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The primary objective was to assess the safety and tolerability of 2 different doses (10 or 30 µg) of GRT-R910 when administered as a boost in healthy adults previously vaccinated with the AstraZeneca, Janssen/Johnson and Johnson, Moderna, or Pfizer/BioNTech Coronavirus disease 2019 (COVID-19) vaccines.
This trial studied a self-amplifying messenger ribonucleic acid (samRNA) based vaccine (GRT-R910) in previously vaccinated adults (≥18 years). GRT-R910 uses a codon optimized, prefusion stabilized Spike (S) cassette with additional T cell epitopes (TCEs) covering multiple epitopes from non-spike proteins to safely drive strong, broad, and durable B and T cell immune responses to Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: GRT-R910 10 µg, age ≥60 years (Receipt of AstraZeneca vaccine) | Experimental | Healthy participants of age ≥60 years received prime dose (on Day 1) of GRT-R910 10 microgram (µg) intramuscularly at least 2 months after receiving a first-generation COVID-19 (AstraZeneca) vaccine primary series. A subset of participants elected to receive a booster vaccination of GRT-R910 10 µg which was administered 113 days after the prime vaccination. Participants not receiving booster dose were followed for 12 months, and participants receiving booster dose were followed for 16 months. |
|
| Cohort 2: GRT-R910 30 µg, age ≥60 years (Receipt of AstraZeneca vaccine) | Experimental | Healthy participants of age ≥60 years received prime dose (on Day 1) of GRT-R910 30 µg intramuscularly at least 2 months after receiving a first-generation COVID-19 (AstraZeneca) vaccine primary series. A subset of participants elected to receive a booster vaccination of GRT-R910 10 µg, which was administered 113 days after the prime vaccination. Participants not receiving booster dose were followed for 12 months, and participants receiving booster dose were followed for 16 months. |
|
| Cohort 3: GRT-R910 10 µg, ≥60 years, (Receipt of AstraZeneca or Janssen COVID-19 vaccine) | Experimental | Healthy participants of age ≥60 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving an adenoviral COVID-19 (AstraZeneca, Janssen) primary series vaccine. Participants were followed for 13 months. |
|
| Cohort 4: GRT-R910 10 µg, ≥60 years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 vaccine) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GRT-R910 | Biological | Injection administered intramuscularly |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With at Least One Solicited Local Adverse Event (AE) Within 8 Days After the Injection of Prime Dose | An AE was defined as any untoward medical occurrence associated with the use of an intervention in humans, whether or not considered intervention-related in a participant or clinical investigation participant who administered a pharmaceutical product regardless of its causal relationship to the study treatment. Solicited local AEs included injection site pain, injection site tenderness, injection site erythema, injection site edema/induration. Solicited AEs (reactogenicity) were collected using a memory aid. | Within 8 Days After the Injection of Prime Dose on Day 1 |
| Number of Participants With at Least One Solicited Local AE Within 8 Days After the Injection of Booster Dose | An AE was defined as any untoward medical occurrence associated with the use of an intervention in humans, whether or not considered intervention-related in a participant or clinical investigation participant who administered a pharmaceutical product regardless of its causal relationship to the study treatment. Solicited local AEs included injection site pain, injection site tenderness, injection site erythema, injection site edema/induration. Solicited AEs (reactogenicity) were collected using a memory aid. | Within 8 Days After the Injection of Booster Dose on Day 113 (Cohorts 1, 2); Within 8 Days After the Injection of Booster Dose on Day 29 (Cohorts 3, 4, 6) |
| Number of Participants With at Least One Solicited Systemic AE Within 8 Days After the Injection of Prime Dose | An AE was defined as any untoward medical occurrence associated with the use of an intervention in humans, whether or not considered intervention-related in a participant or clinical investigation participant who administered a pharmaceutical product regardless of its causal relationship to the study treatment. Solicited systemic AEs included headache, fatigue, malaise, myalgia, arthralgia, nausea, fever, and chills. Solicited AEs (reactogenicity) were collected using a memory aid. | Within 8 Days After the Injection of Prime Dose on Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Immunoglobulin (Ig)G Level (Spike Wild Type [WT] Variant) | Sera were analyzed for Spike (WT variant)-specific IgG levels pre and post administration of GRT-R910 via enzyme-linked immunosorbent assay (ELISA) and reported as ELISA laboratory units (ELU)/mL (amount of antibodies in the sample according to the unit assigned by the standard). | Baseline, Days 15, 29, 57, 58, 86, 113, 142, 180, 209, 293, 365, 394, 478 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Martin, DO | Gritstone bio, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Birmingham NHS | Birmingham | United Kingdom | ||||
| University Hospital of Leicester NHS Trust |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37280238 | Derived | Palmer CD, Scallan CD, Kraemer Tardif LD, Kachura MA, Rappaport AR, Koralek DO, Uriel A, Gitlin L, Klein J, Davis MJ, Venkatraman H, Hart MG, Jaroslavsky JR, Kounlavouth S, Marrali M, Nganje CN, Bae K, Yan T, Leodones K, Egorova M, Hong SJ, Kuan J, Grappi S, Garbes P, Jooss K, Ustianowski A. GRT-R910: a self-amplifying mRNA SARS-CoV-2 vaccine boosts immunity for >/=6 months in previously-vaccinated older adults. Nat Commun. 2023 Jun 6;14(1):3274. doi: 10.1038/s41467-023-39053-9. |
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Of 45 enrolled participants, 1 participant was enrolled in Cohort 5; however, the sponsor decided to terminate this participant prior to the study vaccination and close the recruitment of Cohort 5. As a result, Cohort 5 was removed from the GO-009 study. Therefore, the results include participants enrolled in Cohorts 1, 2, 3, 4, and 6.
The participants were enrolled at 3 sites in United Kingdom. A total of 61 participants were screened and 45 participants were enrolled in 6 cohorts (Cohorts 1 to 6).
