COVID-19Phase 2/3COVID-19NCT05925127
Phase 2/3 Heterologous Boosting Study With Different Dose Levels of Monovalent SARS-CoV-2 rS Vaccines
A Phase 2/3 study testing NVX-CoV2373 (5μg), NVX-CoV2601 (5μg) and NVX-CoV2601(5μg) in people with COVID-19, run by Novavax at 50 sites in United States.
Trial summary
This is a Phase 2/3, randomized, double-blind study to evaluate the safety and immunogenicity of different booster dose levels of the monovalent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) recombinant (r) spike (S) protein nanoparticle (SARS-CoV-2 rS) vaccines with Matrix-M™ adjuvant (NVX-CoV2373… Read more about this study
- Who is it for?
- Ages 50 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- NVX-CoV2373 (5μg), NVX-CoV2601 (5μg) and NVX-CoV2601(5μg)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 994 participants
- Where
- 50 sitesUnited States
- Study dates
- 16 Oct 2023to 21 May 2024
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults ≥ 50 years of age at screening.
- Willing and able to give informed consent prior to study enrollment and to comply with study procedures.
- 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.
- 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.
- Agrees to not participate in any other SARS-CoV-2 prevention or treatment trials for the duration of the study.
- 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.
Who cannot join
- Received COVID-19 vaccines other than a COVID-19 prototype or bivalent licensed mRNA vaccine in the past, inclusive of clinical trial COVID-19 vaccines.
- Participation in research involving receipt of investigational products (drug/biologic/device) within 90 days prior to study vaccination.
- Received influenza vaccination within 14 days prior to first study vaccination, or any other vaccine within 30 days prior to first study vaccination.
- 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.
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- 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.
Trial locations and contacts
50 sites in 1 country.
50 sites in 1 country
United States50 sites
Central Texas Clinical Research, LLC
Austin, Texas, 78705
Velocity Clinical Research, Banning
Banning, California, 99202
Velocity Clinical Research
Baton Rouge, Louisiana, 70809
Velocity Clinical Research
Binghamton, New York, 13905
ARS-Birmingham CRU
Birmingham, Alabama, 35216
Velocity Clinical Research, Chula Vista
Chula Vista, California, 91911
Velocity Clinical Research
Cincinnati, Ohio, 45219
Velocity Clinical Research
Cincinnati, Ohio, 45246
Velocity Clinical Research - Covington
Covington, Louisiana, 70433
Neurostudies CRU
Decatur, Georgia, 30030
Deland CRU
DeLand, Florida, 32720
Velocity Clinical Research, Providence
East Greenwich, Rhode Island, 02818
Tekton Research
Edmond, Oklahoma, 73013
Velocity Clinical Research, Gaffney
Gaffney, South Carolina, 29340
Velocity Clinical Research
Grand Island, Nebraska, 68803
Velocity Clinical Research, Grants Pass
Grants Pass, Oregon, 97527
Velocity Clinical Research, Gulfport
Gulfport, Mississippi, 39503
Health Awareness
Jupiter, Florida, 33458
Velocity Clinical Research, San Diego
La Mesa, California, 91942
Wr-Msra, Llc
Lake City, Florida, 32055
Professional Urgent Care Services
Largo, Florida, 33777
Velocity Clinical Research
Meridian, Idaho, 83642
Velocity Clinical Research, Metairie
Metairie, Louisiana, 70006
Activmed Practices and Research, LLC
Methuen, Massachusetts, 01844
Research Institute of South Florida
Miami, Florida, 33173
Suncoast Research Associates, LLC
Miami, Florida, 33173
Hypercore (Lucas Research)
New Bern, North Carolina, 28562
Health Research of Hampton Roads, Inc
Newport News, Virginia, 23606
Velocity Clinical Research
Norfolk, Nebraska, 68701
Coastal Carolina Research Center an ALCANZA Clinical Research company
North Charleston, South Carolina, 29405
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112
Velocity Clinical Research
Omaha, Nebraska, 68134
Headlands Research Orlando LLC
Orlando, Florida, 32819
Research Your Health
Plano, Texas, 75093
Activmed Practices and Research, LLC
Portsmouth, New Hampshire, 03801
M3 Wake Research Inc
Raleigh, North Carolina, 27612
Clinical Research Partners
Richmond, Virginia, 23226
Artemis Institute for Clinical Research
Riverside, California, 92503
Benchmark Research
San Angelo, Texas, 76904
Artemis - San Diego
San Diego, California, 92103
WR-MCCR
San Diego, California, 92120
Velocity Clinical Research
Savannah, Georgia, 31406
Velocity Clinical Research
Sioux City, Iowa, 51106
CRA Headlands LLC
Stockbridge, Georgia, 30281
Precision Clinical Research, LLC
