Breakthroughs Blog: Zika

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 drug, remdesivir, was shown to protect monkeys against infection with Nipah virus—an emerging pandemic threat for which there is no approved vaccine or cure. The only current treatment is a still experimental monoclonal antibody that was tested during an outbreak in India last year. Remdesivir is also being tested against the Ebola virus in the current outbreak in the Democratic Republic of Congo and has shown some effectiveness against Lassa fever, MERS coronavirus, and respiratory syncytial virus in other studies. In the new study performed by the National Institute of Allergy and Infectious Diseases (NIAID) and the Centers for Disease Control and Prevention, eight African green monkeys were given lethal doses of Nipah virus. The four monkeys who received intravenous remdesivir within 24 hours of infection and daily infusions for 12 days survived, while the four that did not died within eight days. If remdesivir wins approval, “it will give us an extra treatment that could be used relatively quickly,” said Emmie de Wit, a virologist at NIAID, noting that “the average person who reaches a hospital dies within two days, so it’s hard to protect them once they’re infected.” The next step is to test how long after infection the drug can be given and still cure the animals. Women make up just over half of the 35 million people living with HIV worldwide but are underrepresented in clinical trials of potential HIV treatments, cures, and vaccines. A 2016 study performed by amfAR, the Foundation for AIDS Research, found that women represented a mean of only 11 percent of HIV cure trials, 19 percent of antiretroviral drug trials, and 38 percent of vaccine studies. Despite the well-known differences in how the immune systems of men and women respond to the HIV infection and how women respond to some drug treatments, clinical trials continue to rely heavily on the participation of gay men in particular. Further complicating women’s participation in clinical trials is the US Food and Drug Administration’s (FDA) strict rules for including women of childbearing age, leaving most researchers to opt for the easy way out and just enroll men, collecting data from women only after the drug is on the market. As scientists continue to pursue cures for HIV in light of reports of the second patient cured of the infection, researchers must reckon with the longstanding obstacle of the lack of women in clinical trials. The FDA has authorized the first diagnostic test to detect Zika antibodies in human blood to be marketed in the United States. The diagnostic, known as ZIKV Detect 2.0 IgM Capture ELISA, detects the proteins produced by the body’s immune system when it tests for the Zika virus in blood. Though 18 other active tests to detect Zika exist, they have only been allowed under emergency use. This newly approved diagnostic test will only be usable by those with clinical signs and symptoms of Zika or on those who have traveled to regions with active Zika transmissions. FDA Acting Commissioner Ned Sharples noted that the marketing authorization of this Zika diagnostic demonstrates “FDA’s work to protect the public health in emergency response situations.”

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. In pursuit of a malaria vaccine, the biotech firm, Sanaria, has partnered with roboticists at Johns Hopkins University to develop a guillotine to decapitate and dissect out the salivary glands of mosquitoes, which hold the malaria-causing parasite. This guillotine, which can decapitate 30 mosquitoes at a time with the guidance of a “mosquito surgeon,” will help Sanaria effectively mass-produce its malaria vaccine candidate, PfSPZ, which requires one whole malaria parasite per vaccine dose. Eventually automating this process, even partially, would likely boost the mosquito dissection rate above the current average of 300 mosquitoes per hour achieved by highly trained technicians. The PfSPZ vaccine, which is currently in phase 2 clinical trials, is thought to work by inducing killer T cells to attack the parasites in the human body as they’re developing in the liver. Scientists at Oxford University have harvested antibodies from volunteers vaccinated in research trials of an Ebola vaccine to develop a treatment for the viral infection. Traditionally, antibodies intended for treatment are collected from the blood of people who have survived infection. This technique instead uses antibodies collected from those who have been exposed to the Ebola vaccine but not the Ebola virus itself—suggesting that protective therapies can be developed from people who are disease-free. To create the experimental treatment, scientists made a cocktail of four antibodies from trial volunteers who had been given an experimental Ebola vaccine and whose immune system responded to the shot by making antibodies. This cocktail successfully cured six guinea pigs of the virus when administered three days after infection. The research team believes this approach could be used for other emerging diseases caused by viruses. Brazilian researchers say they have developed a simpler, cheaper, and faster method to diagnose the Zika virus that doesn’t require laboratory equipment or trained staff. The method uses a technology called loop-mediated isothermal amplification (RT-Lamp), which amplifies the viral genome of the biological sample to detect the virus. While the current method of detecting Zika virus, polymerase chain reaction (PCR), is considered the gold standard for virus detection, it requires expensive equipment, specialist staff, and laboratories with good infrastructure. On the other hand, RT-Lamp has the ability to detect a very low quantity of the virus and has an individual cost of around US$0.25 compared to $10 for the PCR test. The RT-Lamp technology has long been used for other diseases, such as Ebola, but not for Zika. The authors of the study have requested a patent of this technique and hope to transform the technology into a commercial kit to be used for diagnosing patients.

