NCT06065176

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

Booster Epidemiological Evaluation of Health, Illness and Vaccine Efficacy Study: Randomized Trial to Compare the Clinical Efficacy of Novavax vs. mRNA COVID-19 2023-2024 Updated Vaccines Among Adults in the United States

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,188 (actual)
• Sponsor: Sarang K. Yoon, DO, MOH · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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 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

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 2023-2024 updated COVID-19 vaccine (n=1200) will be randomized into the NVX vaccine group or the Pfizer mRNA vaccine group. Participants will be randomized 1:1 to receive 1 dose of the NVX vaccine versus 1 dose of the Pfizer mRNA vaccine from October to December 2023 (dates may vary slightly based on vaccine availability). Participants who decide not to receive a 2023-2024 updated COVID-19 vaccine during this period will be placed in a non-randomized comparison group (n=300). Participants in all three study arms will complete an online enrollment survey and will self-schedule an in-person enrollment visit. During the visit, all participants will receive a supply of at-home rapid antigen tests for SARS-CoV-2 infection. Those who choose to be in the vaccinated group will also receive either the Novavax vaccine or the Pfizer mRNA vaccine at random. On the first, second, and seventh day after receiving the vaccine, participants will complete an online post-vaccination survey. Beginning after the enrollment visit for a period of 24 weeks, all participants will complete a weekly rapid at-home test and a weekly online survey that surveils for COVID-like illness (CLI)-associated SARS-CoV-2 virus infection, defined as symptoms in the past 7 days including: fever; chills; malaise; fatigue; headache; cough; shortness of breath; sore throat; runny nose or nasal congestion; nausea or vomiting; diarrhea; muscle or body aches; or change in smell or taste. Participants will upload a photo of each weekly test result to the study portal. Those who report new CLI symptoms and those who test positive on their at-home test will complete additional online surveys concerning their illness, as well as another at-home test on the first and third day after the original test. Additionally, all participants will complete a mid- and end-of study survey about their work, health, and opinions about COVID-19, and any COVID-19 and influenza vaccines received. Finally, participants who tested positive for COVID-19 during the study or who had COVID-19 symptoms but did not test positive will complete an online survey about the duration of symptoms and impact on their health. By Summer 2024, study staff will inform participants when the weekly surveys will end and when to stop testing. At the end of the study, participants in the vaccinated group will be notified of which study vaccine they received.

Conditions

• COVID-19
• Vaccine-Preventable Diseases
• SARS CoV 2 Infection
• Upper Respiratory Tract Infection
• Upper Respiratory Disease

Interventions

Type	Name	Description
BIOLOGICAL	Novavax COVID-19 vaccine (2023-2024 formula XBB containing)	Participants will receive a single dose of the Novavax vaccine.
BIOLOGICAL	Pfizer COVID-19 mRNA vaccine (2023-2024 formula XBB containing)	Participants will receive a single dose of the Pfizer vaccine.

Timeline

• Start date: 2023-11-22
• Primary completion: 2024-09-02
• Completion: 2024-09-09
• First posted: 2023-10-03
• Last updated: 2026-01-28
• Results posted: 2025-11-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study