Research Roundup: Kenya 3rd country to roll out malaria vaccine, scientists gene-edit stem cells to treat HIV, and an affordable new test for dengue

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.Scientists from Target Malaria, a research consortium backed by the Bill and Melinda Gates Foundation, have for the first time outside of the lab released genetically sterilized mosquitoes in Burkina Faso to combat malaria. Using a technique known as a gene drive, scientists injected male mosquito embryos with an enzyme that sterilizes them, with the goal of reducing the mosquito population over time. Target Malaria is also developing an enzyme to prevent male mosquitoes from passing on X chromosomes, which results in all male offspring, thereby reducing malaria transmission since female mosquitoes are the ones that primarily bite and transmit disease. Researchers continue to push for new approaches to combat malaria, which killed more than 400,000 people in Africa in 2017. Progress against the disease is stalling, according to the World Health Organization (WHO). Biotech company Themis has raised US$44 million to develop its chikungunya vaccine through a phase 3 trial and move the lead candidate from its immuno-oncology research and development (R&D) program into humans. Themis filed an IPO to raise the funds last year but held off due to “adverse market conditions,” leaving the company to consider other options to fund further development. Last month, Merck invested $200 million in Themis for vaccine R&D, indicating Themis had lined up private financing to fund further development. The phase 3 trial is due to start in the coming months, enroll thousands of participants, and deliver data around the middle of next year. Themis is considering taking the vaccine to market itself. The US Food and Drug Administration (FDA) has accepted an application for approval of Merck’s Ebola vaccine, V920, also known as rVSV∆G-ZEBOV-GP. The vaccine is eligible for priority review and Merck will learn of the FDA’s decision by March 14. If the vaccine receives FDA approval, Merck would become the first company to receive clearance to sell a vaccine against the virus in the United States. In addition to its FDA filing, Merck has had an application for approval in Europe accepted for review earlier this year and has also applied for WHO prequalification status. V920 has been used on an investigational basis during the current Ebola outbreak in the Democratic Republic of the Congo, with only 71 cases among the 93,965 at-risk people who received the vaccine, according to WHO.

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. Human clinical trials are being planned to evaluate whether Ivermectin, a drug used to treat parasitic diseases like river blindness and elephantiasis, could become a new drug to combat malaria. Earlier this year, clinical trials conducted in Burkina Faso using Ivermectin for conditions unrelated to malaria found that it reduced malaria transmission by making the blood of people who were repeatedly vaccinated lethal to mosquitoes. Studies have also found that Ivermectin can kill plasmodium falciparum, the malaria parasite carried by mosquitoes, when administered to humans. The US Centers for Disease Control and Prevention, in collaboration with the Kenya Medical Research Institute (Kemri) and other global health partners, will perform the upcoming trials. Kemri and its partners say they hope this breakthrough could lead to the development of a new class of antimalarials in less than two years. Researchers have devised and tested a new mobile program which encourages tuberculosis (TB) patients to adhere to their treatment regimen. Compliance is a challenge with TB because treatment typically lasts for at least six months and involves multiple daily pills that can cause side effects such as nausea, fever, rashes, and stomach pain. The program, Keheala, texts patients to remind them to take their pills daily and asks them to actively verify that they have done so. Patients are ranked and told where they stand in an “adherence contest” against other patients. If patients do not verify that they have taken their pills, they receive more texts, calls, and finally a clinic is alerted. In the trial conducted, only four percent of patients in the Keheala program had bad outcomes, while 13 percent of those in the control group did. Based on these results, the US Agency for International Development will fund an expansion of this trial. Adherence to medications is crucial in treating TB, as those who miss too many pills often develop drug-resistant strains. As a result of the dengue outbreak sweeping across Bangladesh, the World Health Organization and the International Atomic Energy Agency have agreed to trial an innovative technique, known as the sterile insect technique (SIT), which uses radiation to sterilize male mosquitoes. Once sterilized, the male mosquitoes are released into the wild to mate with female mosquitoes, who then do no reproduce—reducing the mosquito population over time. SIT has been used successfully in parts of Africa to eradicate the tsetse fly which transmits sleeping sickness. Experts believe irradiating insects is better than other ways of controlling the mosquito population as it does not involve introducing non-native species or risk mosquitoes developing resistance to insecticides. The first group of sterilized mosquitoes will be released into the wild in Bangladesh in 2021-22.