Phase 2/3 Heterologous Boosting Study With Different Dose Levels of Monovalent SARS-CoV-2 rS Vaccines
NCT ID: NCT05925127
Last Updated: 2024-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
994 participants
INTERVENTIONAL
2023-10-16
2024-05-21
Brief Summary
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Detailed Description
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Approximately 1,980 participants ≥ 50 years of age who have received a regimen of ≥ 3 doses of a coronavirus disease 2019(COVID-19) vaccine (the last vaccine could have been a bivalent licensed mRNA vaccine) will be included in this study. The last COVID-19 vaccine dose should have been administered ≥ 90 days prior to Day 0.
Approximately 1,800 participants will be randomly assigned in a 1:2:2:2:2:1 ratio to receive NVX-CoV2373 or NVC-CoV2601 in a double-blinded fashion into 1 of 6 monovalent vaccine groups (vaccine groups A to G). Following completion of enrollment into the 6 monovalent vaccine groups, 180 participants will be enrolled in vaccine group G to receive a bivalent licensed mRNA vaccine in an open-label fashion.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
DOUBLE
Study Groups
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Group-A Monovalent NVX-CoV2373 (5 μg)
The Monovalent NVX-CoV2601 of 5 μg of antigen with 50 μg of Matrix-M adjuvant
NVX-CoV2373 (5μg)
Coformulated prototype SARS-CoV-2 rS vaccine with Matrix-M adjuvant: supplied as a solution for preparation for injection, at a concentration of 10 μg/mL and 100 μg adjuvant per mL, respectively
Group-B Monovalent NVX-CoV2601 (5 μg)
Monovalent NVX-CoV2601 (5 μg of antigen with 50 μg of Matrix-M adjuvant)
NVX-CoV2601 (5μg)
The vaccination regimen will comprise one IM injection on Day 0 at a dose of 5 µg of antigen with 50 µg Matrix-M adjuvant.
Group-C Monovalent NVX-CoV2601 (5 μg)
Monovalent NVX-CoV2601 (5 μg of antigen with 75 μg of Matrix-M adjuvant)
NVX-CoV2601(5μg)
The vaccination regimen will comprise one IM injection on Day 0 at a dose of 5 µg of antigen with 75 µg Matrix-M adjuvant.
Group-D Monovalent NVX-CoV2601 (35 μg)
Monovalent NVX-CoV2373 (35 μg of antigen with 50 μg of Matrix-M adjuvant)
NVX-CoV2601 (35μg)
The vaccination regimen will comprise one IM injection on Day 0 at a dose of 35 µg of antigen with 50 µg Matrix-M adjuvant.
Group-E Monovalent NVX-CoV2601(35)
Monovalent NVX-CoV2601 (35 μg of each antigen with a 75 μg of Matrix-M adjuvant)
NVX-CoV2601(35μg)
The vaccination regimen will comprise one IM injection on Day 0 at a dose of 35 µg of antigen with 75 µg Matrix-M adjuvant.
Group-F Monovalent NVX-CoV2601 (50 μg)
Monovalent NVX-CoV2601 (50 μg of each antigen with a 100 μg of Matrix-M adjuvant)
NVX-CoV2601(50μg)
The vaccination regimen will comprise one IM injection on Day 0 at a dose of 50 µg of antigen with 100 µg Matrix-M adjuvant
Group-G Bivalent XBB.1.5
Bivalent XBB.1.5 Omicron subvariant/prototype COVID-19 licensed mRNA vaccine
Bivalent BA.4/5
The bivalent BA.4/5 (or recommended mRNA vaccine at the time of the conduct of this study) Omicron subvariant/prototype licensed mRNA vaccine will be procured and stored per the manufacturer's instructions. For this vaccine group, treatment will be administered open label as a single IM injection
Interventions
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NVX-CoV2373 (5μg)
Coformulated prototype SARS-CoV-2 rS vaccine with Matrix-M adjuvant: supplied as a solution for preparation for injection, at a concentration of 10 μg/mL and 100 μg adjuvant per mL, respectively
NVX-CoV2601 (5μg)
The vaccination regimen will comprise one IM injection on Day 0 at a dose of 5 µg of antigen with 50 µg Matrix-M adjuvant.
