Research Roundup: Promising HIV vaccines, Speedier mRNA vaccine development, HIV prevention methods safe in pregnancy

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 new study that tested Gilead’s antiviral drug, obeldesivir, in primates given a lethal dose of the Ebola Sudan virus found that the drug may be effective in curing infections from the Sudan strain, for which there are currently no approved vaccines or treatments. The study tested a regimen of once-daily pills for ten days. If proven effective in humans and approved, it would be the first oral treatment for any subspecies of Ebola. Moreover, the drug can be stored at room temperature and is relatively inexpensive to manufacture, especially compared to the monoclonal antibodies approved for Ebola Zaire. Previous work in cell culture also showed that obeldesivir seems to work against all known species of Ebola and the related Marburg virus. Further research could confirm the drug's use as a pan-ebolavirus therapy; however, running clinical trials will prove challenging as there are long stretches between outbreaks of Ebola Sudan, in particular.A new initiative led by Imperial College London and co-funded by the Coalition for Epidemic Preparedness Innovations (CEPI) aims to develop next-generation coronavirus vaccines that not only reduce disease severity but also stop viral transmission, reducing the spread of disease. The project will deliberately infect healthy human volunteers with betacoronaviruses, including the virus that causes COVID-19, to test the efficacy of vaccines that are administered via nasal spray. Experts believe this method could be more effective in triggering the highly specialized mucosal immunity that can stop transmission by directly acting at the cells lining the nose, throat, and lungs—where the viruses enter the body. The human challenge trial design of the project is also unique. Imperial College London last year announced that the world’s first COVID-19 human challenge trial was safe, paving the way for broader use of this approach.A research team has discovered an enzyme in the species of sandfly that is primarily responsible for the spread of leishmaniasis in South America that they hope will lead to the development and commercialization of targeted traps to control the insect population and reduce the spread of the disease. Leishmaniasis can be disfiguring, and the severe form, visceral leishmnasis, which mostly occurs in Brazil, can be lethal if left untreated. The researchers analyzed the genome of the Lutzomyia longipalpis, a species of sandfly native to Brazil and South America, and identified the enzyme, Terpene Synthase, which is responsible for making the pheromone used to attract mates, a discovery that could be leveraged for future control technologies.

A new report launched at Davos, from the World Economic Forum and the McKinsey Health Institute, refocused the spotlight on women’s health back in January. The report found a stark gap in health between women and men, adding up to 75 million years of life lost annually due to poor health or early death. This health gap is incredibly costly—closing it would benefit 3.9 billion women and would boost the global economy by $1 trillion by 2040 due to reductions in early deaths and health conditions, as well as the greater capacity for women to make socioeconomic contributions.In recognition of International Women’s Day, GHTC is spotlighting technologies, both available and still in development, that could help close the gender health gap and move us toward gender equity by both addressing the leading causes of morbidity and mortality for women and girls and empowering them to take control of their health and future. 1. CAB-LA and the dapivirine ring for HIV preventionHIV remains a major global challenge, especially for women and girls, who account for more than half of the 37.7 million people living with HIV and 46 percent of new infections in 2022. While the introduction of oral pre-exposure prophylaxis (PrEP) has helped drive significant declines in HIV infections globally, challenges adhering to the regimen of daily pills, as well as issues of stigma, have limited its impact in certain populations, including adolescent girls and young women. Long-acting cabotegravir (CAB-LA), developed by ViiV Healthcare, is a HIV prevention option administered by injection once every two months. CAB-LA offers an option that for many is easier to consistently use and also more discreet to receive than daily oral PrEP, which can reduce a barrier to use for those who fear stigmatization if their HIV status is exposed.The dapivirine ring, developed by the nonprofit International Partnership for Microbicides, is a flexible silicone ring inserted in the vagina that slowly releases the antiretroviral medication dapivirine over one month to reduce the risk of HIV infection. The ring offers an alternative discreet, user-controlled prevention option for women at high risk of HIV who are unable or prefer not to use other prevention methods.2. HPV vaccine and self-sampling for cervical cancer prevention and treatmentCervical cancer is the fourth most common cancer in women globally, but 90 percent of deaths from cervical cancer and more than 80 percent of cases occur in low- and middle-income countries (LMICs). This is mostly due to lack of access to human papillomavirus (HPV) vaccination (nine out of every ten cases of cervical cancer are caused by persistent HPV infection) and cervical screening and treatment services. Ensuring girls and women have access to HPV vaccines and testing can help to address the persistently high burden of preventable HPV cases and cervical cancer deaths.As of 2023, there are six vaccines for HPV available globally, which all protect against the highest-risk types of HPV that cause the most cervical cancers. While there have been many studies demonstrating the safety and efficacy of HPV vaccines, a new study published in January of 2024, which was the first to monitor a national cohort of women over a significantly long period of time (the study looks at women born between 1988 and 1996), found zero cases of cervical cancer—reinforcing HPV vaccines as a lifesaving tool that has and will continue to be a game changer for women’s health. Regular screenings for cervical cancer are globally recommended and are crucial because cervical cancer can be cured if diagnosed and treated early on. Yet 67 percent of women between 20 and 70 have never been screened for cervical cancer (by HPV or other tests). HPV self-sampling, an approach recommended by the World Health Organization (WHO) for women 30 to 60, has been shown to be about as reliable as sampling by health care providers. Additionally, it has also been shown to nearly double use of cervical cancer screening services because it offers privacy and convenience, requires little time and effort, and reduces any embarrassment, pain, or anxiety that may be associated with sampling done by health workers. 