COVID-19, SARS CoV 2 Infection, Upper Respiratory Disease, Upper Respiratory Tract Infection, Vaccine-Preventable Diseases
Conditions
Keywords
COVID-19 vaccines, Rapid antigen test, SARS-CoV-2, Vaccine Efficacy, Real World Evidence
Brief 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.
Interventions
BIOLOGICALNovavax COVID-19 vaccine (2023-2024 formula XBB containing)
Participants will receive a single dose of the Novavax vaccine.
BIOLOGICALPfizer COVID-19 mRNA vaccine (2023-2024 formula XBB containing)
Participants will receive a single dose of the Pfizer vaccine.
Sponsors
Sarang K. Yoon, DO, MOH
Westat
Novavax
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Participants will elect whether they are in the vaccinated group or decline to be in the vaccinated group. So, all participants will be aware of their group assignment. However, those participants in the vaccinated group as well as study investigators will be blinded to study arm assignments within the vaccinated group. A limited number of study staff handling and administering the vaccines will be aware of vaccine assignment and will be trained not to divulge vaccine assignment information to the investigator and study team. Study staff administering vaccine will not be involved with study surveillance to avoid involvement with measurement of study outcomes. The study will provide electronic documentation confirming that participants received one of the study vaccines (without indicating which vaccine) with date of vaccine administration. The electronic documentation of vaccine administration will be password protected to maintain blinding.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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 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)
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Symptomatic SARS-CoV-2 Infections Between Randomized, Study-vaccinated Participants and the Comparator Group | 24 weeks after enrollment | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Symptomatic SARS-CoV-2 Infections Between the Protein Subunit and mRNA Vaccine Groups. | 24 weeks after study enrollment | Difference in the number of symptomatic SARS-CoV-2 infections between the protein subunit and mRNA vaccine groups. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSarang K Yoon, DO
University of Utah
Participant flow
Recruitment details
The BEEHIVE trial enrolled and monitored participants from 22 November 2023 through 9 September 2024. 5590 participants were screened.
Pre-assignment details
1188 total participants enrolled.
Participants by arm
| Arm | Count |
|---|---|
| Novavax COVID-19 Booster 452 participants received 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. | 452 |
| Pfizer COVID-19 Booster 457 participants received 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. | 457 |
| Non-boosted Comparison Group 279 participants did not receive a dose of the study vaccine. | 279 |
| Total | 1,188 |
Baseline characteristics
| Characteristic | Novavax COVID-19 Booster | Pfizer COVID-19 Booster | Non-boosted Comparison Group | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 3 Participants | 5 Participants | 2 Participants | 10 Participants |
| Age, Categorical >=65 years | 40 Participants | 46 Participants | 31 Participants | 117 Participants |
| Age, Categorical Between 18 and 65 years | 409 Participants | 406 Participants | 246 Participants | 1061 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 54 Participants | 49 Participants | 25 Participants | 128 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 398 Participants | 408 Participants | 254 Participants | 1060 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 5 Participants | 1 Participants | 7 Participants |
| Race (NIH/OMB) Asian | 13 Participants | 23 Participants | 15 Participants | 51 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 5 Participants | 1 Participants | 13 Participants |
| Race (NIH/OMB) More than one race | 34 Participants | 25 Participants | 16 Participants | 75 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 4 Participants | 5 Participants | 13 Participants |
| Race (NIH/OMB) White | 393 Participants | 394 Participants | 241 Participants | 1028 Participants |
| Sex/Gender, Customized Sex Assigned at Birth Female | 248 Participants | 250 Participants | 147 Participants | 645 Participants |
| Sex/Gender, Customized Sex Assigned at Birth Male | 203 Participants | 206 Participants | 132 Participants | 541 Participants |
| Sex/Gender, Customized Sex Assigned at Birth Prefer Not to Answer | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 452 | 0 / 457 | 0 / 279 |
| other Total, other adverse events | 401 / 452 | 436 / 457 | 0 / 279 |
| serious Total, serious adverse events | 1 / 452 | 5 / 457 | 0 / 279 |
Outcome results
Primary
Vaccine Effectiveness (VE)
VE in preventing symptomatic SARS-CoV-2 infection 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
Population: mITT population. Combining both vaccinated arms in a single group most appropriately represents the study's primary objective. The two vaccinated arms are assessed relative to each other in the study's secondary objective.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Non-Booster Comparator Group | Vaccine Effectiveness (VE) | 48 Participants |
| Randomized Group | Vaccine Effectiveness (VE) | 94 Participants |
Secondary
Relative Vaccine Effectiveness (VE)
Relative VE (rVE) between the protein subunit and mRNA vaccine groups in preventing symptomatic SARS-CoV-2 infection
Time frame: 24 weeks after study enrollment
Population: mITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Non-Booster Comparator Group | Relative Vaccine Effectiveness (VE) | 52 Participants |
| Randomized Group | Relative Vaccine Effectiveness (VE) | 42 Participants |