NVX-CoV2601(5μg)
The vaccination regimen will comprise one IM injection on Day 0 at a dose of 5 µg of antigen with 75 µg Matrix-M adjuvant.
NVX-CoV2601 (35μg)
The vaccination regimen will comprise one IM injection on Day 0 at a dose of 35 µg of antigen with 50 µg Matrix-M adjuvant.
NVX-CoV2601(35μg)
The vaccination regimen will comprise one IM injection on Day 0 at a dose of 35 µg of antigen with 75 µg Matrix-M adjuvant.
NVX-CoV2601(50μg)
The vaccination regimen will comprise one IM injection on Day 0 at a dose of 50 µg of antigen with 100 µg Matrix-M adjuvant
Bivalent BA.4/5
The bivalent BA.4/5 (or recommended mRNA vaccine at the time of the conduct of this study) Omicron subvariant/prototype licensed mRNA vaccine will be procured and stored per the manufacturer's instructions. For this vaccine group, treatment will be administered open label as a single IM injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Willing and able to give informed consent prior to study enrollment and to comply with study procedures.
3. Female participants of childbearing potential (defined as any participant who has experienced menarche and who is NOT surgically sterile \[ie, hysterectomy, bilateral tubal ligation, or bilateral oophorectomy\] or postmenopausal \[defined as amenorrhea ≥ 12 consecutive months\]) must agree to be heterosexually inactive from at least 28 days prior to enrollment and through the end of the study OR agree to consistently use a medically acceptable method of contraception listed below from ≥ 28 days prior to enrollment and through the end of the study.
4. Is medically stable, as determined by the investigator (based on review of health status, vital signs \[to include body temperature\], medical history, and targeted physical examination \[to include body weight\]). Vital signs must be within medically acceptable ranges prior to the initial study vaccination.
5. Agrees to not participate in any other SARS-CoV-2 prevention or treatment trials for the duration of the study.
6. Have previously received ≥ 3 doses of a COVID-19 prototype or bivalent licensed mRNAvaccine with the last dose having been given ≥ 90 days previously prior to first study booster.
Exclusion Criteria
2. Participation in research involving receipt of investigational products (drug/biologic/device) within 90 days prior to study vaccination.
3. Received influenza vaccination within 14 days prior to first study vaccination, or any other vaccine within 30 days prior to first study vaccination.
4. Any known allergies to products contained in the investigational product. 5. Any history of anaphylaxis to any prior vaccine.
6\. Autoimmune or immunodeficiency disease/condition (iatrogenic or congenital) requiring ongoing immunomodulatory therapy.
7\. Chronic administration (defined as \> 14 continuous days) of immunosuppressant, systemic glucocorticoids, or other immune-modifying drugs within 90 days prior to study vaccination. NOTE: An immunosuppressant dose of glucocorticoid is defined as a systemic dose ≥ 10 mg of prednisone per day or equivalent. The use of topical or intranasal glucocorticoids is permitted. Topical tacrolimus and ocular cyclosporin are permitted. Use of inhaled glucocorticoids is prohibited.
8\. Received immunoglobulin, blood-derived products, or immunosuppressant drugs within 90 days prior to study vaccination, except for rabies immunoglobulin which may be given if medically indicated.
9\. Active cancer (malignancy) on therapy within 3 years prior to study vaccination (with the exception of adequately treated non-melanomatous skin carcinoma or lentigo maligna and uterine cervical carcinoma in situ without evidence of disease, at the discretion of the investigator).
10\. Participants who are breastfeeding, pregnant, or who plan to become pregnant prior to the end of study.
11\. Suspected or known history of alcohol abuse or drug addiction within 2 years prior to the study vaccine dose that, in the opinion of the investigator, might interfere with protocol compliance.
