COVID-19
Conditions
Keywords
SARS-CoV-2 vaccine, Coronavirus Disease (COVID-19)
Brief summary
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.
Detailed description
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).
Interventions
BIOLOGICALGRT-R910
Injection administered intramuscularly
Sponsors
Gritstone bio, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* For Cohorts 1 and 2, have received AstraZeneca's AZD1222 COVID-19 prime and boost vaccine (Covishield®, Vaxzevria®), with the last dose received at least 2 months or more prior to Day 1. * For Cohort 3, have received a primary series of an adenoviral (AstraZeneca AZD1222 \[Covishield®, Vaxzevria®\] or Janssen \[Janssen COVID-19 Vaccine\]) COVID-19 vaccine (under emergency supply procedures or upon full approval and may have received booster doses of an authorized vaccine), with the last dose received at least 2 months or more prior to Day 1. * For Cohorts 4 and 6, have received a primary series of an mRNA (Pfizer/BioNTech \[Comirnaty®\] or Moderna \[Spikevax®\]) COVID-19 vaccine (under emergency supply procedures or upon full approval and may have received booster doses of an authorized vaccine), with the last dose received at least 2 months or more prior to Day 1. * Agree to refrain from blood donation during the course of the study. * Women of childbearing potential (WOCBP)\* must agree to avoid pregnancy and be willing to use a highly effective method of contraception\*\* consistently for 30 days prior to the first study vaccine and for at least 60 days after the last study vaccine * Male subjects of childbearing potential must agree to the use of condoms to ensure effective contraception with a female partner from the time of study vaccination until 3 months after vaccination. Male subjects agree to refrain from sperm donation from the time of first vaccination until 3 months after the last vaccination. Male subjects of childbearing potential are biological males who are post-pubertal and considered fertile until permanently sterile by bilateral orchiectomy or vasectomy. * Plan to remain living in the area for the duration of the study.
Exclusion criteria
* History of prior confirmed COVID-19 (cohorts 1 and 2). * History of prior confirmed (polymerase chain reaction \[PCR\] or antigen test positive) COVID-19 infection as confirmed by a diagnostic laboratory less than 16 weeks (112 days) prior to enrollment (Cohorts 3, 4, and 6). * Positive for SARS-CoV-2 (N-specific) antibody testing and had a history of upper respiratory illness consistent with COVID-19 within the 112 days prior to enrollment (Cohorts 3, 4, and 6). * Prior receipt of a SARS-CoV-2 vaccine other than AstraZeneca's AZD1222 (Covishield®, Vaxzevria®), JNJ-78436735, Pfizer/BioNTech (Comirnaty®), Moderna (Spikevax®), other approved or investigational adenovirus vectored vaccines, approved or investigational vaccines with a lipid nanoparticle (LNP) component, or any other approved or investigational vaccine likely to impact the interpretation of the trial data. * On current treatment or prevention agents with activity against SARS-CoV-2. * Participation in another research study involving receipt of an investigational product in the 60 days preceding enrollment or planned use during the study period. * Receipt or planned receipt of any live, attenuated vaccine within 28 days before or after study vaccination. * Receipt or planned receipt of any subunit or killed vaccine within 14 days before or after vaccination. * Administration of immunoglobulins and/or any blood products within the 3 months preceding the planned administration of first study vaccination or at any time during the study. * Breastfeeding, pregnant, or planning to become pregnant during the course of the study. * Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection with CD4+ T-cells \< 400/mm3, asplenia, recurrent, severe infections and chronic (more than 14 continuous days) immunosuppressant medication within the past 6 months (inhaled, ophthalmic, and topical steroids are allowed). * History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, including urticaria, respiratory difficulty or abdominal pain (or any immediate allergic reaction of any severity to polysorbate due to potential cross-reactive hypersensitivity with the PEG component of the vaccine). * Any history of hereditary angioedema, acquired angioedema, or idiopathic angioedema. * Any history of anaphylaxis, including but not limited to reaction to vaccination. * History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ). * History of serious ongoing, unstable psychiatric condition that in the opinion of the investigator would interfere with study participation. * Bleeding disorder or prior history of significant bleeding or bruising following IM injections or venipuncture. * Suspected or known current alcohol abuse that in the opinion of the investigator would impede compliance with the protocol and schedules of assessments. * Suspected or known current alcohol abuse that in the opinion of the investigator would impede compliance with the protocol and schedules of assessments. Suspected or known drug abuse in the 5 years preceding enrollment. * 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 trial vaccine or interpretation of study results.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | Day 1 Up to 16 months | 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. |
| Change From Baseline in Hemoglobin at Day 37 in Cohorts 3, 4, and 6 | Baseline, Day 37 | — |
| 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 | — |
| Change From Baseline in Hemoglobin 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 8 in Participants Without Booster Dose (Cohorts 1 and 2) | Baseline, Day 8 | — |
| Number of Participants With at Least One Solicited Local Adverse Event (AE) Within 8 Days After the Injection of Prime Dose | Within 8 Days After the Injection of Prime Dose on Day 1 | 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. |
| Number of Participants With at Least One Solicited Local AE Within 8 Days After the Injection of Booster Dose | 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) | 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. |
| Number of Participants With at Least One Solicited Systemic AE Within 8 Days After the Injection of Prime Dose | Within 8 Days After the Injection of Prime Dose on Day 1 | 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. |
| Number of Participants With at Least One Solicited Systemic AE Within 8 Days After the Injection of Booster Dose | 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) | 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. |
| Number of Participants With at Least One Unsolicited Treatment-emergent AEs (TEAEs) Within 28 Days After the Injection of Prime Dose | Within 28 Days After the Injection of Prime Dose on Day 1 | 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. |
| Number of Participants With at Least One Unsolicited TEAEs Within 28 Days After the Injection of Booster Dose | 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) | 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. |
| 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 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 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Immunoglobulin (Ig)G Level (Spike Wild Type [WT] Variant) | Baseline, Days 15, 29, 57, 58, 86, 113, 142, 180, 209, 293, 365, 394, 478 | 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). |
| Change From Baseline in Neutralizing Antibody (nAb) Levels | 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 | 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. |
| Number of Participants With Immunogenicity Response by Spike IgG and nAb Variants | Baseline to 478 days | 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. |
| Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Baseline, Days 8, 29, 58, 113, 142, 180, 209, 293, 365, 478 | 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 \[S2\]). |
| Change From Baseline in T Cell Response by T Cell Epitope (TCE) Pools (ex Vivo ELISpot) | Baseline, Days 8, 29, 58, 113, 142, 180, 209, 293, 365, 478 | 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. |
| Change From Baseline in Immunogenicity Response by TCE Pools (in Vitro Stimulation) | Baseline, Days 8, 29, 58, 113, 142, 180, 209, 293 | 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. |
| Number of Participants With Immunogenicity Response by Spike Pools and TCE Pools (ex Vivo ELISpot) | Baseline to 478 days | 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. |
Countries
United Kingdom
Participant flow
Recruitment details
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).
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 10 |
| 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. | 7 |
| 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. | 10 |
| 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. | 10 |
| 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. | 3 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Miscellaneous | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Participant was early terminated per protocol | 0 | 0 | 3 | 5 | 2 |
| Overall Study | Withdrawal by Subject | 1 | 1 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 68.8 years STANDARD_DEVIATION 6.61 | 66.7 years STANDARD_DEVIATION 5.06 | 65.5 years STANDARD_DEVIATION 3.95 | 73.5 years STANDARD_DEVIATION 5.4 | 33.0 years STANDARD_DEVIATION 11.36 | 66.1 years STANDARD_DEVIATION 11.46 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants | 7 Participants | 10 Participants | 10 Participants | 3 Participants | 40 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) White | 8 Participants | 6 Participants | 9 Participants | 10 Participants | 2 Participants | 35 Participants |
| Sex: Female, Male Female | 4 Participants | 5 Participants | 4 Participants | 4 Participants | 2 Participants | 19 Participants |
| Sex: Female, Male Male | 6 Participants | 2 Participants | 6 Participants | 6 Participants | 1 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 7 | 0 / 10 | 0 / 10 | 0 / 3 |
| other Total, other adverse events | 10 / 10 | 7 / 7 | 10 / 10 | 10 / 10 | 3 / 3 |
| serious Total, serious adverse events | 2 / 10 | 1 / 7 | 0 / 10 | 2 / 10 | 0 / 3 |
Outcome results
Primary
Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 120 in Participants With Booster Dose (Cohorts 1 and 2)
Time frame: Baseline, Day 120
Population: Participants in the SAF population from Cohorts 1 and 2 who received the booster dose and who had available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 120 in Participants With Booster Dose (Cohorts 1 and 2) | Alkaline Phosphatase : Baseline | 82.5 IU/L | Standard Deviation 20.5 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 120 in Participants With Booster Dose (Cohorts 1 and 2) | Alkaline Phosphatase : Change at Day 120 | -2.8 IU/L | Standard Deviation 18.65 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 120 in Participants With Booster Dose (Cohorts 1 and 2) | Alanine Aminotransferase : Baseline | 25.5 IU/L | Standard Deviation 13.34 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 120 in Participants With Booster Dose (Cohorts 1 and 2) | Alanine Aminotransferase : Change at Day 120 | -4.0 IU/L | Standard Deviation 11.03 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 120 in Participants With Booster Dose (Cohorts 1 and 2) | Aspartate Aminotransferase : Baseline | 23.5 IU/L | Standard Deviation 8.38 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 120 in Participants With Booster Dose (Cohorts 1 and 2) | Aspartate Aminotransferase : Change at Day 120 | -0.8 IU/L | Standard Deviation 4.5 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 120 in Participants With Booster Dose (Cohorts 1 and 2) | Aspartate Aminotransferase : Baseline | 18.8 IU/L | Standard Deviation 1.5 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 120 in Participants With Booster Dose (Cohorts 1 and 2) | Alkaline Phosphatase : Baseline | 67.5 IU/L | Standard Deviation 35.75 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 120 in Participants With Booster Dose (Cohorts 1 and 2) | Alanine Aminotransferase : Change at Day 120 | 4.3 IU/L | Standard Deviation 5.68 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 120 in Participants With Booster Dose (Cohorts 1 and 2) | Alkaline Phosphatase : Change at Day 120 | -13.5 IU/L | Standard Deviation 10.41 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 120 in Participants With Booster Dose (Cohorts 1 and 2) | Aspartate Aminotransferase : Change at Day 120 | 1.0 IU/L | Standard Deviation 3.46 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 120 in Participants With Booster Dose (Cohorts 1 and 2) | Alanine Aminotransferase : Baseline | 18.3 IU/L | Standard Deviation 9.39 |
Primary
Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 37 in Cohorts 3, 4, and 6
Time frame: Baseline, Day 37
Population: Participants in SAF population from Cohorts 3, 4, and 6 with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 37 in Cohorts 3, 4, and 6 | Alkaline Phosphatase : Baseline | 75.0 IU/L | Standard Deviation 19.96 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 37 in Cohorts 3, 4, and 6 | Alkaline Phosphatase : Change at Day 37 | -7.9 IU/L | Standard Deviation 8.13 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 37 in Cohorts 3, 4, and 6 | Alanine Aminotransferase : Baseline | 25.6 IU/L | Standard Deviation 8.62 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 37 in Cohorts 3, 4, and 6 | Alanine Aminotransferase : Change at Day 37 | 0.7 IU/L | Standard Deviation 7.83 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 37 in Cohorts 3, 4, and 6 | Aspartate Aminotransferase : Baseline | 25.2 IU/L | Standard Deviation 6.27 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 37 in Cohorts 3, 4, and 6 | Aspartate Aminotransferase : Change at Day 37 | 1.9 IU/L | Standard Deviation 7.04 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 37 in Cohorts 3, 4, and 6 | Aspartate Aminotransferase : Change at Day 37 | 3.1 IU/L | Standard Deviation 8.61 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 37 in Cohorts 3, 4, and 6 | Alkaline Phosphatase : Baseline | 83.9 IU/L | Standard Deviation 20.56 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 37 in Cohorts 3, 4, and 6 | Alanine Aminotransferase : Change at Day 37 | 3.2 IU/L | Standard Deviation 6.92 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 37 in Cohorts 3, 4, and 6 | Aspartate Aminotransferase : Baseline | 26.1 IU/L | Standard Deviation 5.71 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 37 in Cohorts 3, 4, and 6 | Alkaline Phosphatase : Change at Day 37 | 0.2 IU/L | Standard Deviation 11.44 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 37 in Cohorts 3, 4, and 6 | Alanine Aminotransferase : Baseline | 25.1 IU/L | Standard Deviation 9.42 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 37 in Cohorts 3, 4, and 6 | Alkaline Phosphatase : Change at Day 37 | -1.7 IU/L | Standard Deviation 1.15 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 37 in Cohorts 3, 4, and 6 | Alanine Aminotransferase : Baseline | 14.3 IU/L | Standard Deviation 5.51 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 37 in Cohorts 3, 4, and 6 | Aspartate Aminotransferase : Change at Day 37 | -1.0 IU/L | — |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 37 in Cohorts 3, 4, and 6 | Alanine Aminotransferase : Change at Day 37 | 2.7 IU/L | Standard Deviation 0.58 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 37 in Cohorts 3, 4, and 6 | Alkaline Phosphatase : Baseline | 58.7 IU/L | Standard Deviation 6.81 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 37 in Cohorts 3, 4, and 6 | Aspartate Aminotransferase : Baseline | 21.5 IU/L | Standard Deviation 2.12 |
Primary
Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 8 in Cohorts 3, 4, and 6
