases of severe malaria by 22 percent among kids young enough to have received a three-shot regimen. The RTS,S vaccine is notably not a perfect tool, given the limited durability of its protection and lower efficacy, but health experts say this data makes a strong case for broader rollout of RTS,S and the potential of integrating the second approved malaria vaccine, R21, into multipronged efforts to fight malaria.A research team at the Johns Hopkins Bloomberg School of Public Health has shown for the first time that human volunteers can be safely and effectively infected with Zika virus, which could benefit research efforts to gain a greater understanding of the disease and to develop vaccines and treatments to use against it, as none currently exist. This controlled human infection model is useful for research because during the 2015-2016 outbreak, researchers were unable to test experimental products in time before the epidemic subsided, and since, there have not been any large outbreaks. The new model is controversial but has been ruled by US regulators and the World Health Organization as safe and scientifically important.