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The Sabin Vaccine Institute has sent more than 640 doses of its investigational Marburg vaccine to Ethiopia, as the country continues to battle its first-ever outbreak of Marburg, a highly contagious and fatal disease for which there are currently no available vaccines or treatments. Soon after the outbreak was confirmed to be Marburg, Ethiopian authorities coordinated with Sabin and the Biomedical Advanced Research and Development Authority, which is supporting development of the vaccine candidate, to obtain access to doses for an outbreak trial. Sabin and the Ethiopian Ministry of Health have signed a clinical trial agreement under which Sabin is providing doses for a two-cohort Phase 2 open-label trial, involving health care and frontline workers, as well as direct contacts of people with confirmed infections. The vaccine is also being tested in Phase 2 clinical trials in Rwanda, the United States, Uganda, and Kenya, which will hopefully yield evidence to support its continued development and use as a tool in future outbreaks. The Oxford Vaccine Group has vaccinated the first volunteer in a first-in-human trial of its vaccine for Lassa fever, which is caused by Lassa virus, a deadly virus with significant epidemic potential. The trial, funded by CEPI, is being conducted among 31 people between 18 and 51 in Oxford, England, with a second Phase 1 trial in Ghana set to start in early 2026. The vaccine was developed by researchers at the Pandemic Sciences Institute at the University of Oxford and uses the same viral vector platform as the Oxford/AstraZeneca COVID-19 vaccine. The Lassa fever Coalition, led by the West African Health Organization, with support from CEPI and partners, is already working with vaccine developers to accelerate the development and equitable introduction of future vaccines across the West African region, which faces a significant burden of Lassa fever. A Penn State research team has developed a new rapid test that can differentiate active HIV from false positives, which could potentially accelerate the development of a vaccine for HIV. HIV vaccines in development are designed to trigger the body to produce antibodies that target key proteins on the virus’s surface. However, these proteins are also what diagnostic tests detect to confirm an infection, leading trial participants to falsely test positive for HIV, complicating diagnosis and clinical management. Researchers have to use timely and expensive multistep diagnostic procedures to distinguish between those with actual infections and these false positives. The Penn State researchers partnered with the HIV Vaccine Trials Network to test human blood samples with the new testing device, finding that it was highly effective at distinguishing between active infections and false positives and generated results in just five minutes. 

Newly published data shows that the antiviral compound mosnodenvir, developed by Johnson & Johnson, is effective at preventing dengue infection in people deliberately exposed to the virus, which affects millions around the world every year. There are no approved treatments for dengue, and available vaccines face production and efficacy issues. Despite its promise, the future development of the drug is in flux after Johnson & Johnson halted all its infectious disease work last year. Negotiations are underway to find another company to advance the drug, which, if it continues to demonstrate potential, could be used to protect large populations during epidemics, as well as to protect people traveling to endemic areas. Last week, Brazil’s regulatory agency approved the Butantan Institute’s Butantan-DV vaccine for dengue for people aged 12 to 59. The vaccine demonstrated high efficacy in clinical trials against dengue, which causes millions of cases globally, with a substantial burden faced by Brazil. The single-dose vaccine could offer faster and simpler vaccination campaigns compared to existing vaccines. Brazil signed an agreement with WuXi Biologics to deliver approximately 30 million doses of the vaccine in the second half of next year. The results of a human-challenge Phase 2a trial published last week found that an mRNA vaccine was more effective against symptomatic and febrile flu compared to the conventional vaccine. Another trial published last week also found that mRNA flu vaccines were more effective than conventional vaccines. Beyond effectiveness, mRNA vaccines can also be made more quickly, helping ensure that vaccines match circulating flu strains. Additional studies that include older people, those with coexisting illnesses, and school-age children, who face elevated risks, will be required to ensure broad efficacy across populations. 

At the recent Union World Conference on Lung Health, TB Alliance presented the results of a Phase 2 clinical trial showing that the novel antibiotic candidate sorfequiline has the potential to improve tuberculosis (TB) treatment when combined with pretomanid and linezolid in people with drug-sensitive TB. The regimen was more effective than the current standard of care, and sorfequiline also demonstrated greater activity than bedaquiline, a key component of the BPaL regimen, a previous breakthrough that drastically reduced treatment time for most drug-resistant TB. This new treatment could shorten TB therapy even further. TB Alliance is working with partners ahead of the launch of a Phase 3 trial next year. Researchers at the University of California San Diego and partners have developed a new method to combat antibiotic-resistant bacteria, which could pave the way for developing alternatives to traditional antibiotics for treating a wide range of deadly infections, as the global threat of antimicrobial resistance continues to grow. The researchers used bacteriophages (or phages), which are viruses that infect and kill bacteria. Phages have been used to treat bacterial infections for more than 100 years but are usually limited in the bacterial strains they can successfully target. Researchers overcame this by allowing the pages to evolve alongside bacteria in a controlled laboratory setting for 30 days, enabling the phages to adapt their bacterial defenses, becoming more effective at killing a wide variety of bacterial strains, including drug-resistant ones, and better at suppressing bacterial growth for extended periods. Researchers at Indiana University have developed a molecular test that can simultaneously detect three dangerous fungi much faster than traditional methods, helping patients receive accurate, timely treatment against this growing global challenge. The test works by targeting genetic regions unique to each fungus, and it was much faster and more accurate than standard methods, a key advance as fungal infections are often mistaken for other respiratory illnesses. While the test still needs to be clinically validated in further studies, the research team believe it could eventually fill a major gap in fungal diagnostics. 

