A Phase 4 interventional study of Novavax COVID-19 vaccine (2023-2024 formula XBB containing) and Pfizer COVID-19 mRNA vaccine (2023-2024 formula XBB containing) in COVID-19, Vaccine-Preventable Diseases and SARS CoV 2 Infection, sponsored by Sarang K. Yoon, DO, MOH. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-28.
Sponsored by Sarang K. Yoon, DO, MOH · Phase 4, Interventional, and Prevention
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:
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 1,188 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →This is the only study on the registry with Sarang K. Yoon, DO, MOH as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Biological: Novavax COVID-19 vaccine (2023-2024 formula XBB containing)
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.
Biological: Pfizer COVID-19 mRNA vaccine (2023-2024 formula XBB containing)
Participants will not receive a dose of the study vaccine.
Participants will receive a single dose of the Novavax vaccine.
Participants will receive a single dose of the Pfizer vaccine.
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).
Time frame: 24 weeks after enrollment
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.
Time frame: 24 weeks after study enrollment
The BEEHIVE trial enrolled and monitored participants from 22 November 2023 through 9 September 2024. 5590 participants were screened.
| Milestone | Novavax COVID-19 Booster | Pfizer COVID-19 Booster | Non-boosted Comparison Group |
|---|---|---|---|
| Started | 452 | 457 | 279 |
| Completed | 437 | 440 | 266 |
| Not completed | 15 | 17 | 13 |
| Withdrew: Lost to follow-up | 11 | 11 | 10 |
| Withdrew: Withdrawal by subject | 1 | 1 | 2 |
| Withdrew: No longer met eligibility requirements to continue participation. | 3 | 5 | 1 |
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).
| Participants | Non-Booster Comparator Group | Randomized Group |
|---|---|---|
| Number of Symptomatic SARS-CoV-2 Infections Between Randomized, Study-vaccinated Participants and the Comparator Group | 48 | 94 |
Difference in the number of symptomatic SARS-CoV-2 infections between the protein subunit and mRNA vaccine groups.
| Participants | Protein Subunit | mRNA |
|---|---|---|
| Number of Symptomatic SARS-CoV-2 Infections Between the Protein Subunit and mRNA Vaccine Groups. | 52 | 42 |
Collected over From enrollment until the end of follow-up, up to 24 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Novavax COVID-19 Booster | 0/452 (0%) | 1/452 (0.2%) | 401/452 (88.7%) |
| Pfizer COVID-19 Booster | 0/457 (0%) | 5/457 (1.1%) | 436/457 (95.4%) |
| Non-boosted Comparison Group | 0/279 (0%) | 0/279 (0%) | 0/279 (0%) |
| Event | Novavax COVID-19 Booster | Pfizer COVID-19 Booster | Non-boosted Comparison Group |
|---|---|---|---|
| Infections due to complications of surgeryInfections and infestations | 0/452 | 2/457 | 0/279 |
| Emergency Cesarean Section due to premature laborPregnancy, puerperium and perinatal conditions | 1/452 | 1/457 | 0/279 |
| Serious injuries due to auto accidentMusculoskeletal and connective tissue disorders | 0/452 | 1/457 | 0/279 |
| Hospitalization due to mental health crisisPsychiatric disorders | 0/452 | 1/457 | 0/279 |
| Event | Novavax COVID-19 Booster | Pfizer COVID-19 Booster | Non-boosted Comparison Group |
|---|---|---|---|
| Injection Site TendernessMusculoskeletal and connective tissue disorders | 337/452 | 405/457 | 0/279 |
| Injection Site PainMusculoskeletal and connective tissue disorders | 277/452 | 382/457 | 0/279 |
| FatigueImmune system disorders | 175/452 | 251/457 | 0/279 |
| Muscle PainMusculoskeletal and connective tissue disorders | 146/452 | 240/457 | 0/279 |
| MalaiseImmune system disorders | 84/452 | 177/457 | 0/279 |
| HeadacheImmune system disorders | 121/452 | 168/457 | 0/279 |
| Injection Site SwellingMusculoskeletal and connective tissue disorders | 51/452 | 113/457 | 0/279 |
| Joint PainImmune system disorders | 48/452 | 95/457 | 0/279 |
| NauseaImmune system disorders | 26/452 | 42/457 | 0/279 |
| FeverImmune system disorders | 13/452 | 40/457 | 0/279 |
| Age, Categorical(Participants) | Novavax COVID-19 Booster | Pfizer COVID-19 Booster | Non-boosted Comparison Group | Total |
|---|---|---|---|---|
| <=18 years | 3 | 5 | 2 | 10 |
| Between 18 and 65 years | 409 | 406 | 246 | 1061 |
| >=65 years | 40 | 46 | 31 | 117 |
| Sex/Gender, Customized(Participants) | Novavax COVID-19 Booster | Pfizer COVID-19 Booster | Non-boosted Comparison Group | Total |
|---|---|---|---|---|
| Sex Assigned at Birth — Female | 248 | 250 | 147 | 645 |
| Sex Assigned at Birth — Male | 203 | 206 | 132 | 541 |
| Sex Assigned at Birth — Prefer Not to Answer | 1 | 1 | 0 | 2 |
| Race (NIH/OMB)(Participants) | Novavax COVID-19 Booster | Pfizer COVID-19 Booster | Non-boosted Comparison Group | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 1 | 5 | 1 | 7 |
| Asian | 13 | 23 | 15 | 51 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 0 | 1 |
| Black or African American | 7 | 5 | 1 | 13 |
| White | 393 | 394 | 241 | 1028 |
| More than one race | 34 | 25 | 16 | 75 |
| Unknown or Not Reported | 4 | 4 | 5 | 13 |
| Ethnicity (NIH/OMB)(Participants) | Novavax COVID-19 Booster | Pfizer COVID-19 Booster | Non-boosted Comparison Group | Total |
|---|---|---|---|---|
| Hispanic or Latino | 54 | 49 | 25 | 128 |
| Not Hispanic or Latino | 398 | 408 | 254 | 1060 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.