Sunrise, Florida, 33351
TrueBlue Clinical Research
Tampa, Florida, 33609
Tucson Neuroscience Research
Tucson, Arizona, 85710
Velocity Clinical Research, Salt Lake City
West Jordan, Utah, 84088
Trial Management Associates, LLC
Wilmington, North Carolina, 28403
Javara Inc./Wake Forest Health Network, LLC
Winston-Salem, North Carolina, 27157
About this study
Official title: A Phase 2/3, Randomized, Double-Blind Study to Evaluate the Safety and Immunogenicity of Different Booster Dose Levels of Monovalent SARS-CoV-2 rS Vaccines in Adults ≥ 50 Years Previously Vaccinated With COVID-19 mRNA Vaccines
This is a Phase 2/3, randomized, double-blind study to evaluate the safety and immunogenicity of different booster dose levels of the monovalent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) recombinant (r) spike (S) protein nanoparticle (SARS-CoV-2 rS) vaccines with Matrix-M™ adjuvant (NVX-CoV2373 [prototype Wuhan vaccine with Matrix-M adjuvant] or NVX-CoV2601 [Omicron XBB.1.5 subvariant vaccine with Matrix-M adjuvant]).
Read the detailed description
The ongoing COVID-19 pandemic has reached a stage where it is necessary to stablish the framework for periodic national vaccination campaigns.The present study aims to investigate the safety and immunogenicity of different booster dose levels of monovalent and bivalent vaccines in adults ≥ 50 years of age who have already been immunized with ≥ 3 doses of a COVID-19 prototype or bivalent licensed mRNA vaccine. The Boosters of investigational products will be administered ≥ 90 days after the participants received their third dose of a COVID-19 prototype or bivalent licensed mRNA vaccine.
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
- COVID-19
- Being tested
- NVX-CoV2373 (5μg), NVX-CoV2601 (5μg), NVX-CoV2601(5μg), NVX-CoV2601 (35μg), NVX-CoV2601(35μg)
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NVX-CoV2373 (5μg)Biological
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)Biological
Also called Omicron XBB.1.5
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)Biological
Also called Omicron XBB.1.5
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)Biological
Also called Omicron XBB.1.5
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)Biological
Also called Omicron XBB.1.5
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)Biological
Also called Omicron XBB.1.5
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.4/5Biological
Also called Omicron Subvariant/Prototype Licensed mRNA Vaccine
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
| Study group | Role | What they receive |
|---|---|---|
| Group-A Monovalent NVX-CoV2373 (5 μg) | Experimental | The Monovalent NVX-CoV2601 of 5 μg of antigen with 50 μg of Matrix-M adjuvant Receives: Biological: NVX-CoV2373 (5μg) |
| Group-B Monovalent NVX-CoV2601 (5 μg) | Experimental | Monovalent NVX-CoV2601 (5 μg of antigen with 50 μg of Matrix-M adjuvant) Receives: Biological: NVX-CoV2601 (5μg) |
| Group-C Monovalent NVX-CoV2601 (5 μg) | Experimental | Monovalent NVX-CoV2601 (5 μg of antigen with 75 μg of Matrix-M adjuvant) Receives: Biological: NVX-CoV2601(5μg) |
| Group-D Monovalent NVX-CoV2601 (35 μg) | Experimental | Monovalent NVX-CoV2373 (35 μg of antigen with 50 μg of Matrix-M adjuvant) Receives: Biological: NVX-CoV2601 (35μg) |
| Group-E Monovalent NVX-CoV2601(35) | Experimental | Monovalent NVX-CoV2601 (35 μg of each antigen with a 75 μg of Matrix-M adjuvant) Receives: Biological: NVX-CoV2601(35μg) |
| Group-F Monovalent NVX-CoV2601 (50 μg) | Experimental | Monovalent NVX-CoV2601 (50 μg of each antigen with a 100 μg of Matrix-M adjuvant) Receives: Biological: NVX-CoV2601(50μg) |
| Group-G Bivalent XBB.1.5 | Experimental | Bivalent XBB.1.5 Omicron subvariant/prototype COVID-19 licensed mRNA vaccine Receives: Biological: Bivalent BA.4/5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenicity index-Neutralizing antibody expressed as geometric mean titer ratio[GMTR ]against the Omicron subvariant XBB.1.5
Neutralizing antibody To determine if the combination of antigen and adjuvant levels of NVX-CoV2601 GMTR against the Omicron subvariant XBB.1.5 superior(LB of the 95% CI for GMTR > 1.0) to that elicited by NVX-CoV2373
Measured: Day 28
Immunogenicity index-Neutralizing antibody expressed as seroresponse rates (SRRs)against the Omicron subvariant XBB.1.5
Neutralizing antibody SRR against the Omicron XBB.1.5 subvariant elicited by NVXCoV2601 is non-inferior (NI)to the SRR elicited by NVX-CoV2373in participants ≥ 50 years of age previously vaccinated with ≥ 3 doses of a COVID-19 prototype or bivalent licensed mRNA vaccine.