Time frame: Baseline, Day 8
Population: Participants in SAF population from Cohorts 3, 4, and 6 with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 8 in Cohorts 3, 4, and 6 | Alkaline Phosphatase : Baseline | 75.0 IU/L | Standard Deviation 19.96 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 8 in Cohorts 3, 4, and 6 | Alkaline Phosphatase : Change at Day 8 | 7.7 IU/L | Standard Deviation 10.67 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 8 in Cohorts 3, 4, and 6 | Alanine Aminotransferase : Baseline | 25.6 IU/L | Standard Deviation 8.62 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 8 in Cohorts 3, 4, and 6 | Alanine Aminotransferase : Change at Day 8 | -0.4 IU/L | Standard Deviation 5.17 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 8 in Cohorts 3, 4, and 6 | Aspartate Aminotransferase : Baseline | 25.2 IU/L | Standard Deviation 6.27 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 8 in Cohorts 3, 4, and 6 | Aspartate Aminotransferase : Change at Day 8 | -0.1 IU/L | Standard Deviation 4.51 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 8 in Cohorts 3, 4, and 6 | Aspartate Aminotransferase : Change at Day 8 | 1.9 IU/L | Standard Deviation 8.55 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 8 in Cohorts 3, 4, and 6 | Alkaline Phosphatase : Baseline | 83.9 IU/L | Standard Deviation 20.56 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 8 in Cohorts 3, 4, and 6 | Alanine Aminotransferase : Change at Day 8 | 7.2 IU/L | Standard Deviation 15.1 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 8 in Cohorts 3, 4, and 6 | Aspartate Aminotransferase : Baseline | 26.1 IU/L | Standard Deviation 5.71 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 8 in Cohorts 3, 4, and 6 | Alkaline Phosphatase : Change at Day 8 | -6.8 IU/L | Standard Deviation 13.1 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 8 in Cohorts 3, 4, and 6 | Alanine Aminotransferase : Baseline | 25.1 IU/L | Standard Deviation 9.42 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 8 in Cohorts 3, 4, and 6 | Alkaline Phosphatase : Change at Day 8 | -4.7 IU/L | Standard Deviation 1.15 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 8 in Cohorts 3, 4, and 6 | Alanine Aminotransferase : Baseline | 14.3 IU/L | Standard Deviation 5.51 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 8 in Cohorts 3, 4, and 6 | Aspartate Aminotransferase : Change at Day 8 | 1.5 IU/L | Standard Deviation 9.19 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 8 in Cohorts 3, 4, and 6 | Alanine Aminotransferase : Change at Day 8 | 10.0 IU/L | Standard Deviation 14.73 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 8 in Cohorts 3, 4, and 6 | Alkaline Phosphatase : Baseline | 58.7 IU/L | Standard Deviation 6.81 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 8 in Cohorts 3, 4, and 6 | Aspartate Aminotransferase : Baseline | 21.5 IU/L | Standard Deviation 2.12 |
Primary
Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 8 in Participants With Booster Dose (Cohorts 1 and 2)
Time frame: Baseline, Day 8
Population: Participants in the SAF population from Cohorts 1 and 2 who received the booster dose and who had available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 8 in Participants With Booster Dose (Cohorts 1 and 2) | Alkaline Phosphatase : Baseline | 82.5 IU/L | Standard Deviation 20.5 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 8 in Participants With Booster Dose (Cohorts 1 and 2) | Alkaline Phosphatase : Change at Day 8 | 4.8 IU/L | Standard Deviation 22.97 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 8 in Participants With Booster Dose (Cohorts 1 and 2) | Alanine Aminotransferase : Baseline | 25.5 IU/L | Standard Deviation 13.34 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 8 in Participants With Booster Dose (Cohorts 1 and 2) | Alanine Aminotransferase : Change at Day 8 | 2.5 IU/L | Standard Deviation 14.54 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 8 in Participants With Booster Dose (Cohorts 1 and 2) | Aspartate Aminotransferase : Baseline | 23.5 IU/L | Standard Deviation 8.38 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 8 in Participants With Booster Dose (Cohorts 1 and 2) | Aspartate Aminotransferase : Change at Day 8 | 0.6 IU/L | Standard Deviation 6.66 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 8 in Participants With Booster Dose (Cohorts 1 and 2) | Aspartate Aminotransferase : Baseline | 18.8 IU/L | Standard Deviation 1.5 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 8 in Participants With Booster Dose (Cohorts 1 and 2) | Alkaline Phosphatase : Baseline | 67.5 IU/L | Standard Deviation 35.75 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 8 in Participants With Booster Dose (Cohorts 1 and 2) | Alanine Aminotransferase : Change at Day 8 | 3.5 IU/L | Standard Deviation 8.66 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 8 in Participants With Booster Dose (Cohorts 1 and 2) | Alkaline Phosphatase : Change at Day 8 | -12.5 IU/L | Standard Deviation 8.96 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 8 in Participants With Booster Dose (Cohorts 1 and 2) | Aspartate Aminotransferase : Change at Day 8 | 3.0 IU/L | Standard Deviation 4.08 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 8 in Participants With Booster Dose (Cohorts 1 and 2) | Alanine Aminotransferase : Baseline | 18.3 IU/L | Standard Deviation 9.39 |
Primary
Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2)
Time frame: Baseline, Day 8
Population: Participants in the SAF population from Cohorts 1 and 2 who did not receive the booster dose were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2) | Alkaline Phosphatase : Baseline | 75.0 International Units Per Liter (IU/L) | Standard Deviation 14.63 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2) | Alkaline Phosphatase : Change at Day 8 | 4.8 International Units Per Liter (IU/L) | Standard Deviation 13.35 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2) | Alanine Aminotransferase : Baseline | 22.3 International Units Per Liter (IU/L) | Standard Deviation 7.63 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2) | Alanine Aminotransferase : Change at Day 8 | 11.8 International Units Per Liter (IU/L) | Standard Deviation 29.93 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2) | Aspartate Aminotransferase : Baseline | 24.5 International Units Per Liter (IU/L) | Standard Deviation 5.2 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2) | Aspartate Aminotransferase : Change at Day 8 | 5.3 International Units Per Liter (IU/L) | Standard Deviation 11.35 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2) | Aspartate Aminotransferase : Baseline | 18.7 International Units Per Liter (IU/L) | Standard Deviation 2.89 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2) | Alkaline Phosphatase : Baseline | 81.3 International Units Per Liter (IU/L) | Standard Deviation 24.01 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2) | Alanine Aminotransferase : Change at Day 8 | 38.7 International Units Per Liter (IU/L) | Standard Deviation 39.32 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2) | Alkaline Phosphatase : Change at Day 8 | 1.7 International Units Per Liter (IU/L) | Standard Deviation 8.33 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2) | Aspartate Aminotransferase : Change at Day 8 | 14.7 International Units Per Liter (IU/L) | Standard Deviation 10.97 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2) | Alanine Aminotransferase : Baseline | 17.3 International Units Per Liter (IU/L) | Standard Deviation 3.51 |
Primary
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 120 in Participants With Booster Dose (Cohorts 1 and 2)
Time frame: Baseline, Day 120
Population: Participants in the SAF population from Cohorts 1 and 2 who received the booster dose were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 120 in Participants With Booster Dose (Cohorts 1 and 2) | Basophils : Baseline | 0.040 10^9 cells per liter | Standard Deviation 0.0126 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 120 in Participants With Booster Dose (Cohorts 1 and 2) | Basophils : Change at Day 120 | -0.013 10^9 cells per liter | Standard Deviation 0.0103 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 120 in Participants With Booster Dose (Cohorts 1 and 2) | Eosinophils : Baseline | 0.128 10^9 cells per liter | Standard Deviation 0.1783 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 120 in Participants With Booster Dose (Cohorts 1 and 2) | Eosinophils : Change at Day 120 | 0.032 10^9 cells per liter | Standard Deviation 0.0581 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 120 in Participants With Booster Dose (Cohorts 1 and 2) | Lymphocytes : Baseline | 1.510 10^9 cells per liter | Standard Deviation 0.3653 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 120 in Participants With Booster Dose (Cohorts 1 and 2) | Lymphocytes : Change at Day 120 | 0.192 10^9 cells per liter | Standard Deviation 0.1873 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 120 in Participants With Booster Dose (Cohorts 1 and 2) | Monocytes : Baseline | 0.490 10^9 cells per liter | Standard Deviation 0.1456 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 120 in Participants With Booster Dose (Cohorts 1 and 2) | Monocytes : Change at Day 120 | -0.040 10^9 cells per liter | Standard Deviation 0.0363 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 120 in Participants With Booster Dose (Cohorts 1 and 2) | Neutrophils : Baseline | 5.205 10^9 cells per liter | Standard Deviation 1.3505 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 120 in Participants With Booster Dose (Cohorts 1 and 2) | Neutrophils : Change at Day 120 | -2.040 10^9 cells per liter | Standard Deviation 0.8313 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 120 in Participants With Booster Dose (Cohorts 1 and 2) | Platelets : Baseline | 269.0 10^9 cells per liter | Standard Deviation 95.68 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 120 in Participants With Booster Dose (Cohorts 1 and 2) | Platelets : Change at Day 120 | -21.3 10^9 cells per liter | Standard Deviation 36.79 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 120 in Participants With Booster Dose (Cohorts 1 and 2) | Leukocytes : Baseline | 7.37 10^9 cells per liter | Standard Deviation 1.325 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 120 in Participants With Booster Dose (Cohorts 1 and 2) | Leukocytes : Change at Day 120 | -1.87 10^9 cells per liter | Standard Deviation 0.898 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 120 in Participants With Booster Dose (Cohorts 1 and 2) | Platelets : Baseline | 271.8 10^9 cells per liter | Standard Deviation 21.36 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 120 in Participants With Booster Dose (Cohorts 1 and 2) | Basophils : Baseline | 0.063 10^9 cells per liter | Standard Deviation 0.0359 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 120 in Participants With Booster Dose (Cohorts 1 and 2) | Monocytes : Change at Day 120 | -0.108 10^9 cells per liter | Standard Deviation 0.1646 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 120 in Participants With Booster Dose (Cohorts 1 and 2) | Basophils : Change at Day 120 | -0.030 10^9 cells per liter | Standard Deviation 0.0163 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 120 in Participants With Booster Dose (Cohorts 1 and 2) | Leukocytes : Baseline | 6.40 10^9 cells per liter | Standard Deviation 1.679 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 120 in Participants With Booster Dose (Cohorts 1 and 2) | Eosinophils : Baseline | 0.143 10^9 cells per liter | Standard Deviation 0.0846 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 120 in Participants With Booster Dose (Cohorts 1 and 2) | Neutrophils : Baseline | 4.003 10^9 cells per liter | Standard Deviation 1.3023 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 120 in Participants With Booster Dose (Cohorts 1 and 2) | Eosinophils : Change at Day 120 | -0.013 10^9 cells per liter | Standard Deviation 0.0263 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 120 in Participants With Booster Dose (Cohorts 1 and 2) | Platelets : Change at Day 120 | -31.5 10^9 cells per liter | Standard Deviation 54.86 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 120 in Participants With Booster Dose (Cohorts 1 and 2) | Lymphocytes : Baseline | 1.610 10^9 cells per liter | Standard Deviation 0.335 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 120 in Participants With Booster Dose (Cohorts 1 and 2) | Neutrophils : Change at Day 120 | -1.170 10^9 cells per liter | Standard Deviation 0.3218 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 120 in Participants With Booster Dose (Cohorts 1 and 2) | Lymphocytes : Change at Day 120 | -0.143 10^9 cells per liter | Standard Deviation 0.1477 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 120 in Participants With Booster Dose (Cohorts 1 and 2) | Leukocytes : Change at Day 120 | -1.50 10^9 cells per liter | Standard Deviation 0.392 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 120 in Participants With Booster Dose (Cohorts 1 and 2) | Monocytes : Baseline | 0.558 10^9 cells per liter | Standard Deviation 0.2152 |
Primary
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 37 in Cohorts 3, 4, and 6
Time frame: Baseline, Day 37
Population: Participants in the SAF population from Cohorts 3, 4 and 6 were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 37 in Cohorts 3, 4, and 6 | Platelets : Baseline | 230.2 10^9 cells per liter | Standard Deviation 30.53 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 37 in Cohorts 3, 4, and 6 | Lymphocytes : Change at Day 37 | 0.021 10^9 cells per liter | Standard Deviation 0.338 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 37 in Cohorts 3, 4, and 6 | Eosinophils : Baseline | 0.123 10^9 cells per liter | Standard Deviation 0.1311 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 37 in Cohorts 3, 4, and 6 | Neutrophils : Change at Day 37 | -0.136 10^9 cells per liter | Standard Deviation 0.8558 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 37 in Cohorts 3, 4, and 6 | Monocytes : Baseline | 0.481 10^9 cells per liter | Standard Deviation 0.1194 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 37 in Cohorts 3, 4, and 6 | Basophils : Change at Day 37 | -0.013 10^9 cells per liter | Standard Deviation 0.0116 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 37 in Cohorts 3, 4, and 6 | Neutrophils : Baseline | 3.701 10^9 cells per liter | Standard Deviation 1.4781 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 37 in Cohorts 3, 4, and 6 | Monocytes : Change at Day 37 | 0.033 10^9 cells per liter | Standard Deviation 0.1585 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 37 in Cohorts 3, 4, and 6 | Platelets : Change at Day 37 | 37.4 10^9 cells per liter | Standard Deviation 65.25 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 37 in Cohorts 3, 4, and 6 | Eosinophils : Change at Day 37 | 0.013 10^9 cells per liter | Standard Deviation 0.0523 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 37 in Cohorts 3, 4, and 6 | Leukocytes : Change at Day 37 | -0.070 10^9 cells per liter | Standard Deviation 0.99 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 37 in Cohorts 3, 4, and 6 | Basophils : Baseline | 0.047 10^9 cells per liter | Standard Deviation 0.025 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 37 in Cohorts 3, 4, and 6 | Lymphocytes : Baseline | 1.574 10^9 cells per liter | Standard Deviation 0.461 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 37 in Cohorts 3, 4, and 6 | Leukocytes : Baseline | 5.920 10^9 cells per liter | Standard Deviation 1.7261 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 37 in Cohorts 3, 4, and 6 | Platelets : Baseline | 249.4 10^9 cells per liter | Standard Deviation 