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Healthy participants of age ≥60 years received prime dose (on Day 1) of GRT-R910 10 µg intramuscularly at least 2 months after receiving a first-generation COVID-19 (AstraZeneca) vaccine primary series. A subset of participants elected to receive a booster vaccination of GRT-R910 10 µg which was administered 113 days after the prime vaccination. Participants not receiving booster dose were followed for 12 months, and participants receiving booster dose were followed for 16 months. |
| FG001 | Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Healthy participants of age ≥60 years received prime dose (on Day 1) of GRT-R910 30 µg intramuscularly at least 2 months after receiving a first-generation COVID-19 (AstraZeneca) vaccine primary series. A subset of participants elected to receive a booster vaccination of GRT-R910 10 µg, which was administered 113 days after the prime vaccination. Participants not receiving booster dose were followed for 12 months, and participants receiving booster dose were followed for 16 months. |
| FG002 | Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Healthy participants of age ≥60 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving an adenoviral COVID-19 (AstraZeneca, Janssen) primary series vaccine. Participants were followed for 13 months. |
| FG003 | Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Healthy participants of age ≥60 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving a messenger ribonucleic acid (mRNA)-based COVID-19 (Pfizer/BioNTech, Moderna) primary series vaccine. Participants were followed for 13 months. |
| FG004 | Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Healthy participants of age ≥18 to ≤59 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving mRNA-based COVID-19 (Pfizer/BioNTech, Moderna) primary series vaccine. Participants were followed for 13 months. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The Safety Analysis Population (SAF) included all participants who received any dose of GRT-R910.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Healthy participants of age ≥60 years received prime dose (on Day 1) of GRT-R910 10 µg intramuscularly at least 2 months after receiving a first-generation COVID-19 (AstraZeneca) vaccine primary series. A subset of participants elected to receive a booster vaccination of GRT-R910 10 µg which was administered 113 days after the prime vaccination. Participants not receiving booster dose were followed for 12 months, and participants receiving booster dose were followed for 16 months. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With at Least One Solicited Local Adverse Event (AE) Within 8 Days After the Injection of Prime Dose | An AE was defined as any untoward medical occurrence associated with the use of an intervention in humans, whether or not considered intervention-related in a participant or clinical investigation participant who administered a pharmaceutical product regardless of its causal relationship to the study treatment. Solicited local AEs included injection site pain, injection site tenderness, injection site erythema, injection site edema/induration. Solicited AEs (reactogenicity) were collected using a memory aid. | SAF population | Posted | Count of Participants | Participants | No | Within 8 Days After the Injection of Prime Dose on Day 1 |
|
From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Healthy participants of age ≥60 years received prime dose (on Day 1) of GRT-R910 10 microgram (µg) intramuscularly at least 2 months after receiving a first-generation COVID-19 (AstraZeneca) vaccine primary series. A subset of participants elected to receive a booster vaccination of GRT-R910 10 µg which was administered 113 days after the prime vaccination. Participants not receiving booster dose were followed for 12 months, and participants receiving booster dose were followed for 16 months. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute coronary syndrome | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth Martin, Vice President, Clinical Development Infectious Disease | Gritstone bio, Inc. | +1 (877) 520-2233 | clinicalstudies@gritstone.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 9, 2023 | Jul 18, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 9, 2023 | Jul 18, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000720466 | GRT-R910 vaccine |
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| Experimental |
Healthy participants of age ≥60 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving a messenger ribonucleic acid (mRNA)-based COVID-19 (Pfizer/BioNTech, Moderna) primary series vaccine. Participants were followed for 13 months. |
|
| Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 vaccine) | Experimental | Healthy participants of age ≥18 to ≤59 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving mRNA-based COVID-19 (Pfizer/BioNTech, Moderna) primary series vaccine. Participants were followed for 13 months. |
|
| Number of Participants With at Least One Solicited Systemic AE Within 8 Days After the Injection of Booster Dose |
An AE was defined as any untoward medical occurrence associated with the use of an intervention in humans, whether or not considered intervention-related in a participant or clinical investigation participant who administered a pharmaceutical product regardless of its causal relationship to the study treatment. Solicited systemic AEs included headache, fatigue, malaise, myalgia, arthralgia, nausea, fever, and chills. Solicited AEs (reactogenicity) were collected using a memory aid. |
| Within 8 Days After the Injection of Booster Dose on Day 113 (Cohorts 1, 2); Within 8 Days After the Injection of Booster Dose on Day 29 (Cohorts 3, 4, 6) |
| Number of Participants With at Least One Unsolicited Treatment-emergent AEs (TEAEs) Within 28 Days After the Injection of Prime Dose | An AE was defined as any untoward medical occurrence associated with the use of an intervention in humans, whether or not considered intervention-related in a participant or clinical investigation participant who administered a pharmaceutical product regardless of its causal relationship to the study treatment. A TEAE was defined as any event not observed before the first vaccination or any event observed before the first vaccination that worsens in intensity or frequency after exposure. | Within 28 Days After the Injection of Prime Dose on Day 1 |
| Number of Participants With at Least One Unsolicited TEAEs Within 28 Days After the Injection of Booster Dose | An AE was defined as any untoward medical occurrence associated with the use of an intervention in humans, whether or not considered intervention-related in a participant or clinical investigation participant who administered a pharmaceutical product regardless of its causal relationship to the study treatment. A TEAE was defined as any event not observed before the first vaccination or any event observed before the first vaccination that worsens in intensity or frequency after exposure. | Within 28 Days After the Injection of Booster Dose on Day 113 (Cohorts 1, 2); Within 8 Days After the Injection of Booster Dose on Day 29 (Cohorts 3, 4, 6) |
| Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2) | Baseline, Day 8 |
| Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Participants With Booster Dose (Cohorts 1 and 2) | Baseline, Day 8 |
| Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 120 in Participants With Booster Dose (Cohorts 1 and 2) | Baseline, Day 120 |
| Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Cohorts 3, 4, and 6 | Baseline, Day 8 |
| Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 37 in Cohorts 3, 4, and 6 | Baseline, Day 37 |
| Change From Baseline in Hemoglobin at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2) | Baseline, Day 8 |
| Change From Baseline in Hemoglobin at Day 8 in Participants With Booster Dose (Cohorts 1 and 2) | Baseline, Day 8 |
| Change From Baseline in Hemoglobin at Day 120 in Participants With Booster Dose (Cohorts 1 and 2) | Baseline, Day 120 |
| Change From Baseline in Hemoglobin at Day 8 in Cohorts 3, 4, and 6 | Baseline, Day 8 |
| Change From Baseline in Hemoglobin at Day 37 in Cohorts 3, 4, and 6 | Baseline, Day 37 |
| Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2) | Baseline, Day 8 |
| Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 8 in Participants With Booster Dose (Cohorts 1 and 2) | Baseline, Day 8 |
| Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 120 in Participants With Booster Dose (Cohorts 1 and 2) | Baseline, Day 120 |
| Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 8 in Cohorts 3, 4, and 6 | Baseline, Day 8 |
| Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 37 in Cohorts 3, 4, and 6 | Baseline, Day 37 |
| Change From Baseline in Bilirubin and Creatinine at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2) | Baseline, Day 8 |
| Change From Baseline in Bilirubin and Creatinine at Day 8 in Participants With Booster Dose (Cohorts 1 and 2) | Baseline, Day 8 |
| Change From Baseline in Bilirubin and Creatinine at Day 120 in Participants With Booster Dose (Cohorts 1 and 2) | Baseline, Day 120 |
| Change From Baseline in Bilirubin and Creatinine at Day 8 in Cohorts 3, 4, and 6 | Baseline, Day 8 |
| Change From Baseline in Bilirubin and Creatinine at Day 37 in Cohorts 3, 4, and 6 | Baseline, Day 37 |
| Change From Baseline in Creatine Kinase at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2) | Baseline, Day 8 |
| Change From Baseline in Creatine Kinase at Day 8 in Participants With Booster Dose (Cohorts 1 and 2) | Baseline, Day 8 |
| Change From Baseline in Creatine Kinase at Day 120 in Participants With Booster Dose (Cohorts 1 and 2) | Baseline, Day 120 |
| Change From Baseline in Creatine Kinase at Day 8 in Cohorts 3, 4, and 6 | Baseline, Day 8 |
| Change From Baseline in Creatine Kinase at Day 37 in Cohorts 3, 4, and 6 | Baseline, Day 37 |
| Number of Participants With Treatment-emergent Serious AEs (SAEs), AE of Special Interest (AESIs) Including Potentially Immune-mediated Medical Conditions (PIMMCs), Medically Attended AEs (MAAEs), and New Onset Chronic Medical Conditions (NOCMCs) | An AE or adverse experience was defined as any untoward medical occurrence in a participant or clinical investigation participant who was administered a pharmaceutical product, with or without a causal relationship with the vaccine. A TEAE was defined as any event not observed before the first vaccination or any event observed before the first vaccination that worsens in intensity or frequency after exposure. A treatment-emergent SAE was defined as any AE that resulted in death, is life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability/permanent damage, was a congenital anomaly/birth defect, or was an important medical event. Adverse events of special interest were serologically or virologically confirmed SARS-CoV-2 infection or severe COVID-19, NOCMCs, MAAE (hospitalization, an emergency room visit or an otherwise unscheduled visit to or from medical personnel for any reason), and PIMMCs. | Day 1 Up to 16 months |
| Change From Baseline in Neutralizing Antibody (nAb) Levels | Neutralizing antibody titers against live virus were assessed via microneutralization assay. Neutralizing antibody levels were measured for the following variants: WT, Alpha, Beta, Delta, Gamma. | For WT: Baseline, Days 15, 29, 57, 58, 86, 113, 142, 180, 209 293, 365, 394, 478; For Alpha, Beta, Delta, Gamma:Baseline, Days 15, 29, 57, 58, 86, 113, 142, 180, 209 293, 365, 394 |
| Number of Participants With Immunogenicity Response by Spike IgG and nAb Variants | Immunogenicity response defined as >= 2-fold change in the levels from baseline. Response rate was assessed by Spike IgG wild type and nAb Variants [wild type, alpha, beta, gamma, delta]. Number of participants with immunogenicity response at any post-baseline timepoint are provided. | Baseline to 478 days |
| Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Peripheral blood mononuclear cells (PBMCs) were isolated from whole blood. T cell responses to SARS-CoV-2 D614G were assessed via ex vivo IFNγ ELISpot assay (methods). Cells were stimulated with overlapping peptide (OLP) pools containing peptides that were 15 amino acids in length (15mers) and spanning both S subunits (Spike pool 1-2, 3-4 [S1], 5-6, and 7-8 [S2]). | Baseline, Days 8, 29, 58, 113, 142, 180, 209, 293, 365, 478 |
| Change From Baseline in T Cell Response by T Cell Epitope (TCE) Pools (ex Vivo ELISpot) | PBMCs were isolated from whole blood. T cell responses to conserved SARS-CoV-2 viral epitopes were assessed via ex vivo IFNγ ELISpot assay (methods). Responses to Nucleocapsid (Nuc) and open reading frame 3a (ORF3a)/Membrane TCE regions were assessed using OLP pools. | Baseline, Days 8, 29, 58, 113, 142, 180, 209, 293, 365, 478 |
| Change From Baseline in Immunogenicity Response by TCE Pools (in Vitro Stimulation) | PBMCs were isolated from whole blood. T cell responses to conserved SARS-CoV-2 viral epitopes were assessed via IFNγ ELISpot assay following in vitro stimulation. Responses to Nuc, ORF3a, and membrane TCE regions were assessed using OLP pools. | Baseline, Days 8, 29, 58, 113, 142, 180, 209, 293 |
| Number of Participants With Immunogenicity Response by Spike Pools and TCE Pools (ex Vivo ELISpot) | T cell responses to SARS-CoV-2 D614G and conserved non-Spike epitopes were assessed via ex vivo IFNγ ELISpot assay (methods) using OLP pools containing peptides that were 15 amino acids in length and spanning both S subunits (Spike pool 1-2, 3-4 [S1], 5-6, and 7-8 [S2]) and TCE regions Nuc and ORF3a/Membrane. Immunogenicity response was defined as >= 2-fold change in levels from baseline. Response rate to both Spike pools (Spike pool 1-2, 3-4, 5-6, and 7-8) and TCE pools (Nuc OLP and ORF3a/Membrane OLP) was assessed. | Baseline to 478 days |
| Leicester |
| United Kingdom |
| Manchester University | Manchester | United Kingdom |
