ArticleJMIR research protocols2026
Real-World Effectiveness and Noninferiority Evaluation and Comparison of Messenger RNA-Based and Protein-Based COVID-19 Vaccines: Protocol for the BEEHIVE Randomized Study With a Hybrid Effectiveness Design.
Article in JMIR research protocols, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06065176 (Booster Epidemiological Evaluation of Health, Illness and Vaccine Efficacy Study), which is not on this map. Cited by 2 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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 in the United States
Who cites it
2 citing papers in PubMed.
- Real-world evaluation of 2023-2024 XBB.1.5 mRNA and protein-based COVID-19 vaccine reactogenicity from the randomized BEEHIVE trial.Human vaccines & immunotherapeutics · 2026Trial
- Comparative effectiveness of COVID-19 vaccines among health students, focusing on methodological concerns.Antimicrobial stewardship & healthcare epidemiology : ASHE · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
16 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundSurveillance of COVID-19 vaccine effectiveness (VE) was extensive upon vaccine introduction; however, it declined after the withdrawal of pandemic status in May 2023. Continued monitoring of updated vaccine formulations is needed to ensure the maintenance of VE in the face of evolving viral strains.
objectiveThe Booster Epidemiological Evaluation of Health, Illness and Vaccine Efficacy (BEEHIVE) study (NCT06065176), a randomized trial with a hybrid design, was developed to assess the real-world VE of the 2023-2024 Pfizer-BioNTech and Novavax COVID-19 vaccine formulations targeting the XBB.1.5 SARS-CoV-2 variant.
methodsThis study was designed to enroll approximately 1500 participants aged ≥18 years from the Salt Lake City, Utah, area who had previously received ≥2 doses of an authorized messenger RNA (mRNA)-based COVID-19 vaccine but had not received a dose of the 2023-2024 formulation. The study used a randomized, hybrid design comprising 2 blinded groups assigned to receive the 2023-2024 formula of either the Novavax COVID-19 vaccine or the Pfizer-BioNTech COVID-19 vaccine and a nonrandomized, observational control group of volunteers who chose not to receive a 2023-2024 vaccine dose during the study. Follow-up lasted 24 weeks and included symptom surveys and self-administered COVID-19 antigen testing, both occurring weekly. The primary aim was to compare VE (defined as prevention of symptomatic SARS-CoV-2 infection) between study-vaccinated participants and the control group. The secondary aim was to determine the relative VE of the Pfizer-BioNTech mRNA and Novavax 2023-2024 COVID-19 vaccines. Secondary objectives included assessing how the number of previous COVID-19 vaccinations impacted VE of the 2023-2024 COVID-19 vaccines; identifying predictors and associated factors for asymptomatic versus symptomatic infection and/or prolonged or severe illness; examining factors associated with post-COVID-19 conditions; and evaluating participants' knowledge, attitudes, and practices related to COVID-19 vaccination. Participant engagement was maintained via online and text-based reminders and surveys, as well as researcher follow-up.
resultsParticipants were recruited from November 2023 through March 2024, with 452 and 457 participants randomized to the Novavax and Pfizer-BioNTech vaccine groups, respectively, and 279 participants enrolled in the control group. SARS-CoV-2 variants from the XBB, JN.1, KP.2, and KP.3 lineages were in circulation in the United States and the Utah region during data collection. The study ended on September 9, 2024, with results expected to be published in 2026.
conclusionsData from this study will provide valuable real-world VE data for a dose of the Novavax COVID-19 vaccine or the Pfizer-BioNTech COVID-19 vaccine after an mRNA-based COVID-19 primary series.
trial registrationClinicalTrials.gov NCT06065176; https://www.clinicaltrials.gov/study/NCT06065176. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/80858.
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