NCT07051031

COVID-19 Reactogenicity

Reactogenicity, Patient Reported Outcomes and Vaccine Preference in Adults Immunized With Recombinant Protein or mRNA COVID-19 Vaccines

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,000 (estimated)
• Sponsor: Marcel Curlin · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to compare post-vaccination reactions between the protein-based Novavax vaccine and the mNEXSPIKE mRNA-1283 vaccine. Specifically, the study aims to determine the rate of participant-reported symptoms associated with each type of vaccine.

Detailed description

Why is this study being conducted? Many individuals receive a flu vaccine each year, but fewer receive the COVID-19 booster, even though COVID-19 infection can be more severe. One possible reason is concern about vaccine side effects. The goal of this study is to determine whether a different type of COVID-19 vaccine, called Novavax, causes fewer side effects than the more commonly used mRNA vaccines (such as Pfizer or Moderna) when administered as a seasonal booster. What is Novavax? Novavax is a protein-based COVID-19 vaccine approved by the FDA. Earlier studies suggest that fewer side effects may occur with Novavax; however, not many studies have directly compared Novavax with mRNA vaccines What is the purpose of this study? Eligible individuals who qualify for a COVID-19 booster are invited to participate. Participants will receive either the Novavax vaccine or an mRNA vaccine. After vaccination, participants will be asked to report any symptoms or side effects experienced. Collected information will help determine which vaccine may be better tolerated. Why does this matter? By comparing participant experiences, this study aims to identify ways to improve acceptance and accessibility of COVID-19 booster vaccines. Findings may help increase public confidence in vaccination and support ongoing protection against COVID-19.

Conditions

• COVID-19

Interventions

Type	Name	Description
DRUG	Nuvaxovid (NVX-CoV2705)	COVID-19 vaccination
DRUG	mNEXSPIKE mRNA-1283	COVID-19 vaccination

Timeline

• Start date: 2025-10-01
• Primary completion: 2026-06-14
• Completion: 2026-06-14
• First posted: 2025-07-03
• Last updated: 2026-03-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study