{"id":32945,"date":"2020-07-09T09:50:25","date_gmt":"2020-07-09T15:50:25","guid":{"rendered":"https:\/\/www.uchealth.org\/today\/?p=32945"},"modified":"2021-01-21T09:07:59","modified_gmt":"2021-01-21T16:07:59","slug":"moderna-coronavirus-vaccine-trial-colorado-uchealth-university-of-colorado-hospital","status":"publish","type":"post","link":"https:\/\/www.uchealth.org\/today\/moderna-coronavirus-vaccine-trial-colorado-uchealth-university-of-colorado-hospital\/","title":{"rendered":"Moderna coronavirus vaccine trial set to launch at UCHealth University of Colorado Hospital"},"content":{"rendered":"<div style=\"margin-top: 0px; margin-bottom: 0px;\" class=\"sharethis-inline-share-buttons\" ><\/div><p><em><strong>Editor&#8217;s note: For the most up-to-date COVID-19 vaccine information, please <a href=\"https:\/\/www.uchealth.org\/services\/infectious-diseases\/coronavirus-covid-19\/covid-19-vaccine\/\" target=\"_blank\" rel=\"noopener noreferrer\">click here<\/a>.<\/strong><\/em><\/p>\n<p><a href=\"https:\/\/www.uchealth.org\/locations\/uchealth-university-of-colorado-hospital-uch\/\">UCHealth University of Colorado Hospital<\/a> will soon enroll patients in the first large-scale U.S. clinical trial of a coronavirus vaccine.<\/p>\n<p>The <a href=\"https:\/\/investors.modernatx.com\/news-releases\/news-release-details\/moderna-advances-late-stage-development-its-vaccine-mrna-1273\" target=\"_blank\" rel=\"noopener noreferrer\">phase 3 study<\/a> of Moderna\u2019s experimental vaccine will include 1,000 people at University of Colorado Hospital on the <a href=\"https:\/\/www.uchealth.org\/locations\/uchealth-at-university-of-colorado-anschutz-medical-campus\/\">Anschutz Medical Campus<\/a>. In addition, another 30,000 patients nationwide will participate in the trial, which is slated to start this summer, says <a href=\"https:\/\/www.uchealth.org\/provider\/thomas-campbell-md-ms-internal-medicine-1\/\">Dr. Thomas Campbell<\/a>, a <a href=\"https:\/\/medschool.cuanschutz.edu\/\" target=\"_blank\" rel=\"noopener noreferrer\">University of Colorado School of Medicine<\/a> and UCHealth virologist and infectious-disease specialist.<\/p>\n<figure id=\"attachment_32950\" aria-describedby=\"caption-attachment-32950\" style=\"width: 600px\" class=\"wp-caption aligncenter\"><img loading=\"lazy\" decoding=\"async\" class=\"wp-image-32950 size-full\" src=\"https:\/\/uchealth-wp-uploads.s3.amazonaws.com\/wp-content\/uploads\/sites\/6\/2020\/07\/09090648\/NIH-coronavirus-spike-protein-tiny.webp\" alt=\"Moderna coronavirus vaccine trial in Colorado - 3D images of virus particles that cause COVID-19\" width=\"600\" height=\"450\" srcset=\"https:\/\/uchealth-wp-uploads.s3.amazonaws.com\/wp-content\/uploads\/sites\/6\/2020\/07\/09090648\/NIH-coronavirus-spike-protein-tiny.webp 600w, https:\/\/uchealth-wp-uploads.s3.amazonaws.com\/wp-content\/uploads\/sites\/6\/2020\/07\/09090648\/NIH-coronavirus-spike-protein-tiny-300x225.webp 300w, https:\/\/uchealth-wp-uploads.s3.amazonaws.com\/wp-content\/uploads\/sites\/6\/2020\/07\/09090648\/NIH-coronavirus-spike-protein-tiny-150x113.webp 150w, https:\/\/uchealth-wp-uploads.s3.amazonaws.com\/wp-content\/uploads\/sites\/6\/2020\/07\/09090648\/NIH-coronavirus-spike-protein-tiny-200x150.webp 200w\" sizes=\"auto, (max-width: 600px) 100vw, 600px\" \/><figcaption id=\"caption-attachment-32950\" class=\"wp-caption-text\">The Moderna coronavirus vaccine trial in Colorado is due to start later this summer. This image shows 3D prints of a spike protein (in the foreground) and a particle (background) of the virus that causes the new coronavirus. The spike protein enables the virus to enter and infect human cells, and it\u2019s the target of many vaccine candidates, including Moderna\u2019s vaccine. Photo courtesy of the National Institutes of Health.