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Ongoing clinical research study in US children documents the rebound of endemic respiratory viruses, builds foundation for expediting future vaccines and treatments AURORA, Colo., Aug. 7, 2025 /PRNewswire/ -- The first paper from a multi-year clinical research study has been published in The Lancet Infectious Diseases: Dynamics of Endemic Virus Re-emergence in Children in the USA Following the COVID-19 Pandemic (2022-2023): A Longitudinal Immunoepidemiologic Surveillance Study and demonstrates how the approach can improve modeling to better predict future outbreaks. The paper shares findings from a multicenter clinical research study, one of many studies that are part of the recently launched PREMISE (Pandemic Response Repository through Microbial and Immune Surveillance and Epidemiology) program, led by Dr. Daniel Douek at the National Institutes of Health's (NIH) Vaccine Research Center (VRC). Data collected during the first year of the PREMISE study, 2022-2023, shows for the first time how non-pharmaceutical interventions such as masking and distancing targeted towards SARS-CoV-2 during the pandemic also decreased circulation rates of and population immunity to common respiratory pathogens in children. The study provides new evidence-based insight into what was driving the large post-pandemic rebound in these diseases and enables more accurate predictions for the future. This study is a partnership between PREMISE and clinical research sites at academic institutions led by principal investigator Kevin Messacar, MD, PhD, infectious disease specialist at Children's Hospital Colorado, at the central site at University of Colorado Anschutz Medical Campus and Children's Hospital Colorado with additional study sites at University of North Carolina, Weill Cornell Medicine and the University of Alabama at Birmingham. The PREMISE study conducted immunologic surveillance on children younger than 10 years old, by enrolling them and following them for over a year. Through repeat blood sampling, the team could determine what children at varying young ages had immunity to and what they were susceptible to. Through respiratory sampling during illness, researchers were able to determine what infections they experienced. The data showed that most younger children lacked immunity to many normal respiratory viruses during the pandemic, suggesting they had not been exposed, as they typically would have, due to prevention measures in place. Following the lifting of pandemic measures, the level of immunity rose across all pathogens studied, reflective of the unprecedented widespread resurgence of these viruses in children after the end of the pandemic. While most research studies target a specific disease, samples from PREMISE were tested for many common and emerging respiratory viruses, including RSV, influenza and enterovirus D68 (EV-D68), which can cause the polio-like illness, acute flaccid myelitis. The data allowed experts to recreate past circulation patterns and model predictions for future outbreaks with greater accuracy and precision. They showed that PREMISE data from 2022-23 could be used to accurately predict the subsequent wave of disease of the emerging pathogen EV-D68 that occurred in 2024. "Four cohorts of almost 1,000 children have provided an invaluable bank of samples and data," said lead author Hai Nguyen-Tran, MD, infectious disease specialist at Children's Hospital Colorado and assistant professor at University of Colorado School of Medicine. "These are being used to develop 'on the shelf' medical countermeasures, such as antibody treatments and vaccines, for pathogens of interest. Instead of starting from scratch, this study gives us a head start to understand, predict and prepare for future pandemics." Samples and data from the PREMISE study will also be used to learn which parts of viruses the human immune system attacks to become immune, so teams can better design new antibody treatments and effective vaccines to mimic this response. "In the future, this type of immune surveillance can be used to better understand the impact of public interventions on population immunity and future waves of disease," said Dr. Messacar, who is also a professor at University of Colorado School of Medicine. "PREMISE is a great example of a successful research partnership between NIH scientists and clinical researchers in academia, leading to concrete deliverables such as vaccine candidates and monoclonal antibodies that can directly impact public health." This study is fully funded by a subcontract with Frederick National Laboratory for Cancer Research (FNLCR), currently operated by Leidos Biomedical Research, Inc. through Agreement 21X192QT1. FNLCR funding was provided by the NIH Vaccine Research Center within NIAID. The total project funding is $7.98 million over five years. No financing for this project was supplied by nongovernmental sources. ABOUT CHILDREN'S HOSPITAL COLORADO Children's Hospital Colorado is one of the nation's leading and most expansive nonprofit pediatric healthcare systems with a mission to improve the health of children through patient care, education, research and advocacy. Founded in 1908 and ranked among the best children's hospitals in the nation as recognized by U.S. News & World Report, Children's Colorado has established itself as a pioneer in the discovery of innovative and groundbreaking treatments that are shaping the future of pediatric healthcare worldwide. Children's Colorado offers a full spectrum of family-centered care at its urgent, emergency and specialty care locations throughout Colorado, including an academic medical center on the Anschutz Medical Campus in Aurora, hospitals in Colorado Springs, Highlands Ranch and Broomfield, and outreach clinics across the region. For more information, visit or connect with us on Facebook, Instagram and YouTube. Media Contact: Rachael Fowler, Children's Hospital Colorado 24/7 media line: 303-890-8314 [email protected] SOURCE Children's Hospital Colorado WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Tanzania’s northwestern Kagera region serves as a transit hub to neighbouring countries. Image credit: Shutterstock/ Aleksandrkozak. Eight people have likely died from an outbreak of Marburg virus disease (MVD) in a northwestern region of Tanzania, according to the World Health Organization (WHO). The suspected outbreak has occurred in the Kagera region – the area where the first known MVD cases were diagnosed in March 2023. On 10 January 2025, the WHO received reports that five people had died from suspected MVD cases. A day later, this had risen to eight deaths from nine suspected cases, conferring an 89% case fatality ratio. The organisation then issued a disease outbreak alert on 14 January. The