NCT04961541

Completed

Phase 1

A Phase 1/2, Randomized, Observer-Blinded Study to Evaluate the Safety and Immunogenicity of a Quadrivalent Hemagglutinin Nanoparticle Influenza and SARS-CoV-2 rS Nanoparticle Combination Vaccine With Matrix M1™ Adjuvant in Healthy Participants ≥ 50 to ≤ 70 Years of Age

Novavax10 sites in 1 country637 target enrollmentSeptember 8, 2021

InterventionsICC Vaccine qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant

Overview

Phase: Phase 1
Intervention: ICC Vaccine
Conditions: SARS-CoV Infection
Sponsor: Novavax
Enrollment: 637
Locations: 10
Primary Endpoint: Number of Participants With Solicited Local and Systemic Adverse Events (AE's)
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a randomized, observer-blinded, Phase 1/2 study evaluating the safety and immunogenicity of a quadrivalent HA nanoparticle influenza and SARS-CoV-2 rS nanoparticle combination vaccine with Matrix-M1 adjuvant; this combination is referred to as ICC vaccine.

Detailed Description

This is a randomized, observer-blinded, Phase 1/2 study evaluating the safety and immunogenicity of a quadrivalent hemagglutinin (HA) nanoparticle influenza vaccine (qNIV) and severe acute respiratory syndrome coronavirus 2 (SARSCoV2) recombinant spike (rS) nanoparticle combination vaccine with Matrix-M1™ adjuvant; this combination vaccine is referred to as Influenza COVID-19 Combination (ICC) vaccine. The study will enroll approximately 640 healthy (based on history and physical examination) adult male and female participants 50 to 70 years of age, inclusive, targeting participants who are baseline seropositive (either previously infected with SARS-CoV-2 ≥ 8 weeks prior to enrollment, or have been previously immunized against SARS-CoV-2 with a completed regimen of an authorized vaccine at ≥ 8 weeks prior to enrollment). Randomization will be stratified on age ≥ 50 to ≤60 or ≥ 60 to ≤ 70 years to distribute the proportions of each age stratum evenly across vaccine groups.

Registry

clinicaltrials.gov

Start Date

September 8, 2021

End Date

April 22, 2022

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Novavax

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy, medically stable adult males or females ≥ 50 to ≤ 70 years of age at screening.
•Willing and able to give informed consent prior to study enrollment.
•Able to attend study visits, comply with study requirements, and provide reliable and complete reports of AEs.
•Participants must have been baseline seropositive to SARS-CoV-2 defined as either:
•Having completed a primary vaccination series against SARS-CoV-2 with an authorized COVID-19 vaccine with receipt of second/final dose of authorized vaccine ≥ 8 weeks prior to enrollment (first study vaccination).
•Previously infected with SARS CoV-2 ≥ 8 weeks prior to enrollment (first study vaccination).
•Note: Baseline SARS-CoV-2 serostatus determination at screening will be based on vaccination documentation (eg, vaccination card or vaccination registry) or participants' report of a previous SARS-CoV-2 infection.
•Women of childbearing potential (defined as any female participant who is NOT surgically sterile \[ie, hysterectomy, bilateral tubal ligation, or bilateral oophorectomy\] or postmenopausal \[defined as amenorrhea at least 12 consecutive months\]) 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 at least 28 days prior to enrollment and through the end of the study.
•Condoms (male or female) with spermicide (if acceptable in-country)
•Diaphragm with spermicide

