Research Roundup: New TB drug regimen for drug-resistant infections, Gates Foundation to fund study for coronavirus cure, and long-acting treatment for HIV

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 clinical trial to test an experimental vaccine against the novel coronavirus is expected to kick off today. This initial trial will inject 45 healthy participants with different doses of the vaccine candidate co-developed by the National Institutes of Health and Moderna Inc. The goal for the initial trial is to check that the vaccine shows no worrisome safety side effects in order to set the stage for larger efficacy tests. Public health officials say it may take up to 18 months to fully validate the potential vaccine. Dozens of research groups and companies are racing to develop a vaccine against the novel coronavirus. A second vaccine candidates from Inovio Pharmaceuticals is expected to begin safety tests next month. A man initially known as the “London Patient” has become only the second person in the world to be cured of HIV. The man, Adam Castillejo, has decided to go public with his identity one year after being declared free of the virus and now 30 months after ceasing antiretroviral therapy. Mr. Castillejo was cured of HIV after receiving a stem cell treatment for cancer. The donors of these stem cells have an uncommon gene that gives them, and now Mr. Castillejo, protection against HIV by preventing the virus from replicating inside the body. In 2011, Timothy Brown, the "Berlin Patient" became the first person reported as cured of HIV, three and one-half years after having similar treatment. Although this high-risk therapy was primarily used to treat the patients’ cancer—and is not a feasible treatment for millions living with HIV worldwide—it offers hope to finding a cure for HIV using gene therapy. A new collaboration between Medicines for Malaria Venture and the Liverpool School of Tropical Medicine will establish pregnancy registries in malaria-endemic countries in Africa to fill the data gap on the use of antimalarials in one of the most vulnerable populations to malaria. The study will be conducted across three African countries and will capture data on the real-life use of artemisinin-based combination therapies (ACTs)—the standard care for malaria— during all stages of pregnancy, including the first trimester. The goal of the study is to collect enough safety and exposure data that, if positive, would allow for policy change on the use of ACTs in the first trimester of pregnancy. ACTs are currently not recommended in the first trimester of pregnancy owing to a historic lack of safety data.

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.  Last Thursday, the World Health Organization (WHO) launched the first digital version of its latest Model list of Essential Medicines (EML), which provides countries with guidance on the most crucial medicines to have in supply. The EML list has been revised every two years by a group of WHO experts since 1977 but has previously only been published in print or PDF format. The new electronic format makes the EML list more accessible and easily searchable, as users can filter results and export customized lists to Microsoft Excel or Word. More than 150 countries currently use the EML list to determine which medicines best meet their national health needs to compile their own national essential medicines list. US biotech firm Moderna has shipped its first batch of an experimental coronavirus vaccine to US government researchers at the National Institute of Allergy and Infectious Diseases for initial trials that could begin as soon as April. The experimental vaccine candidate will be used in a phase 1 study in the United States, which will test two doses of the vaccine on 45 healthy people. Even if this initial clinical trial is successful, further testing and regulatory approvals would be required before the vaccine could be deployed for widespread use—a process that could take at least one year or 18 months. Moderna is among a slew of companies around the world rapidly trying to identify treatments or develop vaccines against the novel coronavirus that emerged in Wuhan, China late last year, which has infected more than 80,000 people worldwide. The first clinical trial in the United States of a potential treatment for the novel coronavirus is now underway at the University of Nebraska Medical Center. In a draft research plan published last month, WHO said this antiviral medicine remdesivir was considered “the most promising candidate” to treat the novel coronavirus, citing laboratory studies suggesting it might be able to target Severe Acute Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome (MERS)—cousins of the novel coronavirus. Remdesivir, which is made by Gilead Sciences, is part of a study already underway in China to test its efficacy against the novel coronavirus and was previously tested in some Ebola patients in the Democratic Republic of Congo before the study was stopped. Currently, there are no proven treatments or vaccines for the novel coronavirus.