Breakthroughs Blog: Tuberculosis

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 University of Oxford research team published promising results for a new malaria vaccine, R21. The trial, conducted among 409 children in Burkina Faso, found that an initial three doses followed by a booster after one year showed up to 80 percent efficacy in preventing malaria. The developers say the vaccine can be produced for just a few dollars and that they expect the vaccine to be rolled out next year through a manufacturing deal for more than 100 million doses a year with the Serum Institute of India. The rollout of the vaccine will follow an approval process that hinges on the results from a larger trial, which will be published in the coming months. Both India and China have approved needle-free COVID-19 vaccines­—nasal and inhaled versions, respectively. The nasal version, licensed to Bharat Biotech, was developed by scientists at Washington University in St. Louis. CanSino Biologics has developed the inhaled version, which is a version of their own injected vaccine. Both vaccines use harmless cold viruses although the developers of the nasal version are seeking approval to use the vaccine as a regular and booster dose whereas the inhaled version was only tested as a booster. It is unclear when either vaccine will be available for distribution. These needle-free vaccines are just two of more than ten candidates being studied, as scientists are pursuing needle-free vaccines as a potential strategy to improve protection and make vaccines easier to administer, particularly in low-income countries.A new study published in the journal Radiology looked at Google’s artificial intelligence (AI) model for automating tuberculosis (TB) detection compared to radiologists identifying TB on chest X-rays. The model uses AI to analyze X-ray images to determine which patients should receive follow-up confirmatory molecular testing that is expensive and time-consuming. The AI model could address physician shortages as well as improve TB outcomes and lower costs. While the study revealed promising results across large and diverse patient populations, the model needs to be further tested in real world environments with populations that are older and have more atypical presentations of the disease or other lung abnormalities. A study in a Zambian clinic, which will be finished in the coming months will provide further insight into the potential of the model. 

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.Experts are increasingly concerned about connections between Paxlovid, Pfizer’s COVID-19 antiviral drug, and COVID rebound in patients who complete the five-day regimen, especially as Paxlovid use has grown dramatically in recent months. The US Food and Drug Administration (FDA) has asked Pfizer to investigate whether a second course will prevent rebound. A large study previously showed that Paxlovid significantly reduced hospitalizations and deaths in those 65 years and older, but uncertainty remains over the drug’s effectiveness in younger people as well as the link between the drug and COVID rebound. Rebound has also been observed in people who have not taken Paxlovid as well.A new study investigating the effectiveness of the BPaL drug regimen (a combination of bedaquiline, pretomanid, and linezolid) with linezolid at lower doses found that the treatment was still highly effective in patients with drug-resistant tuberculosis (TB) and the number of patients who experienced side effects related to linezolid dropped significantly. BPaL was approved by the FDA in 2019. Although studies showed the drug to be highly effective in drug-resistant TB patients, there was also a high rate of side effects found to be linked to linezolid. The new study, supported by TB Alliance, published in the New England Journal of Medicine indicated that the dosage of linezolid can be halved while maintaining similar efficacy, making the six-month regimen easier and more tolerable for patients.On Wednesday, August 31, the FDA gave emergency use authorizations to Moderna and Pfizer-BioNTech’s Omicron-updated COVID-19 booster shots to be used as single-dose inoculations at least two months after the first booster vaccination. Both vaccines are aimed at targeting both the original COVID-19 and B.A.4 and B.A.4 Omicron subvariants. Whereas Moderna’s booster is approved for all adults 18 years and older, the Pfizer-BioNTech booster is approved for all people 12 years and older. The CDC endorsed the vaccines on Thursday, clearing the way for a quick rollout in the coming weeks. 

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 Project to Accelerate New Treatments for Tuberculosis (PAN-TB) announced a joint development agreement to support phase 2 trials evaluating two investigational combination treatment regimens for active pulmonary tuberculosis (TB). Both regimens combine already registered products with new chemical entities (NCEs). The first combines delamanid and bedaquiline with two NCEs, OPC-167832 and sutezolid, while the second includes pretomanid and bedaquiline with the two NCEs. The trials will test whether these regimens can substantially shorten treatment duration, with the goal of advancing a suitable regimen into phase 3 development. UNICEF has awarded GSK a contract valued at up to US$170 million to produce the first malaria vaccine. The award will pay for 18 million doses of GSK’s RTS,S vaccine over the next three years. UNICEF has stated their hopes that the award will encourage other malaria vaccine developers to continue to innovate new technologies in order to address the burden of malaria, especially to mitigate preventable deaths of children under five years old from the disease. The United Nations agency expects high demand for the vaccine and believes that costs per dose will decrease over time as supply and manufacturing capacity grow in turn.On Monday, August 15, the UK Medicines and Healthcare products Regulatory Agency (MHRA) gave conditional approval to Moderna’s Omicron variant-updated COVID-19 vaccine for use as a booster in adults. The approval is based on clinical data that demonstrated “strong immune response” against the original virus and B.A.1 subvariant and exploratory analysis showing a “good immune response” against the B.A.4 and B.A.5 subvariants as well as no serious safety concerns. The UK’s Joint Committee on Vaccination and Immunisation followed by supporting the use of the updated vaccine the national booster shot campaign starting next month.

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 novel antibody treatment designed to prevent malaria was able to protect against infection in a majority of participants in a phase 1 trial, according to results published last week. The method utilizes a monoclonal antibody, dubbed L9LS, that is optimized to target a protein used by the malaria parasite to infect hosts. The recent trial tested three different doses of the antibody treatment, administered either intravenously or subcutaneously, among 17 healthy volunteers. All participants were then exposed to malaria-carrying mosquitos, and just two participants developed malaria in the weeks following. The results provide proof of principle for a next-generation monoclonal antibody, researchers say, suggesting it could be an important tool in eradicating malaria when used in combination with effective vaccines and other prevention measures.  The US National Institutes of Health is preparing to launch a clinical trial evaluating methods to stretch doses of Jynneos, the only vaccine approved for use against monkeypox in the United States. Researchers will study two adjusted regimens in comparison to the current method, which involves two full doses given 28 days apart. One test group will receive a single dose of the vaccine, and another group will receive two doses, given 28 days apart, that are each one-fifth of a full dose and administered intradermally—or into the skin, rather than under the skin—which has potential to activate powerful immune responses. The study will test whether the dose-sparing approaches generate antibody levels similar to those of the full, two-dose regimen, as well as compare the tolerability and reactogenicity of the two different routes. Results are expected toward the end of 2022.A clinical trial in South Africa has shown that a new vaccine candidate for tuberculosis (TB) is safe for newborns and has fewer side effects than the existing TB vaccine, Bacillus Calmette Guérin (BCG). The experimental vaccine, VPM1002, was developed by genetically modifying the attenuated BCG vaccine strain so that immune cells better recognize the pathogens, in an effort to increase safety and improve efficacy for immunocompromised children. The phase 2 trial compared VPM1002 with BCG in HIV-exposed and non-HIV-exposed newborns and examined the associated safety and immune response, ultimately finding the vaccine candidate safe in both groups of newborns, with fewer side effects than BCG as well as a similar immune response. Researchers plan to continue to evaluate the vaccine among newborns, including its ability to protect against infection, in a phase 3 trial.