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Phase 2/3 Heterologous Boosting Study With Different Dose Levels of Monovalent SARS-CoV-2 rS Vaccines (COVID-19)

Primary Purpose

COVID-19

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
NVX-CoV2373 (5μg)
NVX-CoV2601 (5μg)
NVX-CoV2601(5μg)
NVX-CoV2601 (35μg)
NVX-CoV2601(35μg)
NVX-CoV2601(50μg)
Bivalent BA.4/5
Sponsored by
Novavax
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for COVID-19

Eligibility Criteria

50 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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. 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.

Sites / Locations

  • ARS-Birmingham CRURecruiting
  • Tucson Neuroscience ResearchRecruiting
  • Velocity Clinical Research, BanningRecruiting
  • Velocity Clinical Research, Chula VistaRecruiting
  • Velocity Clinical Research, San DiegoRecruiting
  • Artemis Institute for Clinical ResearchRecruiting
  • Artemis - San DiegoRecruiting
  • WR-MCCRRecruiting
  • Deland CRURecruiting
  • Health AwarenessRecruiting
  • Wr-Msra, LlcRecruiting
  • Professional Urgent Care ServicesRecruiting
  • Research Institute of South FloridaRecruiting
  • Suncoast Research Associates, LLCRecruiting
  • Headlands Research Orlando LLCRecruiting
  • Precision Clinical Research, LLCRecruiting
  • TrueBlue Clinical ResearchRecruiting
  • Neurostudies CRURecruiting
  • Velocity Clinical ResearchRecruiting
  • CRA Headlands LLCRecruiting
  • Velocity Clinical ResearchRecruiting
  • Velocity Clinical ResearchRecruiting
  • Velocity Clinical ResearchRecruiting
  • Velocity Clinical Research - CovingtonRecruiting
  • Velocity Clinical Research, MetairieRecruiting
  • Activmed Practices and Research, LLCRecruiting
  • Velocity Clinical Research, GulfportRecruiting
  • Velocity Clinical ResearchRecruiting
  • Velocity Clinical ResearchRecruiting
  • Velocity Clinical ResearchRecruiting
  • Activmed Practices and Research, LLCRecruiting
  • Velocity Clinical ResearchRecruiting
  • Hypercore (Lucas Research)Recruiting
  • M3 Wake Research IncRecruiting
  • Trial Management Associates, LLCRecruiting
  • Javara Inc./Wake Forest Health Network, LLCRecruiting
  • Velocity Clinical ResearchRecruiting
  • Velocity Clinical ResearchRecruiting
  • Tekton ResearchRecruiting
  • Lynn Health Science InstituteRecruiting
  • Velocity Clinical Research, Grants PassRecruiting
  • Velocity Clinical Research, ProvidenceRecruiting
  • Velocity Clinical Research, GaffneyRecruiting
  • Coastal Carolina Research Center an ALCANZA Clinical Research companyRecruiting
  • Central Texas Clinical Research, LLCRecruiting
  • Research Your HealthRecruiting
  • Benchmark ResearchRecruiting
  • Velocity Clinical Research, Salt Lake CityRecruiting
  • Health Research of Hampton Roads, IncRecruiting
  • Clinical Research PartnersRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Group-A Monovalent NVX-CoV2373 (5 μg)

Group-B Monovalent NVX-CoV2601 (5 μg)

Group-C Monovalent NVX-CoV2601 (5 μg)

Group-D Monovalent NVX-CoV2601 (35 μg)

Group-E Monovalent NVX-CoV2601(35)

Group-F Monovalent NVX-CoV2601 (50 μg)

Group-G Bivalent XBB.1.5

Arm Description

The Monovalent NVX-CoV2601 of 5 μg of antigen with 50 μg of Matrix-M adjuvant

Monovalent NVX-CoV2601 (5 μg of antigen with 50 μg of Matrix-M adjuvant)

Monovalent NVX-CoV2601 (5 μg of antigen with 75 μg of Matrix-M adjuvant)

Monovalent NVX-CoV2373 (35 μg of antigen with 50 μg of Matrix-M adjuvant)

Monovalent NVX-CoV2601 (35 μg of each antigen with a 75 μg of Matrix-M adjuvant)

Monovalent NVX-CoV2601 (50 μg of each antigen with a 100 μg of Matrix-M adjuvant)

Bivalent XBB.1.5 Omicron subvariant/prototype COVID-19 licensed mRNA vaccine

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

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)
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)
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
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.
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.
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
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.
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)
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).
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.

