What side effects are associated with this type of intervention?

Common treatments for COVID-19 include antiviral medications, monoclonal antibodies, and vaccines. For protein subunit vaccines with adjuvants, such as the Novavax vaccine, known side effects typically include injection site reactions (pain, redness, swelling), systemic reactions (fever, fatigue, headache, muscle pain), and, less commonly, allergic reactions. These side effects are generally mild to moderate and resolve within a few days. It is important to discuss any concerns with a healthcare provider to ensure the best treatment plan.

What prior FDA approvals exist?

The FDA has granted Emergency Use Authorization (EUA) for several COVID-19 vaccines, including mRNA vaccines like Pfizer-BioNTech (BNT162b2) and Moderna (mRNA-1273), as well as viral vector vaccines like Johnson & Johnson's Janssen (Ad26.COV2.S). The Novavax vaccine (NVX-CoV2373), a protein subunit vaccine with Matrix-M™ adjuvant, has shown promising results in clinical trials but is not yet FDA-approved. Other treatments authorized for COVID-19 include antiviral drugs like remdesivir and monoclonal antibodies, although their efficacy varies with different SARS-CoV-2 variants.

What other types of research exist?

Promising novel alternatives to the Novavax vaccine with Matrix-M™ adjuvant for COVID-19 patients in 2024 include: 1) mRNA vaccines such as those developed by Pfizer-BioNTech and Moderna, which have shown high efficacy and safety profiles. 2) Viral vector vaccines like the Johnson & Johnson vaccine, which uses a modified adenovirus to deliver the spike protein gene. 3) Other protein subunit vaccines, such as those being developed by Sanofi-GSK, which use recombinant protein technology combined with adjuvants to enhance immune response.

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Virus Vaccine

Novavax Booster for COVID-19

Phase 3

Waitlist Available

Research Sponsored by Novavax

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 to day 180

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing an additional dose of the Novavax COVID-19 vaccine for adults who have already received their previous COVID-19 vaccinations. The goal is to see if this extra dose can improve immunity and ensure safety.

Who is the study for?

Adults aged 18-49 who previously received mRNA COVID-19 vaccines and a Novavax booster at least 180 days ago. Must be in good health, not pregnant or planning pregnancy, agree to use contraception if of childbearing potential, and not participate in other SARS-CoV-2 trials.

What is being tested?

The trial is testing the effectiveness of Novavax's NVX-CoV2373 vaccine as a booster following initial mRNA COVID-19 vaccinations. Participants will receive either the ancestral strain or an alternative/multivalent version with Matrix-M adjuvant.

What are the potential side effects?

Potential side effects may include typical vaccine reactions like soreness at injection site, fatigue, headache, muscle pain, possible allergic reactions but specifics will depend on individual responses to the Novavax vaccine.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 to day 180

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 to day 180

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 to day 180 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Neutralizing Antibody (Nab) responses expressed as Geometric Mean Titers

Secondary study objectives

Human Angiotensin-Converting Enzyme 2 (hACE2) Receptor Binding Inhibition Assay Expressed as Seroresponse (SPR)

Incidence and Relationship of Serious Adverse Events (SAEs)

Incidence and Severity of Adverse Events Special Interests (AESIs)

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Updated COVID-19 VaccineExperimental Treatment1 Intervention

1dose of updated COVID-19 vaccine on Day 1

Group II: NVX CoV2373 (Ancestral strain)Experimental Treatment1 Intervention

1dose of NVX-COV2373 on Day 1

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

NVX-CoV2373

2022

Completed Phase 3

~1690

SARS-CoV-2 rS antigen/Matrix-M Adjuvant

2023

Completed Phase 3

~300

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Protein subunit vaccines, such as the Novavax vaccine with Matrix-M™ adjuvant, work by introducing harmless pieces of the virus (often spike proteins) to the immune system, which then recognizes and learns to fight the actual virus. The Matrix-M™ adjuvant enhances the immune response by stimulating the production of more antibodies and promoting a stronger, longer-lasting immunity. This is crucial for COVID-19 patients as it helps prevent severe illness, reduces transmission, and contributes to herd immunity, ultimately controlling the spread of the virus.

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