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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
Must not have
Chronic administration of immunosuppressant, systemic glucocorticoids, or other immune-modifying drugs within 90 days prior to study vaccination
Participants with a history of myocarditis or pericarditis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 0 to 180
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 50 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I haven't taken immune-suppressing drugs in the last 90 days.
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I have had myocarditis or pericarditis in the past.
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I am on treatment for an autoimmune disease or immunodeficiency.
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I have received a COVID-19 vaccine that is not a prototype or bivalent mRNA vaccine.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 0 to 180
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 0 to 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
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 study objectives
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 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
50 Previous Clinical Trials
113,690 Total Patients Enrolled
Clinical DevelopmentStudy DirectorNovavax
36 Previous Clinical Trials
86,665 Total Patients Enrolled

Media Library

NVX-CoV2373 (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05925127 — Phase 2 & 3
Coronavirus Research Study Groups: Group-G Bivalent XBB.1.5, Group-F Monovalent NVX-CoV2601 (50 μg), Group-B Monovalent NVX-CoV2601 (5 μg), Group-A Monovalent NVX-CoV2373 (5 μg), Group-E Monovalent NVX-CoV2601(35), Group-C Monovalent NVX-CoV2601 (5 μg), Group-D Monovalent NVX-CoV2601 (35 μg)
Coronavirus Clinical Trial 2023: NVX-CoV2373 Highlights & Side Effects. Trial Name: NCT05925127 — Phase 2 & 3
NVX-CoV2373 (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05925127 — Phase 2 & 3
~459 spots leftby Dec 2025
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