Exclusion Criteria

•Any ongoing, symptomatic acute, or chronic illness requiring medical or surgical care.
•Asymptomatic chronic conditions or findings (eg, mild hypertension, dyslipidemia) that are not associated with evidence of end-organ damage are not exclusionary provided that they are being appropriately managed and are clinically stable (ie, unlikely to result in symptomatic illness within the time-course of this study), in the opinion of the investigator.
•Acute or chronic illnesses or conditions which may be reasonably predicted to become symptomatic if treatment were withdrawn or interrupted are exclusionary, even if stable.
•Acute or chronic illnesses reasonably expected to be associated with increased risks in the event of influenza or SARS-CoV-2 infection (eg, cardio-pulmonary diseases, diabetes mellitus, renal or hepatic dysfunction, hemoglobinopathies) are exclusionary, even if stable.
•Participation in research involving an investigational product (drug/biologic/device) within 90 days before the planned date of the first injection.
•Use of COVID-19 prophylactic or treatment monoclonal antibodies or antibody cocktails within 90 days prior to the planned date of the first injection.
•History of a serious reaction to prior influenza vaccination or known allergy to constituents of influenza vaccines - including egg proteins - or polysorbate 80; or any known allergies to products contained in the investigational product.
•Any history of anaphylaxis to any prior vaccine.
•History of Guillain-Barré Syndrome within 6 weeks following a previous influenza vaccine.
•Receipt of any vaccine in the 4 weeks preceding the study vaccination and any influenza vaccine within 2 months preceding the study vaccination. Note: Routine vaccinations will not be allowed until after study Day

Arms & Interventions

Group A and Group C - ICC Vaccine Formulation

2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.

Intervention: ICC Vaccine

Group B -ICC Vaccine Formulation

2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.

Intervention: ICC Vaccine

Group D - ICC Vaccine Formulation

2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.

Intervention: ICC Vaccine

Group E - ICC Vaccine Formulation

2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.

Intervention: ICC Vaccine

Group F- ICC Vaccine Formulation

2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.

Intervention: ICC Vaccine

Group G- ICC Vaccine Formulation

2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.

Intervention: ICC Vaccine

Group H and Group N- ICC Vaccine Formulation

2 doses of Formulation 7. 1 dose each on Day 0 and Day 56.

Intervention: ICC Vaccine

Group I- ICC Vaccine Formulation

2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.

Intervention: ICC Vaccine

Group J -ICC Vaccine Formulation

2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.

Intervention: ICC Vaccine

Group K - ICC Vaccine Formulation

2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.

Intervention: ICC Vaccine

Group L - ICC Vaccine Formulation

2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.

Intervention: ICC Vaccine

Group M -ICC Vaccine Formulation

2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.

Intervention: ICC Vaccine

Group O - qNIV with Matrix-M1 adjuvant

2 doses of Formulation 13. 1 dose each on Days 0 and Day 56 and an additional dose of 5 µg SARS-CoV-2 rS+50 µg Matrix-M1 at Day 70.

Intervention: qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant

Group P- SARS-CoV-2 rS with Matrix-M1 adjuvant

2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.

Intervention: SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant

Outcomes

Primary Outcomes

Number of Participants With Solicited Local and Systemic Adverse Events (AE's)

Time Frame: Day 0 to Day 63

Numbers of participants with solicited local and systemic AEs over the 7 days post-injection after first and second doses.

Number of Participants Reporting All AE's

Time Frame: Day 0 to Day 70

Number of participants reporting all AEs, (solicited and unsolicited), over 70 days after the first dose.

Number of Participants With MAAEs, AESIs (Including PIMMCs), SAEs

Time Frame: Day 0 to Day 180

Number of participants with Medical Attended Adverse Events (MAAE's), Adverse events (AESI's), Including potential immune-mediated medical conditions (PIMMCs), Serious Adverse Events SAEs.