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. According to clinical trial results recently published in the New England Journal of Medicine, tafenoquine—a new single-dose oral antimalarial drug developed by Medicines for Malaria Venture and GlaxoSmithKline—significantly lowered the risk of the recurrence of malaria caused by the Plasmodium vivax (P. vivax) species of the parasite. P. vivax malaria affects approximately 7.5 million people annually and often lies dormant in the liver even after initial treatment, causing debilitating recurring malaria episodes. This single-dose treatment could significantly boost cure rates, as adherence to the standard two-week drug course is difficult in low-resource regions in Southeast Asia, Latin America, and parts of North Africa where this form of malaria is endemic. Based on the results of this clinical trial, the US Food and Drug Administration has already approved tafenoquine for use in July 2018, followed by the Australian Therapeutic Goods Administration in September 2018. A new, long-acting contraceptive designed to be self-administered by women using microneedle skin patch technology could provide a valuable new family planning option, particularly for women in low-resource settings where access to healthcare can be limited. When the patch is applied to the skin, microscopic needles break off and remain under the surface of the skin where biodegradable polymers slowly release the contraceptive drug, levonorgestrel. In animal testing, an experimental microneedle patch provided a therapeutic level of contraceptive hormone for more than a month with a single application. Experimental patches designed for humans have been developed but not yet tested. If the microneedle contraceptive patch does eventually reach the market, it could become the first self-administered, long-acting contraceptive that does not require a conventional needle injection.A new rapid DNA and RNA sequencing device could offer potential to instantly diagnose viruses such as Ebola or Zika at the point of care during an outbreak. Researchers at the French agricultural research institute CIRAD have found a way to use a device known as the Oxford Nanopore MinION device, which can sequence DNA and RNA in real time, to identify plant viruses—and potentially animal and human viruses too. The CIRAD team was able to test and validate the use of this portable device to identify plant viruses quickly and early in the infection process—avoiding the time-consuming and potentially dangerous task of transferring contaminated samples to a lab. The device’s ability to rapidly and accurately detect a virus in plants is a step forward in providing real-time detection of viruses with a mobile device, which would be especially useful in low-resource settings and remote areas. This device has the potential to help public health officials manage outbreaks by reducing the time between taking a sample and diagnosing it as carrying a particular virus—enabling the detection of potential outbreaks at an earlier stage than was previously possible.

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 government of the United Kingdom (UK), through a public-private partnership called UK Research and Innovation, is building the country’s first vaccine manufacturing and innovation center with additional funding and expertise from Janssen, Merck & Co., and Wellcome Trust. The center will focus on creating rapid, cost-effective ways to develop and manufacture vaccines for clinical trials and global distribution, with Ebola and Lassa fever among the infectious diseases the center will tackle. The vaccine manufacturing and innovation center will be based in Oxford and is slated to open in 2022. A comprehensive study in The Lancet Infectious Diseases shows the remarkable genetic diversity of HIV and reveals how the subtypes of the virus are distributed by country and region and where new strains are emerging. The systematic review and global survey found that the greatest diversity of HIV exists in Central Africa and subtype C causes the greatest number of HIV infections globally. Subtype C was also found to be the near-exclusive strain of HIV in southern Africa, where HIV prevalence is highest, strengthening the case for prioritizing the development of an HIV vaccine specific to this subtype. Overall, the study also highlighted the challenging nature of developing a vaccine against a virus that is so genetically diverse and widespread. Researchers from Loyola University Chicago Stritch School of Medicine have developed six antibodies that could be used to test for and potentially treat Zika—a virus which has afflicted more than 1.5 million people worldwide and for which there is no effective vaccine or treatment. Inexpensive to produce and identifiable via means like a simple filter paper test in the field, these antibodies have the potential to provide protection against the virus or could also be used in an antibody-based diagnostic test for Zika, potentially providing an inexpensive and quick means of monitoring for the virus. One researcher noted, “Rapid spread of the disease within the epidemic regions, coupled with migration of infected persons, has underscored the need for rapid, robust and inexpensive diagnostic tools and therapeutics.”