COVID-19 Vaccines for Side Effects

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Marcel Curlin

Disqualifiers: Severe illness, Allergic reactions, Heart inflammation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares the side effects of two COVID-19 vaccines: the protein-based Novavax (Nuvaxovid, NVX-CoV2705) and the mRNA-based Pfizer. Researchers aim to determine which vaccine causes more or fewer post-vaccination symptoms, such as sore arms or tiredness. It suits adults who have received at least one COVID-19 vaccine and are eligible for a seasonal vaccine. As a Phase 4 trial, this research involves FDA-approved vaccines and helps to understand their benefits for more patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What is the safety track record for these treatments?

Research has shown that both the Novavax and Pfizer COVID-19 vaccines are generally safe. Studies have found that the Novavax vaccine is well-tolerated, with serious side effects occurring in less than 0.1% of cases. The FDA has approved it, confirming it meets safety standards for preventing COVID-19.

For the Pfizer-BioNTech vaccine, side effects are usually mild and resolve quickly. Common reactions include soreness at the injection site or a mild fever. Serious side effects, such as allergic reactions, are rare but possible. This vaccine also holds FDA approval, supporting its safety.

Both vaccines have been widely used and are considered effective in protecting against COVID-19. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about these treatments because Nuvaxovid (NVX-CoV2705) and the Pfizer-BioNTech COVID-19 vaccine offer unique approaches to managing side effects. Nuvaxovid is a protein-based vaccine, which means it uses harmless pieces of the virus to train the immune system, potentially leading to fewer side effects compared to traditional vaccines. On the other hand, the Pfizer-BioNTech vaccine utilizes mRNA technology, which instructs cells to produce a spike protein that prompts an immune response. This method has been groundbreaking in its ability to generate a robust immune response quickly. These innovative approaches provide promising alternatives to existing vaccines by offering different mechanisms that could minimize side effects for recipients.

What evidence suggests that this trial's vaccines could be effective for reducing COVID-19 vaccine side effects?

In this trial, participants will receive either the Novavax vaccine, Nuvaxovid, or the Pfizer-BioNTech COVID-19 vaccine. Studies have shown that the Novavax vaccine effectively prevents COVID-19, with an overall success rate of 90.4%. It uses a protein-based method, differing from the mRNA approach of some other vaccines. Research indicates it works well for individuals aged 12 and older. Meanwhile, the Pfizer-BioNTech COVID-19 vaccine has consistently provided strong protection against both mild and severe COVID-19 cases. This vaccine uses mRNA technology to help the body learn to fight the virus. Both vaccines effectively prevent COVID-19, offering good options for protection. ^{1 3 4 5 6}

Are You a Good Fit for This Trial?

This trial is for individuals who are willing to report their reactions after receiving a COVID-19 vaccine. The specific eligibility criteria have not been provided, but typically participants would need to be in good health and without prior adverse reactions to vaccines.

Inclusion Criteria

Signed informed consent form (ICF) and agree to participate in the study

I have received at least one COVID-19 vaccine.

I am 18 or older and can receive the seasonal COVID-19 vaccine.

Exclusion Criteria

Anyone with a medical or mental health issue, or problems with substance use that might make participation risky

History of severe allergic reaction to COVID-19 vaccines

I do not have a severe illness, infection, or a fever today.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Vaccination

Participants receive either the Novavax vaccine or an mRNA vaccine

1 day

1 visit (in-person)

Post-vaccination Monitoring

Participants report symptoms and side effects after receiving the vaccine

1-2 weeks

Follow-up

Participants are monitored for safety and effectiveness after vaccination

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Nuvaxovid (NVX-CoV2705)
• Pfizer-BioNTech COVID-19 vaccine

Trial Overview The study is comparing the reactogenicity, or side effects post-vaccination, between two COVID-19 vaccines: Pfizer-BioNTech's mRNA vaccine and Novavax's protein-based Nuvaxovid (NVX-CoV2373).

How Is the Trial Designed?

Group I: Pfizer Vaccine Experimental Treatment 1 Intervention

mRNA-based vaccine

Group II: Novavax Vaccine Experimental Treatment 1 Intervention

Protein-based vaccine

Who Is Running the Clinical Trial?

Marcel Curlin

Lead Sponsor

Citations

1. ir.novavax.com ir.novavax.com/press-releases/2025-08-27-Novavaxs-Nuvaxovid-TM-2025-2026-Formula-COVID-19-Vaccine-Approved-in-the-U-S

Novavax's Nuvaxovid™ 2025-2026 Formula COVID-19 ... Nuvaxovid is a vaccine indicated for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 65 years of age and older, or ...

2. yalemedicine.org yalemedicine.org/news/novavax-covid-vaccine

Novavax's COVID-19 Vaccine: Your Questions Answered Trial results, published in The New England Journal of Medicine, showed it to have 90.4% overall efficacy.

3. pro.campus.sanofi pro.campus.sanofi/us/products/nuvaxovid/efficacy

Clinical Trial Results and Study Designs | NUVAXOVID™ Explore the efficacy of NUVAXOVID™ (COVID-19 Vaccine, Adjuvanted) for individuals 65+ and those 12-64 with an underlying condition that puts them at high ...

4. ema.europa.eu ema.europa.eu/en/medicines/human/EPAR/nuvaxovid

Nuvaxovid | European Medicines Agency (EMA) Results from two main clinical trials found that Nuvaxovid was effective at preventing COVID-19 in people from 12 years of age when given as primary vaccination ...

5. fda.gov fda.gov/files/vaccines%2C%20blood%20%26%20biologics/published/Package-Insert-and-Patient-Package-Insert-NUVAXOVID.pdf

Package Insert and Patient Package Insert - NUVAXOVID Vaccine efficacy in participants without evidence of SARS-CoV-2 infection through 6 days after. 1118 the second dose is presented in Table 12. The efficacy of ...

6. pro.campus.sanofi pro.campus.sanofi/us/products/nuvaxovid/tolerability

NUVAXOVID™ Vaccine Tolerability Profile Booster Dose: NUVAXOVID has a well established tolerability profile in patients aged 18+1,2. ≤0.1% of patients experienced higher severity (Grade 4) ...