Measured: Day 28
Secondary outcomes (10)
Neutralizing antibody expressed as geometric mean titer ratio[GMTR ]against the Omicron subvariant XBB.1.5
Neutralizing antibody (GMTR) at relevant time points Days 28 to 180 from baseline (Day 0) and analyzed by dose (5, 10, and 25 µg)
Measured: Day 28
Immunogenicity index- IgG antibody Anti-S expressed as geometric mean Elisa units GMEUs (EU/mL)
Immunoglobulin G (IgG) antibody Anti-S expressed as geometric mean Elisa units GMEUs (EU/mL) at relevant time points (Days 0 to 180) and analyzed by dose (5, 10, and 25 µg)
Measured: Day 0 to 180
Immunogenicity index- Neutralizing antibody titers of post-booster by baseline anti-SARS-CoV-2 NP
Neutralizing antibody titers of post-booster by baseline anti-SARS-CoV-2 NP status day-28
Measured: Day-28
Immunogenicity index- Serum IgG levels to SARS-CoV-2 S protein at Day 28 of post-booster
Serum IgG levels to SARS-CoV-2 S protein at Day 28 post-booster by baseline anti-SARS-CoV-2 NP status.
Measured: Day-28
Safety Index-Incidence, duration, and severity of solicited local and systemic AEs expressed as GMT
Incidence, duration, and severity of solicited local and systemic AEs for 7 days following vaccination.
Measured: 7 days
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)
Incidence and relationship of Medically Attended Adverse Event(s) (MAAEs), Adverse event(s) of Special Interest (AESIs), and Serious Adverse Event(s) (SAEs) [ Time Frame: Day 0 to Day 180 ] Incidence and relationship of MAAEs, AESIs (predefined list), and SAEs throughout the study
Measured: Day 0 to 180
Safety Index -Incidence, Severity, and relationship of unsolicitated Adverse Event(s) Through 28 days after vaccination by vaccine group p(vaccine groups A to G).
Incidence, Severity, and relationship of unsolicitated Adverse Event(s) Through 28 days after vaccination by vaccine group p(vaccine groups A to G).s the overall safety of single-dose regimens containing NVX-CoV2601, NVX-CoV2373, or mRNA vaccine by vaccine group in participants ≥ 50 years of age previously vaccinated with ≥ 3 doses of a COVID-19 prototype or bivalentlicensed mRNA vaccine.
Measured: Day 0 to 180
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
hACE2 receptor binding inhibition assay to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 viruses at relevant time points (Days 0, 28, and 180) and analyzed by dose (5, 10, and 25 µg)
Measured: Day 0 to 180
hACE2 receptor binding inhibition assay to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 viruses expressed as GMFR
hACE2 receptor binding inhibition assay to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 viruses at relevant time points (Days 0, 28, and 180) and analyzed by dose (5, 10, and 25 µg).
Measured: Day 0 to 180
hACE2 receptor binding inhibition assay to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 S proteins expressed as SRR
hACE2 receptor binding inhibition assay to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 S proteins at relevant time points (Days 0, 28, and 180)and analyzed by previous vaccine combination received. Derived/calculated endpoints based on these data will include SRRs.