59.23 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 37 in Cohorts 3, 4, and 6 | Basophils : Baseline | 0.047 10^9 cells per liter | Standard Deviation 0.0125 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 37 in Cohorts 3, 4, and 6 | Basophils : Change at Day 37 | -0.014 10^9 cells per liter | Standard Deviation 0.0117 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 37 in Cohorts 3, 4, and 6 | Eosinophils : Baseline | 0.126 10^9 cells per liter | Standard Deviation 0.0875 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 37 in Cohorts 3, 4, and 6 | Eosinophils : Change at Day 37 | 0.001 10^9 cells per liter | Standard Deviation 0.0669 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 37 in Cohorts 3, 4, and 6 | Lymphocytes : Baseline | 1.639 10^9 cells per liter | Standard Deviation 0.9816 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 37 in Cohorts 3, 4, and 6 | Lymphocytes : Change at Day 37 | -0.140 10^9 cells per liter | Standard Deviation 0.3636 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 37 in Cohorts 3, 4, and 6 | Monocytes : Baseline | 0.508 10^9 cells per liter | Standard Deviation 0.116 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 37 in Cohorts 3, 4, and 6 | Monocytes : Change at Day 37 | -0.107 10^9 cells per liter | Standard Deviation 0.1846 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 37 in Cohorts 3, 4, and 6 | Neutrophils : Baseline | 3.921 10^9 cells per liter | Standard Deviation 0.7834 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 37 in Cohorts 3, 4, and 6 | Neutrophils : Change at Day 37 | -0.125 10^9 cells per liter | Standard Deviation 0.7983 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 37 in Cohorts 3, 4, and 6 | Platelets : Change at Day 37 | -4.5 10^9 cells per liter | Standard Deviation 21.18 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 37 in Cohorts 3, 4, and 6 | Leukocytes : Baseline | 6.240 10^9 cells per liter | Standard Deviation 1.2834 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 37 in Cohorts 3, 4, and 6 | Leukocytes : Change at Day 37 | -0.390 10^9 cells per liter | Standard Deviation 0.8556 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 37 in Cohorts 3, 4, and 6 | Leukocytes : Baseline | 4.633 10^9 cells per liter | Standard Deviation 0.7506 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 37 in Cohorts 3, 4, and 6 | Neutrophils : Change at Day 37 | 0.000 10^9 cells per liter | Standard Deviation 1.4504 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 37 in Cohorts 3, 4, and 6 | Lymphocytes : Baseline | 1.507 10^9 cells per liter | Standard Deviation 0.1793 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 37 in Cohorts 3, 4, and 6 | Eosinophils : Change at Day 37 | -0.033 10^9 cells per liter | Standard Deviation 0.0153 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 37 in Cohorts 3, 4, and 6 | Platelets : Baseline | 267.0 10^9 cells per liter | Standard Deviation 23.58 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 37 in Cohorts 3, 4, and 6 | Eosinophils : Baseline | 0.107 10^9 cells per liter | Standard Deviation 0.0569 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 37 in Cohorts 3, 4, and 6 | Basophils : Baseline | 0.043 10^9 cells per liter | Standard Deviation 0.0115 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 37 in Cohorts 3, 4, and 6 | Platelets : Change at Day 37 | 13.3 10^9 cells per liter | Standard Deviation 60.68 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 37 in Cohorts 3, 4, and 6 | Basophils : Change at Day 37 | -0.017 10^9 cells per liter | Standard Deviation 0.0115 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 37 in Cohorts 3, 4, and 6 | Monocytes : Change at Day 37 | -0.030 10^9 cells per liter | Standard Deviation 0.1044 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 37 in Cohorts 3, 4, and 6 | Monocytes : Baseline | 0.373 10^9 cells per liter | Standard Deviation 0.1464 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 37 in Cohorts 3, 4, and 6 | Leukocytes : Change at Day 37 | -0.280 10^9 cells per liter | Standard Deviation 1.4153 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 37 in Cohorts 3, 4, and 6 | Neutrophils : Baseline | 2.643 10^9 cells per liter | Standard Deviation 0.6831 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 37 in Cohorts 3, 4, and 6 | Lymphocytes : Change at Day 37 | -0.253 10^9 cells per liter | Standard Deviation 0.1343 |
Primary
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Cohorts 3, 4, and 6
Time frame: Baseline, Day 8
Population: Participants in the SAF population from Cohorts 3, 4 and 6 were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Cohorts 3, 4, and 6 | Platelets : Baseline | 230.2 10^9 cells per liter | Standard Deviation 30.53 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Cohorts 3, 4, and 6 | Lymphocytes : Change at Day 8 | -0.006 10^9 cells per liter | Standard Deviation 0.2913 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Cohorts 3, 4, and 6 | Eosinophils : Baseline | 0.123 10^9 cells per liter | Standard Deviation 0.1311 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Cohorts 3, 4, and 6 | Neutrophils : Change at Day 8 | -0.645 10^9 cells per liter | Standard Deviation 0.7103 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Cohorts 3, 4, and 6 | Monocytes : Baseline | 0.481 10^9 cells per liter | Standard Deviation 0.1194 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Cohorts 3, 4, and 6 | Basophils : Change at Day 8 | -0.020 10^9 cells per liter | Standard Deviation 0.0176 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Cohorts 3, 4, and 6 | Neutrophils : Baseline | 3.701 10^9 cells per liter | Standard Deviation 1.4781 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Cohorts 3, 4, and 6 | Monocytes : Change at Day 8 | -0.066 10^9 cells per liter | Standard Deviation 0.0929 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Cohorts 3, 4, and 6 | Platelets : Change at Day 8 | 12.5 10^9 cells per liter | Standard Deviation 41.25 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Cohorts 3, 4, and 6 | Eosinophils : Change at Day 8 | 0.022 10^9 cells per liter | Standard Deviation 0.0721 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Cohorts 3, 4, and 6 | Leukocytes : Change at Day 8 | -0.650 10^9 cells per liter | Standard Deviation 0.9058 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Cohorts 3, 4, and 6 | Basophils : Baseline | 0.047 10^9 cells per liter | Standard Deviation 0.025 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Cohorts 3, 4, and 6 | Lymphocytes : Baseline | 1.574 10^9 cells per liter | Standard Deviation 0.461 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Cohorts 3, 4, and 6 | Leukocytes : Baseline | 5.920 10^9 cells per liter | Standard Deviation 1.7261 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Cohorts 3, 4, and 6 | Platelets : Baseline | 249.4 10^9 cells per liter | Standard Deviation 59.23 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Cohorts 3, 4, and 6 | Basophils : Baseline | 0.047 10^9 cells per liter | Standard Deviation 0.0125 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Cohorts 3, 4, and 6 | Basophils : Change at Day 8 | -0.022 10^9 cells per liter | Standard Deviation 0.0132 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Cohorts 3, 4, and 6 | Eosinophils : Baseline | 0.126 10^9 cells per liter | Standard Deviation 0.0875 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Cohorts 3, 4, and 6 | Eosinophils : Change at Day 8 | 0.009 10^9 cells per liter | Standard Deviation 0.0493 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Cohorts 3, 4, and 6 | Lymphocytes : Baseline | 1.639 10^9 cells per liter | Standard Deviation 0.9816 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Cohorts 3, 4, and 6 | Lymphocytes : Change at Day 8 | -0.170 10^9 cells per liter | Standard Deviation 0.2732 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Cohorts 3, 4, and 6 | Monocytes : Baseline | 0.508 10^9 cells per liter | Standard Deviation 0.116 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Cohorts 3, 4, and 6 | Monocytes : Change at Day 8 | -0.131 10^9 cells per liter | Standard Deviation 0.1058 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Cohorts 3, 4, and 6 | Neutrophils : Baseline | 3.921 10^9 cells per liter | Standard Deviation 0.7834 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Cohorts 3, 4, and 6 | Neutrophils : Change at Day 8 | -1.041 10^9 cells per liter | Standard Deviation 0.6897 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Cohorts 3, 4, and 6 | Platelets : Change at Day 8 | -20.3 10^9 cells per liter | Standard Deviation 25.58 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Cohorts 3, 4, and 6 | Leukocytes : Baseline | 6.240 10^9 cells per liter | Standard Deviation 1.2834 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Cohorts 3, 4, and 6 | Leukocytes : Change at Day 8 | -1.350 10^9 cells per liter | Standard Deviation 0.6042 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Cohorts 3, 4, and 6 | Leukocytes : Baseline | 4.633 10^9 cells per liter | Standard Deviation 0.7506 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Cohorts 3, 4, and 6 | Neutrophils : Change at Day 8 | -0.920 10^9 cells per liter | Standard Deviation 0.9885 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Cohorts 3, 4, and 6 | Lymphocytes : Baseline | 1.507 10^9 cells per liter | Standard Deviation 0.1793 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Cohorts 3, 4, and 6 | Eosinophils : Change at Day 8 | -0.047 10^9 cells per liter | Standard Deviation 0.0289 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Cohorts 3, 4, and 6 | Platelets : Baseline | 267.0 10^9 cells per liter | Standard Deviation 23.58 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Cohorts 3, 4, and 6 | Eosinophils : Baseline | 0.107 10^9 cells per liter | Standard Deviation 0.0569 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Cohorts 3, 4, and 6 | Basophils : Baseline | 0.043 10^9 cells per liter | Standard Deviation 0.0115 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Cohorts 3, 4, and 6 | Platelets : Change at Day 8 | -19.7 10^9 cells per liter | Standard Deviation 70.32 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Cohorts 3, 4, and 6 | Basophils : Change at Day 8 | -0.023 10^9 cells per liter | Standard Deviation 0.0058 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Cohorts 3, 4, and 6 | Monocytes : Change at Day 8 | -0.120 10^9 cells per liter | Standard Deviation 0.1323 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Cohorts 3, 4, and 6 | Monocytes : Baseline | 0.373 10^9 cells per liter | Standard Deviation 0.1464 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Cohorts 3, 4, and 6 | Leukocytes : Change at Day 8 | -1.367 10^9 cells per liter | Standard Deviation 0.8963 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Cohorts 3, 4, and 6 | Neutrophils : Baseline | 2.643 10^9 cells per liter | Standard Deviation 0.6831 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Cohorts 3, 4, and 6 | Lymphocytes : Change at Day 8 | -0.293 10^9 cells per liter | Standard Deviation 0.0306 |
Primary
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Participants With Booster Dose (Cohorts 1 and 2)
Time frame: Baseline, Day 8
Population: Participants in the SAF population from Cohorts 1 and 2 who received the booster dose were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Participants With Booster Dose (Cohorts 1 and 2) | Basophils : Baseline | 0.040 10^9 cells per liter | Standard Deviation 0.0126 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Participants With Booster Dose (Cohorts 1 and 2) | Basophils : Change at Day 8 | -0.020 10^9 cells per liter | Standard Deviation 0.011 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Participants With Booster Dose (Cohorts 1 and 2) | Eosinophils : Baseline | 0.128 10^9 cells per liter | Standard Deviation 0.1783 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Participants With Booster Dose (Cohorts 1 and 2) | Eosinophils : Change at Day 8 | 0.037 10^9 cells per liter | Standard Deviation 0.0866 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Participants With Booster Dose (Cohorts 1 and 2) | Lymphocytes : Baseline | 1.510 10^9 cells per liter | Standard Deviation 0.3653 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Participants With Booster Dose (Cohorts 1 and 2) | Lymphocytes : Change at Day 8 | 0.088 10^9 cells per liter | Standard Deviation 0.1731 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Participants With Booster Dose (Cohorts 1 and 2) | Monocytes : Baseline | 0.490 10^9 cells per liter | Standard Deviation 0.1456 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Participants With Booster Dose (Cohorts 1 and 2) | Monocytes : Change at Day 8 | -0.028 10^9 cells per liter | Standard Deviation 0.0708 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Participants With Booster Dose (Cohorts 1 and 2) | Neutrophils : Baseline | 5.205 10^9 cells per liter | Standard Deviation 1.3505 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Participants With Booster Dose (Cohorts 1 and 2) | Neutrophils : Change at Day 8 | -1.165 10^9 cells per liter | Standard Deviation 0.8976 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Participants With Booster Dose (Cohorts 1 and 2) | Platelets : Baseline | 269.0 10^9 cells per liter | Standard Deviation 95.68 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Participants With Booster Dose (Cohorts 1 and 2) | Platelets : Change at Day 8 | -43.5 10^9 cells per liter | Standard Deviation 54.7 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Participants With Booster Dose (Cohorts 1 and 2) | Leukocytes : Baseline | 7.37 10^9 cells per liter | Standard Deviation 1.325 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Participants With Booster Dose (Cohorts 1 and 2) | Leukocytes : Change at Day 8 | -1.07 10^9 cells per liter | Standard Deviation 0.954 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Participants With Booster Dose (Cohorts 1 and 2) | Platelets : Baseline | 271.8 10^9 cells per liter | Standard Deviation 21.36 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Participants With Booster Dose (Cohorts 1 and 2) | Basophils : Baseline | 0.063 10^9 cells per liter | Standard Deviation 0.0359 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Participants With Booster Dose (Cohorts 1 and 2) | Monocytes : Change at Day 8 | -0.053 10^9 cells per liter | Standard Deviation 0.0789 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Participants With Booster Dose (Cohorts 1 and 2) | Basophils : Change at Day 8 | -0.030 10^9 cells per liter | Standard Deviation 0.0216 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Participants With Booster Dose (Cohorts 1 and 2) | Leukocytes : Baseline | 6.40 10^9 cells per liter | Standard Deviation 1.679 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Participants With Booster Dose (Cohorts 1 and 2) | Eosinophils : Baseline | 0.143 10^9 cells per liter | Standard Deviation 0.0846 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Participants With Booster Dose (Cohorts 1 and 2) | Neutrophils : Baseline | 4.003 10^9 cells per liter | Standard Deviation 1.3023 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Participants With Booster Dose (Cohorts 1 and 2) | Eosinophils : Change at Day 8 | -0.043 10^9 cells per liter | Standard Deviation 0.015 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Participants With Booster Dose (Cohorts 1 and 2) | Platelets : Change at Day 8 | -26.5 10^9 cells per liter | Standard Deviation 42.07 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Participants With Booster Dose (Cohorts 1 and 2) | Lymphocytes : Baseline | 1.610 10^9 cells per liter | Standard Deviation 0.335 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Participants With Booster Dose (Cohorts 1 and 2) | Neutrophils : Change at Day 8 | -0.970 10^9 cells per liter | Standard Deviation 1.0519 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Participants With Booster Dose (Cohorts 1 and 2) | Lymphocytes : Change at Day 8 | -0.223 10^9 cells per liter | Standard Deviation 0.1209 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Participants With Booster Dose (Cohorts 1 and 2) | Leukocytes : Change at Day 8 | -1.35 10^9 cells per liter | Standard Deviation 0.929 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Participants With Booster Dose (Cohorts 1 and 2) | Monocytes : Baseline | 0.558 10^9 cells per liter | Standard Deviation 0.2152 |
