What side effects are associated with this type of intervention?

Common side effects of COVID-19 vaccines, including those similar to the XBB.1.5 SARS-CoV-2 recombinant spike protein nanoparticle vaccine adjuvanted with Matrix-M™, typically include local reactions at the injection site (such as pain, redness, and swelling), systemic reactions (such as fever, fatigue, headache, muscle pain, chills, and joint pain), and, less frequently, gastrointestinal symptoms (such as nausea). Adjuvanted vaccines, which include an additional component to enhance the immune response, may also cause more pronounced local and systemic reactions. Serious side effects are rare but can include allergic reactions, myocarditis, and thrombosis with thrombocytopenia syndrome (TTS). It is important to discuss any concerns with a healthcare provider to weigh the benefits and risks of vaccination.

What prior FDA approvals exist?

The FDA has previously approved several COVID-19 vaccines and treatments that enhance the immune response. Notably, mRNA vaccines such as Pfizer-BioNTech's BNT162b2 and Moderna's mRNA-1273 have been authorized, which use lipid nanoparticles to deliver mRNA encoding the spike protein, prompting an immune response. Additionally, the Novavax COVID-19 vaccine (NVX-CoV2373) is a protein subunit vaccine that presents the spike protein to the immune system, similar to the XBB.1.5 vaccine being studied. These vaccines have been shown to be effective in generating robust immune responses and have been critical in managing the COVID-19 pandemic.

What other types of research exist?

Promising novel alternatives to the XBB.1.5 SARS-CoV-2 recombinant spike protein nanoparticle vaccine adjuvanted with Matrix-M™ for COVID-19 patients in 2024 include: 1) Intranasal lentiviral boosters, which target lung mucosa and reinforce waning immunity. 2) mRNA vaccines, such as CVnCoV, which have shown high levels of virus-neutralizing antibodies and protection in preclinical studies. 3) Nanoparticle-based vaccines targeting TLR4, TLR7/8, TLR9, and RIG-I receptors, which enhance broad and efficient immune responses.

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Virus Therapy

Vaccine for COVID-19 (COVID-19 Trial)

Verified Trial

Phase 2 & 3

Recruiting

Research Sponsored by Novavax

Eligibility Criteria Checklist

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

Must have

Have you been sick in the last 12 months (e.g., fever, chills, sore throat, dry cough, etc..)?

Be between 18 and 65 years old

Must not have

Have you received an FDA-authorized vaccine for COVID-19?

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 28 to day 180

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new COVID-19 booster vaccine for adults who either had previous mRNA vaccines or had COVID-19 but were not vaccinated. The vaccine aims to improve protection against the Omicron XBB.1.5 variant by enhancing the immune response.

Who is the study for?

This trial is for adults over 18 who've had an mRNA COVID-19 vaccine or are seropositive but unvaccinated. Participants must not join other SARS-CoV-2 studies during this time and should have no autoimmune conditions, allergies to vaccine ingredients, or history of myocarditis/pericarditis.

What is being tested?

The study tests a booster dose of the XBB.1.5 COVID-19 vaccine in previously vaccinated individuals and a single dose in those unvaccinated but with natural immunity. It's open-label, meaning everyone knows which treatment they're getting.

What are the potential side effects?

Potential side effects may include typical reactions like soreness at the injection site, fever, fatigue, headaches, muscle pain, chills and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been sick with symptoms like fever or cough in the last year.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 28 to day 180

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 28 to day 180

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 28 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

Part 1: Pseudovirus neutralization (inhibitory dilution at a concentration of 50%; ID 50 ) to the NVX-CoV2601 vaccine

Part 1: Seroresponse Rates (SRRs) in ID 50 titers to the NVXCoV2601 vaccine

Part 2: ID 50 (Geometric Mean Titers) GMTs to the XBB.1.5 Omicron subvariant

+1 more

Secondary study objectives

Part 1: Anti-S immunoglobulin G (IgG) geometric mean concentrations (GMCs, EU/mL) to the NVX-CoV2601 vaccine at relevant time points

Part 1: ID 50 GMTs to the XBB.1.5 Omicron subvariant

Part 1: ID 50 geometric mean fold rise (GMFR) to the XBB.1.5 Omicron subvariant at relevant time points (Days 28 and 180) from baseline (Day 0).

+9 more

Side effects data

From 2023 Phase 4 trial • 267 Patients • NCT05007041

COVID-19 Infection

Upper Respiratory Infection

Cardiovascular Accident (CVA), Unspecified Mechanism

Left partial cranial nerve III palsy

Acute Hyperkalemia

Shortness of Breath

Acute pulmonary embolism and acute deep vein thrombosis

100%

80%

60%

40%

20%

Study treatment Arm

Recombinant Zoster Vaccine (RZV) and High-Dose Quadrivalent Influenza Vaccine

Recombinant Zoster Vaccine (RZV) and Quadrivalent Adjuvanted Influenza Vaccine

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Group-A XBB.1.5 Vaccine (Booster)Experimental Treatment1 Intervention

The Monovalent [5 μg/50 μg] NVX-CoV2601 XBB.1.5 Vaccine (Booster)

Group II: Group-B The monovalent XBB.1.5 Vaccine (Single Dose).Active Control1 Intervention

Group-B The monovalent [5 μg/50 μg] NVX-CoV2601 XBB.1.5 Vaccine (Single Dose).

0 / 2Eligibility criteria met

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

Common treatments for COVID-19, such as the XBB.1.5 SARS-CoV-2 recombinant spike protein nanoparticle vaccine adjuvanted with Matrix-M™, work by enhancing the immune system's ability to recognize and combat the virus. This vaccine presents the spike protein to the immune system and uses the Matrix-M™ adjuvant to boost the immune response. Similar mechanisms are seen in mRNA vaccines, which instruct cells to produce the spike protein, and antiviral drugs like Remdesivir, which inhibit viral replication. Monoclonal antibodies provide direct immunity by targeting the virus. These treatments are essential as they help prevent infection, reduce viral load, and alleviate severe symptoms, ultimately improving patient outcomes.

The Molecular Basis of COVID-19 Pathogenesis, Conventional and Nanomedicine Therapy.