Secondary Outcomes

MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Titers (GMT)(Day 0 to Day 182)
MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMT(Day 0 to Day 70)
MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMFR(Day 28 to Day 70)
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the Hemagglutinin (HA) Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Geometric Mean Titers (GMTs)(Day 0 to Day 182)
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as GMTs(Day 0 to Day 182)
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as GMTs(Day 0 to Day 182)
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as GMTs(Day 0 to Day 182)
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as GMTs(Day 0 to Day 182)
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as GMTs(Day 0 to Day 182)
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as GMTs(Day 0 to Day 182)
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as GMTs(Day 0 to Day 182)
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Fold Rise (GMFRPost/Pre)(Day 28 to Day 182)
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as (GMFRPost/Pre)(Day 28 to Day 182)
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as (GMFRPost/Pre)(Day 28 to Day 182)
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as (GMFRPost/Pre)(Day 28 to Day 182)
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as (GMFRPost/Pre)(Day 28 to Day 182)
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as (GMFRPost/Pre)(Day 28 to Day 182)
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as (GMFRPost/Pre)(Day 28 to Day 182)
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as (GMFRPost/Pre)(Day 28 to Day 182)
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Seroconversion Rate (SCR)(Day 28 to Day 182)
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR(Day 28 to Day 182)
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR(Day 28 to Day 182)
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR(Day 28 to Day 182)
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR(Day 28 to Day 182)
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR(Day 28 to Day 182)
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR(Day 28 to Day 182)
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR(Day 28 to Day 182)
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Titer Ratio (GMTR)(Day 28 to Day 182)
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR(Day 28 to Day 182)
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR(Day 28 to Day 182)
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR(Day 28 to Day 182)
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR(Day 28 to Day 182)
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as GMTR(Day 28 to Day 182)
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR(Day 28 to Day 182)
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype)Expressed as GMTR(Day 28 to Day 182)
Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Seroprotection Rate (SPR).(Day 28 to Day 182)
Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as SPR(Day 28 to Day 182)
Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as SPR(Day 28 to Day 182)
Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as SPR(Day 28 to Day 182)
Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as SPR(Day 28 to Day 182)
Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as SPR(Day 28 to Day 182)
Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as SPR(Day 28 to Day 182)
Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as SPR(Day 28 to Day 182)
MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Fold Rise (GMFR)(Day 28 to Day 182)
MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as SCR(Day 28 to Day 182)
MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as SCR(Day 28 to Day 182)
MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as GMTR(Day 28 to Day 182)
MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Expressed as GMTR(Day 28 to Day 182)
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMT(Day 0 to Day 182)
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMT(Day 0 to Day 182)
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMT(Day 0 to Day 182)
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMT(Day 0 to Day 182)
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMT(Day 0 to Day 182)
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMT(Day 0 to Day 182)
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype) Expressed as GMT(Day 0 to Day 182)
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington (Victoria Subtype)Expressed as GMT(Day 0 to Day 182)
Microneutralization (MN50) Antibody Responses Influenza A/Brisbane (H1N1 Subtype) Expressed as GMFR(Day 28 to Day 182)
Microneutralization (MN50) Antibody Responses Influenza A/Kansas (H3N2 Subtype) Expressed as GMFR(Day 28 to Day 182)
Microneutralization (MN50) Antibody Responses Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMFR(Day 28 to Day 182)
Microneutralization (MN50) Antibody Responses Influenza A/Cambodia (H3N2 Subtype) Expressed as GMFR(Day 28 to Day 182)
Microneutralization (MN50) Antibody Responses Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMFR(Day 28 to Day 182)
Microneutralization (MN50) Antibody Responses Influenza B/Maryland (Victoria Subtype) Expressed as GMFR(Day 28 to Day 182)
Microneutralization (MN50) Antibody Responses Influenza B/Phuket (Yamagata Subtype) Expressed as GMFR(Day 28 to Day 182)
Microneutralization (MN50) Antibody Responses Influenza B/Washington (Victoria Subtype) Expressed as GMFR(Day 28 to Day 182)
Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as SCR(Day 28 to Day 182)
Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR(Day 28 to Day 182)
Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR(Day 28 to Day 182)
Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR(Day 28 to Day 182)
Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR(Day 28 to Day 182)
Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR(Day 28 to Day 182)
Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR(Day 28 to Day 182)
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR(Day 28 to Day 182)
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR(Day 28 to Day 182)
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR(Day 28 to Day 182)
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR(Day 28 to Day 182)
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype)Expressed as GMTR(Day 28 to Day 182)
Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR(Day 28 to Day 182)
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMTR(Day 28 to Day 182)
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR(Day 28 to Day 182)
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington(VictoriaSubtype) Expressed as GMTR(Day 28 to Day 182)
Serum Immunoglobulin G (IgG) Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as Geometric Mean ELISA Unit (GMEU)(Day 0 to Day 182)
Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMEU(Day 0 to Day 182)
Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as GMFR(Day 28 to Day 182)
Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMFR(Day 28 to Day 182)
Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as SCR(Day 28 to Day 182)
Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as SCR(Day 28 to Day 182)
Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as Geometric Mean ELISA Unit Ratio (GMEUR)(Day 28 to Day 182)
Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 (Wuhan) Spike Protein Expressed as GMEUR(Day 28 to Day 182)