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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
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 belowSelect...
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
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 moreSecondary 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 moreSide effects data
From 2023 Phase 4 trial • 267 Patients • NCT050070418%
COVID-19 Infection
7%
Upper Respiratory Infection
1%
Cardiovascular Accident (CVA), Unspecified Mechanism
1%
Left partial cranial nerve III palsy
1%
Acute Hyperkalemia
1%
Shortness of Breath
1%
Acute pulmonary embolism and acute deep vein thrombosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Recombinant Zoster Vaccine (RZV) and High-Dose Quadrivalent Influenza Vaccine
Recombinant Zoster Vaccine (RZV) and Quadrivalent Adjuvanted Influenza Vaccine
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).
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.
The Molecular Basis of COVID-19 Pathogenesis, Conventional and Nanomedicine Therapy.
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Who is running the clinical trial?
NovavaxLead Sponsor
49 Previous Clinical Trials
108,044 Total Patients Enrolled
Clinical DevelopmentStudy DirectorNovavax, Inc.
36 Previous Clinical Trials
86,999 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have received a COVID-19 vaccine that is not Moderna or Pfizer.I have been sick with symptoms like fever or cough in the last year.I am on treatment for an autoimmune or immunodeficiency disease.You have allergies to any of the ingredients in the experimental treatment.You have had a severe allergic reaction called anaphylaxis to a vaccine in the past.I have a history of heart inflammation.
Research Study Groups:
This trial has the following groups:- Group 1: Group-A XBB.1.5 Vaccine (Booster)
- Group 2: Group-B The monovalent XBB.1.5 Vaccine (Single Dose).
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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