Breakthroughs Blog: HIV/AIDS

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. An experimental hormone-free birth control pill for men appears to be safe and well-tolerated in an early-stage, in-human study and successfully prevented sperm production in mammal studies. The drug, YCT-529, is being developed by YourChoice Therapeutics and Quotient Sciences and works by interfering with the vitamin A signaling necessary for sperm production. There are no male birth control pills available, but, in the future, an option like YCT-529 could help prevent unwanted pregnancies and reduce the burden traditionally placed on women for contraception.Last week, an international team of researchers reported that their Phase 3 clinical trial found that a vaccine that protects against five strains of meningitis is safe and effective, a finding that supports is use in routine childhood immunization programs in high-burden countries. The trial was conducted in babies and toddlers in Mali, one of the countries in the sub-Saharan African meningitis belt, so-called because of its high incidence rates and regular large-scale epidemics of meningitis. Previous trials demonstrated positive results for the vaccine in children over 12 months and adults. The vaccine could be a game-changer for meningitis control, and its affordability would also enable broad scale-up.Gilead recently published early data suggesting that a new formulation of its drug, lenacapavir, could be used to prevent HIV infection with just one shot per year. These exciting results follow data published last year that the drug could provide virtually complete protection with a twice-a-year shot. Reducing the dosage even further will only improve adherence by reducing the cost and burden on those taking the drug and their health care providers. The two-dose formulation of the drug is already under regulatory review, but Gilead is planning a Phase 3 trial of the once-yearly version to begin later this year.

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 team of Brazilian researchers has developed a simple test that can detect exposure to any of the four strains of dengue virus, as well as the Zika virus, as dengue cases continue to rise to a concerning degree in the region. The test was first validated with blood samples from mice experimentally infected with the viruses and then with hundreds of blood samples donated by people during the 2015-2017 Brazilian Zika epidemic. It uses technology that can be easily adapted for use in automated systems and rapid point-of-care tests and could serve as a key tool in the case of a Zika outbreak, allowing health care providers to test the immunity of at-risk groups while accounting for the possibility of cross-reactivity with antibodies produced after infection by dengue.Last week, IAVI and Biofabri announced that the first doses of tuberculosis (TB) vaccine candidate MTBVAC have been administered in a critical large-scale Phase 2b trial testing the safety and efficacy of MTBVAC to prevent active TB lung disease in adolescents and adults. While there is a vaccine for TB, it is more than 100 years old and has limited efficacy in preventing pulmonary TB, the most common form in adults. A new vaccine could be a game changer in the global fight against this leading infectious disease. MTBVAC is also a single-shot vaccine, making it easier to administer in low-resource and remote settings, and the partners developing it are committed to ensuring that, if proven successful in further trials, there will be a sufficient, affordable supply in the places where it is most needed.The Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) last week announced a $2 million award to Immunethep to develop a vaccine against invasive strains of Escherichia coli. The funding will support work on a conjugate peptide-based vaccine candidate designed to induce immunity to E coli, which can cause serious, life-threatening infections that are becoming harder to treat with the rising prevalence of antimicrobial resistance. There are currently no vaccines for E coli. The candidate has demonstrated efficacy against E coli, as well as four other priority bacterial pathogens in animal models, and, if it continues to prove successful, could be a key tool for preventing serious bacterial infections in vulnerable populations.

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 prospective cohort study of patients with drug-resistant tuberculosis (TB) found that the six-month, all-oral BPaL (bedaquiline, pretomanid, and linezolid)-based regimens recommended by the World Health Organization were safe and highly effective, providing critical data from real-world settings with a high burden of drug-resistant TB to support global guidelines recommending their use. The results were comparable to previous Phase 3 clinical trials testing the regimens. Further research is needed to test the regimens among other key populations, including children and people with severe forms of extrapulmonary TB.A recently published analysis found that the 2023 global supply of seasonal influenza vaccines has been stable since 2019, suggesting that production capacity was sustained through the COVID-19 pandemic. Monitoring seasonal vaccine production capacity is important for estimating the capacity to manufacture vaccines in the case of an outbreak of pandemic influenza because pandemic influenza vaccines are produced primarily by the same or similar manufacturers, technology, and facilities as seasonal flu vaccines. The analysis found drastic disparities in production capacity between high-income and low- and middle-income countries and found that the majority of pandemic vaccines, in the case of a novel flu pandemic in the near future, would be egg-based. The author noted that advancing novel influenza vaccines, including mRNA vaccines, could greatly improve global production capacity and pandemic preparedness in the face of pandemic influenza, given they would be faster to produce than egg-based vaccines.A team of researchers has engineered an improved paper-based device for collecting and transporting blood samples of HIV patients. In low-resource settings with limited clinical and laboratory facilities, paper-based devices have become one way that HIV patients can collect their blood to be shipped and analyzed in distant laboratories. The new device has wax-printed patterns that create precise channels and collection spots, ensuring that it consistently collects the same volume of blood and thereby reducing the chances of inaccurate readings. A clinical pilot found that the device more accurately measured the extent of HIV infection compared to the industry gold standard and was also better at detecting drug-resistant viral mutations, enabling physicians to make better care decisions.

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 US Food and Drug Administration granted Fast Track authorization to LimmaTech Biologics' vaccine candidate targeting the Staphylococcus aureus bacterium, which is a major source of sickness and death around the world, causing infections that are becoming harder to treat as the pathogen develops resistance to traditional antibiotic treatments. There is currently no vaccine to prevent infections caused by S. aureus. The authorization will expedite the review process for the product, which will undergo Phase 1 clinical trial testing later this year.  In two Phase 3 trials, a new combination treatment for patients with virologically suppressed HIV-1 demonstrated promising results, underlining the potential of islatravir in combination with other antiretrovirals to address the treatment needs of people living with HIV. The once-daily, oral, two-drug, single-tablet regimen consists of the investigational drug islatravir and doravirine, which was approved in 2018 as a single-agent treatment and in combination with other drugs. Islatravir is also being studied in other early- and late-stage HIV combination treatment trials.  A recently published study found that an mRNA vaccine designed by the US Centers for Disease Control and Prevention and Moderna successfully protected ferrets from the avian influenza virus, which continues its worrying spread across the United States. Blood serum taken from immunized ferrets was also able to neutralize a sample of the virus taken from a patient who contracted bird flu after coming into contact with dairy cows, which have been at the center of the outbreak. While there are three avian influenza vaccines approved in the United States, they were designed for past variants of the virus rather than the clade behind the current outbreak, and they are not mRNA vaccines, which, as demonstrated during the COVID-19 pandemic, can be rapidly produced and scaled up in the face of an emergency.