<\/figcaption><\/figure>\n<p>Campbell\u2019s team will internally recruit UCHealth patients, staff and providers based on a hierarchy of criteria, he says. Those in high-risk occupations such as essential workers in crowded facilities, people living in residential facilities and high-risk health care workers will be first up, Campbell says. People at risk of becoming seriously ill with COVID-19, including seniors and those with medical problems such as diabetes, obesity, heart disease, lung disease, and chronic kidney disease, will also be a priority, he says.<\/p>\n<p>The UCHealth team will also invite individuals in higher-risk groups to participate in the study including Black, Indigenous and Hispanic patients.<\/p>\n<p>After identifying possible trial participants, representatives from UCHealth will contact the patients and staff members through <a href=\"https:\/\/www.uchealth.org\/access-my-health-connection\/\">My Health Connection<\/a> to invite them to participate, if interested.<\/p>\n<p>\u201cThe emphasis is on demonstrating the efficacy of the vaccine in people who are at most risk of getting COVID-19,\u201d Campbell said.<\/p>\n<h3><strong>The phases of Moderna coronavirus vaccine trials<\/strong><\/h3>\n<p>The trial will involve an initial injection and a booster 28 days later. It\u2019s not a challenge trial: that is, patients will not be exposed intentionally to the virus that causes COVID-19. The huge number of participants, though, will allow the study\u2019s leaders to compare the number and severity of coronavirus infections among those who got the vaccine with those who did not. Campbell says his team intends to move quickly and have all 1,000 patients injected with a first dose within eight weeks \u2013 and many would have received the booster by then also.<\/p>\n<p>The study will follow patients for two years. That doesn\u2019t mean a commercial vaccine must wait until 2022. In a best-case scenario, compelling preliminary results could bring speedy approval from the U.S. Food and Drug Administration (FDA). Were that to happen, widespread vaccination of the general public could roll out by next spring, Campbell says.<\/p>\n<figure id=\"attachment_32872\" aria-describedby=\"caption-attachment-32872\" style=\"width: 400px\" class=\"wp-caption alignright\"><img loading=\"lazy\" decoding=\"async\" class=\"wp-image-32872\" src=\"https:\/\/uchealth-wp-uploads.s3.amazonaws.com\/wp-content\/uploads\/sites\/6\/2020\/07\/06115733\/Thomas-Campbell-June-2020-tiny.webp\" alt=\"Dr. Thomas Campbell, headshot. Campbell is leading the new phase 3 Moderna coronavirus trial in Colorado.\" width=\"400\" height=\"250\" srcset=\"https:\/\/uchealth-wp-uploads.s3.amazonaws.com\/wp-content\/uploads\/sites\/6\/2020\/07\/06115733\/Thomas-Campbell-June-2020-tiny.webp 800w, https:\/\/uchealth-wp-uploads.s3.amazonaws.com\/wp-content\/uploads\/sites\/6\/2020\/07\/06115733\/Thomas-Campbell-June-2020-tiny-300x187.webp 300w, https:\/\/uchealth-wp-uploads.s3.amazonaws.com\/wp-content\/uploads\/sites\/6\/2020\/07\/06115733\/Thomas-Campbell-June-2020-tiny-768x479.webp 768w, https:\/\/uchealth-wp-uploads.s3.amazonaws.com\/wp-content\/uploads\/sites\/6\/2020\/07\/06115733\/Thomas-Campbell-June-2020-tiny-150x94.webp 150w, https:\/\/uchealth-wp-uploads.s3.amazonaws.com\/wp-content\/uploads\/sites\/6\/2020\/07\/06115733\/Thomas-Campbell-June-2020-tiny-200x125.webp 200w\" sizes=\"auto, (max-width: 400px) 100vw, 400px\" \/><figcaption id=\"caption-attachment-32872\" class=\"wp-caption-text\">Dr. Thomas Campbell leads the team testing the Moderna coronavirus trial in Colorado at UCHealth University of Colorado Hospital.