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Virus Therapy
SARS-CoV-2 rS Vaccines for COVID-19 (COVID-19 Trial)
Phase 2 & 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
Adults ≥ 50 years of age at screening
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 0 to 180
Awards & highlights
COVID-19 Trial Summary
This trial studies the safety and effectiveness of two experimental SARS-CoV-2 vaccines with a new type of adjuvant.
Who is the study for?
This trial is for adults over 50 who've had at least 3 doses of a COVID-19 mRNA vaccine, with the last dose given more than 90 days ago. They must be willing to avoid other COVID trials and use contraception if necessary. Excluded are those with allergies to trial ingredients, immune conditions requiring treatment, recent immunosuppressants or blood products, history of heart inflammation, active cancer in the past 3 years, pregnancy or breastfeeding.Check my eligibility
What is being tested?
The study tests different booster doses of SARS-CoV-2 rS vaccines (NVX-CoV2373 & NVX-CoV2601) against new variants like Omicron XBB.1.5. It's randomized and double-blind; participants don't know which dose they receive to compare safety and immune response.See study design
What are the potential side effects?
Potential side effects may include typical reactions such as soreness at injection site, fatigue, headache, muscle pain, feverish feelings similar to previous COVID-19 vaccinations but specific risks will be monitored throughout the trial.
COVID-19 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 50 years old or older.
COVID-19 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 0 to 180
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 0 to 180
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Immunogenicity index-Neutralizing antibody expressed as geometric mean titer ratio[GMTR ]against the Omicron subvariant XBB.1.5
Immunogenicity index-Neutralizing antibody expressed as seroresponse rates (SRRs)against the Omicron subvariant XBB.1.5
Secondary outcome measures
Human angiotensin-converting enzyme 2 (hACE2) receptor binding inhibition assay to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 viruses expressed as GMTs
Immunogenicity index- IgG antibody Anti-S expressed as geometric mean Elisa units GMEUs (EU/mL)
Immunogenicity index- Neutralizing antibody titers of post-booster by baseline anti-SARS-CoV-2 NP
+7 moreCOVID-19 Trial Design
7Treatment groups
Experimental Treatment
Group I: Group-G Bivalent XBB.1.5Experimental Treatment1 Intervention
Bivalent XBB.1.5 Omicron subvariant/prototype COVID-19 licensed mRNA vaccine
Group II: Group-F Monovalent NVX-CoV2601 (50 μg)Experimental Treatment1 Intervention
Monovalent NVX-CoV2601 (50 μg of each antigen with a 100 μg of Matrix-M adjuvant)
Group III: Group-E Monovalent NVX-CoV2601(35)Experimental Treatment1 Intervention
Monovalent NVX-CoV2601 (35 μg of each antigen with a 75 μg of Matrix-M adjuvant)
Group IV: Group-D Monovalent NVX-CoV2601 (35 μg)Experimental Treatment1 Intervention
Monovalent NVX-CoV2373 (35 μg of antigen with 50 μg of Matrix-M adjuvant)
Group V: Group-C Monovalent NVX-CoV2601 (5 μg)Experimental Treatment1 Intervention
Monovalent NVX-CoV2601 (5 μg of antigen with 75 μg of Matrix-M adjuvant)
Group VI: Group-B Monovalent NVX-CoV2601 (5 μg)Experimental Treatment1 Intervention
Monovalent NVX-CoV2601 (5 μg of antigen with 50 μg of Matrix-M adjuvant)
Group VII: Group-A Monovalent NVX-CoV2373 (5 μg)Experimental Treatment1 Intervention
The Monovalent NVX-CoV2601 of 5 μg of antigen with 50 μg of Matrix-M adjuvant
Find a Location
Who is running the clinical trial?
NovavaxLead Sponsor
46 Previous Clinical Trials
104,584 Total Patients Enrolled
17 Trials studying COVID-19
69,415 Patients Enrolled for COVID-19
Clinical DevelopmentStudy DirectorNovavax
35 Previous Clinical Trials
86,871 Total Patients Enrolled
15 Trials studying COVID-19
64,217 Patients Enrolled for COVID-19
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken immune-suppressing drugs in the last 90 days.I haven't taken immunosuppressants or blood products in the last 90 days, except for rabies treatment if needed.I have had myocarditis or pericarditis in the past.I've had 3 or more COVID-19 mRNA vaccine doses, with the last one over 90 days ago.I am 50 years old or older.I am on treatment for an autoimmune disease or immunodeficiency.I have been treated for cancer within the last 3 years.You have had a problem with drinking too much alcohol or using drugs in the past 2 years.I have received a COVID-19 vaccine that is not a prototype or bivalent mRNA vaccine.I haven't had the flu shot or any vaccine in the last 14 and 30 days, respectively.
Research Study Groups:
This trial has the following groups:- Group 1: Group-B Monovalent NVX-CoV2601 (5 μg)
- Group 2: Group-G Bivalent XBB.1.5
- Group 3: Group-E Monovalent NVX-CoV2601(35)
- Group 4: Group-C Monovalent NVX-CoV2601 (5 μg)
- Group 5: Group-D Monovalent NVX-CoV2601 (35 μg)
- Group 6: Group-F Monovalent NVX-CoV2601 (50 μg)
- Group 7: Group-A Monovalent NVX-CoV2373 (5 μg)
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 multiple research centers running this trial within the US?
"To name a few, 47 sites are currently involved in this trial; these include Tucson Neuroscience Research in Tucson, Velocity Clinical Research, Banning and Velocity Clinical Research, Chula Vista."
Answered by AI
Is enrollment still open for participation in this experiment?
"Clinicaltrials.gov reports that this clinical trial, which was first posted on August 30th 2023 and last updated July 2nd 2023, is no longer recruiting participants. Nevertheless, there are numerous alternate studies actively seeking volunteers with 799 trials open to recruitment at this time."
Answered by AI
Who can join this medical experiment?
"Eligible participants for this coronavirus clinical trial must have contracted the virus and fall between 18 to 50 years of age. A total of 1980 patients are necessary for full enrollment."
Answered by AI
Is the enrollment criteria for this project open to individuals aged 40 or older?
"This clinical trial is open to applicants aged 18 - 50. In comparison, there are 115 studies for minors and 699 dedicated trials for those past the age of 65."
Answered by AI
What is the primary objective of this trial?
"This clinical trial's primary objective, which will be assessed over a 28-day period, is to measure the Immunogenicity index - Neutralizing antibody expressed as seroresponse rates (SRRs) against the Omicron subvariant BA.5. Secondary objectives include measuring Safety Index -Incidence and relationship of Medically Attended Adverse Event(s) (MAAEs), Adverse event(s) of Special Interest (AESIs), and Serious Adverse Event(s) (SAEs); Immunogenicity index- IgG antibody Anti-S expressed as geometric mean Elisa units GMEUs ("
Answered by AI
Who else is applying?
What site did they apply to?
Velocity Clinical Research, Chula Vista
Deland CRU
WR-MCCR
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
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