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<h2 class="element-invisible">You are here</h2><div class="breadcrumb"><a href="/">Home</a> » <a href="/news-events">News & Events</a> » <a href="/news-events/nih-research-matters">NIH Research Matters</a></div> <div class="l-region l-region--section-header">
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<div about="/news-events/nih-research-matters/temperature-stable-tb-vaccine-safe-provokes-immune-response" typeof="sioc:Item foaf:Document" class="ds-1col node node--nih-research-matters view-mode-full node--full node--nih-research-matters--full clearfix">
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<p class="publishdate"><span property="dc:date" datatype="xsd:dateTime" content="2023-03-14T00:00:00-04:00" class="date-display-single">March 14, 2023</span></p><div class='syndicate'><h1>Temperature-stable TB vaccine is safe and provokes immune response</h1><div class="callout callout-with-border"><h3>At a Glance</h3>
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<ul>
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<li>An experimental tuberculosis vaccine that can be stored at room temperature was safe and provoked an immune response in a phase 1 clinical trial.</li>
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<li>If proven effective in larger trials, the vaccine could make tuberculosis prevention more accessible to those most at risk.</li>
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</ul></div><div class="media-float-right"><div class="ds-1col file file-image file-image-jpeg view-mode-floated_media clearfix">
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<picture title="Mycobacterium tuberculosis bacteria in lungs">
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<!--[if IE 9]><video style="display: none;"><![endif]-->
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<source srcset="https://www.nih.gov/sites/default/files/styles/floated_media_breakpoint-large/public/news-events/research-matters/2023/20230314-tb.jpg?itok=hwHtNpxZ&timestamp=1678801898 1x" media="screen and (min-width: 960px)" />
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<source srcset="https://www.nih.gov/sites/default/files/styles/floated_media_breakpoint-medium/public/news-events/research-matters/2023/20230314-tb.jpg?itok=5xlkvZsT&timestamp=1678801898 1x" media="screen and (min-width: 800px)" />
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<source srcset="https://www.nih.gov/sites/default/files/styles/floated_media_breakpoint-medium-small/public/news-events/research-matters/2023/20230314-tb.jpg?itok=XeE3S5wh&timestamp=1678801898 1x" media="screen and (min-width: 600px)" />
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<source srcset="https://www.nih.gov/sites/default/files/styles/floated_media_breakpoint-small/public/news-events/research-matters/2023/20230314-tb.jpg?itok=CmpdG72j&timestamp=1678801898 1x" media="screen and (min-width: 480px)" />
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<source srcset="https://www.nih.gov/sites/default/files/styles/floated_media_breakpoint-tiny/public/news-events/research-matters/2023/20230314-tb.jpg?itok=Rd1jvs4r&timestamp=1678801898 1x" media="screen and (min-width: 0)" />
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<img src="https://www.nih.gov/sites/default/files/styles/floated_media_breakpoint-medium/public/news-events/research-matters/2023/20230314-tb.jpg?itok=5xlkvZsT&timestamp=1678801898" alt="Mycobacterium tuberculosis bacteria in lungs." title="Mycobacterium tuberculosis bacteria in lungs" />
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</picture><span class="caption">The bacterium that causes tuberculosis, Mycobacterium tuberculosis, typically affects the lungs, but can also affect other parts of the body. Left untreated, the disease can be deadly. </span><span class="credit">Kateryna Kon / Shutterstock</span></div>
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</div><p>Tuberculosis (TB) is a contagious disease caused by infection with <em>Mycobacterium tuberculosis</em> bacteria. It spreads through the air when a person with TB disease of the lungs or throat coughs, speaks, sings, or even just breathes. While TB typically affects the lungs, it can also affect other parts of the body, including the kidney, spine, and brain. Without proper treatment, the disease can be deadly: it killed 1.6 million people worldwide in 2021 alone.</p>
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||
<p>Only one vaccine is currently available for preventing TB, and it is only partly effective. A class of improved vaccines, called adjuvanted subunit vaccines, have shown promise in clinical testing. But so far, all need to be kept refrigerated, which can be costly and difficult in low-resource areas. Unfortunately, these are often the same areas where the TB burden is greatest. A vaccine that could be stored at room temperatures would be much easier to deliver where it's needed most.</p>
