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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
COVID-19 Trial Summary
This trial will evaluate the safety & effectiveness of a booster vaccine for adults who have received or are COVID-19 seropositive.
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.Check my eligibility
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.See study design
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.
COVID-19 Trial 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:COVID-19 Trial 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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
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 2012 Phase 3 trial • 6104 Patients • NCT0134659227%
Injection site pain
25%
Pyrexia
14%
Decreased appetite
14%
Upper respiratory tract infection
14%
Diarrhea
10%
Injection site erythema
9%
Nasopharyngitis
9%
Irritability postvaccinal
9%
Headache
8%
Vomiting
8%
Injection site induration
7%
Myalgia
7%
Hypersomnia
7%
Injection site swelling
7%
Fatigue
6%
Crying
6%
Injection site hemorrhage
4%
Gastroenteritis
1%
Pneumonia
1%
Animal Bite
100%
80%
60%
40%
20%
0%
Study treatment Arm
ATIV (6 to <72 Months)
TIV (6 to <72 Months)
Comparator TIV (6 to <72 Months)
COVID-19 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).
Find a Location
Who is running the clinical trial?
NovavaxLead Sponsor
46 Previous Clinical Trials
105,904 Total Patients Enrolled
17 Trials studying COVID-19
70,735 Patients Enrolled for COVID-19
Clinical DevelopmentStudy DirectorNovavax, Inc.
35 Previous Clinical Trials
88,255 Total Patients Enrolled
15 Trials studying COVID-19
65,537 Patients Enrolled for COVID-19
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any age restrictions for this research endeavor?
"This research requires participants to be younger than 54 years old and of legal adult age."
Answered by AI
Who is eligible to be included in this research endeavor?
"To qualify for this covid-19 related trial, applicants must be aged 18 to 54 and have a confirmed diagnosis of the virus. 660 individuals will ultimately make up the study population."
Answered by AI
How many healthcare facilities are participating in this research initiative?
"Tekton Research in Yukon, Oklahoma, DM Clinical Research in Philadelphia, Pennsylvania, and AMR in Knoxville, Tennessee are just a few of the 30 medical centres that are currently participating in this trial."
Answered by AI
Is enrollment open for this medical experiment?
"According to clinicaltrials.gov, this medical research is not currently enlisting patients. The study was posted on August 22nd 2023 and its last update occured July 28th of the same year. However, there are 653 other clinical trials actively recruiting participants at present time."
Answered by AI
What are the specific objectives of this clinical investigation?
"This medical trial will measure the primary outcome of seroresponse rates (SRR) over a 28 day period following 1st vaccination relative to the historical control group. Secondary objectives include determining pseudo virus neutralization titers expressed as GMT, GMFR and SPR at relevant time points from baseline."
Answered by AI
Who else is applying?
What site did they apply to?
AMR
EmVenio Research Site Illinois
Quantum Clinical Trials
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
Why did patients apply to this trial?
Wanting to help science. I’ve never received a covid 19 vaccine ever. Help the humanity and make some money on the side.
PatientReceived 1 prior treatment
I was told this is a paid trial. My family is in need. To contribute to help protect the world from this disease.
PatientReceived no prior treatments
How responsive is this trial?
Average response time
- < 2 Days
Typically responds via
Phone Call
Most responsive sites:
- EmVenio Research Site Alabama: < 48 hours
- Quantum Clinical Trials: < 48 hours
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