Measured: Day 0 to 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2023
- Study start16 Oct 2023
- Primary completion21 May 2024
- Study completion21 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 994 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novavax
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Development, Study director, Novavax
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05925127
- Sponsor's protocol ID
- 2019nCoV-205
- Acronym
- COVID-19
- Status last verified
- Dec 2024
- First submitted
- 27 Jun 2023
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2/3, Randomized, Double-Blind Study to Evaluate the Safety and Immunogenicity of Different Booster Dose Levels of Monovalent SARS-CoV-2 rS Vaccines in Adults ≥ 50 Years Previously Vaccinated With COVID-19 mRNA Vaccines
- ClinicalTrials.gov ID
- NCT05925127
- Acronym / sponsor ID
- COVID-19 / 2019nCoV-205
- Conditions
- COVID-19
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 994 participants (actual)
- Lead sponsor
- NovavaxIndustry (pharma, biotech, devices)
- Study start
- 16 Oct 2023 (actual)
- Primary completion
- 21 May 2024 (actual)
- Study completion
- 21 May 2024 (actual)
- First posted
- 29 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 2/3, randomized, double-blind study to evaluate the safety and immunogenicity of different booster dose levels of the monovalent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) recombinant (r) spike (S) protein nanoparticle (SARS-CoV-2 rS) vaccines with Matrix-M™ adjuvant (NVX-CoV2373 [prototype Wuhan vaccine with Matrix-M adjuvant] or NVX-CoV2601 [Omicron XBB.1.5 subvariant vaccine with Matrix-M adjuvant]).
Detailed description
The ongoing COVID-19 pandemic has reached a stage where it is necessary to stablish the framework for periodic national vaccination campaigns.The present study aims to investigate the safety and immunogenicity of different booster dose levels of monovalent and bivalent vaccines in adults ≥ 50 years of age who have already been immunized with ≥ 3 doses of a COVID-19 prototype or bivalent licensed mRNA vaccine. The Boosters of investigational products will be administered ≥ 90 days after the participants received their third dose of a COVID-19 prototype or bivalent licensed mRNA vaccine.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Group-A Monovalent NVX-CoV2373 (5 μg) | Experimental | Biological: NVX-CoV2373 (5μg)The Monovalent NVX-CoV2601 of 5 μg of antigen with 50 μg of Matrix-M adjuvant |
| Group-B Monovalent NVX-CoV2601 (5 μg) | Experimental | Biological: NVX-CoV2601 (5μg)Monovalent NVX-CoV2601 (5 μg of antigen with 50 μg of Matrix-M adjuvant) |
| Group-C Monovalent NVX-CoV2601 (5 μg) | Experimental | Biological: NVX-CoV2601(5μg)Monovalent NVX-CoV2601 (5 μg of antigen with 75 μg of Matrix-M adjuvant) |
| Group-D Monovalent NVX-CoV2601 (35 μg) | Experimental | Biological: NVX-CoV2601 (35μg)Monovalent NVX-CoV2373 (35 μg of antigen with 50 μg of Matrix-M adjuvant) |
| Group-E Monovalent NVX-CoV2601(35) | Experimental | Biological: NVX-CoV2601(35μg)Monovalent NVX-CoV2601 (35 μg of each antigen with a 75 μg of Matrix-M adjuvant) |
| Group-F Monovalent NVX-CoV2601 (50 μg) | Experimental | Biological: NVX-CoV2601(50μg)Monovalent NVX-CoV2601 (50 μg of each antigen with a 100 μg of Matrix-M adjuvant) |
| Group-G Bivalent XBB.1.5 | Experimental | Biological: Bivalent BA.4/5Bivalent XBB.1.5 Omicron subvariant/prototype COVID-19 licensed mRNA vaccine |
Who may qualify
- Ages
- 50 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults ≥ 50 years of age at screening.
- Willing and able to give informed consent prior to study enrollment and to comply with study procedures.
- 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.
- 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.
- Agrees to not participate in any other SARS-CoV-2 prevention or treatment trials for the duration of the study.
Key exclusion criteria (13 listed)
- Received COVID-19 vaccines other than a COVID-19 prototype or bivalent licensed mRNA vaccine in the past, inclusive of clinical trial COVID-19 vaccines.
- Participation in research involving receipt of investigational products (drug/biologic/device) within 90 days prior to study vaccination.