Full Information

First Posted
June 27, 2023
Last Updated
October 18, 2023
Sponsor
Novavax
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1. Study Identification

Unique Protocol Identification Number
NCT05925127
Brief Title
Phase 2/3 Heterologous Boosting Study With Different Dose Levels of Monovalent SARS-CoV-2 rS Vaccines
Acronym
COVID-19
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 16, 2023 (Actual)
Primary Completion Date
May 23, 2024 (Anticipated)
Study Completion Date
November 14, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novavax

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief 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 [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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1980 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group-A Monovalent NVX-CoV2373 (5 μg)
Arm Type
Experimental
Arm Description
The Monovalent NVX-CoV2601 of 5 μg of antigen with 50 μg of Matrix-M adjuvant
Arm Title
Group-B Monovalent NVX-CoV2601 (5 μg)
Arm Type
Experimental
Arm Description
Monovalent NVX-CoV2601 (5 μg of antigen with 50 μg of Matrix-M adjuvant)
Arm Title
Group-C Monovalent NVX-CoV2601 (5 μg)
Arm Type
Experimental
Arm Description
Monovalent NVX-CoV2601 (5 μg of antigen with 75 μg of Matrix-M adjuvant)
Arm Title
Group-D Monovalent NVX-CoV2601 (35 μg)
Arm Type
Experimental
Arm Description
Monovalent NVX-CoV2373 (35 μg of antigen with 50 μg of Matrix-M adjuvant)
Arm Title
Group-E Monovalent NVX-CoV2601(35)
Arm Type
Experimental
Arm Description
Monovalent NVX-CoV2601 (35 μg of each antigen with a 75 μg of Matrix-M adjuvant)
Arm Title
Group-F Monovalent NVX-CoV2601 (50 μg)
Arm Type
Experimental
Arm Description
Monovalent NVX-CoV2601 (50 μg of each antigen with a 100 μg of Matrix-M adjuvant)
Arm Title
Group-G Bivalent XBB.1.5
Arm Type
Experimental
Arm Description
Bivalent XBB.1.5 Omicron subvariant/prototype COVID-19 licensed mRNA vaccine
Intervention Type
Biological
Intervention Name(s)
NVX-CoV2373 (5μg)
Intervention Description
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
Intervention Type
Biological
Intervention Name(s)
NVX-CoV2601 (5μg)
Other Intervention Name(s)
Omicron XBB.1.5
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
NVX-CoV2601(5μg)
Other Intervention Name(s)
Omicron XBB.1.5
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
NVX-CoV2601 (35μg)
Other Intervention Name(s)
Omicron XBB.1.5
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
NVX-CoV2601(35μg)
Other Intervention Name(s)
Omicron XBB.1.5
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
NVX-CoV2601(50μg)
Other Intervention Name(s)
Omicron XBB.1.5
Intervention Description
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
Intervention Type
Biological
Intervention Name(s)
Bivalent BA.4/5
Other Intervention Name(s)
Omicron Subvariant/Prototype Licensed mRNA Vaccine
Intervention Description
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
Primary Outcome Measure Information:
Title
Immunogenicity index-Neutralizing antibody expressed as geometric mean titer ratio[GMTR ]against the Omicron subvariant XBB.1.5
Description
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
Time Frame
Day 28
Title
Immunogenicity index-Neutralizing antibody expressed as seroresponse rates (SRRs)against the Omicron subvariant XBB.1.5
Description
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.
Time Frame
Day 28
Secondary Outcome Measure Information:
Title
Neutralizing antibody expressed as geometric mean titer ratio[GMTR ]against the Omicron subvariant XBB.1.5
Description
Neutralizing antibody (GMTR) at relevant time points Days 28 to 180 from baseline (Day 0) and analyzed by dose (5, 10, and 25 µg)
Time Frame
Day 28
Title
Immunogenicity index- IgG antibody Anti-S expressed as geometric mean Elisa units GMEUs (EU/mL)
Description
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)
Time Frame
Day 0 to 180
Title
Immunogenicity index- Neutralizing antibody titers of post-booster by baseline anti-SARS-CoV-2 NP
Description
Neutralizing antibody titers of post-booster by baseline anti-SARS-CoV-2 NP status day-28
Time Frame
Day-28
Title
Immunogenicity index- Serum IgG levels to SARS-CoV-2 S protein at Day 28 of post-booster
Description
Serum IgG levels to SARS-CoV-2 S protein at Day 28 post-booster by baseline anti-SARS-CoV-2 NP status.
Time Frame
Day-28
Title
Safety Index-Incidence, duration, and severity of solicited local and systemic AEs expressed as GMT
Description
Incidence, duration, and severity of solicited local and systemic AEs for 7 days following vaccination.
Time Frame
7 days
Title
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)
Description
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
Time Frame
Day 0 to 180
Title
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).
Description
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.
Time Frame
Day 0 to 180
Title
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
Description
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)
Time Frame
Day 0 to 180
Title
hACE2 receptor binding inhibition assay to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 viruses expressed as GMFR
Description
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).
Time Frame
Day 0 to 180
Title
hACE2 receptor binding inhibition assay to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 S proteins expressed as SRR
Description
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.
Time Frame
Day 0 to 180