WHO said samples from two patients are currently being analysed to confirm MVD infection. The suspected cases, which also include healthcare workers, presented with symptoms such as headaches, fever, and vomiting blood. External haemorrhage—bleeding from orifices —was seen in the later stages of the disease. The organisation said the regional risk of this suspected outbreak is high due to Kagera’s transit hub role. The region serves as a place for significant cross-border movement to countries such as Rwanda, Uganda, Burundi and the Democratic Republic of the Congo, meaning there is a potential for MVD to spread to neighbouring countries. The national risk is also assessed as high by the agency due to the delayed detection and isolation of cases. The WHO has currently placed the global risk as low, stating that there has so far been no confirmed international spread. The agency did, however, allude to Kagera’s airport that connects to Tanzania’s largest city Dar es Salaam, where international air travel is possible. WHO Director-General Dr Tedros Adhanom Ghebreyesus said in a statement: “We would expect further cases in coming days as disease surveillance improves. WHO has offered its full assistance to the government of Tanzania, and affected communities. “We recommend neighbouring countries be on alert and prepared to manage potential cases. We do not recommend travel or trade restrictions with Tanzania at this time.” MVD is not easily transmissible, being spread through direct contact with bodily fluids. The virus can be difficult to distinguish from other infectious diseases such as malaria and other haemorrhagic fevers, with infection confirmed by diagnostic lab analysis. A species of fruit bat is considered to be the natural host of the virus, which can spread to humans working in mines or caves, but the WHO said the source of the current outbreak in Tanzania is unknown. Vaccine development Whilst there are no approved vaccines or antiviral treatments for MVD, a range of candidates are in development. The WHO has prioritised four vaccine candidates, all viral-vectored based, to combat future outbreaks. The first to enter clinical trials was cAd3-Marburg developed by the Vaccine Research Centre at the National Institute of Allergy and Infectious Diseases (NIAID). A Phase II trial (NCT05817422) was launched in October 2023 following a successful Phase I trial (NCT03475056), which showed the vaccine conferred a robust antibody response in 95% of participants. The UK’s University of Oxford has also developed a vaccine called ChAdOx1 Marburg, which entered clinical trials in July 2024. In the US, the US Food and Drug Administration awarded orphan drug designation to a vaccine being developed by Soligenix in April 2024 after positive preclinical data.

Three different HIV antibodies each independently protected monkeys from acquiring simian-HIV (SHIV) in a placebo-controlled proof-of-concept study intended to inform development of a preventive HIV vaccine for people. The antibodies -- a human broadly neutralizing antibody and two antibodies isolated from previously vaccinated monkeys -- target the fusion peptide, a site on an HIV surface protein that helps the virus fuse with and enter cells. Three different HIV antibodies each independently protected monkeys from acquiring simian-HIV (SHIV) in a placebo-controlled proof-of-concept study intended to inform development of a preventive HIV vaccine for people. The antibodies -- a human broadly neutralizing antibody and two antibodies isolated from previously vaccinated monkeys -- target the fusion peptide, a site on an HIV surface protein that helps the virus fuse with and enter cells. The study, published in Science Translational Medicine, was led by the Vaccine Research Center (VRC) at the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. Antibodies that target the fusion peptide can neutralize diverse strains of HIV in vitro, that is, in a test tube or culture dish outside of a living organism. The NIAID VRC isolated a fusion peptide-directed human antibody, called VRC34.01, from a person living with HIV who donated blood samples for research. They also isolated two antibodies from rhesus macaques -- a species of monkey with immune systems like humans' -- who previously had received a vaccine regimen designed to generate fusion peptide-directed antibodies. Demonstrating that these antibodies protect animals would validate the fusion peptide as a target for human vaccine design. SHIV challenge -- administering an infective dose of SHIV -- to rhesus macaques is a widely used animal model for assessing the performance of HIV antibodies and vaccines. In this study, rhesus macaques in each of four groups received a single intravenous infusion of one type of antibody -- a 2.5 or 10 mg/kg of bodyweight dose of VRC34.01, or one of the two vaccine-elicited rhesus macaque antibodies -- and other monkeys received a placebo infusion. To determine the protective effect of the antibodies, each monkey was challenged five days after infusion with a strain of SHIV known to be sensitive to fusion peptide-directed antibodies. All monkeys that received a placebo infusion acquired SHIV following the challenge. Among monkeys that received VRC34.01 infusions, none receiving the 10 mg/kg dose and 25% of those receiving the 2.5 mg/kg dose acquired SHIV. Of those that received the vaccine-elicited rhesus macaque antibodies, no monkeys receiving the antibody called DFPH-a.15 acquired SHIV, and 25% of those receiving the antibody called DF1W-a.01 acquired SHIV. Over time, the concentration of antibodies in the blood of animals that received DFPH-a.15 declined. Those animals were re-challenged 30 days later to see if the lower concentration of antibodies had a decreased protective effect, and half of them acquired SHIV. The three antibodies studied each provided statistically significant protection from SHIV, and the effect was dose dependent, that is, highest in monkeys with greater antibody concentrations in their blood. According to the authors, these findings represent the proof-of-concept that fusion peptide-directed antibodies can provide protection against SHIV and help determine the concentration of antibodies a vaccine would need to generate to be protective. They suggest that their findings on vaccine-elicited antibodies in some animals support further work to design preventive HIV vaccine concepts targeting the fusion peptide. They conclude that an effective HIV vaccine targeting the HIV fusion peptide likely will need to expand upon the concepts used in this study, by generating multiple varieties of fusion peptide-directed antibodies. This would increase the likelihood that the vaccine could maintain a preventive effect across the vastly diverse HIV variants in circulation.