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Active, Not Recruiting

NCT Number: NCT07051031

COVID-19 Reactogenicity

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Oregon Health and Sciences University

Portland, Oregon, 97239, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Adults eligible for seasonal COVID-19 vaccine, ages 18 and older Signed informed consent form (ICF) and agree to participate in the study Prior receipt of one or more COVID-19 vaccines

Exclusion criteria

  • If a person is experiencing a moderate or severe illness or infection (as judged by the study investigator) or has a fever (temperature of 38.0°C or higher) on the day they are supposed to participate in the study, they should not join until they are feeling better and the fever is gone.
  • Anyone with a medical or mental health issue, or problems with substance use that might make taking part in the study risky
  • People who have had a severe allergic reaction to COVID-19 vaccines in the past
  • Those who have been diagnosed with inflammation in or around the heart after receiving a COVID-19 vaccine
  • Individuals who have received any other vaccine within a week before joining the study or who plan to get a vaccine on the same day as the study or within 7 days afterward

Treatment and study plan

Nuvaxovid (NVX-CoV2705)

Drug

COVID-19 vaccination

mNEXSPIKE mRNA-1283

Drug

COVID-19 vaccination

Primary outcomes

  1. Number of Participants Reporting ≥1 Systemic Symptom Within 7 Days Post-Vaccination

    Time frame: within 7 days post vaccination

    Proportion and number of participants who report at least one systemic symptom (e.g., fever, fatigue, myalgia, headache, chills) within 7 days following COVID-19 booster vaccination, as collected via daily symptom diary.

Sponsors and collaborators

Lead sponsor

Marcel Curlin

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 3, 2025
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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