12\. Any other condition that, in the opinion of the investigator, would pose a health risk to the participant if enrolled or could interfere with evaluation of the study vaccine or interpretation of study results (including neurologic or psychiatric conditions likely to impair the quality of safety reporting).
13\. Study team member or immediate family member of any study team member (inclusive of Sponsor, contract research organization (CRO), and study site personnel involved in the conduct or planning of the study).
14\. Participants with a history of myocarditis or pericarditis.
50 Years
99 Years
ALL
Yes
Sponsors
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Novavax
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Development
Role: STUDY_DIRECTOR
Novavax
Locations
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ARS-Birmingham CRU
Birmingham, Alabama, United States
Tucson Neuroscience Research
Tucson, Arizona, United States
Velocity Clinical Research, Banning
Banning, California, United States
Velocity Clinical Research, Chula Vista
Chula Vista, California, United States
Velocity Clinical Research, San Diego
La Mesa, California, United States
Artemis Institute for Clinical Research
Riverside, California, United States
Artemis - San Diego
San Diego, California, United States
WR-MCCR
San Diego, California, United States
Deland CRU
DeLand, Florida, United States
Health Awareness
Jupiter, Florida, United States
Wr-Msra, Llc
Lake City, Florida, United States
Professional Urgent Care Services
Largo, Florida, United States
Research Institute of South Florida
Miami, Florida, United States
Suncoast Research Associates, LLC
Miami, Florida, United States
Headlands Research Orlando LLC
Orlando, Florida, United States
Precision Clinical Research, LLC
Sunrise, Florida, United States
TrueBlue Clinical Research
Tampa, Florida, United States
Neurostudies CRU
Decatur, Georgia, United States
Velocity Clinical Research
Savannah, Georgia, United States
CRA Headlands LLC
Stockbridge, Georgia, United States
Velocity Clinical Research
Meridian, Idaho, United States
Velocity Clinical Research
Sioux City, Iowa, United States
Velocity Clinical Research
Baton Rouge, Louisiana, United States
Velocity Clinical Research - Covington
Covington, Louisiana, United States
Velocity Clinical Research, Metairie
Metairie, Louisiana, United States
Activmed Practices and Research, LLC
Methuen, Massachusetts, United States
Velocity Clinical Research, Gulfport
Gulfport, Mississippi, United States
Velocity Clinical Research
Grand Island, Nebraska, United States
Velocity Clinical Research
Norfolk, Nebraska, United States
Velocity Clinical Research
Omaha, Nebraska, United States
Activmed Practices and Research, LLC
Portsmouth, New Hampshire, United States
Velocity Clinical Research
Binghamton, New York, United States
Hypercore (Lucas Research)
New Bern, North Carolina, United States
M3 Wake Research Inc
Raleigh, North Carolina, United States
Trial Management Associates, LLC
Wilmington, North Carolina, United States
Javara Inc./Wake Forest Health Network, LLC
Winston-Salem, North Carolina, United States
Velocity Clinical Research
Cincinnati, Ohio, United States
Velocity Clinical Research
Cincinnati, Ohio, United States
Tekton Research
Edmond, Oklahoma, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States
Velocity Clinical Research, Grants Pass
Grants Pass, Oregon, United States
Velocity Clinical Research, Providence
East Greenwich, Rhode Island, United States
Velocity Clinical Research, Gaffney
Gaffney, South Carolina, United States
Coastal Carolina Research Center an ALCANZA Clinical Research company
North Charleston, South Carolina, United States
Central Texas Clinical Research, LLC
Austin, Texas, United States
Research Your Health
Plano, Texas, United States
Benchmark Research
San Angelo, Texas, United States
Velocity Clinical Research, Salt Lake City
West Jordan, Utah, United States
Health Research of Hampton Roads, Inc
Newport News, Virginia, United States
Clinical Research Partners
Richmond, Virginia, United States
Countries
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Other Identifiers
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2019nCoV-205
Identifier Type: -
Identifier Source: org_study_id