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Novavax Customer Service Center
Phone
1-844-Novavax (668-2829)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Development
Organizational Affiliation
Novavax
Official's Role
Study Director
Facility Information:
Facility Name
ARS-Birmingham CRU
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35216
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hayes Williams
Phone
205-757-8212
First Name & Middle Initial & Last Name & Degree
Hayes Williams
Facility Name
Tucson Neuroscience Research
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Mutterperl
Phone
520-230-1373
First Name & Middle Initial & Last Name & Degree
Robert Mutterperl
Facility Name
Velocity Clinical Research, Banning
City
Banning
State/Province
California
ZIP/Postal Code
99202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Judith Kirstein
Phone
951-755-0223
First Name & Middle Initial & Last Name & Degree
Judith Kirstein
Facility Name
Velocity Clinical Research, Chula Vista
City
Chula Vista
State/Province
California
ZIP/Postal Code
91911
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Waters
Phone
619-955-5246
First Name & Middle Initial & Last Name & Degree
Michael Waters
Facility Name
Velocity Clinical Research, San Diego
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
J. Scott Overcash
Phone
619-567-1550
First Name & Middle Initial & Last Name & Degree
J. Scott Overcash
Facility Name
Artemis Institute for Clinical Research
City
Riverside
State/Province
California
ZIP/Postal Code
92503
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jack Vu
Phone
951-374-1190
First Name & Middle Initial & Last Name & Degree
Jack Vu
Facility Name
Artemis - San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Johnson
Phone
619-202-4562
First Name & Middle Initial & Last Name & Degree
Daniel Johnson
Facility Name
WR-MCCR
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Todd Simmons
Phone
619-521-2830
First Name & Middle Initial & Last Name & Degree
Todd Simmons
Facility Name
Deland CRU
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bruce Rankin
Phone
386-785-2400
Ext
373
First Name & Middle Initial & Last Name & Degree
Bruce Rankin
Facility Name
Health Awareness
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ronald Surowitz
Phone
561-741-2033
First Name & Middle Initial & Last Name & Degree
Ronald Surowitz
Facility Name
Wr-Msra, Llc
City
Lake City
State/Province
Florida
ZIP/Postal Code
32055
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guy Strauss
Phone
386-438-8977
First Name & Middle Initial & Last Name & Degree
Guy Strauss
Facility Name
Professional Urgent Care Services
City
Largo
State/Province
Florida
ZIP/Postal Code
33777
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hiten Upadhyay
Phone
727-347-8839
First Name & Middle Initial & Last Name & Degree
Hiten Upadhyay
Facility Name
Research Institute of South Florida
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roberto Sotolongo
Phone
305-279-3545
First Name & Middle Initial & Last Name & Degree
Roberto Sotolongo
Facility Name
Suncoast Research Associates, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jorge Caso
Phone
786-623-3135
First Name & Middle Initial & Last Name & Degree
Jorge Caso
Facility Name
Headlands Research Orlando LLC
City
Orlando
State/Province
Florida
ZIP/Postal Code
32819
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher Galloway
Phone
407-705-3471
First Name & Middle Initial & Last Name & Degree
Christopher Galloway
Facility Name
Precision Clinical Research, LLC
City
Sunrise
State/Province
Florida
ZIP/Postal Code
33351
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jason Haffizulla
Phone
954-915-9991
First Name & Middle Initial & Last Name & Degree
Jason Haffizulla
Facility Name
TrueBlue Clinical Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julian Melamed
Phone
813-948-7550
First Name & Middle Initial & Last Name & Degree