Primary
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2)
Time frame: Baseline, Day 8
Population: Participants in SAF population from Cohorts 1 and 2 who did not receive the booster dose were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2) | Basophils : Baseline | 0.033 10^9 cells per liter | Standard Deviation 0.015 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2) | Basophils : Change at Day 8 | -0.003 10^9 cells per liter | Standard Deviation 0.0126 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2) | Eosinophils : Baseline | 0.185 10^9 cells per liter | Standard Deviation 0.142 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2) | Eosinophils : Change at Day 8 | 0.073 10^9 cells per liter | Standard Deviation 0.1333 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2) | Lymphocytes : Baseline | 1.338 10^9 cells per liter | Standard Deviation 0.7852 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2) | Lymphocytes : Change at Day 8 | -0.053 10^9 cells per liter | Standard Deviation 0.2109 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2) | Monocytes : Baseline | 0.430 10^9 cells per liter | Standard Deviation 0.1722 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2) | Monocytes : Change at Day 8 | -0.023 10^9 cells per liter | Standard Deviation 0.1195 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2) | Neutrophils : Baseline | 3.170 10^9 cells per liter | Standard Deviation 1.1786 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2) | Neutrophils : Change at Day 8 | -0.443 10^9 cells per liter | Standard Deviation 0.9483 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2) | Platelets : Baseline | 199.8 10^9 cells per liter | Standard Deviation 65.2 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2) | Platelets : Change at Day 8 | -5.5 10^9 cells per liter | Standard Deviation 19.49 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2) | Leukocytes : Baseline | 5.15 10^9 cells per liter | Standard Deviation 1.808 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2) | Leukocytes : Change at Day 8 | -0.43 10^9 cells per liter | Standard Deviation 1.348 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2) | Platelets : Baseline | 276.0 10^9 cells per liter | Standard Deviation 53.86 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2) | Basophils : Baseline | 0.017 10^9 cells per liter | Standard Deviation 0.0153 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2) | Monocytes : Change at Day 8 | 0.010 10^9 cells per liter | Standard Deviation 0.05 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2) | Basophils : Change at Day 8 | -0.003 10^9 cells per liter | Standard Deviation 0.0115 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2) | Leukocytes : Baseline | 7.00 10^9 cells per liter | Standard Deviation 0.794 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2) | Eosinophils : Baseline | 0.137 10^9 cells per liter | Standard Deviation 0.0874 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2) | Neutrophils : Baseline | 5.057 10^9 cells per liter | Standard Deviation 0.5036 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2) | Eosinophils : Change at Day 8 | -0.040 10^9 cells per liter | Standard Deviation 0.0794 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2) | Platelets : Change at Day 8 | -39.0 10^9 cells per liter | Standard Deviation 29.87 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2) | Lymphocytes : Baseline | 1.203 10^9 cells per liter | Standard Deviation 0.8739 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2) | Neutrophils : Change at Day 8 | -1.610 10^9 cells per liter | Standard Deviation 0.9681 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2) | Lymphocytes : Change at Day 8 | -0.187 10^9 cells per liter | Standard Deviation 0.5052 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2) | Leukocytes : Change at Day 8 | -1.83 10^9 cells per liter | Standard Deviation 1.266 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2) | Monocytes : Baseline | 0.570 10^9 cells per liter | Standard Deviation 0.1442 |
Primary
Change From Baseline in Bilirubin and Creatinine at Day 120 in Participants With Booster Dose (Cohorts 1 and 2)
Time frame: Baseline, Day 120
Population: Participants in the SAF population from Cohorts 1 and 2 who received the booster dose were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Bilirubin and Creatinine at Day 120 in Participants With Booster Dose (Cohorts 1 and 2) | Bilirubin : Baseline | 7.0 µmol/L | Standard Deviation 2.68 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Bilirubin and Creatinine at Day 120 in Participants With Booster Dose (Cohorts 1 and 2) | Bilirubin : Change at Day 120 | 0.2 µmol/L | Standard Deviation 2.56 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Bilirubin and Creatinine at Day 120 in Participants With Booster Dose (Cohorts 1 and 2) | Creatinine : Baseline | 66.8 µmol/L | Standard Deviation 13.41 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Bilirubin and Creatinine at Day 120 in Participants With Booster Dose (Cohorts 1 and 2) | Creatinine : Change at Day 120 | 2.7 µmol/L | Standard Deviation 8.87 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Bilirubin and Creatinine at Day 120 in Participants With Booster Dose (Cohorts 1 and 2) | Creatinine : Change at Day 120 | -3.8 µmol/L | Standard Deviation 8.66 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Bilirubin and Creatinine at Day 120 in Participants With Booster Dose (Cohorts 1 and 2) | Bilirubin : Baseline | 9.0 µmol/L | Standard Deviation 3.56 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Bilirubin and Creatinine at Day 120 in Participants With Booster Dose (Cohorts 1 and 2) | Creatinine : Baseline | 69.3 µmol/L | Standard Deviation 23.41 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Bilirubin and Creatinine at Day 120 in Participants With Booster Dose (Cohorts 1 and 2) | Bilirubin : Change at Day 120 | -1.0 µmol/L | Standard Deviation 3.46 |
Primary
Change From Baseline in Bilirubin and Creatinine at Day 37 in Cohorts 3, 4, and 6
Time frame: Baseline, Day 37
Population: Participants in SAF population from Cohorts 3, 4, and 6 with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Bilirubin and Creatinine at Day 37 in Cohorts 3, 4, and 6 | Bilirubin : Baseline | 8.2 µmol/L | Standard Deviation 3.16 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Bilirubin and Creatinine at Day 37 in Cohorts 3, 4, and 6 | Bilirubin : Change at Day 37 | -1.2 µmol/L | Standard Deviation 2.3 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Bilirubin and Creatinine at Day 37 in Cohorts 3, 4, and 6 | Creatinine : Baseline | 66.6 µmol/L | Standard Deviation 16.15 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Bilirubin and Creatinine at Day 37 in Cohorts 3, 4, and 6 | Creatinine : Change at Day 37 | 5.2 µmol/L | Standard Deviation 6.53 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Bilirubin and Creatinine at Day 37 in Cohorts 3, 4, and 6 | Creatinine : Change at Day 37 | -1.2 µmol/L | Standard Deviation 4.39 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Bilirubin and Creatinine at Day 37 in Cohorts 3, 4, and 6 | Bilirubin : Baseline | 7.6 µmol/L | Standard Deviation 3.06 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Bilirubin and Creatinine at Day 37 in Cohorts 3, 4, and 6 | Creatinine : Baseline | 63.7 µmol/L | Standard Deviation 14.94 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Bilirubin and Creatinine at Day 37 in Cohorts 3, 4, and 6 | Bilirubin : Change at Day 37 | -0.4 µmol/L | Standard Deviation 2.07 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Bilirubin and Creatinine at Day 37 in Cohorts 3, 4, and 6 | Creatinine : Change at Day 37 | 1.7 µmol/L | Standard Deviation 5.51 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Bilirubin and Creatinine at Day 37 in Cohorts 3, 4, and 6 | Bilirubin : Change at Day 37 | -4.0 µmol/L | Standard Deviation 0 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Bilirubin and Creatinine at Day 37 in Cohorts 3, 4, and 6 | Creatinine : Baseline | 61.3 µmol/L | Standard Deviation 5.86 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Bilirubin and Creatinine at Day 37 in Cohorts 3, 4, and 6 | Bilirubin : Baseline | 19.3 µmol/L | Standard Deviation 14.74 |
Primary
Change From Baseline in Bilirubin and Creatinine at Day 8 in Cohorts 3, 4, and 6
Time frame: Baseline, Day 8
Population: Participants in SAF population from Cohorts 3, 4, and 6 with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Bilirubin and Creatinine at Day 8 in Cohorts 3, 4, and 6 | Bilirubin : Baseline | 8.2 µmol/L | Standard Deviation 3.16 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Bilirubin and Creatinine at Day 8 in Cohorts 3, 4, and 6 | Bilirubin : Change at Day 8 | -0.8 µmol/L | Standard Deviation 2.57 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Bilirubin and Creatinine at Day 8 in Cohorts 3, 4, and 6 | Creatinine : Baseline | 66.6 µmol/L | Standard Deviation 16.15 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Bilirubin and Creatinine at Day 8 in Cohorts 3, 4, and 6 | Creatinine : Change at Day 8 | 3.7 µmol/L | Standard Deviation 4.42 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Bilirubin and Creatinine at Day 8 in Cohorts 3, 4, and 6 | Creatinine : Change at Day 8 | 0.8 µmol/L | Standard Deviation 2.95 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Bilirubin and Creatinine at Day 8 in Cohorts 3, 4, and 6 | Bilirubin : Baseline | 7.6 µmol/L | Standard Deviation 3.06 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Bilirubin and Creatinine at Day 8 in Cohorts 3, 4, and 6 | Creatinine : Baseline | 63.7 µmol/L | Standard Deviation 14.94 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Bilirubin and Creatinine at Day 8 in Cohorts 3, 4, and 6 | Bilirubin : Change at Day 8 | 0.3 µmol/L | Standard Deviation 1.64 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Bilirubin and Creatinine at Day 8 in Cohorts 3, 4, and 6 | Creatinine : Change at Day 8 | -2.0 µmol/L | Standard Deviation 4 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Bilirubin and Creatinine at Day 8 in Cohorts 3, 4, and 6 | Bilirubin : Change at Day 8 | -8.0 µmol/L | Standard Deviation 9.85 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Bilirubin and Creatinine at Day 8 in Cohorts 3, 4, and 6 | Creatinine : Baseline | 61.3 µmol/L | Standard Deviation 5.86 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Bilirubin and Creatinine at Day 8 in Cohorts 3, 4, and 6 | Bilirubin : Baseline | 19.3 µmol/L | Standard Deviation 14.74 |
Primary
Change From Baseline in Bilirubin and Creatinine at Day 8 in Participants With Booster Dose (Cohorts 1 and 2)
Time frame: Baseline, Day 8
Population: Participants in the SAF population from Cohorts 1 and 2 who received the booster dose were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Bilirubin and Creatinine at Day 8 in Participants With Booster Dose (Cohorts 1 and 2) | Bilirubin : Baseline | 7.0 µmol/L | Standard Deviation 2.68 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Bilirubin and Creatinine at Day 8 in Participants With Booster Dose (Cohorts 1 and 2) | Bilirubin : Change at Day 8 | 0.3 µmol/L | Standard Deviation 1.75 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Bilirubin and Creatinine at Day 8 in Participants With Booster Dose (Cohorts 1 and 2) | Creatinine : Baseline | 66.8 µmol/L | Standard Deviation 13.41 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Bilirubin and Creatinine at Day 8 in Participants With Booster Dose (Cohorts 1 and 2) | Creatinine : Change at Day 8 | 3.5 µmol/L | Standard Deviation 2.26 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Bilirubin and Creatinine at Day 8 in Participants With Booster Dose (Cohorts 1 and 2) | Creatinine : Change at Day 8 | -3.3 µmol/L | Standard Deviation 6.65 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Bilirubin and Creatinine at Day 8 in Participants With Booster Dose (Cohorts 1 and 2) | Bilirubin : Baseline | 9.0 µmol/L | Standard Deviation 3.56 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Bilirubin and Creatinine at Day 8 in Participants With Booster Dose (Cohorts 1 and 2) | Creatinine : Baseline | 69.3 µmol/L | Standard Deviation 23.41 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Bilirubin and Creatinine at Day 8 in Participants With Booster Dose (Cohorts 1 and 2) | Bilirubin : Change at Day 8 | 1.5 µmol/L | Standard Deviation 2.08 |
Primary
Change From Baseline in Bilirubin and Creatinine at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2)
Time frame: Baseline, Day 8
Population: Participants in the SAF population from Cohorts 1 and 2 who did not receive the booster dose were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Bilirubin and Creatinine at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2) | Bilirubin : Baseline | 8.3 micromole per liter (µmol/L) | Standard Deviation 4.43 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Bilirubin and Creatinine at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2) | Bilirubin : Change at Day 8 | 2.3 micromole per liter (µmol/L) | Standard Deviation 1.71 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Bilirubin and Creatinine at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2) | Creatinine : Baseline | 79.0 micromole per liter (µmol/L) | Standard Deviation 15.87 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Bilirubin and Creatinine at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2) | Creatinine : Change at Day 8 | 4.5 micromole per liter (µmol/L) | Standard Deviation 7.72 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Bilirubin and Creatinine at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2) | Creatinine : Change at Day 8 | -3.7 micromole per liter (µmol/L) | Standard Deviation 3.79 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Bilirubin and Creatinine at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2) | Bilirubin : Baseline | 7.7 micromole per liter (µmol/L) | Standard Deviation 4.73 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Bilirubin and Creatinine at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2) | Creatinine : Baseline | 66.3 micromole per liter (µmol/L) | Standard Deviation 14.36 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Bilirubin and Creatinine at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2) | Bilirubin : Change at Day 8 | -0.3 micromole per liter (µmol/L) | Standard Deviation 2.52 |
Primary
Change From Baseline in Creatine Kinase at Day 120 in Participants With Booster Dose (Cohorts 1 and 2)
Time frame: Baseline, Day 120
Population: Participants in the SAF population from Cohorts 1 and 2 who received the booster dose were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Creatine Kinase at Day 120 in Participants With Booster Dose (Cohorts 1 and 2) | Creatine Kinase : Baseline | 1.2917 μkat/L | Standard Deviation 0.5212 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Creatine Kinase at Day 120 in Participants With Booster Dose (Cohorts 1 and 2) | Creatine Kinase : Change at Day 120 | 0.0750 μkat/L | Standard Deviation 0.5691 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Creatine Kinase at Day 120 in Participants With Booster Dose (Cohorts 1 and 2) | Creatine Kinase : Baseline | 1.4708 μkat/L | Standard Deviation 0.6065 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Creatine Kinase at Day 120 in Participants With Booster Dose (Cohorts 1 and 2) | Creatine Kinase : Change at Day 120 | -0.5625 μkat/L | Standard Deviation 0.264 |