<\/figcaption><\/figure>\n<p>The FDA requires three phases of human clinical trials before it approves a drug (that\u2019s in addition to having shown that the drug works in petri dishes, mice, and other animals). Phase 1 involves tens of people to make sure the drug is safe. Phase 2 generally involves hundreds of people and focuses on safety as well as what doses seem to work best. Phase 3 typically involves thousands of people and is used to prove safety and effectiveness.<\/p>\n<p>Clinical trials normally proceed in sequential order over several years. These are not normal times. The phase 3 trial is launching with Moderna\u2019s <a href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04283461\" target=\"_blank\" rel=\"noopener noreferrer\">phase 1 trial<\/a> data soon to be published and the <a href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04405076\" target=\"_blank\" rel=\"noopener noreferrer\">phase 2 trial<\/a> having just launched in late May. But the initial findings have been promising enough \u2013 and the desperation for a means of attaining COVID-19 herd immunity without swamping hospitals great enough \u2013 that the pace of science is being pushed to its very limits.<\/p>\n<h3><strong>How Moderna coronavirus vaccine trial in Colorado works<\/strong><\/h3>\n<p>For the time being, Moderna calls its experimental vaccine mRNA-1273. It\u2019s one of perhaps <a href=\"https:\/\/www.nytimes.com\/interactive\/2020\/science\/coronavirus-vaccine-tracker.html\" target=\"_blank\" rel=\"noopener noreferrer\">140 vaccine candidates<\/a> under development. As of June 29, those included 11 in phase 1 testing, eight in phase 2 testing, and three in phase 3 testing. One has been approved: the CanSino Biologics vaccine, which the China\u2019s Central Military Commission <a href=\"https:\/\/www.reuters.com\/article\/us-health-coronavirus-china-vaccine\/cansinos-covid-19-vaccine-candidate-approved-for-military-use-in-china-idUSKBN2400DZ\" target=\"_blank\" rel=\"noopener noreferrer\">approved<\/a> on June 25 for immunizing the country\u2019s military personnel. That vaccine, similar to the one <a href=\"https:\/\/medicalxpress.com\/news\/2020-06-astrazeneca-covid-vaccine-europe.html\" target=\"_blank\" rel=\"noopener noreferrer\">being developed<\/a> by the University of Oxford and AstraZeneca, uses modified adenoviruses \u2013 viruses that typically cause the common cold \u2013 to inject genetic material into human cells.<\/p>\n<p>Viruses exist to inject genetic material into living cells. They do so with the dark intent (if a submicroscopic living-dead bundle of molecules can have intent) of hijacking cellular machinery to produce copies of the viruses themselves. In the case of the CanSino Biologics and Oxford-AstraZeneca vaccines, the adenovirus genetic material hijacks cells to produce copies not of themselves, but rather of the spike proteins that protrude from the fatty sphere of the SARS-CoV-2 virus that causes COVID-19. The body\u2019s immune system then recognizes the harmless, unmoored spike proteins as invaders and makes antibodies to recognize them. If actual coronaviruses later appear, those antibodies glom onto the viruses\u2019 spike proteins, and the immune system, forewarned, takes those viruses out. At least that\u2019s the idea.<\/p>\n<p>That\u2019s also the idea with the Moderna coronavirus vaccine. The big difference is that Moderna\u2019s vaccine does away with the modified adenoviruses as a delivery system. Instead, the Moderna vaccine packs its spike-protein-recipe genetic material \u2013 in this case messenger RNA (mRNA) \u2013 into nanoscale fatty globs that cells absorb.<\/p>\n<p>After the injection, Campbell says, \u201conce that RNA molecule is within muscle cells, those muscle cells start to make the coronavirus spike protein, which our body recognizes as a foreign protein, and then produces an immune response.\u201d<\/p>\n<h3><strong>Controlling the coronavirus pandemic through vaccines<\/strong><\/h3>\n<p>Vaccination using mRNA or DNA molecules, <a href=\"https:\/\/cen.acs.org\/pharmaceuticals\/vaccines\/coronavirus-help-mRNA-DNA-vaccines\/98\/i14\" target=\"_blank\" rel=\"noopener noreferrer\">should it prove effective<\/a>, would be pathbreaking, Campbell adds.<\/p>\n<p>\u201cIf it works for the coronavirus, it will not only be a significant step forward for controlling the coronavirus pandemic, but it will also be a proof that this strategy can work and be implemented in practice,\u201d he said. \u201cThe advantage of using the mRNA approach is that it can be scaled up very rapidly. It\u2019s much easier to make mRNA molecules in large quantities than it is to make purified viral proteins, or inactivated viruses, or virus-like particles.\u201d<\/p>\n<p>While the use of adenovirus to inject genetic material for a vaccine has been <a href=\"https:\/\/cen.acs.org\/pharmaceuticals\/vaccines\/Adenoviral-vectors-new-COVID-19\/98\/i19\" target=\"_blank\" rel=\"noopener noreferrer\">in the works<\/a> longer than mRNA technologies, it\u2019s also new. No human vaccine using adenoviruses has yet been approved (though a <a href=\"https:\/\/nrc.canada.ca\/en\/stories\/keeping-our-furry-friends-healthy-artemis-technologies-inc-partners-nrc-produce-successful\" target=\"_blank\" rel=\"noopener noreferrer\">rabies vaccine<\/a> for animals has).<\/p>\n<p>If these or other emerging vaccines work, \u201cIt could be a real game-changer for the pandemic,\u201d Campbell said. He cautioned, though, that most vaccine candidates ultimately fail \u2013 something we must be prepared to face with coronavirus vaccines being developed <a href=\"https:\/\/www.hhs.gov\/about\/news\/2020\/06\/16\/fact-sheet-explaining-operation-warp-speed.html\" target=\"_blank\" rel=\"noopener noreferrer\">at warp speed<\/a>. But with the abundance of brainpower and money pouring into coronavirus vaccine development, he\u2019s optimistic.<\/p>\n<p>\u201cI\u2019m elated by the pace of progress. It\u2019s unheard of for any viral infection to have a vaccine progress at this rate. It\u2019s really a great testament to how much can be done when people put their minds to something and work together,\u201d Campbell said. \u201cWherever this will take us from here, and whatever our chances of success are, I\u2019m certainly hopeful.\u201d<\/p>\n<p>To read UCHealth&#8217;s press release, <a href=\"https:\/\/www.uchealth.org\/today\/covid-19-vaccine-trial-to-launch-in-colorado\/\">click here<\/a>.<\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Editor&#8217;s note: For the most up-to-date COVID-19 vaccine information, please click here. UCHealth University of Colorado Hospital will soon enroll patients in the first large-scale U.S. clinical trial of a coronavirus vaccine. The phase 3 study of Moderna\u2019s experimental vaccine will include 1,000 people at University of Colorado Hospital on the Anschutz Medical Campus. In [&hellip;]<\/p>\n","protected":false},"author":23,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_relevanssi_hide_post":"","_relevanssi_hide_content":"","_relevanssi_pin_for_all":"","_relevanssi_pin_keywords":"","_relevanssi_unpin_keywords":"","_relevanssi_related_keywords":"","_relevanssi_related_include_ids":"","_relevanssi_related_exclude_ids":"","_relevanssi_related_no_append":"","_relevanssi_related_not_related":"","_relevanssi_related_posts":"","_relevanssi_noindex_reason":"","footnotes":""},"categories":[5,8],"tags":[4859,4860,9069,162,4781],"class_list":["post-32945","post","type-post","status-publish","format-standard","hentry","category-innovative-care","category-news","tag-coronavirus","tag-covid-19","tag-covid-19-vaccine","tag-infectious-diseases","tag-research-in-health-care"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.4 (Yoast SEO v27.4) - 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