Julian Melamed
Facility Name
Neurostudies CRU
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marshall Nash
Phone
404-475-0552
First Name & Middle Initial & Last Name & Degree
Marshall Nash
Facility Name
Velocity Clinical Research
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul Bradley
Phone
912-443-4253
First Name & Middle Initial & Last Name & Degree
Paul Bradley
Facility Name
CRA Headlands LLC
City
Stockbridge
State/Province
Georgia
ZIP/Postal Code
30281
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jon Finley
Phone
770-507-6867
First Name & Middle Initial & Last Name & Degree
Jon Finley
Facility Name
Velocity Clinical Research
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Turner
Phone
208-370-2292
First Name & Middle Initial & Last Name & Degree
Mark Turner
Facility Name
Velocity Clinical Research
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Ensz
Phone
712-639-6300
First Name & Middle Initial & Last Name & Degree
David Ensz
Facility Name
Velocity Clinical Research
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katherine Pearce
Phone
225-900-7739
First Name & Middle Initial & Last Name & Degree
Katherine Pearce
Facility Name
Velocity Clinical Research - Covington
City
Covington
State/Province
Louisiana
ZIP/Postal Code
70433
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
William Beacham
Phone
985-273-0855
First Name & Middle Initial & Last Name & Degree
William Beacham
Facility Name
Velocity Clinical Research, Metairie
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Scott Striplin
Phone
504-304-7191
First Name & Middle Initial & Last Name & Degree
Scott Striplin
Facility Name
Activmed Practices and Research, LLC
City
Methuen
State/Province
Massachusetts
ZIP/Postal Code
01844
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael McCartney
Phone
978-655-7155
First Name & Middle Initial & Last Name & Degree
Michael McCartney
Facility Name
Velocity Clinical Research, Gulfport
City
Gulfport
State/Province
Mississippi
ZIP/Postal Code
39503
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul Matherne
Phone
228-206-1283
First Name & Middle Initial & Last Name & Degree
Paul Matherne
Facility Name
Velocity Clinical Research
City
Grand Island
State/Province
Nebraska
ZIP/Postal Code
68803
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adam Brosz
Phone
308-365-8900
First Name & Middle Initial & Last Name & Degree
Adam Brosz
Facility Name
Velocity Clinical Research
City
Norfolk
State/Province
Nebraska
ZIP/Postal Code
68701
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charles Harper
Phone
402-371-0797
First Name & Middle Initial & Last Name & Degree
Charles Harper
Facility Name
Velocity Clinical Research
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frederick Raiser
Phone
402-933-6500
First Name & Middle Initial & Last Name & Degree
Frederick Raiser
Facility Name
Activmed Practices and Research, LLC
City
Portsmouth
State/Province
New Hampshire
ZIP/Postal Code
03801
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bertrand Cole
Phone
978-655-7155
First Name & Middle Initial & Last Name & Degree
Bertrand Cole
Facility Name
Velocity Clinical Research
City
Binghamton
State/Province
New York
ZIP/Postal Code
13905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frank Eder
Phone
607-800-5777
First Name & Middle Initial & Last Name & Degree
Frank Eder
Facility Name
Hypercore (Lucas Research)
City
New Bern
State/Province
North Carolina
ZIP/Postal Code
28562
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claire Presswood
Phone
252-222-5700
First Name & Middle Initial & Last Name & Degree
Claire Presswood
Facility Name
M3 Wake Research Inc
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisa Cohen Hong
Phone
919-781-2514
First Name & Middle Initial & Last Name & Degree
Lisa Cohen Hong
Facility Name
Trial Management Associates, LLC
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28403
