COVID-19Phase 4NCT07051031
COVID-19 Reactogenicity
A Phase 4 study testing Nuvaxovid (NVX-CoV2705) and mNEXSPIKE mRNA-1283 in people with COVID-19, run by Marcel Curlin at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- Nuvaxovid (NVX-CoV2705) and mNEXSPIKE mRNA-1283
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2025to 14 Jun 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health and Sciences University
Portland, Oregon, 97239
About this study
Official title: Reactogenicity, Patient Reported Outcomes and Vaccine Preference in Adults Immunized With Recombinant Protein or mRNA COVID-19 Vaccines
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.
Read the 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
- Being tested
- Nuvaxovid (NVX-CoV2705), mNEXSPIKE mRNA-1283
- 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
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nuvaxovid (NVX-CoV2705)Drug
COVID-19 vaccination
mNEXSPIKE mRNA-1283Drug
COVID-19 vaccination
| Study group | Role | What they receive |
|---|---|---|
| Novavax Vaccine | Experimental | Protein-based vaccine Receives: Drug: Nuvaxovid (NVX-CoV2705) |
| mNEXSPIKE mRNA-1283 | Experimental | mRNA-based vaccine Receives: Drug: mNEXSPIKE mRNA-1283 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within 7 days post vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start1 Oct 2025
- Primary completion14 Jun 2026 (estimated)
- Study completion14 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marcel Curlin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marcel Curlin, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07051031
- Sponsor's protocol ID
- VBA 501
- Status last verified
- Jul 2025
- First submitted
- 1 Jul 2025
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reactogenicity, Patient Reported Outcomes and Vaccine Preference in Adults Immunized With Recombinant Protein or mRNA COVID-19 Vaccines
- ClinicalTrials.gov ID
- NCT07051031
- Acronym / sponsor ID
- VBA 501
- 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
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Marcel CurlinUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 14 Jun 2026 (estimated)
- Study completion
- 14 Jun 2026 (estimated)
- First posted
- 3 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Novavax Vaccine | Experimental | Drug: Nuvaxovid (NVX-CoV2705)Protein-based vaccine |
| mNEXSPIKE mRNA-1283 | Experimental | Drug: mNEXSPIKE mRNA-1283mRNA-based vaccine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (5 listed)
- 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 is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nuvaxovid (NVX-CoV2705)COVID-19 vaccination | Drug | Novavax Vaccine |
| mNEXSPIKE mRNA-1283COVID-19 vaccination | Drug | mNEXSPIKE mRNA-1283 |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nuvaxovid (NVX-CoV2705) and mNEXSPIKE mRNA-1283 in people with COVID-19, run by Marcel Curlin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Reporting ≥1 Systemic Symptom Within 7 Days Post-Vaccination (time frame: within 7 days post vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.