We are in Phase 3* of the Resumption of Research Phased Plan
* For principal investigators who have had a plan approved for resumption.
Email research-covid@uky.edu with questions concerning research and COVID-19 policies.
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Next Steps for Campus Vaccine Rollout
On Feb 8, President Capilouto sent a message to the campus community about the next steps for vaccination. Read the full message here.
- In accordance with state guidance, we anticipate in the coming weeks scheduling people on campus and in the community who fall into phase 1c of the vaccination process – those classified as essential workers for businesses and institutions like ours.
- That means we will begin vaccinating in earnest all campus employees. You are essential.
- To expedite that process, we ask our employees – who have not yet registered – to go to ukvaccine.org to register if they would like to receive a vaccine.
- Registering gets you in the queue, so that when we start to send out invites to schedule, you will be on the list.
- If you already have registered, you don’t need to do so again.
- If you are due – or will be soon – for your booster shot, go to ukvaccine.org to submit a request for a booster shot by selecting that option on the request screener.
- As always, if you have questions, please email vaccine@uky.edu or call our customer service center at 859-218-0111.
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Vaccine Clinic Volunteers Needed
Community members who are credentialed to provide vaccinations are encouraged to volunteer in clinical positions at the UK COVID-19 vaccination clinic at Kroger Field. In addition, University of Kentucky employees without credentials can sign up for non-clinical roles such as registration check-in and wayfinding which are critical to the daily vaccine clinic operations. Those interested in volunteering in either clinical or non-clinical positions can sign up here. |
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Recruitment Begins for Phase 3 Clinical Trial of Janssen’s COVID-19 Vaccine Candidate
On Feb 9, the University of Kentucky announced that UK has been selected as a testing site for the Janssen Pharmaceutical Companies of Johnson & Johnson’s Phase 3 clinical research study ENSEMBLE 2, which is evaluating the safety and efficacy of a two-dose regimen of Janssen’s COVID-19 vaccine candidate.
The Phase 3 ENSEMBLE 2 study is a randomized, double-blind, placebo-controlled clinical trial in up to 30,000 adults 18 years old and older. The trial will include people both with and without comorbidities associated with an increased risk for severe COVID-19.
UK was the top enrolling site in the world for the ongoing Phase 3 ENSEMBLE study, which evaluated a single-dose regimen of Janssen’s investigational vaccine. Recently released interim results of that global trial showed that a single dose of their vaccine candidate completely prevented hospitalization and death from COVID-19 and was 85 percent effective in preventing severe illness — even against the South Africa variant. The investigational vaccine was 72% effective in the U.S. for preventing moderate to severe illness.
The two-dose ENSEMBLE 2 study is running in parallel to and separate from that ongoing Phase 3 ENSEMBLE single-dose trial, which enrolled more than 43,000 participants across three continents. Conducting the ENSEMBLE and ENSEMBLE 2 trials in parallel will provide valuable insights into the dosing schedules and help determine a path forward in both the short term and the long term to potentially help end the fast-moving COVID-19 pandemic.
UK will enroll up to 200 adults, 18 years and older from the Lexington area in the ENSEMBLE 2 trial. Nearly 900 local volunteers are participating in the single-dose ENSEMBLE trial. Participants in both trials will be monitored for up to two years to ensure robust safety and efficacy data.
The UK Center for Clinical and Translational Science (CCTS) is implementing the ENSEMBLE and ENSEMBLE 2 trials at UK. Anyone interested in learning more and possibly volunteering in the ENSEMBLE 2 study can visit UK’s website at www.StopCOVIDKy.com, where you can answer a confidential pre-screening survey that will help the study team determine if you qualify. |
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Wastewater Analysis of Coronavirus in Kentucky (WACKY)
For the past eight months, a team led by James Keck (College of Medicine) and Scott Berry (College of Engineering) has been developing novel technologies and streamlined protocols to enable measurement of SARS-CoV-2 RNA in various wastewater and environmental samples. These samples include dormitory effluent, nursing home effluent, samples collected from wastewater treatment plants, and streamflow samples. These capabilities allow the team to monitor the prevalence of SARS-CoV-2 at the facility and community levels, supporting more efficiently deployment of clinical testing resources. The team recently identified a high SARS-CoV-2 level in a dormitory at the University of Kentucky, prompting targeted clinical testing of dormitory residents, which subsequently identified 15 infected individuals just prior to sending students home for Thanksgiving.
This highly multidisciplinary project encompasses many innovative elements. Berry’s engineering team developed technology that significantly accelerates and simplifies the wastewater-to-answer workflow. Testing can be completed in only ~4 hours with <2 hours of hands-on time, facilitating same-day results and rapid response. Keck and his collaborators continue to build testing capability across the Commonwealth, including within vulnerable populations (nursing home residents) and underserved regions (Appalachia). With biostatistician Reuben Adatorwovor, the team is developing predictive statistical models linking wastewater data to clinical data (e.g., if we measure a SARS-CoV-2 concentration of 300 copies per mL of wastewater, what clinical positivity rate are we likely to encounter?). Going forward, they plan to combine all of these elements into a van-based mobile lab platform that can deploy into rural locations and monitor SARS-CoV-2 prevalence.
