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Virus Therapy

Updated COVID-19 Vaccines for COVID-19 (BEEHIVE Trial)

Q: Has the Novavax COVID-19 booster undergone FDA verification?

<p>We assign a safety rating of 3 to Novavax <a href="https://www.withpower.com/clinical-trials/covid">COVID</a>-19 booster, as it has achieved Phase 4 trial status and is approved for clinical use.</p>

Phase 4

Recruiting

Led By Sarang K Yoon, DO

Research Sponsored by Sarang K. Yoon, DO, MOH

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥18 years

Previously received ≥ 2-doses of US FDA-authorized mRNA vaccines

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 weeks post vaccination or study enrollment date

Awards & highlights

BEEHIVE Trial Summary

This trial is testing two 2023-2024 COVID-19 vaccines to find out how well they protect against the virus & if one offers better protection than not getting a vaccine. Participants can choose to get a vaccine (50/50 chance of Novavax or Pfizer) or not, and will complete surveys & tests.

Who is the study for?

This trial is for adults over 18 who've had at least two doses of an FDA-authorized mRNA COVID-19 vaccine, can read and respond to English messages, plan to stay in the Salt Lake City area for a year, have daily internet access and text messaging on their phone. They must be willing to do online surveys and self-collect weekly COVID-19 tests.Check my eligibility

What is being tested?

The study compares the effectiveness of two updated COVID-19 vaccines: Novavax and Pfizer's new formulas containing XBB. Participants will randomly receive one of these or may choose not to get vaccinated but still partake in other study activities like surveys and testing.See study design

What are the potential side effects?

Potential side effects are not detailed here but generally could include soreness at injection site, fatigue, headache, muscle pain, chills, fever, nausea; similar to earlier versions of the vaccines.

BEEHIVE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have received at least 2 doses of an mRNA vaccine approved by the FDA.

BEEHIVE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 weeks post vaccination or study enrollment date

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 weeks post vaccination or study enrollment date

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 weeks post vaccination or study enrollment date for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

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

BEEHIVE Trial Design

3Treatment groups

Active Control

Group I: Novavax COVID-19 boosterActive Control1 Intervention

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.

Group II: Pfizer COVID-19 boosterActive Control1 Intervention

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.

Group III: Non-boosted comparison groupActive Control1 Intervention

Participants will not receive a dose of the study vaccine.

0 / 2Eligibility criteria met

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Who is running the clinical trial?

WestatOTHER

43 Previous Clinical Trials

35,674 Total Patients Enrolled

Sarang K. Yoon, DO, MOHLead Sponsor

NovavaxIndustry Sponsor

46 Previous Clinical Trials

105,064 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the aggregate quantity of participants involved in this investigation?

"Yes, the data posted on clinicaltrials.gov indicate that this medical trial is actively enlisting participants and has been since November 22nd 2023. The study needs to recruit 1500 individuals from a single site in order to complete its research goals."

Answered by AI

Has the Novavax COVID-19 booster undergone FDA verification?

"We assign a safety rating of 3 to Novavax COVID-19 booster, as it has achieved Phase 4 trial status and is approved for clinical use."

Answered by AI

Are there any remaining openings in the clinical trial for participation?

"Affirmative. According to clinicaltrials.gov, this investigation is actively recruiting applicants and was initially posted on November 22nd 2023 with the most recent edit also taking place on that same day. The study requires 1500 participants from 1 medical centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Sarang K. Yoon, DO, MOH 2023. "The Efficacy of the 2023-2024 Updated COVID-19 Vaccines Against COVID-19 Infection". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06065176.

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