COVID-19 Reactogenicity

NCT07051031 | Active Not Recruiting Phase 4 FDA Drug

• 1 other identifier: VBA 501
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COVID-19

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

Outcome Measures

Primary Outcomes (1)

• Number of Participants Reporting ≥1 Systemic Symptom 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.

  within 7 days post vaccination

Study Arms (2)

Novavax Vaccine

EXPERIMENTAL

Protein-based vaccine

Drug: Nuvaxovid (NVX-CoV2705)

mNEXSPIKE mRNA-1283

EXPERIMENTAL

mRNA-based vaccine

Drug: mNEXSPIKE mRNA-1283

Interventions

Nuvaxovid (NVX-CoV2705) DRUG

COVID-19 vaccination

Novavax Vaccine

mNEXSPIKE mRNA-1283 DRUG

COVID-19 vaccination

mNEXSPIKE mRNA-1283

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marcel Curlin: lead

Study Sites (1)

Oregon Health and Sciences University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

NVX-CoV2373 adjuvated lipid nanoparticle

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Director

Study Record Dates

• First Submitted: July 1, 2025
• First Posted: July 3, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): June 14, 2026
• Study Completion (Estimated): June 14, 2026
• Last Updated: March 4, 2026

Record last verified: 2025-07

Locations

US (1)