MSGID: 1:317/3 63d89974   
   PID: hpt/lnx 1.9.0-cur 2019-01-08   
   TID: hpt/lnx 1.9.0-cur 2019-01-08   
    Marburg vaccine shows promising results in first-in-human study    
      
     Date:   
         January 30, 2023   
     Source:   
         NIH/National Institute of Allergy and Infectious Diseases   
     Summary:   
         A new article shows that an experimental vaccine against Marburg   
         virus (MARV) was safe and induced an immune response in a small,   
         first-in-human clinical trial. The vaccine could someday be an   
         important tool to respond to Marburg virus outbreaks.   
      
      
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   FULL STORY   
   ==========================================================================   
   A newly published paper in The Lancetshows that an experimental vaccine   
   against Marburg virus (MARV) was safe and induced an immune response   
   in a small, first- in-human clinical trial. The vaccine, developed by   
   researchers at the National Institute of Allergy and Infectious Diseases   
   (NIAID), part of the National Institutes of Health, could someday be an   
   important tool to respond to Marburg virus outbreaks.   
      
      
   ==========================================================================   
   This first-in-human, Phase 1 study tested an experimental MARV vaccine   
   candidate, known as cAd3-Marburg, which was developed at NIAID's Vaccine   
   Research Center (VRC). This vaccine uses a modified chimpanzee adenovirus   
   called cAd3, which can no longer replicate or infect cells, and displays   
   a glycoprotein found on the surface of MARV to induce immune responses   
   against the virus. The cAd3 vaccine platform demonstrated a good safety   
   profile in prior clinical trials when used in investigational Ebola   
   virus and Sudan virus vaccines developed by the VRC.   
      
   MARV, a filovirus in the same family as Ebola virus, causes a rapidly   
   progressive febrile illness that leads to shock and death in a large   
   proportion of infected individuals. Many scientists think that MARV   
   disease outbreaks in humans begin by when the virus makes the jump   
   from its primary animal host, which is likely to be certain chronically   
   infected bats in sub-Saharan Africa.   
      
   The symptoms of MARV disease are akin to those seen with Ebola virus   
   disease and can include fever, headache, chills, rash, abdominal pain,   
   vomiting, and diarrhea. As the disease progresses, patients may suffer   
   from multiple organ dysfunction, delirium, and significant bleeding from   
   the gastrointestinal tract or other sites that may result in death. No   
   approved vaccines or specific therapies are available for MARV disease,   
   aside from supportive care. While some experimental vaccines have   
   previously been tested, none have proven to be both highly effective   
   and to provide durable protection. In areas of Africa where a vaccine   
   for Marburg is most needed, a single-dose vaccine that could protect   
   recipients over a long period of time would be a crucial part of quelling   
   outbreaks.   
      
   In this study, 40 healthy adult volunteers were enrolled at the Walter   
   Reed Army Institute of Research Clinical Trials Center in Silver Spring,   
   Maryland.   
      
   They received a single dose of either a low dose of the vaccine (1x1010   
   particle units) or a higher dose (1x1011 particle units). For safety, the   
   volunteers were enrolled in a dose-escalation plan. Three participants   
   received the lower dose. Then, when they did not exhibit severe adverse   
   reactions after the first seven days, the trial proceeded to enroll the   
   remaining 17 volunteers. The same procedure was also used for the higher   
   dose group.   
      
   Volunteers were monitored for adverse reactions to the investigational   
   vaccine and evaluated at regular intervals for 48 weeks to track their   
   immune responses.   
      
   The trial's safety results were encouraging: There were no serious adverse   
   events, and the experimental vaccine was well-tolerated. One participant   
   in the higher dose group developed a fever following vaccination, but it   
   resolved by the following day. In addition, the investigational vaccine   
   appeared to induce strong, long-lasting immunity to the MARV glycoprotein:   
   95% of participants in the trial exhibited a robust antibody response   
   after vaccination, and 70% maintained that response for more than   
   48 weeks.   
      
   Plans are in place to conduct further trials of the cAd3-Marburg   
   vaccine in Ghana, Kenya, Uganda, and the United States. If additional   
   data supports the promising results seen in the Phase 1 trial, the   
   cAd3-Marburg virus vaccine could someday be used in emergency responses   
   to MARV outbreaks.   
      
       * RELATED_TOPICS   
             o Health_&_Medicine   
                   # Vaccines # Viruses # Ebola # Cold_and_Flu   
             o Plants_&_Animals   
                   # Virology # Bird_Flu_Research # Microbes_and_More #   
                   Veterinary_Medicine   
       * RELATED_TERMS   
             o Flu_vaccine o H5N1 o Pandemic o Natural_killer_cell o HIV   
             o Epstein-Barr_virus o MMR_vaccine o Avian_flu   
      
   ==========================================================================   
   Story Source: Materials provided by   
   NIH/National_Institute_of_Allergy_and_Infectious Diseases. Note: Content   
   may be edited for style and length.   
      
      
   ==========================================================================   
   Journal Reference:   
      1. Melinda J Hamer, Katherine V Houser, Amelia R Hofstetter, Ana   
      M Ortega-   
         Villa, Christine Lee, Anne Preston, Brooke Augustine, Charla   
         Andrews, Galina V Yamshchikov, Somia Hickman, Steven Schech,   
         Jack N Hutter, Paul T Scott, Paige E Waterman, Mihret F Amare,   
         Victoria Kioko, Casey Storme, Kayvon Modjarrad, Melanie D McCauley,   
         Merlin L Robb, Martin R Gaudinski, Ingelise J Gordon, LaSonji   
         A Holman, Alicia T Widge, Larisa Strom, Myra Happe, Josephine   
         H Cox, Sandra Vazquez, Daphne A Stanley, Tamar Murray, Caitlyn   
         N M Dulan, Ruth Hunegnaw, Sandeep R Narpala, Phillip A Swanson,   
         Manjula Basappa, Jagada Thillainathan, Marcelino Padilla, Britta   
         Flach, Sarah O'Connell, Olga Trofymenko, Patricia Morgan, Emily E   
         Coates, Jason G Gall, Adrian B McDermott, Richard A Koup, John R   
         Mascola, Aure'lie Ploquin, Nancy J Sullivan, Julie A Ake, Julie E   
         Ledgerwood, Rebecca Lampley, Brenda Larkin, Pamela Costner, Hope   
         Wilson, Mike Read. Safety, tolerability, and immunogenicity of the   
         chimpanzee adenovirus type 3- vectored Marburg virus (cAd3-Marburg)   
         vaccine in healthy adults in the USA: a first-in-human, phase 1,   
         open-label, dose-escalation trial. The Lancet, 2023; 401 (10373):   
         294 DOI: 10.1016/S0140-6736(22)02400-X   
   ==========================================================================   
      
   Link to news story:   
   https://www.sciencedaily.com/releases/2023/01/230130130531.htm   
      
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