| Participant was early terminated per protocol |
|
| Miscellaneous |
|
| BG001 | Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Healthy participants of age ≥60 years received prime dose (on Day 1) of GRT-R910 30 µg intramuscularly at least 2 months after receiving a first-generation COVID-19 (AstraZeneca) vaccine primary series. A subset of participants elected to receive a booster vaccination of GRT-R910 10 µg, which was administered 113 days after the prime vaccination. Participants not receiving booster dose were followed for 12 months, and participants receiving booster dose were followed for 16 months. |
| BG002 | Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Healthy participants of age ≥60 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving an adenoviral COVID-19 (AstraZeneca, Janssen) primary series vaccine. Participants were followed for 13 months. |
| BG003 | Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Healthy participants of age ≥60 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving a messenger ribonucleic acid (mRNA)-based COVID-19 (Pfizer/BioNTech, Moderna) primary series vaccine. Participants were followed for 13 months. |
| BG004 | Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Healthy participants of age ≥18 to ≤59 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving mRNA-based COVID-19 (Pfizer/BioNTech, Moderna) primary series vaccine. Participants were followed for 13 months. |
| BG005 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| OG001 | Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Healthy participants of age ≥60 years received prime dose (on Day 1) of GRT-R910 30 µg intramuscularly at least 2 months after receiving a first-generation COVID-19 (AstraZeneca) vaccine primary series. A subset of participants elected to receive a booster vaccination of GRT-R910 10 µg, which was administered 113 days after the prime vaccination. Participants not receiving booster dose were followed for 12 months, and participants receiving booster dose were followed for 16 months. |
| OG002 | Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Healthy participants of age ≥60 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving an adenoviral COVID-19 (AstraZeneca, Janssen) primary series vaccine. Participants were followed for 13 months. |
| OG003 | Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Healthy participants of age ≥60 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving a messenger ribonucleic acid (mRNA)-based COVID-19 (Pfizer/BioNTech, Moderna) primary series vaccine. Participants were followed for 13 months. |
| OG004 | Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Healthy participants of age ≥18 to ≤59 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving mRNA-based COVID-19 (Pfizer/BioNTech, Moderna) primary series vaccine. Participants were followed for 13 months. |
|
|
| Primary | Number of Participants With at Least One Solicited Local AE Within 8 Days After the Injection of Booster Dose | An AE was defined as any untoward medical occurrence associated with the use of an intervention in humans, whether or not considered intervention-related in a participant or clinical investigation participant who administered a pharmaceutical product regardless of its causal relationship to the study treatment. Solicited local AEs included injection site pain, injection site tenderness, injection site erythema, injection site edema/induration. Solicited AEs (reactogenicity) were collected using a memory aid. | Participants in the SAF population who received booster dose and submitted any data for the solicited AEs. | Posted | Count of Participants | Participants | No | Within 8 Days After the Injection of Booster Dose on Day 113 (Cohorts 1, 2); Within 8 Days After the Injection of Booster Dose on Day 29 (Cohorts 3, 4, 6) |
|
|
|
| Primary | Number of Participants With at Least One Solicited Systemic AE Within 8 Days After the Injection of Prime Dose | An AE was defined as any untoward medical occurrence associated with the use of an intervention in humans, whether or not considered intervention-related in a participant or clinical investigation participant who administered a pharmaceutical product regardless of its causal relationship to the study treatment. Solicited systemic AEs included headache, fatigue, malaise, myalgia, arthralgia, nausea, fever, and chills. Solicited AEs (reactogenicity) were collected using a memory aid. | SAF population | Posted | Count of Participants | Participants | No | Within 8 Days After the Injection of Prime Dose on Day 1 |
|
|
|
| Primary | Number of Participants With at Least One Solicited Systemic AE Within 8 Days After the Injection of Booster Dose | An AE was defined as any untoward medical occurrence associated with the use of an intervention in humans, whether or not considered intervention-related in a participant or clinical investigation participant who administered a pharmaceutical product regardless of its causal relationship to the study treatment. Solicited systemic AEs included headache, fatigue, malaise, myalgia, arthralgia, nausea, fever, and chills. Solicited AEs (reactogenicity) were collected using a memory aid. | Participants in the SAF population who received booster dose and submitted any data for the solicited AEs. | Posted | Count of Participants | Participants | No | Within 8 Days After the Injection of Booster Dose on Day 113 (Cohorts 1, 2); Within 8 Days After the Injection of Booster Dose on Day 29 (Cohorts 3, 4, 6) |
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|
|
| Primary | Number of Participants With at Least One Unsolicited Treatment-emergent AEs (TEAEs) Within 28 Days After the Injection of Prime Dose | An AE was defined as any untoward medical occurrence associated with the use of an intervention in humans, whether or not considered intervention-related in a participant or clinical investigation participant who administered a pharmaceutical product regardless of its causal relationship to the study treatment. A TEAE was defined as any event not observed before the first vaccination or any event observed before the first vaccination that worsens in intensity or frequency after exposure. | SAF population | Posted | Count of Participants | Participants | No | Within 28 Days After the Injection of Prime Dose on Day 1 |
|
|
|
| Primary | Number of Participants With at Least One Unsolicited TEAEs Within 28 Days After the Injection of Booster Dose | An AE was defined as any untoward medical occurrence associated with the use of an intervention in humans, whether or not considered intervention-related in a participant or clinical investigation participant who administered a pharmaceutical product regardless of its causal relationship to the study treatment. A TEAE was defined as any event not observed before the first vaccination or any event observed before the first vaccination that worsens in intensity or frequency after exposure. | Participants in the SAF population who received booster dose were analyzed. | Posted | Count of Participants | Participants | No | Within 28 Days After the Injection of Booster Dose on Day 113 (Cohorts 1, 2); Within 8 Days After the Injection of Booster Dose on Day 29 (Cohorts 3, 4, 6) |