Primary
Change From Baseline in Creatine Kinase at Day 37 in Cohorts 3, 4, and 6
Time frame: Baseline, Day 37
Population: Participants in the SAF population from Cohorts 3, 4 and 6 with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Creatine Kinase at Day 37 in Cohorts 3, 4, and 6 | Creatine Kinase : Baseline | 2.2217 μkat/L | Standard Deviation 1.0841 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Creatine Kinase at Day 37 in Cohorts 3, 4, and 6 | Creatine Kinase : Change at Day 37 | -0.4217 μkat/L | Standard Deviation 0.6258 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Creatine Kinase at Day 37 in Cohorts 3, 4, and 6 | Creatine Kinase : Baseline | 1.9067 μkat/L | Standard Deviation 0.7348 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Creatine Kinase at Day 37 in Cohorts 3, 4, and 6 | Creatine Kinase : Change at Day 37 | -0.3583 μkat/L | Standard Deviation 0.4508 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Creatine Kinase at Day 37 in Cohorts 3, 4, and 6 | Creatine Kinase : Baseline | 1.8056 μkat/L | Standard Deviation 0.7473 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Creatine Kinase at Day 37 in Cohorts 3, 4, and 6 | Creatine Kinase : Change at Day 37 | -0.4417 μkat/L | Standard Deviation 0.1532 |
Primary
Change From Baseline in Creatine Kinase at Day 8 in Cohorts 3, 4, and 6
Time frame: Baseline, Day 8
Population: Participants in the SAF population from Cohorts 3, 4 and 6 were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Creatine Kinase at Day 8 in Cohorts 3, 4, and 6 | Creatine Kinase : Change at Day 8 | -0.4833 μkat/L | Standard Deviation 0.5619 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Creatine Kinase at Day 8 in Cohorts 3, 4, and 6 | Creatine Kinase : Baseline | 2.2217 μkat/L | Standard Deviation 1.0841 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Creatine Kinase at Day 8 in Cohorts 3, 4, and 6 | Creatine Kinase : Baseline | 1.9067 μkat/L | Standard Deviation 0.7348 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Creatine Kinase at Day 8 in Cohorts 3, 4, and 6 | Creatine Kinase : Change at Day 8 | -0.1217 μkat/L | Standard Deviation 0.435 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Creatine Kinase at Day 8 in Cohorts 3, 4, and 6 | Creatine Kinase : Baseline | 1.8056 μkat/L | Standard Deviation 0.7473 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Creatine Kinase at Day 8 in Cohorts 3, 4, and 6 | Creatine Kinase : Change at Day 8 | -0.4444 μkat/L | Standard Deviation 0.4703 |
Primary
Change From Baseline in Creatine Kinase at Day 8 in Participants With Booster Dose (Cohorts 1 and 2)
Time frame: Baseline, Day 8
Population: Participants in the SAF population from Cohorts 1 and 2 who received the booster dose were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Creatine Kinase at Day 8 in Participants With Booster Dose (Cohorts 1 and 2) | Creatine Kinase : Baseline | 1.2917 μkat/L | Standard Deviation 0.5212 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Creatine Kinase at Day 8 in Participants With Booster Dose (Cohorts 1 and 2) | Creatine Kinase : Change at Day 8 | -0.1417 μkat/L | Standard Deviation 0.2736 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Creatine Kinase at Day 8 in Participants With Booster Dose (Cohorts 1 and 2) | Creatine Kinase : Baseline | 1.4708 μkat/L | Standard Deviation 0.6065 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Creatine Kinase at Day 8 in Participants With Booster Dose (Cohorts 1 and 2) | Creatine Kinase : Change at Day 8 | -0.2458 μkat/L | Standard Deviation 0.2002 |
Primary
Change From Baseline in Creatine Kinase at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2)
Time frame: Baseline, Day 8
Population: Participants in the SAF population from Cohorts 1 and 2 who did not receive the booster dose were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Creatine Kinase at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2) | Creatine Kinase : Baseline | 1.3083 microkatal per liter (μkat/L) | Standard Deviation 0.3869 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Creatine Kinase at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2) | Creatine Kinase : Change at Day 8 | -0.2083 microkatal per liter (μkat/L) | Standard Deviation 0.168 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Creatine Kinase at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2) | Creatine Kinase : Baseline | 1.1056 microkatal per liter (μkat/L) | Standard Deviation 0.5453 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Creatine Kinase at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2) | Creatine Kinase : Change at Day 8 | -0.3556 microkatal per liter (μkat/L) | Standard Deviation 0.3417 |
Primary
Change From Baseline in Hemoglobin at Day 120 in Participants With Booster Dose (Cohorts 1 and 2)
Time frame: Baseline, Day 120
Population: Participants in the SAF population from Cohorts 1 and 2 who received the booster dose were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Hemoglobin at Day 120 in Participants With Booster Dose (Cohorts 1 and 2) | Hemoglobin : Baseline | 137.8 g/L | Standard Deviation 13.01 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Hemoglobin at Day 120 in Participants With Booster Dose (Cohorts 1 and 2) | Hemoglobin : Change at Day 120 | -4.8 g/L | Standard Deviation 4.54 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Hemoglobin at Day 120 in Participants With Booster Dose (Cohorts 1 and 2) | Hemoglobin : Baseline | 144.8 g/L | Standard Deviation 7.97 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Hemoglobin at Day 120 in Participants With Booster Dose (Cohorts 1 and 2) | Hemoglobin : Change at Day 120 | -5.3 g/L | Standard Deviation 2.75 |
Primary
Change From Baseline in Hemoglobin at Day 37 in Cohorts 3, 4, and 6
Time frame: Baseline, Day 37
Population: Participants in the SAF population from Cohorts 3, 4 and 6 were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Hemoglobin at Day 37 in Cohorts 3, 4, and 6 | Hemoglobin : Baseline | 136.3 g/L | Standard Deviation 9.25 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Hemoglobin at Day 37 in Cohorts 3, 4, and 6 | Hemoglobin : Change at Day 37 | -8.0 g/L | Standard Deviation 4.62 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Hemoglobin at Day 37 in Cohorts 3, 4, and 6 | Hemoglobin : Baseline | 139.0 g/L | Standard Deviation 8.69 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Hemoglobin at Day 37 in Cohorts 3, 4, and 6 | Hemoglobin : Change at Day 37 | -6.6 g/L | Standard Deviation 4.53 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Hemoglobin at Day 37 in Cohorts 3, 4, and 6 | Hemoglobin : Baseline | 130.3 g/L | Standard Deviation 6.03 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Hemoglobin at Day 37 in Cohorts 3, 4, and 6 | Hemoglobin : Change at Day 37 | -11.0 g/L | Standard Deviation 6.08 |
Primary
Change From Baseline in Hemoglobin at Day 8 in Cohorts 3, 4, and 6
Time frame: Baseline, Day 8
Population: Participants in the SAF population from Cohorts 3, 4 and 6 were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Hemoglobin at Day 8 in Cohorts 3, 4, and 6 | Hemoglobin : Baseline | 136.3 g/L | Standard Deviation 9.25 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Hemoglobin at Day 8 in Cohorts 3, 4, and 6 | Hemoglobin : Change at Day 8 | -5.9 g/L | Standard Deviation 3.25 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Hemoglobin at Day 8 in Cohorts 3, 4, and 6 | Hemoglobin : Baseline | 139.0 g/L | Standard Deviation 8.69 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Hemoglobin at Day 8 in Cohorts 3, 4, and 6 | Hemoglobin : Change at Day 8 | -4.8 g/L | Standard Deviation 5.45 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Hemoglobin at Day 8 in Cohorts 3, 4, and 6 | Hemoglobin : Baseline | 130.3 g/L | Standard Deviation 6.03 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Hemoglobin at Day 8 in Cohorts 3, 4, and 6 | Hemoglobin : Change at Day 8 | -5.7 g/L | Standard Deviation 6.35 |
Primary
Change From Baseline in Hemoglobin at Day 8 in Participants With Booster Dose (Cohorts 1 and 2)
Time frame: Baseline, Day 8
Population: Participants in the SAF population from Cohorts 1 and 2 who received the booster dose were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Hemoglobin at Day 8 in Participants With Booster Dose (Cohorts 1 and 2) | Hemoglobin : Baseline | 137.8 g/L | Standard Deviation 13.01 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Hemoglobin at Day 8 in Participants With Booster Dose (Cohorts 1 and 2) | Hemoglobin : Change at Day 8 | -5.5 g/L | Standard Deviation 5.24 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Hemoglobin at Day 8 in Participants With Booster Dose (Cohorts 1 and 2) | Hemoglobin : Baseline | 144.8 g/L | Standard Deviation 7.97 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Hemoglobin at Day 8 in Participants With Booster Dose (Cohorts 1 and 2) | Hemoglobin : Change at Day 8 | -7.0 g/L | Standard Deviation 10.1 |
Primary
Change From Baseline in Hemoglobin at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2)
Time frame: Baseline, Day 8
Population: Participants in the SAF population from Cohorts 1 and 2 who did not receive the booster dose were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Hemoglobin at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2) | Hemoglobin : Baseline | 131.5 g/L | Standard Deviation 12.58 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Hemoglobin at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2) | Hemoglobin : Change at Day 8 | -3.8 g/L | Standard Deviation 3.5 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Hemoglobin at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2) | Hemoglobin : Baseline | 136.7 g/L | Standard Deviation 11.85 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Hemoglobin at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2) | Hemoglobin : Change at Day 8 | -4.0 g/L | Standard Deviation 1.73 |
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.
Time frame: Within 8 Days After the Injection of Prime Dose on Day 1
Population: SAF population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Number of Participants With at Least One Solicited Local Adverse Event (AE) Within 8 Days After the Injection of Prime Dose | 8 Participants |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Number of Participants With at Least One Solicited Local Adverse Event (AE) Within 8 Days After the Injection of Prime Dose | 6 Participants |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Number of Participants With at Least One Solicited Local Adverse Event (AE) Within 8 Days After the Injection of Prime Dose | 10 Participants |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Number of Participants With at Least One Solicited Local Adverse Event (AE) Within 8 Days After the Injection of Prime Dose | 10 Participants |
| Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Number of Participants With at Least One Solicited Local Adverse Event (AE) Within 8 Days After the Injection of Prime Dose | 3 Participants |
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.
Time frame: 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)
Population: Participants in the SAF population who received booster dose and submitted any data for the solicited AEs.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Number of Participants With at Least One Solicited Local AE Within 8 Days After the Injection of Booster Dose | 6 Participants |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Number of Participants With at Least One Solicited Local AE Within 8 Days After the Injection of Booster Dose | 4 Participants |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Number of Participants With at Least One Solicited Local AE Within 8 Days After the Injection of Booster Dose | 8 Participants |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Number of Participants With at Least One Solicited Local AE Within 8 Days After the Injection of Booster Dose | 6 Participants |
| Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Number of Participants With at Least One Solicited Local AE Within 8 Days After the Injection of Booster Dose | 3 Participants |
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.
Time frame: 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)
Population: Participants in the SAF population who received booster dose and submitted any data for the solicited AEs.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Number of Participants With at Least One Solicited Systemic AE Within 8 Days After the Injection of Booster Dose | 4 Participants |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Number of Participants With at Least One Solicited Systemic AE Within 8 Days After the Injection of Booster Dose | 4 Participants |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Number of Participants With at Least One Solicited Systemic AE Within 8 Days After the Injection of Booster Dose | 8 Participants |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Number of Participants With at Least One Solicited Systemic AE Within 8 Days After the Injection of Booster Dose | 6 Participants |
| Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Number of Participants With at Least One Solicited Systemic AE Within 8 Days After the Injection of Booster Dose | 3 Participants |
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.
Time frame: Within 8 Days After the Injection of Prime Dose on Day 1
Population: SAF population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Number of Participants With at Least One Solicited Systemic AE Within 8 Days After the Injection of Prime Dose | 8 Participants |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Number of Participants With at Least One Solicited Systemic AE Within 8 Days After the Injection of Prime Dose | 7 Participants |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Number of Participants With at Least One Solicited Systemic AE Within 8 Days After the Injection of Prime Dose | 10 Participants |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Number of Participants With at Least One Solicited Systemic AE Within 8 Days After the Injection of Prime Dose | 9 Participants |
| Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Number of Participants With at Least One Solicited Systemic AE Within 8 Days After the Injection of Prime Dose | 3 Participants |
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.
Time frame: 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)
Population: Participants in the SAF population who received booster dose were analyzed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Number of Participants With at Least One Unsolicited TEAEs Within 28 Days After the Injection of Booster Dose | 4 Participants |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Number of Participants With at Least One Unsolicited TEAEs Within 28 Days After the Injection of Booster Dose | 4 Participants |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Number of Participants With at Least One Unsolicited TEAEs Within 28 Days After the Injection of Booster Dose | 4 Participants |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Number of Participants With at Least One Unsolicited TEAEs Within 28 Days After the Injection of Booster Dose | 4 Participants |
| Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Number of Participants With at Least One Unsolicited TEAEs Within 28 Days After the Injection of Booster Dose | 2 Participants |
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.
