Status:
COMPLETED
The Efficacy of the 2023-2024 Updated COVID-19 Vaccines Against COVID-19 Infection
Lead Sponsor:
Sarang K. Yoon, DO, MOH
Collaborating Sponsors:
Westat
Novavax
Conditions:
COVID-19
Vaccine-Preventable Diseases
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this research study is to find out how well two different 2023-2024 updated COVID-19 vaccines protect people from COVID-19 (the disease caused by the SARS-CoV-2 virus), and to determine...
Detailed Description
For the BEEHIVE Study, UT seeks to enroll 1,500 participants living in the greater Salt Lake City area during the upcoming 2023-2024 COVID-19 season. Participants who intend to get vaccinated with the...
Eligibility Criteria
Inclusion
- Age ≥18 years
- Previously received ≥ 2-doses of US FDA-authorized mRNA vaccines
- Comfortable reading and responding to text messages and emails sent in English or having an interpreter assist them
- Plan to remain in the greater Salt Lake City area for the next 12 months
- Daily access to the internet (via cell phone, laptop, desktop, or tablet) and a phone with text messaging capabilities
- Willingness to complete weekly symptom and illness surveillance surveys sent via text and email
- Willingness to complete an online survey at enrollment, mid-study, and end-of-study surveys
- Willingness to be contacted periodically by study staff via text, email, and/or telephone as part of study activities
- Willingness to self-collect rapid antigen tests (RAT; approved by FDA EUA for COVID-19 detection) weekly and when prompted for study purposes, and to send results via the study portal
- Willingness to self-collect additional rapid antigen test (approved by FDA EUA for COVID-19 detection) if experiencing a qualifying symptomatic illness or upon RAT-confirmation of an asymptomatic infection
- Willingness to attend in-person visit to receive supply of rapid antigen tests and training on their use (all participants) and to receive a COVID-19 booster (if in randomized group)
Exclusion
- Lives with another person who is already enrolled in this study as reported by the subject on the Eligibility Survey (Appendix C. Eligibility Survey)
- Previous hypersensitivity reaction to the study vaccines as reported by the subject on the Eligibility Survey (Appendix C. Eligibility Survey)
- Recent infection \[Real time Reverse Transcription Polymerase Chain Reaction assay (RT-PCR) and/or RAT confirmed infection ≤ 90 days of trial vaccine administration
- Receipt of a COVID-19 vaccine within ≤ 90 days of trial vaccine administration
- Participation in other vaccine trials
- Medical history of immunosuppression
- Receipt of J\&J vaccine prior to study enrollment
- Receipt of any investigational prevention therapies for SARS-CoV-2 infections, such as prophylactic antiviral medications or other immune system modifying interventions within ≤ 90 days of trial vaccine administration
- Unwillingness to provide electronic consent
- Unwillingness to self-report occupation, work responsibilities, and prior COVID-19 illness.
Key Trial Info
Start Date :
November 22 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 9 2024
Estimated Enrollment :
1188 Patients enrolled
Trial Details
Trial ID
NCT06065176
Start Date
November 22 2023
End Date
September 9 2024
Last Update
November 21 2025
Active Locations (1)
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1
University of Utah School of Medicine
Salt Lake City, Utah, United States, 84108