Clinical trial NCT06065176: The Efficacy of the 2023-2024 Updated COVID-19 Vaccines Against COVID-19 Infection
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
Overall status: COMPLETED
Phase: PHASE4
Conditions: 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
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: Westat
name: Novavax
First posted: 2023-10-03
Enrollment: 1188
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

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 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.

Primary outcomes:
measure: Number of participants with Covid-like illness (CLI)-associated SARS-CoV-2 infection in the booster (received 2023-2024 updated COVID-19 vaccine) and non-booster groups
timeFrame: up to 24 weeks post vaccination or study enrollment date
measure: Number of participants with Covid-like illness (CLI)-associated SARS-CoV-2 infection in the Pfizer and Novavax booster (2023-2024 updated COVID-19 vaccine) groups
timeFrame: up to 24 weeks post vaccination or study enrollment date
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah School of Medicine
state: Utah
Study officials:
affiliation: University of Utah
name: Sarang K Yoon, DO
role: PRINCIPAL_INVESTIGATOR
References: