Breakthroughs Blog: Research Roundup

An international research team, led by scientists at the University of Maryland School of Medicine, shared the results of the Phase 1 trial of a novel vaccine designed to protect against typhoid fever and non-typhoidal Salmonella infections, reporting that the vaccine produced a strong immune response and was safe and well-tolerated in a small group of healthy US adults. These encouraging findings pave the way for the next step of evaluating the vaccine in children. A single vaccine that targets Typhoid fever and non-typhoid Salmonella, both leading causes of illness and death in children in Africa, could be a game-changer for pediatric health. The vaccine could also help protect people in the United States and other high-income countries, where some types of Salmonella are common causes of foodborne illness. Following the example of the US military, who often wear uniforms treated with insecticide to repel mosquitoes in malaria-endemic regions, a research team has tested a similar approach to try to protect young children, who face a significant burden of malaria in sub-Saharan Africa. While existing vector control tools, such as insecticide-treated bednets, only protect children while they’re sleeping, a large randomized controlled trial in Uganda tested the efficacy of insecticide-treated baby wraps, used in conjunction with bednets. The trial found that the baby wraps were highly effective at preventing malaria infections. The dramatic scale of the reduction of new infections also suggests that malaria-carrying mosquitoes were biting during the daytime more often than previously thought, which could help guide the development of new vector control tools and approaches. Last week, The Safety of Antimalarials in the FIRst trimEster (SAFIRE) consortium announced that it had enrolled its first patient in Mali, marking the official start of the first-ever Phase 3 adaptive platform trial evaluating the efficacy and safety of antimalarial drugs in the first trimester of pregnancy. The trial is a landmark achievement that could not only help fill the crucial gap of safe and effective options for pregnant women at risk of malaria, but it is also a step toward equity and inclusion for clinical research and drug development in general, which have long excluded pregnant women, fueling the gap in the first place. SAFIRE partners have shared that early formative research in the communities where the trial will take place was a crucial step in ensuring that the design and process were appropriate and acceptable to the communities. The study will continue to progress in Mali, Burkina Faso, and Kenya. 

Last week, the World Health Organization (WHO) published its latest reports on the new antibacterial agents and diagnostics in the pipeline, seeking to encourage research and development (R&D) to invigorate the sparse pipeline of tools to address the growing global threat of antibiotic resistance. The report highlights a lack of innovation in the antibacterial pipeline and major gaps in antibacterials targeting the most critical bacterial threats and addressing needs like pediatric formulations and oral treatments for outpatient use. There are similar persistent gaps for diagnostics, including a lack of new tests that are affordable, robust, and easy to use in low-resource settings. A new study, led by Imperial College London and supported by the Coalition for Epidemic Preparedness Innovations (CEPI) found that vaccines designed to protect against a wide range of coronaviruses, including a novel sarbecovirus, the type of coronavirus that includes the viruses that caused SARS and COVID-19, could be a gamechanger in a future global coronavirus pandemic, dramatically reducing deaths and disruption. A broad vaccine like this could be manufactured and stockpiled before an outbreak arises and quickly rolled out when a new outbreak is identified, providing protection to high-risk populations 60 years and older. This immediate protection could be a powerful stopgap while a new vaccine targeting the specific virus behind the outbreak is developed. An international research team has developed a simple, affordable HPV test that delivers results in less than an hour outside of a specialized laboratory, which could be a breakthrough for improving access to cervical cancer screening for women in low-resource settings. Cervical cancer continues to cause more than 350,000 deaths every year, particularly in low- and middle-income countries with limited regular access to cervical cancer screening. The test uses a swab sample and a battery-operated portable device, projected to cost less than $8 each, and it was found to be highly accurate compared to the reference standard. 

A Phase 1 clinical trial testing an experimental monoclonal antibody for malaria found that the highest dose of the treatment studied was highly effective in preventing malaria. Researchers from the University of Maryland, Sanaria, the Vital Narrative consultancy, and the Gates Medical Research Institute tested the monoclonal antibody, MAM01, in 37 adults who had never been exposed to malaria, who received either a single dose of varying sizes or a placebo, and then were infected by the bites of infected mosquitoes. None of the three recipients who received the highest dose had malaria parasites in their blood after infection. The monoclonal antibody could prove to be an important treatment option that provides immediate, high-level, and long-lasting protection with just one doseA Japanese research team has isolated natural compounds from marine sponges that demonstrate an ability to kill parasites that cause leishmaniasis, which affects approximately 12 million people around the world. Current treatments are highly toxic, cause serious side effects, and can be prohibitively expensive, leaving patients, particularly in low-income communities, which face a disproportionate burden of leishmaniasis, unable to access or complete treatment. Drug resistance is also complicating leishmaniasis treatment efforts. These findings could guide research into new treatment approaches and could potentially also be applied to other protozoan diseases like Chagas disease and African sleeping sickness. A new CRISPR-based RNA test could help track the parasites that spread Human African trypanosomiasis, or sleeping sickness, which affects around 500 people per year and many more livestock animals. The test can identify parasite species living in an animal’s blood, helping public health workers carry out targeted treatment of infected animals and prevent transmission to humans. This One Health approach to zoonotic or parasitic diseases could also be rolled out to address other diseases, such as Chagas disease or leishmaniasis.  

An international research team led by the University of Liverpool has discovered an exciting new class of antibiotics with the potential to target some of the world’s most dangerous multidrug-resistant bacteria, including MRSA and Enterococcus faecium, as experts continue to warn of the growing global threat of antimicrobial resistance. The new class, Novltex, targets a key component of bacterial cell walls that does not mutate, meaning that, unlike traditional antibiotics, it could offer long-lasting protection against antibiotic-resistant strains of bacteria. Novltex is a synthetically designed platform, making it cheaper to produce and easier to scale up for global use than common antibiotics that utilize complex, expensive natural molecules. In studies so far, researchers found Novltex to be potent and fast-acting, even at low doses, and safe. A research team led by investigators at Weill Cornell Medicine has been awarded a five-year, $20.8 million grant from the National Institute of Allergy and Infectious Diseases at the US National Institutes of Health to further the preclinical development of a promising experimental HIV vaccine for pediatric populations. Experts agree that a preventive vaccine for HIV could help turn the tide of the pandemic. Previous studies of the experimental vaccine found that it was safe and may be effective in infants, although it seems to only work in young immune systems, not in adults. The new funding will support optimization of the vaccine in preparation for clinical trials in infants in parts of the world with a high burden of HIV. Researchers at Tulane University have designed an optimized CRISPR-based tuberculosis (TB) test that uses a simple tongue swab, which, if it continues to demonstrate promise, could be a breakthrough for TB testing. Current TB tests often rely on sputum, which can be difficult to collect and which not everyone can produce, and require sophisticated laboratory equipment and skilled health care workers, leading to gaps in diagnosis, particularly in low-resource settings. The researchers built on a previous CRISPR-based TB test, developing an assay that they found to be highly effective using tongue swabs and also highly sensitive in detecting TB in respiratory, pediatric stool, and spinal fluid samples. This painless and low-resource method could improve access to TB testing, particularly at the point of care in remote and low-resource communities.