It’s been a difficult year for people worldwide who live with, are at risk of, or research HIV. Funding reductions and shifting priorities among key donors have disrupted or halted critical research and health services. Around the world, major international donors have reduced their funding for global HIV programming, leading to stoppages and cutbacks of lifesaving care. In the United States, new policies and grant terminations at the Department of Health and Human Services have significantly disrupted HIV research. The integration of the US Agency for International Development into the Department of State and resulting award terminations also interrupted HIV research and service delivery globally.These reductions risk undermining hard-won global progress and could lead to a resurgence in cases. Already, we’re seeing declines in HIV testing and treatment initiation this year. This is especially disheartening given exciting progress in recent years: at the end of 2024, new HIV infections were down 40 percent and AIDS-related deaths down 50 percent since 2010. The last few years have also brought exciting research advances, building momentum toward breakthroughs that could change the course of the global pandemic.With science yielding fruit and new donor countries and private funders stepping up, there is still hope that through renewed partnership and investment, we can regain momentum toward ending HIV/AIDS as a global public health threat. Here are some of the year’s most exciting advances in HIV research and innovation this year that inspire optimism amid significant challenges.A breakthrough in HIV prevention and accessIn June 2025, the US Food and Drug Administration approved lenacapavir as the first twice-yearly injectable drug for HIV prevention, marking a major milestone in the fight against the virus, While the drug, developed by Gilead using evidence from NIH-funded research, was previously approved for treating multidrug-resistant HIV, the new indication offers a discrete, twice-annual alternative to daily pills or bi-monthly injections, making prevention more accessible and easier to maintain. The approval followed highly successful clinical trials, which were notable not only for how effective the drug was across key populations, but also for their inclusion of historically underserved populations.Following the FDA’s decision, Gilead and the Global Fund to Fight AIDS, Tuberculosis and Malaria announced an access agreement that will see Gilead supply doses, at no profit, for up to two million people over three years. The Gates Foundation and Indian manufacturer Hetero Labs are also partnering to manufacture generic lenacapavir at an affordable price. The World Health Organization swiftly recommended the drug’s use, and South Africa’s regulatory authority approved it at record speed, the first such approval in Africa. It’s exciting to see partners work together to help ensure this breakthrough can be accessible in the communities where it is most needed quickly and affordably, a sharp divergence from past HIV product rollouts that saw years-long delays before people in low- and middle-income countries received access to new tools. Earlier this year, Gilead also published data suggesting a once-yearly version of the drug may be possible, with Phase 3 trials to begin later this year.Lenacapavir is not the only exciting advance in long-acting HIV prevention we saw in 2025. Merck’s investigational once-monthly oral prevention pill was found to be well tolerated in adults in a Phase 2 trial and is now undergoing Phase 3 trials in sub-Saharan Africa. Meanwhile, a single gene therapy injection given at birth showed promise in protecting primates from infection for at least three years in preclinical research. If this solution advances, it could be a gamechanger for preventing mother-to-child HIV transmission.Broadly neutralizing antibodies for long-term HIV control and cureBroadly neutralizing antibodies (bnAbs), which are made naturally by some individuals and target parts of the HIV virus that are less prone to mutation, are also showing promise in HIV treatment, prevention, and cure strategies. Studies have shown that bnAbs can effectively neutralize a broad range of HIV strains and bnAb combinations can maintain viral suppression in the absence of antiretroviral therapy, but challenges remain around their cost, global scalability, and the potential for viral resistance.Researchers are testing combination approaches with other drugs to potentially enhance the efficacy of bnAbs in controlling HIV. Study results presented earlier this year found that more than half of study participants living with HIV who received a pair of bnAbs plus the drug N-803 experienced delayed viral rebound or maintained a low or suppressed viral load during interruption from antiretroviral treatment. N-803, which is approved as a treatment for bladder cancer, appears to help reactivate and eliminate dormant HIV virus.Gilead also shared promising results from a Phase 2 trial earlier this year combining lenacapavir with two bnAbs as treatment for HIV. This regimen is the most advanced bnAbs-based treatment to date, with Phase 3 trials expected to start soon.Beyond treatment, many leading HIV scientists believe that a vaccine that elicits the production of bnAbs could be key to targeting the tricky, mutating virus. IAVI and partners developed immunogens, a type of antigen that can trigger an immune response, for use in a vaccine strategy to induce bnAb production, which demonstrated success in several Phase 1 clinical trials. A new study looking at data from two of the trials shows that this targeted vaccine strategy can successfully activate early immune responses relevant to HIV, an important step toward an HIV vaccine. The candidates use an mRNA vaccine platform, enabling faster production and clinical testing.While bnAbs have the potential to transform HIV prevention and treatment, further research is needed to overcome cost and delivery barriers to ensure that future innovations can be rapidly scaled up and distributed to the communities who can benefit most from them.While global HIV efforts have faced setbacks this year, we’ve also seen the extraordinary progress that’s possible when partners unite around innovation. New tools and approaches are emerging that could change the course of the global HIV/AIDS pandemic, preventing millions of new infections and deaths every year. But their impact depends on what happens next. To realize their full potential, countries, donors, and partners must come together and recommit to fund research, prioritize equitable access, and accelerate the scale-up of new tools. The future of the HIV/AIDS response hinges on how we meet this moment.