|
|
|
| Primary | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2) | Participants in SAF population from Cohorts 1 and 2 who did not receive the booster dose were analyzed. | Posted | Mean | Standard Deviation | 10^9 cells per liter | Baseline, Day 8 |
|
|
|
| Primary | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Participants With Booster Dose (Cohorts 1 and 2) | Participants in the SAF population from Cohorts 1 and 2 who received the booster dose were analyzed. | Posted | Mean | Standard Deviation | 10^9 cells per liter | Baseline, Day 8 |
|
|
|
| Primary | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 120 in Participants With Booster Dose (Cohorts 1 and 2) | Participants in the SAF population from Cohorts 1 and 2 who received the booster dose were analyzed. | Posted | Mean | Standard Deviation | 10^9 cells per liter | Baseline, Day 120 |
|
|
|
| Primary | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Cohorts 3, 4, and 6 | Participants in the SAF population from Cohorts 3, 4 and 6 were analyzed. | Posted | Mean | Standard Deviation | 10^9 cells per liter | Baseline, Day 8 |
|
|
|
| Primary | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 37 in Cohorts 3, 4, and 6 | Participants in the SAF population from Cohorts 3, 4 and 6 were analyzed. | Posted | Mean | Standard Deviation | 10^9 cells per liter | Baseline, Day 37 |
|
|
|
| Primary | Change From Baseline in Hemoglobin at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2) | Participants in the SAF population from Cohorts 1 and 2 who did not receive the booster dose were analyzed. | Posted | Mean | Standard Deviation | g/L | Baseline, Day 8 |
|
|
|
| Primary | Change From Baseline in Hemoglobin at Day 8 in Participants With Booster Dose (Cohorts 1 and 2) | Participants in the SAF population from Cohorts 1 and 2 who received the booster dose were analyzed. | Posted | Mean | Standard Deviation | g/L | Baseline, Day 8 |
|
|
|
| Primary | Change From Baseline in Hemoglobin at Day 120 in Participants With Booster Dose (Cohorts 1 and 2) | Participants in the SAF population from Cohorts 1 and 2 who received the booster dose were analyzed. | Posted | Mean | Standard Deviation | g/L | Baseline, Day 120 |
|
|
|
| Primary | Change From Baseline in Hemoglobin at Day 8 in Cohorts 3, 4, and 6 | Participants in the SAF population from Cohorts 3, 4 and 6 were analyzed. | Posted | Mean | Standard Deviation | g/L | Baseline, Day 8 |
|
|
|
| Primary | Change From Baseline in Hemoglobin at Day 37 in Cohorts 3, 4, and 6 | Participants in the SAF population from Cohorts 3, 4 and 6 were analyzed. | Posted | Mean | Standard Deviation | g/L | Baseline, Day 37 |
|
|
|
| Primary | Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2) | Participants in the SAF population from Cohorts 1 and 2 who did not receive the booster dose were analyzed. | Posted | Mean | Standard Deviation | International Units Per Liter (IU/L) | Baseline, Day 8 |
|
|
|
| Primary | Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 8 in Participants With Booster Dose (Cohorts 1 and 2) | Participants in the SAF population from Cohorts 1 and 2 who received the booster dose and who had available data were analyzed. | Posted | Mean | Standard Deviation | IU/L | Baseline, Day 8 |
|
|
|
| Primary | Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 120 in Participants With Booster Dose (Cohorts 1 and 2) | Participants in the SAF population from Cohorts 1 and 2 who received the booster dose and who had available data were analyzed. | Posted | Mean | Standard Deviation | IU/L | Baseline, Day 120 |
|
|
|
| Primary | Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 8 in Cohorts 3, 4, and 6 | Participants in SAF population from Cohorts 3, 4, and 6 with available data were analyzed. | Posted | Mean | Standard Deviation | IU/L | Baseline, Day 8 |
|
|
|
| Primary | Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 37 in Cohorts 3, 4, and 6 | Participants in SAF population from Cohorts 3, 4, and 6 with available data were analyzed. | Posted | Mean | Standard Deviation | IU/L | Baseline, Day 37 |
|
|
|
| Primary | Change From Baseline in Bilirubin and Creatinine at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2) | Participants in the SAF population from Cohorts 1 and 2 who did not receive the booster dose were analyzed. | Posted | Mean | Standard Deviation | micromole per liter (µmol/L) | Baseline, Day 8 |
|
|
|
| Primary | Change From Baseline in Bilirubin and Creatinine at Day 8 in Participants With Booster Dose (Cohorts 1 and 2) | Participants in the SAF population from Cohorts 1 and 2 who received the booster dose were analyzed. | Posted | Mean | Standard Deviation | µmol/L | Baseline, Day 8 |
|
|
|
| Primary | Change From Baseline in Bilirubin and Creatinine at Day 120 in Participants With Booster Dose (Cohorts 1 and 2) | Participants in the SAF population from Cohorts 1 and 2 who received the booster dose were analyzed. | Posted | Mean | Standard Deviation | µmol/L | Baseline, Day 120 |
|
|
|
| Primary | Change From Baseline in Bilirubin and Creatinine at Day 8 in Cohorts 3, 4, and 6 | Participants in SAF population from Cohorts 3, 4, and 6 with available data were analyzed. | Posted | Mean | Standard Deviation | µmol/L | Baseline, Day 8 |
|
|
|
| Primary | Change From Baseline in Bilirubin and Creatinine at Day 37 in Cohorts 3, 4, and 6 | Participants in SAF population from Cohorts 3, 4, and 6 with available data were analyzed. | Posted | Mean | Standard Deviation | µmol/L | Baseline, Day 37 |
|
|
|
| Primary | Change From Baseline in Creatine Kinase at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2) | Participants in the SAF population from Cohorts 1 and 2 who did not receive the booster dose were analyzed. | Posted | Mean | Standard Deviation | microkatal per liter (μkat/L) | Baseline, Day 8 |
|
|
|
| Primary | Change From Baseline in Creatine Kinase at Day 8 in Participants With Booster Dose (Cohorts 1 and 2) | Participants in the SAF population from Cohorts 1 and 2 who received the booster dose were analyzed. | Posted | Mean | Standard Deviation | μkat/L | Baseline, Day 8 |
|
|
|
| Primary | Change From Baseline in Creatine Kinase at Day 120 in Participants With Booster Dose (Cohorts 1 and 2) | Participants in the SAF population from Cohorts 1 and 2 who received the booster dose were analyzed. | Posted | Mean | Standard Deviation | μkat/L | Baseline, Day 120 |
|
|
|
| Primary | Change From Baseline in Creatine Kinase at Day 8 in Cohorts 3, 4, and 6 | Participants in the SAF population from Cohorts 3, 4 and 6 were analyzed. | Posted | Mean | Standard Deviation | μkat/L | Baseline, Day 8 |
|
|
|
| Primary | Change From Baseline in Creatine Kinase at Day 37 in Cohorts 3, 4, and 6 | Participants in the SAF population from Cohorts 3, 4 and 6 with available data were analyzed. | Posted | Mean | Standard Deviation | μkat/L | Baseline, Day 37 |
