The Efficacy of the 2023-2024 Updated COVID-19 Vaccines Against COVID-19 Infection

Completed · Phase 4

Conditions studied: COVID-19, Vaccine-Preventable Diseases, SARS CoV 2 Infection, Upper Respiratory Tract Infection, Upper Respiratory Disease

In brief

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 if getting a 2023-2024 updated vaccine provides better protection from COVID-19 than not getting a vaccine. If the participant chooses to get a 2023-2024 updated COVID-19 vaccine as part of this study, they will have a 50/50 chance of receiving either the Novavax or Pfizer mRNA vaccine. If the participant decides not to get a 2023-2024 updated COVID-19 vaccine, the participant can still participate in other study activities. STUDY ACTIVITIES: * An online enrollment survey * An in-person enrollment visit * Weekly online surveys for 20 weeks * Weekly COVID-19 tests for 20 weeks * Additional online surveys if you have COVID-19 symptoms or tested positive for COVID-19. * Additional COVID-19 tests if you have COVID-19 symptoms or tested positive. * Online survey questions in the middle and at the end of the study

Key facts

Study ID

NCT06065176

Run by

Sarang K. Yoon, DO, MOH

People needed

1188

Starts

2023-11-22

Expected to finish

2024-09-09

Last updated by the study team

2026-01-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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.

Where it is running

• University of Utah School of Medicine — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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