Time frame: Within 28 Days After the Injection of Prime Dose on Day 1
Population: SAF population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Number of Participants With at Least One Unsolicited Treatment-emergent AEs (TEAEs) Within 28 Days After the Injection of Prime Dose | 5 Participants |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Number of Participants With at Least One Unsolicited Treatment-emergent AEs (TEAEs) Within 28 Days After the Injection of Prime Dose | 6 Participants |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Number of Participants With at Least One Unsolicited Treatment-emergent AEs (TEAEs) Within 28 Days After the Injection of Prime Dose | 7 Participants |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Number of Participants With at Least One Unsolicited Treatment-emergent AEs (TEAEs) Within 28 Days After the Injection of Prime Dose | 8 Participants |
| Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Number of Participants With at Least One Unsolicited Treatment-emergent AEs (TEAEs) Within 28 Days After the Injection of Prime Dose | 3 Participants |
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.
Time frame: Day 1 Up to 16 months
Population: SAF population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | 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) | SAEs | 2 Participants |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | 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) | Serologically or Virologically Confirmed Relevant to COVID-19 | 7 Participants |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | 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) | NOCMCs | 5 Participants |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | 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) | MAAEs | 6 Participants |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | 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) | All AESIs | 9 Participants |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | 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) | Severe COVID-19 | 0 Participants |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | 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) | PIMMCs | 1 Participants |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | 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) | PIMMCs | 0 Participants |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | 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) | Severe COVID-19 | 0 Participants |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | 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) | All AESIs | 6 Participants |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | 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) | SAEs | 1 Participants |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | 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) | NOCMCs | 3 Participants |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | 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) | MAAEs | 5 Participants |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | 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) | Serologically or Virologically Confirmed Relevant to COVID-19 | 6 Participants |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | 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) | Severe COVID-19 | 0 Participants |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | 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) | SAEs | 0 Participants |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | 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) | All AESIs | 9 Participants |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | 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) | MAAEs | 5 Participants |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | 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) | PIMMCs | 0 Participants |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | 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) | NOCMCs | 2 Participants |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | 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) | Serologically or Virologically Confirmed Relevant to COVID-19 | 7 Participants |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | 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) | MAAEs | 8 Participants |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | 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) | Serologically or Virologically Confirmed Relevant to COVID-19 | 2 Participants |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | 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) | PIMMCs | 0 Participants |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | 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) | All AESIs | 9 Participants |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | 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) | NOCMCs | 3 Participants |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | 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) | SAEs | 2 Participants |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | 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) | Severe COVID-19 | 0 Participants |
| Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | 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) | MAAEs | 2 Participants |
| Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | 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) | SAEs | 0 Participants |
| Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | 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) | Severe COVID-19 | 0 Participants |
| Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | 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) | PIMMCs | 0 Participants |
| Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | 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) | All AESIs | 3 Participants |
| Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | 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) | NOCMCs | 1 Participants |
| Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | 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) | Serologically or Virologically Confirmed Relevant to COVID-19 | 2 Participants |
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.
Time frame: Baseline, Days 8, 29, 58, 113, 142, 180, 209, 293
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Immunogenicity Response by TCE Pools (in Vitro Stimulation) | Nuc OLP : Change at Day 113 | 1341.7 SFU per 10^6 cells | Standard Deviation 1743.64 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Immunogenicity Response by TCE Pools (in Vitro Stimulation) | Membrane OLP : Baseline | 993.6 SFU per 10^6 cells | Standard Deviation 1190.16 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Immunogenicity Response by TCE Pools (in Vitro Stimulation) | Nuc OLP : Change at Day 142 | 656.7 SFU per 10^6 cells | Standard Deviation 772.89 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Immunogenicity Response by TCE Pools (in Vitro Stimulation) | ORF3a OLP : Change at Day 293 | -385.0 SFU per 10^6 cells | Standard Deviation 544.47 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Immunogenicity Response by TCE Pools (in Vitro Stimulation) | Membrane OLP : Change at Day 113 | 281.0 SFU per 10^6 cells | Standard Deviation 1127.42 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Immunogenicity Response by TCE Pools (in Vitro Stimulation) | Nuc OLP : Baseline | 502.5 SFU per 10^6 cells | Standard Deviation 609.64 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Immunogenicity Response by TCE Pools (in Vitro Stimulation) | Nuc OLP : Change at Day 293 | 315.0 SFU per 10^6 cells | Standard Deviation 1154.69 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Immunogenicity Response by TCE Pools (in Vitro Stimulation) | Membrane OLP : Change at Day 29 | -95.0 SFU per 10^6 cells | Standard Deviation 1336.77 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Immunogenicity Response by TCE Pools (in Vitro Stimulation) | ORF3a OLP : Change at Day 29 | -81.4 SFU per 10^6 cells | Standard Deviation 425.82 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Immunogenicity Response by TCE Pools (in Vitro Stimulation) | Nuc OLP : Change at Day 8 | -122.5 SFU per 10^6 cells | Standard Deviation 637.16 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Immunogenicity Response by TCE Pools (in Vitro Stimulation) | ORF3a OLP : Change at Day 8 | -125.0 SFU per 10^6 cells | Standard Deviation 441.99 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Immunogenicity Response by TCE Pools (in Vitro Stimulation) | Membrane OLP : Change at Day 142 | 843.0 SFU per 10^6 cells | Standard Deviation 1741.89 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Immunogenicity Response by TCE Pools (in Vitro Stimulation) | Membrane OLP : Change at Day 8 | 152.5 SFU per 10^6 cells | Standard Deviation 608.04 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Immunogenicity Response by TCE Pools (in Vitro Stimulation) | ORF3a OLP : Baseline | 472.1 SFU per 10^6 cells | Standard Deviation 485.03 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Immunogenicity Response by TCE Pools (in Vitro Stimulation) | ORF3a OLP : Change at Day 142 | 211.0 SFU per 10^6 cells | Standard Deviation 446.86 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Immunogenicity Response by TCE Pools (in Vitro Stimulation) | ORF3a OLP : Change at Day 113 | 170.0 SFU per 10^6 cells | Standard Deviation 604.78 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Immunogenicity Response by TCE Pools (in Vitro Stimulation) | Membrane OLP : Change at Day 293 | -280.0 SFU per 10^6 cells | Standard Deviation 1909.19 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Immunogenicity Response by TCE Pools (in Vitro Stimulation) | Nuc OLP : Change at Day 29 | 206.7 SFU per 10^6 cells | Standard Deviation 498.15 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Immunogenicity Response by TCE Pools (in Vitro Stimulation) | Nuc OLP : Change at Day 8 | 353.6 SFU per 10^6 cells | Standard Deviation 2385.88 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Immunogenicity Response by TCE Pools (in Vitro Stimulation) | Membrane OLP : Change at Day 29 | 1041.3 SFU per 10^6 cells | Standard Deviation 882.95 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Immunogenicity Response by TCE Pools (in Vitro Stimulation) | Nuc OLP : Change at Day 29 | -360.8 SFU per 10^6 cells | Standard Deviation 3094.77 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Immunogenicity Response by TCE Pools (in Vitro Stimulation) | Membrane OLP : Change at Day 113 | 0.0 SFU per 10^6 cells | — |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Immunogenicity Response by TCE Pools (in Vitro Stimulation) | Membrane OLP : Change at Day 142 | 281.7 SFU per 10^6 cells | Standard Deviation 617.7 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Immunogenicity Response by TCE Pools (in Vitro Stimulation) | Nuc OLP : Baseline | 1823.6 SFU per 10^6 cells | Standard Deviation 2091.63 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Immunogenicity Response by TCE Pools (in Vitro Stimulation) | Membrane OLP : Change at Day 180 | 1075.0 SFU per 10^6 cells | — |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Immunogenicity Response by TCE Pools (in Vitro Stimulation) | Nuc OLP : Change at Day 113 | 10.0 SFU per 10^6 cells | Standard Deviation 748.55 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Immunogenicity Response by TCE Pools (in Vitro Stimulation) | Nuc OLP : Change at Day 142 | 655.0 SFU per 10^6 cells | Standard Deviation 1079.11 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Immunogenicity Response by TCE Pools (in Vitro Stimulation) | Nuc OLP : Change at Day 180 | 140.0 SFU per 10^6 cells | — |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Immunogenicity Response by TCE Pools (in Vitro Stimulation) | ORF3a OLP : Baseline | 695.8 SFU per 10^6 cells | Standard Deviation 1328.89 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Immunogenicity Response by TCE Pools (in Vitro Stimulation) | ORF3a OLP : Change at Day 8 | -555.0 SFU per 10^6 cells | Standard Deviation 1544.96 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Immunogenicity Response by TCE Pools (in Vitro Stimulation) | Membrane OLP : Change at Day 8 | 235.8 SFU per 10^6 cells | Standard Deviation 1078.42 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Immunogenicity Response by TCE Pools (in Vitro Stimulation) | ORF3a OLP : Change at Day 29 | 126.3 SFU per 10^6 cells | Standard Deviation 259.27 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Immunogenicity Response by TCE Pools (in Vitro Stimulation) | ORF3a OLP : Change at Day 113 | 0.0 SFU per 10^6 cells | — |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Immunogenicity Response by TCE Pools (in Vitro Stimulation) | ORF3a OLP : Change at Day 142 | 68.3 SFU per 10^6 cells | Standard Deviation 70.06 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Immunogenicity Response by TCE Pools (in Vitro Stimulation) | ORF3a OLP : Change at Day 180 | 495.0 SFU per 10^6 cells | — |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Immunogenicity Response by TCE Pools (in Vitro Stimulation) | Membrane OLP : Baseline | 347.5 SFU per 10^6 cells | Standard Deviation 270.4 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Immunogenicity Response by TCE Pools (in Vitro Stimulation) | ORF3a OLP : Change at Day 58 | -15.0 SFU per 10^6 cells | Standard Deviation 232.86 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Immunogenicity Response by TCE Pools (in Vitro Stimulation) | Nuc OLP : Change at Day 8 | -1280.8 SFU per 10^6 cells | Standard Deviation 2440.97 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Immunogenicity Response by TCE Pools (in Vitro Stimulation) | Nuc OLP : Change at Day 58 | -183.3 SFU per 10^6 cells | Standard Deviation 409.95 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Immunogenicity Response by TCE Pools (in Vitro Stimulation) | Membrane OLP : Change at Day 8 | 1794.0 SFU per 10^6 cells | Standard Deviation 3722.19 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Immunogenicity Response by TCE Pools (in Vitro Stimulation) | Membrane OLP : Change at Day 209 | 125.0 SFU per 10^6 cells | Standard Deviation 176.78 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Immunogenicity Response by TCE Pools (in Vitro Stimulation) | Membrane OLP : Baseline | 1277.0 SFU per 10^6 cells | Standard Deviation 2005.93 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Immunogenicity Response by TCE Pools (in Vitro Stimulation) | Membrane OLP : Change at Day 29 | -190.0 SFU per 10^6 cells | Standard Deviation 299.14 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Immunogenicity Response by TCE Pools (in Vitro Stimulation) | ORF3a OLP : Change at Day 209 | 0.0 SFU per 10^6 cells | Standard Deviation 0 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Immunogenicity Response by TCE Pools (in Vitro Stimulation) | Nuc OLP : Baseline | 2292.5 SFU per 10^6 cells | Standard Deviation 2198.52 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Immunogenicity Response by TCE Pools (in Vitro Stimulation) | ORF3a OLP : Change at Day 8 | 163.0 SFU per 10^6 cells | Standard Deviation 560.8 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Immunogenicity Response by TCE Pools (in Vitro Stimulation) | Nuc OLP : Change at Day 29 | -541.3 SFU per 10^6 cells | Standard Deviation 479.69 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Immunogenicity Response by TCE Pools (in Vitro Stimulation) | ORF3a OLP : Baseline | 364.0 SFU per 10^6 cells | Standard Deviation 355.17 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Immunogenicity Response by TCE Pools (in Vitro Stimulation) | Membrane OLP : Change at Day 58 | 973.3 SFU per 10^6 cells | Standard Deviation 848.27 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Immunogenicity Response by TCE Pools (in Vitro Stimulation) | ORF3a OLP : Change at Day 29 | -86.3 SFU per 10^6 cells | Standard Deviation 248.04 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Immunogenicity Response by TCE Pools (in Vitro Stimulation) | Nuc OLP : Change at Day 209 | 2487.5 SFU per 10^6 cells | Standard Deviation 3744.13 |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Immunogenicity Response by TCE Pools (in Vitro Stimulation) | ORF3a OLP : Change at Day 29 | 111.3 SFU per 10^6 cells | Standard Deviation 105.39 |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Immunogenicity Response by TCE Pools (in Vitro Stimulation) | Nuc OLP : Baseline | 2890.0 SFU per 10^6 cells | Standard Deviation 3792.1 |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Immunogenicity Response by TCE Pools (in Vitro Stimulation) | Nuc OLP : Change at Day 8 | 145.8 SFU per 10^6 cells | Standard Deviation 669.91 |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Immunogenicity Response by TCE Pools (in Vitro Stimulation) | Nuc OLP : Change at Day 29 | 371.0 SFU per 10^6 cells | Standard Deviation 2366.67 |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Immunogenicity Response by TCE Pools (in Vitro Stimulation) | Nuc OLP : Change at Day 58 | 1482.5 SFU per 10^6 cells | Standard Deviation 2755.78 |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Immunogenicity Response by TCE Pools (in Vitro Stimulation) | ORF3a OLP : Baseline | 298.8 SFU per 10^6 cells | Standard Deviation 249.21 |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Immunogenicity Response by TCE Pools (in Vitro Stimulation) | ORF3a OLP : Change at Day 8 | 66.3 SFU per 10^6 cells | Standard Deviation 101.93 |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Immunogenicity Response by TCE Pools (in Vitro Stimulation) | ORF3a OLP : Change at Day 58 | 155.0 SFU per 10^6 cells | Standard Deviation 330.95 |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Immunogenicity Response by TCE Pools (in Vitro Stimulation) | ORF3a OLP : Change at Day 209 | -340.0 SFU per 10^6 cells | — |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Immunogenicity Response by TCE Pools (in Vitro Stimulation) | Membrane OLP : Baseline | 645.0 SFU per 10^6 cells | Standard Deviation 434.4 |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Immunogenicity Response by TCE Pools (in Vitro Stimulation) | Membrane OLP : Change at Day 8 | 1846.3 SFU per 10^6 cells | Standard Deviation 2972.9 |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Immunogenicity Response by TCE Pools (in Vitro Stimulation) | Membrane OLP : Change at Day 29 | 1290.0 SFU per 10^6 cells | Standard Deviation 2321.25 |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Immunogenicity Response by TCE Pools (in Vitro Stimulation) | Membrane OLP : Change at Day 58 | 2308.3 SFU per 10^6 cells | Standard Deviation 4019.82 |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Immunogenicity Response by TCE Pools (in Vitro Stimulation) | Membrane OLP : Change at Day 209 | -820.0 SFU per 10^6 cells | — |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Immunogenicity Response by TCE Pools (in Vitro Stimulation) | Nuc OLP : Change at Day 209 | -615.0 SFU per 10^6 cells | Standard Deviation 466.69 |
| Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Immunogenicity Response by TCE Pools (in Vitro Stimulation) | Nuc OLP : Change at Day 8 | -4355.0 SFU per 10^6 cells | Standard Deviation 6264.97 |
| Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Immunogenicity Response by TCE Pools (in Vitro Stimulation) | Nuc OLP : Baseline | 10397.5 SFU per 10^6 cells | Standard Deviation 3680.49 |
| Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Immunogenicity Response by TCE Pools (in Vitro Stimulation) | Nuc OLP : Change at Day 58 | 55.0 SFU per 10^6 cells | — |
| Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Immunogenicity Response by TCE Pools (in Vitro Stimulation) | Nuc OLP : Change at Day 29 | -5890.0 SFU per 10^6 cells | Standard Deviation 8683.27 |
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).