|
|
|
| Primary | Number of Participants With Treatment-emergent Serious AEs (SAEs), AE of Special Interest (AESIs) Including Potentially Immune-mediated Medical Conditions (PIMMCs), Medically Attended AEs (MAAEs), and New Onset Chronic Medical Conditions (NOCMCs) | An AE or adverse experience was defined as any untoward medical occurrence in a participant or clinical investigation participant who was administered a pharmaceutical product, with or without a causal relationship with the vaccine. A TEAE was defined as any event not observed before the first vaccination or any event observed before the first vaccination that worsens in intensity or frequency after exposure. A treatment-emergent SAE was defined as any AE that resulted in death, is life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability/permanent damage, was a congenital anomaly/birth defect, or was an important medical event. Adverse events of special interest were serologically or virologically confirmed SARS-CoV-2 infection or severe COVID-19, NOCMCs, MAAE (hospitalization, an emergency room visit or an otherwise unscheduled visit to or from medical personnel for any reason), and PIMMCs. | SAF population | Posted | Count of Participants | Participants | No | Day 1 Up to 16 months |
|
|
|
| Secondary | Change From Baseline in Immunoglobulin (Ig)G Level (Spike Wild Type [WT] Variant) | Sera were analyzed for Spike (WT variant)-specific IgG levels pre and post administration of GRT-R910 via enzyme-linked immunosorbent assay (ELISA) and reported as ELISA laboratory units (ELU)/mL (amount of antibodies in the sample according to the unit assigned by the standard). | Immunogenicity analysis population included participants who received assigned dose(s) at baseline and had at least one available assessment at post-baseline. Participants with available data were analyzed. Data from timepoints collected after reported COVID-19 diagnosis or receipt of external vaccine were excluded. | Posted | Mean | Standard Deviation | ELU/mL | Baseline, Days 15, 29, 57, 58, 86, 113, 142, 180, 209, 293, 365, 394, 478 |
|
|
|
| Secondary | Change From Baseline in Neutralizing Antibody (nAb) Levels | Neutralizing antibody titers against live virus were assessed via microneutralization assay. Neutralizing antibody levels were measured for the following variants: WT, Alpha, Beta, Delta, Gamma. | Participants in immunogenicity analysis population with available data were analyzed. Data from timepoints collected after reported COVID-19 diagnosis or receipt of external vaccine were excluded. | Posted | Mean | Standard Deviation | titers | For WT: Baseline, Days 15, 29, 57, 58, 86, 113, 142, 180, 209 293, 365, 394, 478; For Alpha, Beta, Delta, Gamma:Baseline, Days 15, 29, 57, 58, 86, 113, 142, 180, 209 293, 365, 394 |
|
|
|
| Secondary | Number of Participants With Immunogenicity Response by Spike IgG and nAb Variants | Immunogenicity response defined as >= 2-fold change in the levels from baseline. Response rate was assessed by Spike IgG wild type and nAb Variants [wild type, alpha, beta, gamma, delta]. Number of participants with immunogenicity response at any post-baseline timepoint are provided. | Participants in immunogenicity analysis population with available data were analyzed. Data from timepoints collected after reported COVID-19 diagnosis or receipt of external vaccine were excluded. | Posted | Count of Participants | Participants | No | Baseline to 478 days |
|
|
|
| Secondary | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Peripheral blood mononuclear cells (PBMCs) were isolated from whole blood. T cell responses to SARS-CoV-2 D614G were assessed via ex vivo IFNγ ELISpot assay (methods). Cells were stimulated with overlapping peptide (OLP) pools containing peptides that were 15 amino acids in length (15mers) and spanning both S subunits (Spike pool 1-2, 3-4 [S1], 5-6, and 7-8 [S2]). | Participants in immunogenicity analysis population with available data were analyzed. Data from timepoints collected after reported COVID-19 diagnosis or receipt of external vaccine were excluded. | Posted | Mean | Standard Deviation | Spot Forming Unit (SFU) per 10^6 cells | Baseline, Days 8, 29, 58, 113, 142, 180, 209, 293, 365, 478 |
|
|
|
| Secondary | Change From Baseline in T Cell Response by T Cell Epitope (TCE) Pools (ex Vivo ELISpot) | PBMCs were isolated from whole blood. T cell responses to conserved SARS-CoV-2 viral epitopes were assessed via ex vivo IFNγ ELISpot assay (methods). Responses to Nucleocapsid (Nuc) and open reading frame 3a (ORF3a)/Membrane TCE regions were assessed using OLP pools. | Participants in immunogenicity analysis population with available data were analyzed. Data from timepoints collected after reported COVID-19 diagnosis or receipt of external vaccine were excluded. | Posted | Mean | Standard Deviation | SFU per 10^6 cells | Baseline, Days 8, 29, 58, 113, 142, 180, 209, 293, 365, 478 |
|
|
|
| Secondary | Change From Baseline in Immunogenicity Response by TCE Pools (in Vitro Stimulation) | PBMCs were isolated from whole blood. T cell responses to conserved SARS-CoV-2 viral epitopes were assessed via IFNγ ELISpot assay following in vitro stimulation. Responses to Nuc, ORF3a, and membrane TCE regions were assessed using OLP pools. | Participants in immunogenicity analysis population with available data were analyzed. Data from timepoints collected after reported COVID-19 diagnosis or receipt of external vaccine were excluded. | Posted | Mean | Standard Deviation | SFU per 10^6 cells | Baseline, Days 8, 29, 58, 113, 142, 180, 209, 293 |
|
|
|
| Secondary | Number of Participants With Immunogenicity Response by Spike Pools and TCE Pools (ex Vivo ELISpot) | T cell responses to SARS-CoV-2 D614G and conserved non-Spike epitopes were assessed via ex vivo IFNγ ELISpot assay (methods) using OLP pools containing peptides that were 15 amino acids in length and spanning both S subunits (Spike pool 1-2, 3-4 [S1], 5-6, and 7-8 [S2]) and TCE regions Nuc and ORF3a/Membrane. Immunogenicity response was defined as >= 2-fold change in levels from baseline. Response rate to both Spike pools (Spike pool 1-2, 3-4, 5-6, and 7-8) and TCE pools (Nuc OLP and ORF3a/Membrane OLP) was assessed. | Participants in immunogenicity analysis population with available data were analyzed. Data from timepoints collected after reported COVID-19 diagnosis or receipt of external vaccine were excluded. | Posted | Count of Participants | Participants | No | Baseline to 478 days |
|
|
|
| 0 |
| 10 |
| 2 |
| 10 |
| 10 |
| 10 |
| EG001 | Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Healthy participants of age ≥60 years received prime dose (on Day 1) of GRT-R910 30 µg intramuscularly at least 2 months after receiving a first-generation COVID-19 (AstraZeneca) vaccine primary series. A subset of participants elected to receive a booster vaccination of GRT-R910 10 µg, which was administered 113 days after the prime vaccination. Participants not receiving booster dose were followed for 12 months, and participants receiving booster dose were followed for 16 months. | 0 | 7 | 1 | 7 | 7 | 7 |