- Received influenza vaccination within 14 days prior to first study vaccination, or any other vaccine within 30 days prior to first study vaccination.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Biological | Group-A Monovalent NVX-CoV2373 (5 μg) |
| NVX-CoV2601 (5μg)Also: Omicron XBB.1.5The vaccination regimen will comprise one IM injection on Day 0 at a dose of 5 µg of antigen with 50 µg Matrix-M adjuvant. | Biological | Group-B Monovalent NVX-CoV2601 (5 μg) |
| NVX-CoV2601(5μg)Also: Omicron XBB.1.5The vaccination regimen will comprise one IM injection on Day 0 at a dose of 5 µg of antigen with 75 µg Matrix-M adjuvant. | Biological | Group-C Monovalent NVX-CoV2601 (5 μg) |
| NVX-CoV2601 (35μg)Also: Omicron XBB.1.5The vaccination regimen will comprise one IM injection on Day 0 at a dose of 35 µg of antigen with 50 µg Matrix-M adjuvant. | Biological | Group-D Monovalent NVX-CoV2601 (35 μg) |
| NVX-CoV2601(35μg)Also: Omicron XBB.1.5The vaccination regimen will comprise one IM injection on Day 0 at a dose of 35 µg of antigen with 75 µg Matrix-M adjuvant. | Biological | Group-E Monovalent NVX-CoV2601(35) |
| NVX-CoV2601(50μg)Also: Omicron XBB.1.5The vaccination regimen will comprise one IM injection on Day 0 at a dose of 50 µg of antigen with 100 µg Matrix-M adjuvant | Biological | Group-F Monovalent NVX-CoV2601 (50 μg) |
| Bivalent BA.4/5Also: Omicron Subvariant/Prototype Licensed mRNA VaccineThe 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 | Biological | Group-G Bivalent XBB.1.5 |
Primary outcome
Immunogenicity index-Neutralizing antibody expressed as geometric mean titer ratio[GMTR ]against the Omicron subvariant XBB.1.5
Time frame: Day 28
Neutralizing antibody To determine if the combination of antigen and adjuvant levels of NVX-CoV2601 GMTR against the Omicron subvariant XBB.1.5 superior(LB of the 95% CI for GMTR > 1.0) to that elicited by NVX-CoV2373
Immunogenicity index-Neutralizing antibody expressed as seroresponse rates (SRRs)against the Omicron subvariant XBB.1.5
Time frame: Day 28
Neutralizing antibody SRR against the Omicron XBB.1.5 subvariant elicited by NVXCoV2601 is non-inferior (NI)to the SRR elicited by NVX-CoV2373in participants ≥ 50 years of age previously vaccinated with ≥ 3 doses of a COVID-19 prototype or bivalent licensed mRNA vaccine.
10 secondary outcomes
Neutralizing antibody expressed as geometric mean titer ratio[GMTR ]against the Omicron subvariant XBB.1.5
Time frame: Day 28
Immunogenicity index- IgG antibody Anti-S expressed as geometric mean Elisa units GMEUs (EU/mL)
Time frame: Day 0 to 180
Immunogenicity index- Neutralizing antibody titers of post-booster by baseline anti-SARS-CoV-2 NP
Time frame: Day-28
Immunogenicity index- Serum IgG levels to SARS-CoV-2 S protein at Day 28 of post-booster
Time frame: Day-28
Safety Index-Incidence, duration, and severity of solicited local and systemic AEs expressed as GMT
Time frame: 7 days
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)
Time frame: Day 0 to 180
Safety Index -Incidence, Severity, and relationship of unsolicitated Adverse Event(s) Through 28 days after vaccination by vaccine group p(vaccine groups A to G).
Time frame: Day 0 to 180
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
Time frame: Day 0 to 180
hACE2 receptor binding inhibition assay to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 viruses expressed as GMFR
Time frame: Day 0 to 180
hACE2 receptor binding inhibition assay to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 S proteins expressed as SRR
Time frame: Day 0 to 180
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Development study director
Novavax
50 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing NVX-CoV2373 (5μg), NVX-CoV2601 (5μg) and NVX-CoV2601(5μg) in people with COVID-19, run by Novavax at 50 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immunogenicity index-Neutralizing antibody expressed as geometric mean titer ratio[GMTR ]against the Omicron subvariant XBB.1.5 (time frame: Day 28). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2024.