The Efficacy of the 2023-2024 Updated COVID-19 Vaccines Against COVID-19 Infection (BEEHIVE)
COVID-19, Vaccine-Preventable Diseases, SARS CoV 2 Infection
About this trial
This is an interventional prevention trial for COVID-19 focused on measuring COVID-19 vaccines, Rapid antigen test, SARS-CoV-2, Vaccine Efficacy, Real World Evidence
Eligibility Criteria
Inclusion Criteria: 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 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 Criteria: 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
No Intervention
Novavax COVID-19 booster
Pfizer COVID-19 booster
Non-boosted comparison group
Participants will receive a single dose (0.5 ml) of study vaccine Novavax COVID-19 vaccine, 2023-2024 formula (XBB containing) in the deltoid muscle of the arm.
Participants will receive a single dose (0.3 ml) of study vaccine Pfizer mRNA COVID-19 vaccine, 2023-2024 formula (XBB containing) in the deltoid muscle of the arm.
Participants will not receive a dose of the study vaccine.