| EG002 | Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Healthy participants of age ≥60 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving an adenoviral COVID-19 (AstraZeneca, Janssen) primary series vaccine. Participants were followed for 13 months. | 0 | 10 | 0 | 10 | 10 | 10 |
| EG003 | Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Healthy participants of age ≥60 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving a messenger ribonucleic acid (mRNA)-based COVID-19 (Pfizer/BioNTech, Moderna) primary series vaccine. Participants were followed for 13 months. | 0 | 10 | 2 | 10 | 10 | 10 |
| EG004 | Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Healthy participants of age ≥18 to ≤59 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving mRNA-based COVID-19 (Pfizer/BioNTech, Moderna) primary series vaccine. Participants were followed for 13 months. | 0 | 3 | 0 | 3 | 3 | 3 |
| Coronary artery disease | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
|
| Diffuse large B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
|
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
|
| Prostate cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
|
| Pneumonia bacterial | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
|
| Atrioventricular block first degree | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
|
| Bundle branch block left | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
|
| Ocular hyperaemia | Eye disorders | MedDRA 26.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 26.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 26.0 | Systematic Assessment |
|
| Feverish (Chills/Sweating) | General disorders | MedDRA 26.0 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 26.0 | Systematic Assessment |
|
| Headache | General disorders | MedDRA 26.0 | Systematic Assessment |
|
| Muscle Pain | General disorders | MedDRA 26.0 | Systematic Assessment |
|
| Arthralgia | General disorders | MedDRA 26.0 | Systematic Assessment |
|
| Nausea or Vomiting | General disorders | MedDRA 26.0 | Systematic Assessment |
|
| Injection site swelling | General disorders | MedDRA 26.0 | Systematic Assessment |
|
| Fever | General disorders | MedDRA 26.0 | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA 26.0 | Systematic Assessment |
|
| Injection site bruising | General disorders | MedDRA 26.0 | Systematic Assessment |
|
| Injection site pruritus | General disorders | MedDRA 26.0 | Systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
|
| Acute sinusitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
|
| Immunisation reaction | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
|
| Epicondylitis | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
|
| Electrocardiogram QT prolonged | Investigations | MedDRA 26.0 | Systematic Assessment |
|
| Lipase increased | Investigations | MedDRA 26.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 26.0 | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
|
Not provided
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| Eosinophils : Baseline |
|
| Eosinophils : Change at Day 8 |
|
| Lymphocytes : Baseline |
|
| Lymphocytes : Change at Day 8 |
|
| Monocytes : Baseline |
|
| Monocytes : Change at Day 8 |
|
| Neutrophils : Baseline |
|
| Neutrophils : Change at Day 8 |
|
| Platelets : Baseline |
|
| Platelets : Change at Day 8 |
|
| Leukocytes : Baseline |
|
| Leukocytes : Change at Day 8 |
|
| Eosinophils : Baseline |
|
| Eosinophils : Change at Day 8 |
|
| Lymphocytes : Baseline |
|
| Lymphocytes : Change at Day 8 |
|
| Monocytes : Baseline |
|
| Monocytes : Change at Day 8 |
|
| Neutrophils : Baseline |
|
| Neutrophils : Change at Day 8 |
|
| Platelets : Baseline |
|
| Platelets : Change at Day 8 |
|
| Leukocytes : Baseline |
|
| Leukocytes : Change at Day 8 |
|
| Eosinophils : Baseline |
|
| Eosinophils : Change at Day 120 |
|
| Lymphocytes : Baseline |
|
| Lymphocytes : Change at Day 120 |
|
| Monocytes : Baseline |
|
| Monocytes : Change at Day 120 |
|
| Neutrophils : Baseline |
|
| Neutrophils : Change at Day 120 |
|
| Platelets : Baseline |
|
| Platelets : Change at Day 120 |
|
| Leukocytes : Baseline |
|
| Leukocytes : Change at Day 120 |
|
|
| Eosinophils : Baseline |
|
| Eosinophils : Change at Day 8 |
|
| Lymphocytes : Baseline |
|
| Lymphocytes : Change at Day 8 |
|
| Monocytes : Baseline |
|
| Monocytes : Change at Day 8 |
|
| Neutrophils : Baseline |
|
| Neutrophils : Change at Day 8 |
|
| Platelets : Baseline |
|
| Platelets : Change at Day 8 |
|
| Leukocytes : Baseline |
|
| Leukocytes : Change at Day 8 |
|
|
| Eosinophils : Baseline |
|
| Eosinophils : Change at Day 37 |
|
| Lymphocytes : Baseline |
|
| Lymphocytes : Change at Day 37 |
|
| Monocytes : Baseline |
|
| Monocytes : Change at Day 37 |
|
| Neutrophils : Baseline |
|
| Neutrophils : Change at Day 37 |
|
| Platelets : Baseline |
|
| Platelets : Change at Day 37 |
|
| Leukocytes : Baseline |
|
| Leukocytes : Change at Day 37 |
|
|
|
| Alanine Aminotransferase : Baseline |
|
| Alanine Aminotransferase : Change at Day 8 |
|
| Aspartate Aminotransferase : Baseline |
|
| Aspartate Aminotransferase : Change at Day 8 |
|
| Alkaline Phosphatase : Change at Day 8 |
|
|
| Alanine Aminotransferase : Baseline |
|
|
| Alanine Aminotransferase : Change at Day 8 |
|
|
| Aspartate Aminotransferase : Baseline |
|
|
| Aspartate Aminotransferase : Change at Day 8 |
|
|
| Alkaline Phosphatase : Change at Day 120 |
|
|
| Alanine Aminotransferase : Baseline |
|
|
| Alanine Aminotransferase : Change at Day 120 |
|
|
| Aspartate Aminotransferase : Baseline |
|
|
| Aspartate Aminotransferase : Change at Day 120 |
|
|
| Alkaline Phosphatase : Change at Day 8 |
|
|
| Alanine Aminotransferase : Baseline |
|
|
| Alanine Aminotransferase : Change at Day 8 |
|
|
| Aspartate Aminotransferase : Baseline |
|
|
| Aspartate Aminotransferase : Change at Day 8 |
|
|
| Alkaline Phosphatase : Change at Day 37 |
|
|
| Alanine Aminotransferase : Baseline |
|
|
| Alanine Aminotransferase : Change at Day 37 |
|
|
| Aspartate Aminotransferase : Baseline |
|
|
| Aspartate Aminotransferase : Change at Day 37 |
|
|
| Creatinine : Baseline |
|
| Creatinine : Change at Day 8 |
|
| Creatinine : Baseline |
|
| Creatinine : Change at Day 8 |
|
| Creatinine : Baseline |
|
| Creatinine : Change at Day 120 |
|
| Bilirubin : Change at Day 8 |
|
|
| Creatinine : Baseline |
|
|
| Creatinine : Change at Day 8 |
|
|
| Bilirubin : Change at Day 37 |
|
|
| Creatinine : Baseline |
|
|
| Creatinine : Change at Day 37 |
|
|
|
| Creatine Kinase : Change at Day 37 |
|
|
| All AESIs |
|
| MAAEs |
|
| Severe COVID-19 |
|
| PIMMCs |
|
| NOCMCs |
|
| Serologically or Virologically Confirmed Relevant to COVID-19 |
|
|
| Change at Day 15 |
|
|
| Change at Day 29 |
|
|
| Change at Day 57 |
|
|
| Change at Day 58 |
|
|
| Change at Day 86 |
|
