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

Primary Purpose

COVID-19, Vaccine-Preventable Diseases, SARS CoV 2 Infection

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Novavax COVID-19 vaccine (2023-2024 formula XBB containing)
Pfizer COVID-19 mRNA vaccine (2023-2024 formula XBB containing)
Sponsored by
Sarang K. Yoon, DO, MOH
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    Arm Type

    Active Comparator

    Active Comparator

    No Intervention

    Arm Label

    Novavax COVID-19 booster

    Pfizer COVID-19 booster

    Non-boosted comparison group

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    To determine if getting a 2023-2024 updated COVID-19 vaccine provides better protection from COVID-19 (the disease caused by the SARS-CoV-2 virus) than not getting an 2023-2024 updated COVID-19 vaccine.
    How many participants who received the 2023-2024 updated COVID-19 vaccine developed Covid-like illness (CLI)-associated SARS-CoV-2 infection (diagnosed by study rapid antigen tests) compared with how many participant who declined the updated vaccine. Comparing the number of infections in each group to calculate the hazard ratios of Covid-like illness (CLI)-associated SARS-CoV-2 infection among participants who receive the 2023-2024 updated COVID-19 vaccine and participant who decline the updated vaccine. Beginning time at risk starts with the first active surveillance contact. End of time at risk is illness onset with rapid antigen test confirmed SARS-CoV-2 infection or the last submitted response to the study surveillance.
    Comparing how well two different 2023-2024 updated COVID-19 vaccines protect people from COVID-19 (the disease caused by the SARS-CoV-2 virus)
    How many participants who received the 2023-2024 updated Novavax COVID-19 vaccine developed Covid-like illness (CLI)-associated SARS-CoV-2 infection (diagnosed by study rapid antigen tests) compared with how many participant participants who received the 2023-2024 updated Pfizer mRNA COVID-19 vaccine. Comparing the number of infections in each group to calculate the hazard ratios of Covid-like illness (CLI)-associated SARS-CoV-2 infection among participants who receive the Novavax vaccine and participant who received the Pfizer mRNA vaccine.

    Secondary Outcome Measures

    Full Information

    First Posted
    September 29, 2023
    Last Updated
    September 29, 2023
    Sponsor
    Sarang K. Yoon, DO, MOH
    Collaborators
    Westat, Novavax
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06065176
    Brief Title
    The Efficacy of the 2023-2024 Updated COVID-19 Vaccines Against COVID-19 Infection
    Acronym
    BEEHIVE
    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 18-49 and 50+ Years in the United States
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 16, 2023 (Anticipated)
    Primary Completion Date
    July 30, 2024 (Anticipated)
    Study Completion Date
    July 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Sarang K. Yoon, DO, MOH
    Collaborators
    Westat, Novavax

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    COVID-19, Vaccine-Preventable Diseases, SARS CoV 2 Infection, Upper Respiratory Tract Infection, Upper Respiratory Disease
    Keywords
    COVID-19 vaccines, Rapid antigen test, SARS-CoV-2, Vaccine Efficacy, Real World Evidence

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    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
    ParticipantInvestigatorOutcomes 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.
    Allocation
    Randomized
    Enrollment
    1500 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Novavax COVID-19 booster
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Pfizer COVID-19 booster
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Non-boosted comparison group
    Arm Type
    No Intervention
    Arm Description
    Participants will not receive a dose of the study vaccine.
    Intervention Type
    Biological
    Intervention Name(s)
    Novavax COVID-19 vaccine (2023-2024 formula XBB containing)
    Intervention Description
    Participants will receive a single dose of the Novavax vaccine.
    Intervention Type
    Biological
    Intervention Name(s)
    Pfizer COVID-19 mRNA vaccine (2023-2024 formula XBB containing)
    Intervention Description
    Participants will receive a single dose of the Pfizer vaccine.
    Primary Outcome Measure Information:
    Title
    To determine if getting a 2023-2024 updated COVID-19 vaccine provides better protection from COVID-19 (the disease caused by the SARS-CoV-2 virus) than not getting an 2023-2024 updated COVID-19 vaccine.
    Description
    How many participants who received the 2023-2024 updated COVID-19 vaccine developed Covid-like illness (CLI)-associated SARS-CoV-2 infection (diagnosed by study rapid antigen tests) compared with how many participant who declined the updated vaccine. Comparing the number of infections in each group to calculate the hazard ratios of Covid-like illness (CLI)-associated SARS-CoV-2 infection among participants who receive the 2023-2024 updated COVID-19 vaccine and participant who decline the updated vaccine. Beginning time at risk starts with the first active surveillance contact. End of time at risk is illness onset with rapid antigen test confirmed SARS-CoV-2 infection or the last submitted response to the study surveillance.
    Time Frame
    up to 24 weeks post vaccination or study enrollment date
    Title
    Comparing how well two different 2023-2024 updated COVID-19 vaccines protect people from COVID-19 (the disease caused by the SARS-CoV-2 virus)
    Description
    How many participants who received the 2023-2024 updated Novavax COVID-19 vaccine developed Covid-like illness (CLI)-associated SARS-CoV-2 infection (diagnosed by study rapid antigen tests) compared with how many participant participants who received the 2023-2024 updated Pfizer mRNA COVID-19 vaccine. Comparing the number of infections in each group to calculate the hazard ratios of Covid-like illness (CLI)-associated SARS-CoV-2 infection among participants who receive the Novavax vaccine and participant who received the Pfizer mRNA vaccine.
    Time Frame
    up to 24 weeks post vaccination or study enrollment date

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sarang K Yoon, DO
    Phone
    801-203-0320
    Email
    sarang.yoon@hsc.utah.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jacob McKell
    Phone
    801-203-0320
    Email
    u6039902@utah.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sarang K Yoon, DO
    Organizational Affiliation
    University of Utah
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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