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||
<p>A team of researchers led by Dr. Christopher Fox at the Access to Advanced Health Institute (AAHI) in Seattle developed a freeze-dried, temperature-stable form of an adjuvanted subunit vaccine. The vaccine can be stored at human body temperature for three months. The team conducted a phase 1 clinical trial, funded by NIH, to determine the vaccine’s safety and ability to provoke an immune response. Forty-eight participants received either the temperature-stable or a previous, non-temperature stable form of the vaccine. Both vaccines were administered in two injections eight weeks apart. Results appeared in <em>Nature Communications </em>on March 6, 2023.</p>
|
||
|
||
<p>Both versions of the vaccine were safe and well-tolerated, with similar patterns of adverse events. Common problems included pain at the injection site, fatigue, headache, and muscle ache. All adverse events were mild to moderate, and none were severe or serious.</p>
|
||
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||
<p>Participants in both groups produced antibodies in response to the vaccine. But those receiving the temperature-stable form made more than those receiving the non-temperature stable one. Participants receiving the temperature-stable vaccine also had more antibody-producing cells in their bloodstreams. In addition, both vaccine versions elicited immune system T cells, which help recognize and kill pathogens. </p>
|
||
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||
<p>The results suggest that the temperature-stable version of the vaccine is as safe and provokes as strong an immune response as the previous version. If proven effective in larger clinical trials, the vaccine could have a major impact on global TB prevention.</p>
|
||
|
||
<p>“Equitable access to vaccines has been significantly impeded by [refrigeration] requirements and, as observed with COVID-19, no one is safe until everyone is safe,” says AAHI CEO and study co-author Dr. Corey Casper.</p>
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<p>—by Brian Doctrow, Ph.D.</p></div><h2 class="label-above">Related Links</h2><ul class="spaced print-urls"><li><a href="https://www.nih.gov/news-events/nih-research-matters/bivalent-boosters-provide-better-protection-against-severe-covid-19" target="_top">Bivalent Boosters Provide Better Protection Against Severe COVID-19</a></li><li><a href="https://www.nih.gov/news-events/nih-research-matters/t-cells-protect-against-covid-19-absence-antibody-response" target="_top">T Cells Protect Against COVID-19 In Absence of Antibody Response</a></li><li><a href="https://www.nih.gov/news-events/nih-research-matters/antibodies-recognize-new-sars-cov-2-omicron-variant-after-booster" target="_top">Antibodies Recognize New Sars-Cov-2 Omicron Variant After Booster</a></li><li><a href="https://www.nih.gov/news-events/nih-research-matters/experimental-coronavirus-vaccine-highly-effective" target="_top">Experimental Coronavirus Vaccine Highly Effective</a></li><li><a href="https://www.nih.gov/news-events/nih-research-matters/old-tb-vaccine-may-work-better-when-delivered-intravenously" target="_top">Old TB Vaccine May Work Better When Delivered Intravenously</a></li><li><a href="https://www.nih.gov/news-events/nih-research-matters/early-sentinels-multidrug-resistant-tb" target="_top">Early Sentinels of Multidrug-Resistant TB</a></li><li><a href="https://www.nih.gov/news-events/nih-research-matters/development-antibiotics-treat-tuberculosis" target="_top">Development of Antibiotics to Treat Tuberculosis</a></li><li><a href="https://www.nih.gov/news-events/nih-research-matters/predicting-effective-drug-combinations-tb" target="_top">Predicting Effective Drug Combinations for TB</a></li><li><a href="https://www.niaid.nih.gov/diseases-conditions/tuberculosis" target="_top">Tuberculosis</a></li></ul><p class="footnote"><strong class="label-inline">References: </strong><a href="https://pubmed.ncbi.nlm.nih.gov/36878897/">Safety and immunogenicity of a thermostable ID93 + GLA-SE tuberculosis vaccine candidate in healthy adults.</a> Sagawa ZK, Goman C, Frevol A, Blazevic A, Tennant J, Fisher B, Day T, Jackson S, Lemiale F, Toussaint L, Kalisz I, Jiang J, Ondrejcek L, Mohamath R, Vergara J, Lew A, Beckmann AM, Casper C, Hoft DF, Fox CB. <em>Nat Commun</em>. 2023 Mar 6;14(1):1138. doi: 10.1038/s41467-023-36789-2. PMID: 36878897.</p><p class="footnote"><strong class="label-inline">Funding: </strong>NIH’s National Institute of Allergy and Infectious Diseases (NIAID).</p>
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