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

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

Active, not recruiting
COVID-19

Drug: Nuvaxovid (NVX-CoV2705)

COVID-19 vaccination

Drug: mNEXSPIKE mRNA-1283

COVID-19 vaccination

Eligibility Criteria

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
United States
Locations

Oregon Health and Sciences University
Portland, Oregon, United States

Not Provided

Marcel Curlin
NCT Number
Keywords
Covid-19
Novavax
COVID-19 Reactogenicity
COVID-19 vaccine side effects
Novavax vs mRNA booster
Protein-based COVID vaccine
Seasonal COVID-19 booster comparison
COVID-Vaccine tolerability study
COVID-19 Post-vaccination symptoms
COVID-19 immunization study
COVID-19 Vaccine safety and daily functioning
COVID-19 Patient-reported outcomes
Novavax booster trial
mNEXSPIKE mRNA-1283
Moderna
MeSH Terms
COVID-19
NVX-CoV2373 adjuvated lipid nanoparticle