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COVID-19Phase 4BEEHIVENCT06065176

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

A Phase 4 study testing Novavax COVID-19 vaccine (2023-2024 formula XBB containing) and Pfizer COVID-19 mRNA vaccine (2023-2024 formula XBB containing) in people with COVID-19 and Vaccine-Preventable Diseases, run by Sarang K. Yoon, DO, MOH at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Novavax COVID-19 vaccine (2023-2024 formula XBB containing) and Pfizer COVID-19 mRNA vaccine (2023-2024 formula XBB containing)
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,188 participants
Where
1 siteUnited States
Study dates
22 Nov 2023to 9 Sep 2024
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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)

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Utah School of Medicine

    Salt Lake City, Utah, 84108

Other trials in United States

About this study

Official title: 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

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.

Read more

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
Read the 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.

Being tested
Novavax COVID-19 vaccine (2023-2024 formula XBB containing), Pfizer COVID-19 mRNA vaccine (2023-2024 formula XBB containing)
Keywords
COVID-19 vaccines, Rapid antigen test, SARS-CoV-2, Vaccine Efficacy, Real World Evidence
Medical subject headings
COVID-19, Vaccine-Preventable Diseases, Respiratory Tract Infections, Respiration Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Novavax COVID-19 vaccine (2023-2024 formula XBB containing)Biological

    Participants will receive a single dose of the Novavax vaccine.

  • Pfizer COVID-19 mRNA vaccine (2023-2024 formula XBB containing)Biological

    Participants will receive a single dose of the Pfizer vaccine.

Study groups in NCT06065176
Study groupRoleWhat they receive
Novavax COVID-19 boosterActive comparatorParticipants 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.
Receives: Biological: Novavax COVID-19 vaccine (2023-2024 formula XBB containing)
Pfizer COVID-19 boosterActive comparatorParticipants 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.
Receives: Biological: Pfizer COVID-19 mRNA vaccine (2023-2024 formula XBB containing)
Non-boosted comparison groupNo interventionParticipants will not receive a dose of the study vaccine.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Symptomatic SARS-CoV-2 Infections Between Randomized, Study-vaccinated Participants and the Comparator Group

    Difference in the number of symptomatic SARS-CoV-2 infections between randomized, study-vaccinated participants and the comparator group who did not receive an updated COVID-19 vaccine (2023-2024 formula).

    Measured: 24 weeks after enrollment

Secondary outcomes (1)
  1. Number of Symptomatic SARS-CoV-2 Infections Between the Protein Subunit and mRNA Vaccine Groups.

    Difference in the number of symptomatic SARS-CoV-2 infections between the protein subunit and mRNA vaccine groups.

    Measured: 24 weeks after study enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Oct 2023
  2. Study start22 Nov 2023
  3. Primary completion2 Sep 2024
  4. Study completion9 Sep 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
This randomized, three arm, active comparator trial will compare the clinical efficacy of a single dose of the Novavax 2023-2024 updated COVID-19 vaccine (Arm 1) with a single dose of the Pfizer mRNA 2023-2024 updated COVID-19 vaccine (Arm 2) as well as non-vaccinated comparison group (Arm 3). The participants who elect to receive a 2023-2024 updated COVID-19 vaccine are randomized into the Novavax (Arm 1) or Pfizer mRNA (Arm 2) vaccine groups. The non-vaccinated comparison group is nonrandomized.
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
1,188 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06065176
Sponsor's protocol ID
00172738
Acronym
BEEHIVE
Status last verified
Nov 2025
First submitted
29 Sep 2023
Last updated
28 Jan 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Yoon SK, Phillips AL, Zhao H, Yan F, Chen D, Zhuang Y, Thiese MS, Rowley EAK, McKell J, Yates A, Griffin J, Battan-Wraith S, Campbell R, Fink RV, Williams J, Green N, Allison T, Zhang Y, Ball SW, Toback S, Rousculp MD, Ellsworth GL. Real-world evaluation of 2023-2024 XBB.1.5 mRNA and protein-based COVID-19 vaccine reactogenicity from the randomized BEEHIVE trial. Hum Vaccin Immunother. 2026 Dec;22(1):2735182. doi: 10.1080/21645515.2026.2735182. Epub 2026 Sep 29.

    PubMed 42811742
  • Yoon SK, Ellsworth GL, Battan-Wraith S, Phillips AL, Fink RV, Griffin J, Rowley EAK, McKell J, Smith AS, Campbell R, Williams J, Ball SW, Zhao H, Warren B, Rousculp MD, Thiese MS. Real-World Effectiveness and Noninferiority Evaluation and Comparison of Messenger RNA-Based and Protein-Based COVID-19 Vaccines: Protocol for the BEEHIVE Randomized Study With a Hybrid Effectiveness Design. JMIR Res Protoc. 2026 Jan 27;15:e80858. doi: 10.2196/80858.

    PubMed 41592795

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Novavax COVID-19 vaccine (2023-2024 formula XBB containing) and Pfizer COVID-19 mRNA vaccine (2023-2024 formula XBB containing) in people with COVID-19 and Vaccine-Preventable Diseases, run by Sarang K. Yoon, DO, MOH at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Symptomatic SARS-CoV-2 Infections Between Randomized, Study-vaccinated Participants and the Comparator Group (time frame: 24 weeks after enrollment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06065176, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.

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