Time frame: Baseline, Days 15, 29, 57, 58, 86, 113, 142, 180, 209, 293, 365, 394, 478
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Immunoglobulin (Ig)G Level (Spike Wild Type [WT] Variant) | Baseline | 1472.7 ELU/mL | Standard Deviation 2054.3 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Immunoglobulin (Ig)G Level (Spike Wild Type [WT] Variant) | Change at Day 113 | 5338.6 ELU/mL | Standard Deviation 2788.22 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Immunoglobulin (Ig)G Level (Spike Wild Type [WT] Variant) | Change at Day 57 | 13611.5 ELU/mL | Standard Deviation 15451.74 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Immunoglobulin (Ig)G Level (Spike Wild Type [WT] Variant) | Change at Day 478 | 6280.8 ELU/mL | — |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Immunoglobulin (Ig)G Level (Spike Wild Type [WT] Variant) | Change at Day 365 | 6717.5 ELU/mL | — |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Immunoglobulin (Ig)G Level (Spike Wild Type [WT] Variant) | Change at Day 293 | 8168.6 ELU/mL | Standard Deviation 1102.84 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Immunoglobulin (Ig)G Level (Spike Wild Type [WT] Variant) | Change at Day 180 | 5617.7 ELU/mL | Standard Deviation 3997.75 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Immunoglobulin (Ig)G Level (Spike Wild Type [WT] Variant) | Change at Day 142 | 9912.1 ELU/mL | Standard Deviation 3698.76 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Immunoglobulin (Ig)G Level (Spike Wild Type [WT] Variant) | Change at Day 29 | 11895.9 ELU/mL | Standard Deviation 13649.88 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Immunoglobulin (Ig)G Level (Spike Wild Type [WT] Variant) | Change at Day 478 | 1787.8 ELU/mL | — |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Immunoglobulin (Ig)G Level (Spike Wild Type [WT] Variant) | Baseline | 927.4 ELU/mL | Standard Deviation 1432.97 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Immunoglobulin (Ig)G Level (Spike Wild Type [WT] Variant) | Change at Day 29 | 18911.4 ELU/mL | Standard Deviation 33885.5 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Immunoglobulin (Ig)G Level (Spike Wild Type [WT] Variant) | Change at Day 57 | 18389.1 ELU/mL | Standard Deviation 32185.66 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Immunoglobulin (Ig)G Level (Spike Wild Type [WT] Variant) | Change at Day 113 | 4429.0 ELU/mL | Standard Deviation 4194.22 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Immunoglobulin (Ig)G Level (Spike Wild Type [WT] Variant) | Change at Day 142 | 4325.1 ELU/mL | Standard Deviation 998.99 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Immunoglobulin (Ig)G Level (Spike Wild Type [WT] Variant) | Change at Day 180 | 43597.9 ELU/mL | — |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Immunoglobulin (Ig)G Level (Spike Wild Type [WT] Variant) | Change at Day 293 | 1550.2 ELU/mL | — |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Immunoglobulin (Ig)G Level (Spike Wild Type [WT] Variant) | Baseline | 8154.3 ELU/mL | Standard Deviation 10615.6 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Immunoglobulin (Ig)G Level (Spike Wild Type [WT] Variant) | Change at Day 58 | 26631.5 ELU/mL | Standard Deviation 40900.86 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Immunoglobulin (Ig)G Level (Spike Wild Type [WT] Variant) | Change at Day 29 | 12487.0 ELU/mL | Standard Deviation 32915.21 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Immunoglobulin (Ig)G Level (Spike Wild Type [WT] Variant) | Change at Day 209 | 19612.2 ELU/mL | Standard Deviation 25727.45 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Immunoglobulin (Ig)G Level (Spike Wild Type [WT] Variant) | Change at Day 86 | 19988.1 ELU/mL | Standard Deviation 29698.91 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Immunoglobulin (Ig)G Level (Spike Wild Type [WT] Variant) | Change at Day 15 | 127.6 ELU/mL | Standard Deviation 187.31 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Immunoglobulin (Ig)G Level (Spike Wild Type [WT] Variant) | Change at Day 394 | 29156.7 ELU/mL | Standard Deviation 34271.63 |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Immunoglobulin (Ig)G Level (Spike Wild Type [WT] Variant) | Change at Day 58 | 20522.6 ELU/mL | Standard Deviation 23369.31 |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Immunoglobulin (Ig)G Level (Spike Wild Type [WT] Variant) | Change at Day 86 | 19290.2 ELU/mL | Standard Deviation 29851.34 |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Immunoglobulin (Ig)G Level (Spike Wild Type [WT] Variant) | Change at Day 394 | 19892.7 ELU/mL | Standard Deviation 29538.44 |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Immunoglobulin (Ig)G Level (Spike Wild Type [WT] Variant) | Change at Day 15 | 2172.0 ELU/mL | Standard Deviation 5047.29 |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Immunoglobulin (Ig)G Level (Spike Wild Type [WT] Variant) | Baseline | 16841.9 ELU/mL | Standard Deviation 25813.96 |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Immunoglobulin (Ig)G Level (Spike Wild Type [WT] Variant) | Change at Day 209 | 13302.7 ELU/mL | Standard Deviation 35861.57 |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Immunoglobulin (Ig)G Level (Spike Wild Type [WT] Variant) | Change at Day 29 | 6894.5 ELU/mL | Standard Deviation 10642.03 |
| Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Immunoglobulin (Ig)G Level (Spike Wild Type [WT] Variant) | Change at Day 394 | -2550.5 ELU/mL | — |
| Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Immunoglobulin (Ig)G Level (Spike Wild Type [WT] Variant) | Baseline | 14127.5 ELU/mL | Standard Deviation 12307.51 |
| Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Immunoglobulin (Ig)G Level (Spike Wild Type [WT] Variant) | Change at Day 29 | -811.4 ELU/mL | Standard Deviation 4591.85 |
| Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Immunoglobulin (Ig)G Level (Spike Wild Type [WT] Variant) | Change at Day 58 | 2764.7 ELU/mL | Standard Deviation 4119.63 |
| Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Immunoglobulin (Ig)G Level (Spike Wild Type [WT] Variant) | Change at Day 15 | -1710.6 ELU/mL | Standard Deviation 4374.86 |
| Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Immunoglobulin (Ig)G Level (Spike Wild Type [WT] Variant) | Change at Day 86 | 3598.0 ELU/mL | Standard Deviation 4584.89 |
| Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Immunoglobulin (Ig)G Level (Spike Wild Type [WT] Variant) | Change at Day 209 | 669.2 ELU/mL | — |
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.
Time frame: 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
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Alpha Variant : Baseline | 212.2 titers | Standard Deviation 321.43 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Gamma Variant : Change at Day 29 | 1595.7 titers | Standard Deviation 1258.32 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Beta Variant : Baseline | 46.8 titers | Standard Deviation 24.53 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Alpha Variant : Change at Day 365 | 758.0 titers | — |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Alpha Variant : Change at Day 293 | 1282.0 titers | Standard Deviation 944.69 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Alpha Variant : Change at Day 180 | 700.3 titers | Standard Deviation 1330.07 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Alpha Variant : Change at Day 142 | 1222.0 titers | Standard Deviation 341.83 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Alpha Variant : Change at Day 113 | 742.0 titers | Standard Deviation 435.92 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Alpha Variant : Change at Day 29 | 2015.5 titers | Standard Deviation 1970.93 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Gamma Variant : Baseline | 42.2 titers | Standard Deviation 19.02 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Alpha Variant : Change at Day 57 | 1791.3 titers | Standard Deviation 1761.22 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike WT Variant : Change at Day 29 | 2736.7 titers | Standard Deviation 2296.58 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Gamma Variant : Change at Day 293 | 774.0 titers | Standard Deviation 15.56 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Delta Variant : Change at Day 365 | 361.0 titers | — |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Delta Variant : Change at Day 293 | 359.5 titers | Standard Deviation 6.36 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Delta Variant : Change at Day 180 | 543.0 titers | Standard Deviation 332.5 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike WT Variant : Change at Day 57 | 3069.6 titers | Standard Deviation 3084.54 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike WT Variant : Baseline | 389.3 titers | Standard Deviation 648.63 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Delta Variant : Change at Day 142 | 743.3 titers | Standard Deviation 455.08 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Delta Variant : Change at Day 113 | 505.0 titers | Standard Deviation 364.87 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Delta Variant : Change at Day 57 | 1346.5 titers | Standard Deviation 1108.33 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Delta Variant : Change at Day 29 | 881.7 titers | Standard Deviation 463.61 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Delta Variant : Baseline | 30.7 titers | Standard Deviation 20.15 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Beta Variant : Change at Day 365 | 353.0 titers | — |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike WT Variant : Change at Day 113 | 1877.0 titers | Standard Deviation 1083.54 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Gamma Variant : Change at Day 365 | 508.0 titers | — |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike WT Variant : Change at Day 142 | 3933.0 titers | Standard Deviation 2349.21 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Gamma Variant : Change at Day 180 | 1110.0 titers | Standard Deviation 732.28 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike WT Variant : Change at Day 180 | 2722.7 titers | Standard Deviation 2504.27 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Gamma Variant : Change at Day 142 | 979.7 titers | Standard Deviation 1110.39 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Beta Variant : Change at Day 293 | 360.0 titers | Standard Deviation 77.78 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Beta Variant : Change at Day 180 | 473.0 titers | Standard Deviation 187.93 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Beta Variant : Change at Day 142 | 599.3 titers | Standard Deviation 426.48 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike WT Variant : Change at Day 293 | 2527.3 titers | Standard Deviation 1758.06 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Gamma Variant : Change at Day 113 | 568.3 titers | Standard Deviation 432.6 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike WT Variant : Change at Day 365 | 469.0 titers | — |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Beta Variant : Change at Day 113 | 541.0 titers | Standard Deviation 442.36 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Beta Variant : Change at Day 57 | 938.2 titers | Standard Deviation 483.1 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Beta Variant : Change at Day 29 | 620.2 titers | Standard Deviation 359.53 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike WT Variant : Change at Day 478 | 1059.0 titers | — |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Gamma Variant : Change at Day 57 | 1824.8 titers | Standard Deviation 1702.96 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Gamma Variant : Change at Day 29 | 2597.3 titers | Standard Deviation 4419 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike WT Variant : Baseline | 364.1 titers | Standard Deviation 531.95 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike WT Variant : Change at Day 29 | 5698.4 titers | Standard Deviation 8043.68 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike WT Variant : Change at Day 57 | 6195.9 titers | Standard Deviation 11607.01 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike WT Variant : Change at Day 113 | 1273.0 titers | Standard Deviation 998.27 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike WT Variant : Change at Day 142 | 1479.0 titers | Standard Deviation 804.08 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike WT Variant : Change at Day 180 | 11020.0 titers | — |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike WT Variant : Change at Day 293 | 412.0 titers | — |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike WT Variant : Change at Day 478 | 163.0 titers | — |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Alpha Variant : Baseline | 145.8 titers | Standard Deviation 199.14 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Alpha Variant : Change at Day 29 | 5750.8 titers | Standard Deviation 11303.79 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Alpha Variant : Change at Day 57 | 11060.3 titers | Standard Deviation 25154.49 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Alpha Variant : Change at Day 113 | 690.7 titers | Standard Deviation 501.34 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Alpha Variant : Change at Day 142 | 647.0 titers | Standard Deviation 381.84 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Alpha Variant : Change at Day 180 | 9089.0 titers | — |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Beta Variant : Baseline | 54.8 titers | Standard Deviation 58.38 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Beta Variant : Change at Day 29 | 1645.0 titers | Standard Deviation 2331.97 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Beta Variant : Change at Day 57 | 1651.0 titers | Standard Deviation 2729.72 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Beta Variant : Change at Day 113 | 531.0 titers | Standard Deviation 255.69 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Beta Variant : Change at Day 142 | 608.0 titers | Standard Deviation 445.48 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Beta Variant : Change at Day 180 | 4357.0 titers | — |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Delta Variant : Baseline | 130.8 titers | Standard Deviation 287.88 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Delta Variant : Change at Day 29 | 2620.2 titers | Standard Deviation 4221.31 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Delta Variant : Change at Day 57 | 3149.2 titers | Standard Deviation 6124.92 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Delta Variant : Change at Day 113 | 455.0 titers | Standard Deviation 232.27 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Delta Variant : Change at Day 142 | 312.5 titers | Standard Deviation 26.16 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Delta Variant : Change at Day 180 | 8896.0 titers | — |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Gamma Variant : Baseline | 64.8 titers | Standard Deviation 118.26 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Gamma Variant : Change at Day 57 | 3001.5 titers | Standard Deviation 5634.38 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Gamma Variant : Change at Day 113 | 683.7 titers | Standard Deviation 466.31 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Gamma Variant : Change at Day 142 | 610.0 titers | Standard Deviation 571.34 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Gamma Variant : Change at Day 180 | 4826.0 titers | — |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Alpha Variant : Change at Day 394 | 2430.0 titers | — |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Alpha Variant : Baseline | 472.5 titers | Standard Deviation 318.83 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Gamma Variant : Change at Day 58 | 12835.0 titers | Standard Deviation 21500 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Beta Variant : Baseline | 3049.0 titers | Standard Deviation 5611.44 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Beta Variant : Change at Day 15 | 241.0 