3. Next-generation contraceptivesAn estimated 257 million people globally who want to avoid pregnancy are not using safe, modern methods of contraception, leading to unintended pregnancies and then unsafe abortions, which cause up to 13 percent of all maternal deaths. Unacceptable or unsuitable contraception options are one of the leading causes of unintended pregnancy. An estimated 40 percent of women in LMICs who use a contraceptive stop within a year because of challenges, including side effects, the burden of sticking to a daily regimen, and the time and monetary cost of having to travel, sometimes far distances, to get new prescriptions. Introduction of the daily oral birth control pill helped contribute to a major increase in contraceptive use globally over the past 50 years, but contraception technology has not seen major innovations in generations, and the field is deeply underfunded, highlighting the need for new, less burdensome contraceptive options.Lyndra Therapeutics is developing a once-monthly contraceptive pill, currently in preclinical development, that could serve as one such alternative. Researchers are also developing longer-acting injectable contraceptive products, including a six-month injectable contraceptive being advanced by FHI 360. Microarray patches are another novel contraceptive option in early-stage development—they work by releasing hormones over several months and are discreet and easy to use at home. Contraception, and specifically access to a variety of contraceptive options that fit varying needs, allows women and girls to have autonomy over their bodies and lives. There remains a gap in further research into nonhormonal contraceptive options that cause fewer uncomfortable side effects or contraceptives for men that take the burden off of women.4. AI-enabled ultrasoundsAlmost 800 women died from preventable causes related to pregnancy and childbirth every day in 2020. While there are many contributing factors, one significant challenge is lack of access to diagnostic tools like ultrasounds. Fifty percent of women in LMICs received no ultrasound scans during the course of their pregnancy. Even where ultrasounds are available, they are usually bulky, expensive, and require specializing training or knowledge to operate, forcing patients to travel to specific health care facilities to access them. New technologies like Philip’s Lumify Handheld Ultrasound, which can be connected to a mobile device, offer a more compact, portable option in emergency situations or in low-resource settings when traditional ultrasounds are not available or are not feasible. The Bill & Melinda Gates Foundation is funding Philips to accelerate the adoption of artificial intelligence (AI) algorithms that can be used with the scanner to simplify the identification of key pregnancy abnormalities, with results already showing that the AI-enabled technology helped to improve informed decision-making in the care of pregnant women in rural, underserved communities. Nimble, compact technologies like this ensure that more women have access to basic, lifesaving technologies and that women, along with their health care providers, can make informed decisions about their health and pregnancy, reducing the likelihood of death from preventable causes.5. Postpartum bleeding solutionsPostpartum hemorrhage (PPH), or excessive bleeding after childbirth, is the world’s leading cause of maternal death and can lead to lasting disability and psychological trauma, despite being preventable and treatable. Adolescent pregnancies carry a higher risk of postpartum hemorrhage because adolescent uteruses are not fully developed enough to sustain a healthy pregnancy—pregnancy complications, as well as unsafe abortions, are the leading cause of death among 15- to 19-year-old girls globally.PATH and Sinapi developed a technology, called the Ellavi uterine balloon tamponade, which builds on a low-cost solution some health care providers had been using to combat PPH called a “condom catheter,” which uses items commonly found and self-assembled in a clinic to insert a condom into the uterus and then fill it with water to exert pressure on the uterine walls and stop the flow of blood. The Ellavi device was optimized to be a high-quality, simple-to-manufacture and -use, and affordable version of the “condom catheter” that could be deployed globally to save even more lives. Another simple, inexpensive solution to PPH comes in the form of a plastic sheet with a pouch to collect and measure the volume of blood loss. This tool helps health care providers better recognize when women are in danger and take action. In one large-scale study in Africa, this sheet, when used in combination with other WHO-recommended treatment options for PPH, reduced the number of women experiencing severe bleeding by 60 percent and also reduced the number of deaths from PPH.These innovative but simple and low-cost technologies are not moneymakers, but they can greatly reduce preventable maternal deaths, particularly among adolescents, illustrating a paradox in women’s health—the gap persists because many technologies that could have a tremendous impact, particularly in LMICs, do not necessarily yield the greatest profit.While these five solutions highlighted have the potential to save lives and empower women, it is clear that closing the cavernous gender gap in health will require many more new tools and improved access to existing ones. Greater investment in R&D for conditions that specifically affect women and girls and expanded roles for women and girls to engage and lead across the R&D sector can help ensure more breakthroughs are realized in our lifetimes and that resulting tools are designed with the diverse needs of women and girls in mind.