|
| Change at Day 113 |
|
|
| Change at Day 142 |
|
|
| Change at Day 180 |
|
|
| Change at Day 209 |
|
|
| Change at Day 293 |
|
|
| Change at Day 365 |
|
|
| Change at Day 394 |
|
|
| Change at Day 478 |
|
|
|
| Spike WT Variant : Change at Day 15 |
|
|
| Spike WT Variant : Change at Day 29 |
|
|
| Spike WT Variant : Change at Day 57 |
|
|
| Spike WT Variant : Change at Day 58 |
|
|
| Spike WT Variant : Change at Day 86 |
|
|
| Spike WT Variant : Change at Day 113 |
|
|
| Spike WT Variant : Change at Day 142 |
|
|
| Spike WT Variant : Change at Day 180 |
|
|
| Spike WT Variant : Change at Day 209 |
|
|
| Spike WT Variant : Change at Day 293 |
|
|
| Spike WT Variant : Change at Day 365 |
|
|
| Spike WT Variant : Change at Day 394 |
|
|
| Spike WT Variant : Change at Day 478 |
|
|
| Spike Alpha Variant : Baseline |
|
|
| Spike Alpha Variant : Change at Day 15 |
|
|
| Spike Alpha Variant : Change at Day 29 |
|
|
| Spike Alpha Variant : Change at Day 57 |
|
|
| Spike Alpha Variant : Change at Day 58 |
|
|
| Spike Alpha Variant : Change at Day 86 |
|
|
| Spike Alpha Variant : Change at Day 113 |
|
|
| Spike Alpha Variant : Change at Day 142 |
|
|
| Spike Alpha Variant : Change at Day 180 |
|
|
| Spike Alpha Variant : Change at Day 209 |
|
|
| Spike Alpha Variant : Change at Day 293 |
|
|
| Spike Alpha Variant : Change at Day 365 |
|
|
| Spike Alpha Variant : Change at Day 394 |
|
|
| Spike Beta Variant : Baseline |
|
|
| Spike Beta Variant : Change at Day 15 |
|
|
| Spike Beta Variant : Change at Day 29 |
|
|
| Spike Beta Variant : Change at Day 57 |
|
|
| Spike Beta Variant : Change at Day 58 |
|
|
| Spike Beta Variant : Change at Day 86 |
|
|
| Spike Beta Variant : Change at Day 113 |
|
|
| Spike Beta Variant : Change at Day 142 |
|
|
| Spike Beta Variant : Change at Day 180 |
|
|
| Spike Beta Variant : Change at Day 209 |
|
|
| Spike Beta Variant : Change at Day 293 |
|
|
| Spike Beta Variant : Change at Day 365 |
|
|
| Spike Beta Variant : Change at Day 394 |
|
|
| Spike Delta Variant : Baseline |
|
|
| Spike Delta Variant : Change at Day 15 |
|
|
| Spike Delta Variant : Change at Day 29 |
|
|
| Spike Delta Variant : Change at Day 57 |
|
|
| Spike Delta Variant : Change at Day 58 |
|
|
| Spike Delta Variant : Change at Day 86 |
|
|
| Spike Delta Variant : Change at Day 113 |
|
|
| Spike Delta Variant : Change at Day 142 |
|
|
| Spike Delta Variant : Change at Day 180 |
|
|
| Spike Delta Variant : Change at Day 209 |
|
|
| Spike Delta Variant : Change at Day 293 |
|
|
| Spike Delta Variant : Change at Day 365 |
|
|
| Spike Delta Variant : Change at Day 394 |
|
|
| Spike Gamma Variant : Baseline |
|
|
| Spike Gamma Variant : Change at Day 15 |
|
|
| Spike Gamma Variant : Change at Day 29 |
|
|
| Spike Gamma Variant : Change at Day 57 |
|
|
| Spike Gamma Variant : Change at Day 58 |
|
|
| Spike Gamma Variant : Change at Day 86 |
|
|
| Spike Gamma Variant : Change at Day 113 |
|
|
| Spike Gamma Variant : Change at Day 142 |
|
|
| Spike Gamma Variant : Change at Day 180 |
|
|
| Spike Gamma Variant : Change at Day 209 |
|
|
| Spike Gamma Variant : Change at Day 293 |
|
|
| Spike Gamma Variant : Change at Day 365 |
|
|
| Spike Gamma Variant : Change at Day 394 |
|
|
|
| nAb WT |
|
|
| nAb Alpha |
|
|
| nAb Beta |
|
|
| nAb Delta |
|
|
| nAb Gamma |
|
|
|
| Spike pool 1_2 : Change at Day 8 |
|
|
| Spike pool 1_2 : Change at Day 29 |
|
|
| Spike pool 1_2 : Change at Day 58 |
|
|
| Spike pool 1_2 : Change at Day 113 |
|
|
| Spike pool 1_2 : Change at Day 142 |
|
|
| Spike pool 1_2 : Change at Day 180 |
|
|
| Spike pool 1_2 : Change at Day 209 |
|
|
| Spike pool 1_2 : Change at Day 293 |
|
|
| Spike pool 1_2 : Change at Day 365 |
|
|
| Spike pool 1_2 : Change at Day 478 |
|
|
| Spike pool 3_4 : Baseline |
|
|
| Spike pool 3_4 : Change at Day 8 |
|
|
| Spike pool 3_4 : Change at Day 29 |
|
|
| Spike pool 3_4 : Change at Day 58 |
|
|
| Spike pool 3_4 : Change at Day 113 |
|
|
| Spike pool 3_4 : Change at Day 142 |
|
|
| Spike pool 3_4 : Change at Day 180 |
|
|
| Spike pool 3_4 : Change at Day 209 |
|
|
| Spike pool 3_4 : Change at Day 293 |
|
|
| Spike pool 3_4 : Change at Day 365 |
|
| Spike pool 3_4 : Change at Day 478 |
|
|
| Spike pool 5_6 : Baseline |
|
|
| Spike pool 5_6 : Change at Day 8 |
|
|
| Spike pool 5_6 : Change at Day 29 |
|
|
| Spike pool 5_6 : Change at Day 58 |
|
|
| Spike pool 5_6 : Change at Day 113 |
|
|
| Spike pool 5_6 : Change at Day 142 |
|
|
| Spike pool 5_6 : Change at Day 180 |
|
|
| Spike pool 5_6 : Change at Day 209 |
|
|
| Spike pool 5_6 : Change at Day 293 |
|
|
| Spike pool 5_6 : Change at Day 365 |
|
| Spike pool 5_6 : Change at Day 478 |
|
|
| Spike pool 7_8 : Baseline |
|
|
| Spike pool 7_8 : Change at Day 8 |
|
|
| Spike pool 7_8 : Change at Day 29 |
|
|
| Spike pool 7_8 : Change at Day 58 |
|
|
| Spike pool 7_8 : Change at Day 113 |
|
|
| Spike pool 7_8 : Change at Day 142 |
|
|
| Spike pool 7_8 : Change at Day 180 |
|
|
| Spike pool 7_8 : Change at Day 209 |
|
|
| Spike pool 7_8 : Change at Day 293 |
|
|
| Spike pool 7_8 : Change at Day 365 |
|
| Spike pool 7_8 : Change at Day 478 |
|
|
|
| Nuc OLP : Change at Day 8 |
|
|
| Nuc OLP : Change at Day 29 |
|
|
| Nuc OLP : Change at Day 58 |
|
|
| Nuc OLP : Change at Day 113 |
|
|
| Nuc OLP : Change at Day 142 |
|
|
| Nuc OLP : Change at Day 180 |
|
|
| Nuc OLP : Change at Day 209 |
|
|
| Nuc OLP : Change at Day 293 |
|
|
| Nuc OLP : Change at Day 365 |
|
| Nuc OLP : Change at Day 478 |
|
| ORF3a/Membrane OLP : Baseline |
|
|
| ORF3a/Membrane OLP : Change at Day 8 |
|
|
| ORF3a/Membrane OLP : Change at Day 29 |
|
|
| ORF3a/Membrane OLP : Change at Day 58 |
|
|
| ORF3a/Membrane OLP : Change at Day 113 |
|
|
| ORF3a/Membrane OLP : Change at Day 142 |
|
|
| ORF3a/Membrane OLP : Change at Day 180 |
|
|
| ORF3a/Membrane OLP : Change at Day 209 |
|
|
| ORF3a/Membrane OLP : Change at Day 293 |
|
|
| ORF3a/Membrane OLP : Change at Day 365 |
|
| ORF3a/Membrane OLP : Change at Day 478 |
|
|
| Nuc OLP : Change at Day 8 |
|
|
| Nuc OLP : Change at Day 29 |
|
|
| Nuc OLP : Change at Day 58 |
|
|
| Nuc OLP : Change at Day 113 |
|
|
| Nuc OLP : Change at Day 142 |
|
|
| Nuc OLP : Change at Day 180 |
|
|
| Nuc OLP : Change at Day 209 |
|
|
| Nuc OLP : Change at Day 293 |
|
|
| ORF3a OLP : Baseline |
|
|
| ORF3a OLP : Change at Day 8 |
|
|
| ORF3a OLP : Change at Day 29 |
|
|
| ORF3a OLP : Change at Day 58 |
|
|
| ORF3a OLP : Change at Day 113 |
|
|
| ORF3a OLP : Change at Day 142 |
|
|
| ORF3a OLP : Change at Day 180 |
|
|
| ORF3a OLP : Change at Day 209 |
|
|
| ORF3a OLP : Change at Day 293 |
|
|
| Membrane OLP : Baseline |
|
|
| Membrane OLP : Change at Day 8 |
|
|
| Membrane OLP : Change at Day 29 |
|
|
| Membrane OLP : Change at Day 58 |
|
|
| Membrane OLP : Change at Day 113 |
|
|
| Membrane OLP : Change at Day 142 |
|
|
| Membrane OLP : Change at Day 180 |
|
|
| Membrane OLP : Change at Day 209 |
|
|
| Membrane OLP : Change at Day 293 |
|
|
|
| Spike Pool 3_4 |
|
|
| Spike Pool 5_6 |
|
|
| Spike Pool 7_8 |
|
|
| TCE Pool : Nuc OLP |
|
|
| TCE Pool : Mem/ORF3a OLP |
|
|