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
William Jones
Phone
910-338-1555
First Name & Middle Initial & Last Name & Degree
William Jones
Facility Name
Javara Inc./Wake Forest Health Network, LLC
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Sanders
Phone
336-297-7553
First Name & Middle Initial & Last Name & Degree
John Sanders
Facility Name
Velocity Clinical Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bain Butcher
Phone
513-381-4100
First Name & Middle Initial & Last Name & Degree
Bain Butcher
Facility Name
Velocity Clinical Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45246
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charles Eger
Phone
513-671-8080
First Name & Middle Initial & Last Name & Degree
Charles Eger
Facility Name
Tekton Research
City
Edmond
State/Province
Oklahoma
ZIP/Postal Code
73013
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kyle Rickner
Phone
405-534-5609
First Name & Middle Initial & Last Name & Degree
Kyle Rickner
Facility Name
Lynn Health Science Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carl Griffen
Phone
405-601-3808
First Name & Middle Initial & Last Name & Degree
Carl Griffen
Facility Name
Velocity Clinical Research, Grants Pass
City
Grants Pass
State/Province
Oregon
ZIP/Postal Code
97527
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Delgado
Phone
541-237-0323
First Name & Middle Initial & Last Name & Degree
John Delgado
Facility Name
Velocity Clinical Research, Providence
City
East Greenwich
State/Province
Rhode Island
ZIP/Postal Code
02818
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Fried
Phone
401-648-7753
First Name & Middle Initial & Last Name & Degree
David Fried
Facility Name
Velocity Clinical Research, Gaffney
City
Gaffney
State/Province
South Carolina
ZIP/Postal Code
29340
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Erb
Phone
864-488-1283
First Name & Middle Initial & Last Name & Degree
David Erb
Facility Name
Coastal Carolina Research Center an ALCANZA Clinical Research company
City
North Charleston
State/Province
South Carolina
ZIP/Postal Code
29405
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cayce Tangeman
Phone
843-856-3784
First Name & Middle Initial & Last Name & Degree
Cayce Tangeman
Facility Name
Central Texas Clinical Research, LLC
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cynthia Brinson
Phone
512-480-9660
First Name & Middle Initial & Last Name & Degree
Cynthia Brinson
Facility Name
Research Your Health
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeffrey Adelglass
Phone
972-999-1155
First Name & Middle Initial & Last Name & Degree
Jeffrey Adelglass
Facility Name
Benchmark Research
City
San Angelo
State/Province
Texas
ZIP/Postal Code
76904
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Darrell Herrington
Phone
325-716-1355
First Name & Middle Initial & Last Name & Degree
Darrell Herrington
Facility Name
Velocity Clinical Research, Salt Lake City
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Richards
Phone
801-542-8190
First Name & Middle Initial & Last Name & Degree
John Richards
Facility Name
Health Research of Hampton Roads, Inc
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23606
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
George Freeman
Phone
757-591-8100
First Name & Middle Initial & Last Name & Degree
George Freeman
Facility Name
Clinical Research Partners
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23226
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leroy Vaughan
Phone
804-477-3045
First Name & Middle Initial & Last Name & Degree
Leroy Vaughan

12. IPD Sharing Statement

Links:
URL
http://novavaxperegrinestudy.com
Description
Novavax's COVID Vaccine: Explained

Learn more about this trial

Phase 2/3 Heterologous Boosting Study With Different Dose Levels of Monovalent SARS-CoV-2 rS Vaccines

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