Funded by the COVID-19 Unified Research Experts (CURE) Alliance Pilot Program through the Office of the Vice President for Research, this research resulted in preliminary data that has yielded impressive results. Keck and Berry have recently received a $1.3 million contract from the CDC focused on nursing home SARS-CoV-2 surveillance and a $3.4 million NIH U01 grant focused on SARS-CoV-2 monitoring in Eastern Kentucky. Additionally, the team is also exploring feasibility of several other post-COVID applications of the capabilities developed over the past eight months. |
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Promoting Research on COVID-19 and Rheumatic, Musculoskeletal and Skin Diseases
NOT-AR-21-012 | First available: February 5, 2021 | Expires: November 19, 2021
This Notice of Special Interest NOSI) from the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) encourages, but is not limited to, research applications focused on:
- Susceptibility to, prevalence, risk assessment, and clinical management of COVID-19 among patients with underlying rheumatic, musculoskeletal, and/or skin diseases;
- The impacts of drugs or other targeted therapies that are used to treat diseases within the mission of NIAMS on susceptibility, severity, and management of COVID-19;
- Health disparities and social/behavioral factors that contribute to risk of infection, organ injury and adverse outcomes in COVID-19 patients with underlying rheumatic, musculoskeletal, and/or skin diseases;
- Impact of COVID-19 vaccination of patients with underlying rheumatic, musculoskeletal, and/or skin diseases;
- Characterization of long-term post-acute sequelae occurring in recovered COVID-19 patients with co-existing rheumatic, musculoskeletal, and/or skin diseases;
- Characterization of NIAMS-mission related long-term post-acute sequelae (e.g. muscle pain, joint pain, biobehavioral changes, skin rash, arthritis, etc.) occurring in recovered COVID-19 patients.
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Availability of Emergency Administrative Supplements to Clinical and Translational Science Award (CTSA) Program Awards to Address 2019 Novel Coronavirus Disease (COVID-19) Public Health Needs
NOT-TR-21-011 | Expiration date: June 2, 2021
The National Center for Advancing Translational Sciences (NCATS) is issuing this Notice of Special Interest (NOSI) to highlight the urgent need for projects that address the COVID-19 Public Health Emergency. The Clinical and Translational Science Award (CTSA) Program is uniquely qualified to contribute to these efforts. NCATS expects to issue 2-9 awards (anticipated to be $30,000 to $60,000 Direct Costs) for provision of clinical data in specified formats to support illness/infection status/surveillance determinations and/or clinical study data. |
Research to Address Vaccine Hesitancy, Uptake and Implementation among Populations that Experience Health Disparities
NOT-MD-21-008 | First available: February 5, 2021 | Expires: January 08, 2022
Key questions to be addressed include but are not limited to:
- What interventions and strategies are most effective to increase the reach, access, acceptance, and vaccine completion among populations that experience health disparities?
- How can evidence-based interventions that have reduced vaccine hesitancy and increased both access and uptake of other vaccinations (e.g., influenza and HPV) be adapted and/or adopted to increase the uptake of the SARS-CoV-2 vaccine?
- How can social media, digital marketing, and other innovative technologies (such as smart phone applications) be integrated into vaccine promotion interventions to identify and address the sources of misinformation regarding vaccination?
- How can vaccine-related communications on coronavirus, HPV, influenza, and other vaccines be generated and promoted by clinicians and healthcare systems to be community and culturally appropriate?
- What are effective culturally specific and/or community competent approaches for reducing barriers and increasing the vaccination uptake and completion?
- What service delivery or organizational level policies are effective in facilitating broad vaccination uptake and reducing barriers such as stigma, distrust, fear, discrimination, and exposure to misinformation?
- What are effective dissemination and implementation strategies related to vaccination in clinical and community settings?
- What rapid data collection methods (e.g., rapid ethnographic assessments) can be used to identify and prioritize vaccine interventions in communities?
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Administrative Supplements for COVID-19 Impacted NIMH Research
NOT-MH-21-120 | First Available: January 05, 2021 | Expires: June 02, 2023
The National Institute of Mental Health (NIMH) is supporting administrative supplements (in scope of parent award) to cover unanticipated costs caused by the COVID-19 pandemic or related mitigation efforts that could not be covered by rebudgeting existing funds. NIMH acknowledges that we will not be able to fund all requests. To stretch these resources, the NIMH asks that non-monetary solutions be considered and exhausted before requesting additional funds and that investigators apply only in cases of significant need. In addition, to distribute the costs of these supplements over the next few years, the NIMH encourages the submission of administrative supplements only in the last year of award, although special consideration may be given in unusual circumstances. Supplement applications for funding consideration during the first year of the parent award (new and competing renewals) will not be considered responsive to this NOSI. This NOSI is not intended to support COVID-related research. Applicants requesting support for COVID-related research should submit a supplement in response to NOT-MH-20-047 “Notice of Special Interest (NOSI) regarding the Availability of Administrative Supplements and Urgent Competitive Revisions for Mental Health Research on the 2019 Novel Coronavirus.” |
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If you have general questions related to research operations during the COVID-19 pandemic or would like to report non-compliance of a laboratory or PI as it relates to the UK Resumption of Research Plan please email research-covid@uky.edu.
Below are specific contacts that provide specialized services to support our research community:
Biological Safety
Brandy Nelson, brandy.nelson@uky.edu, (859) 257-1049
Office of Sponsored Projects Administration (OSPA)
Contact your college RA or CGO, call (859) 257-9420, or visit www.research.uky.edu/office-sponsored-projects-administration
Office of Research Integrity (ORI) rs_ori@uky.edu, (859) 257-9428
Proposal Development Office (PDO) pdo@uky.edu
Office of Technology Commercialization (OTC) otcinfo@uky.edu, (859) 323-1054
Office of the Attending Veterinarian
Mark Suckow, msuckow@uky.edu, (859) 257-1117 |
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