titers | Standard Deviation 101.82 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Beta Variant : Change at Day 29 | 946.0 titers | Standard Deviation 1918.04 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Beta Variant : Change at Day 58 | 491.0 titers | Standard Deviation 480.77 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Beta Variant : Change at Day 86 | 551.3 titers | Standard Deviation 242.88 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike WT Variant : Change at Day 394 | 5771.5 titers | Standard Deviation 6639.03 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Gamma Variant : Change at Day 86 | 5854.3 titers | Standard Deviation 9508.49 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Beta Variant : Change at Day 209 | 59.0 titers | — |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike WT Variant : Change at Day 209 | 1896.3 titers | Standard Deviation 1539 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Beta Variant : Change at Day 394 | 29.0 titers | — |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Delta Variant : Baseline | 204.6 titers | Standard Deviation 89.47 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Delta Variant : Change at Day 15 | 66.5 titers | Standard Deviation 72.83 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike WT Variant : Change at Day 86 | 12417.2 titers | Standard Deviation 28027 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Delta Variant : Change at Day 29 | 2190.8 titers | Standard Deviation 4501.32 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Delta Variant : Change at Day 58 | 5775.0 titers | Standard Deviation 10376.28 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Delta Variant : Change at Day 86 | 2020.5 titers | Standard Deviation 2913.95 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike WT Variant : Change at Day 58 | 27494.5 titers | Standard Deviation 60940.14 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike WT Variant : Baseline | 1598.8 titers | Standard Deviation 1614.15 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Delta Variant : Change at Day 209 | 859.5 titers | Standard Deviation 211.42 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike WT Variant : Change at Day 29 | 7199.6 titers | Standard Deviation 20163.93 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Delta Variant : Change at Day 394 | 1478.5 titers | Standard Deviation 437.7 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Gamma Variant : Change at Day 209 | 394.0 titers | — |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Gamma Variant : Baseline | 751.8 titers | Standard Deviation 638.95 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Gamma Variant : Change at Day 15 | 4.0 titers | Standard Deviation 230.52 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Gamma Variant : Change at Day 394 | 310.0 titers | — |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Gamma Variant : Change at Day 29 | 6524.3 titers | Standard Deviation 12990.41 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Alpha Variant : Change at Day 29 | 5824.3 titers | Standard Deviation 10927.2 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Alpha Variant : Change at Day 58 | 10524.0 titers | Standard Deviation 15090.23 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Alpha Variant : Change at Day 86 | 12548.7 titers | Standard Deviation 16593.11 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike WT Variant : Change at Day 15 | -181.5 titers | Standard Deviation 150.61 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Alpha Variant : Change at Day 15 | 151.0 titers | Standard Deviation 4.24 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Alpha Variant : Change at Day 209 | 9643.0 titers | — |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Delta Variant : Change at Day 15 | 556.0 titers | Standard Deviation 903.7 |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Alpha Variant : Change at Day 394 | 3497.0 titers | Standard Deviation 4154.15 |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike WT Variant : Baseline | 1770.6 titers | Standard Deviation 2197.25 |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Delta Variant : Change at Day 394 | 2093.7 titers | Standard Deviation 2175.41 |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Gamma Variant : Change at Day 29 | 643.8 titers | Standard Deviation 722.95 |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Delta Variant : Change at Day 58 | 1591.0 titers | Standard Deviation 1515.13 |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Beta Variant : Baseline | 728.2 titers | Standard Deviation 714.93 |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike WT Variant : Change at Day 86 | 9031.7 titers | Standard Deviation 9679.5 |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Alpha Variant : Baseline | 2888.6 titers | Standard Deviation 3326.23 |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Beta Variant : Change at Day 15 | 1325.3 titers | Standard Deviation 1151.95 |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Delta Variant : Change at Day 86 | 861.0 titers | Standard Deviation 1075.02 |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Delta Variant : Baseline | 939.4 titers | Standard Deviation 1439.18 |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Gamma Variant : Change at Day 58 | 2440.7 titers | Standard Deviation 1763.62 |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike WT Variant : Change at Day 58 | 11316.4 titers | Standard Deviation 15472.5 |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Beta Variant : Change at Day 29 | 438.0 titers | Standard Deviation 923.19 |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Beta Variant : Change at Day 394 | 2556.0 titers | Standard Deviation 2736.07 |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike WT Variant : Change at Day 394 | 6617.8 titers | Standard Deviation 8217.53 |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Alpha Variant : Change at Day 58 | 1534.0 titers | Standard Deviation 1431.72 |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Gamma Variant : Baseline | 1823.0 titers | Standard Deviation 2042.95 |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Beta Variant : Change at Day 58 | 908.7 titers | Standard Deviation 725.16 |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Gamma Variant : Change at Day 209 | -295.7 titers | Standard Deviation 1059.91 |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Delta Variant : Change at Day 29 | 441.2 titers | Standard Deviation 598.52 |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Beta Variant : Change at Day 86 | 1479.3 titers | Standard Deviation 2024.13 |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Gamma Variant : Change at Day 394 | 1800.3 titers | Standard Deviation 3177.44 |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Alpha Variant : Change at Day 15 | -473.3 titers | Standard Deviation 2492.24 |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Gamma Variant : Change at Day 15 | 383.3 titers | Standard Deviation 577.54 |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Alpha Variant : Change at Day 209 | 906.0 titers | Standard Deviation 419.01 |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Gamma Variant : Change at Day 86 | 1361.3 titers | Standard Deviation 1933.56 |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike WT Variant : Change at Day 209 | 4046.8 titers | Standard Deviation 4136.43 |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Delta Variant : Change at Day 209 | 463.0 titers | Standard Deviation 1029.03 |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Alpha Variant : Change at Day 29 | 508.2 titers | Standard Deviation 2193.32 |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Beta Variant : Change at Day 209 | 474.7 titers | Standard Deviation 799.09 |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike WT Variant : Change at Day 29 | 1520.0 titers | Standard Deviation 1481.62 |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike WT Variant : Change at Day 15 | 1291.3 titers | Standard Deviation 943.07 |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Alpha Variant : Change at Day 86 | 2793.7 titers | Standard Deviation 1513.65 |
| Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike WT Variant : Change at Day 86 | 1252.7 titers | Standard Deviation 1158.66 |
| Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Beta Variant : Change at Day 394 | 204.0 titers | — |
| Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike WT Variant : Baseline | 2876.3 titers | Standard Deviation 2313.05 |
| Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Alpha Variant : Baseline | 2131.3 titers | Standard Deviation 1220.58 |
| Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Delta Variant : Baseline | 1111.3 titers | Standard Deviation 817.14 |
| Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Delta Variant : Change at Day 15 | 35.7 titers | Standard Deviation 169.21 |
| Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Alpha Variant : Change at Day 29 | 492.7 titers | Standard Deviation 169.21 |
| Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Gamma Variant : Change at Day 209 | -103.0 titers | — |
| Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Delta Variant : Change at Day 29 | 72.0 titers | Standard Deviation 263.9 |
| Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike WT Variant : Change at Day 58 | 1684.3 titers | Standard Deviation 1330.26 |
| Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Delta Variant : Change at Day 58 | 202.7 titers | Standard Deviation 76.05 |
| Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Delta Variant : Change at Day 86 | 1040.7 titers | Standard Deviation 1058.26 |
| Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Gamma Variant : Change at Day 394 | -428.0 titers | — |
| Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Alpha Variant : Change at Day 58 | 962.7 titers | Standard Deviation 829 |
| Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike WT Variant : Change at Day 29 | 403.0 titers | Standard Deviation 492.63 |
| Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Delta Variant : Change at Day 209 | 2272.0 titers | — |
| Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Alpha Variant : Change at Day 86 | 6464.3 titers | Standard Deviation 6400.08 |
| Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Alpha Variant : Change at Day 394 | 1441.0 titers | — |
| Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Delta Variant : Change at Day 394 | 2571.0 titers | — |
| Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike WT Variant : Change at Day 15 | 886.0 titers | Standard Deviation 751.13 |
| Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Beta Variant : Baseline | 692.7 titers | Standard Deviation 333.52 |
| Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Alpha Variant : Change at Day 15 | 462.3 titers | Standard Deviation 670 |
| Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Beta Variant : Change at Day 15 | 670.0 titers | Standard Deviation 323.3 |
| Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike WT Variant : Change at Day 394 | 9904.0 titers | — |
| Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Gamma Variant : Change at Day 29 | 668.7 titers | Standard Deviation 654.71 |
| Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Beta Variant : Change at Day 29 | 120.7 titers | Standard Deviation 298.41 |
| Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Gamma Variant : Change at Day 58 | 549.7 titers | Standard Deviation 905.99 |
| Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Beta Variant : Change at Day 58 | 355.0 titers | Standard Deviation 499.88 |
| Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Gamma Variant : Baseline | 1387.7 titers | Standard Deviation 836.53 |
| Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Beta Variant : Change at Day 86 | 1535.0 titers | Standard Deviation 1004.73 |
| Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike WT Variant : Change at Day 209 | 3767.0 titers | — |
| Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Gamma Variant : Change at Day 86 | 633.0 titers | Standard Deviation 405.82 |
| Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Gamma Variant : Change at Day 15 | 30.3 titers | Standard Deviation 277.62 |
| Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Beta Variant : Change at Day 209 | 396.0 titers | — |
| Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in Neutralizing Antibody (nAb) Levels | Spike Alpha Variant : Change at Day 209 | 8843.0 titers | — |
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 \[S2\]).
Time frame: Baseline, Days 8, 29, 58, 113, 142, 180, 209, 293, 365, 478
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 5_6 : Change at Day 8 | 11.6 Spot Forming Unit (SFU) per 10^6 cells | Standard Deviation 37.03 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 5_6 : Baseline | 34.4 Spot Forming Unit (SFU) per 10^6 cells | Standard Deviation 32.37 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 3_4 : Change at Day 478 | 225.0 Spot Forming Unit (SFU) per 10^6 cells | — |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 3_4 : Change at Day 8 | 10.3 Spot Forming Unit (SFU) per 10^6 cells | Standard Deviation 27.79 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 7_8 : Change at Day 29 | 8.4 Spot Forming Unit (SFU) per 10^6 cells | Standard Deviation 23.37 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 3_4 : Change at Day 293 | 58.3 Spot Forming Unit (SFU) per 10^6 cells | Standard Deviation 92.68 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 3_4 : Change at Day 180 | 0.0 Spot Forming Unit (SFU) per 10^6 cells | — |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 3_4 : Change at Day 142 | 14.2 Spot Forming Unit (SFU) per 10^6 cells | Standard Deviation 53.7 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 3_4 : Change at Day 29 | 24.1 Spot Forming Unit (SFU) per 10^6 cells | Standard Deviation 38.52 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 1_2 : Change at Day 29 | 46.7 Spot Forming Unit (SFU) per 10^6 cells | Standard Deviation 119.95 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 3_4 : Change at Day 113 | 4.6 Spot Forming Unit (SFU) per 10^6 cells | Standard Deviation 22.16 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 7_8 : Change at Day 293 | 7.5 Spot Forming Unit (SFU) per 10^6 cells | Standard Deviation 9.01 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 7_8 : Change at Day 8 | 3.4 Spot Forming Unit (SFU) per 10^6 cells | Standard Deviation 9.54 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 7_8 : Baseline | 20.9 Spot Forming Unit (SFU) per 10^6 cells | Standard Deviation 6.94 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 5_6 : Change at Day 478 | 15.0 Spot Forming Unit (SFU) per 10^6 cells | — |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 5_6 : Change at Day 293 | 5.8 Spot Forming Unit (SFU) per 10^6 cells | Standard Deviation 19.42 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 5_6 : Change at Day 180 | 0.0 Spot Forming Unit (SFU) per 10^6 cells | — |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 5_6 : Change at Day 142 | -5.4 Spot Forming Unit (SFU) per 10^6 cells | Standard Deviation 25.02 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 1_2 : Change at Day 113 | -0.8 Spot Forming Unit (SFU) per 10^6 cells | Standard Deviation 37.1 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 7_8 : Change at Day 180 | 0.0 Spot Forming Unit (SFU) per 10^6 cells | — |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 1_2 : Change at Day 142 | -13.8 Spot Forming Unit (SFU) per 10^6 cells | Standard Deviation 33.61 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 1_2 : Change at Day 8 | -5.0 Spot Forming Unit (SFU) per 10^6 cells | Standard Deviation 41.06 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 1_2 : Change at Day 180 | 1.3 Spot Forming Unit (SFU) per 10^6 cells | Standard Deviation 40.66 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 7_8 : Change at Day 478 | 20.0 Spot Forming Unit (SFU) per 10^6 cells | — |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 5_6 : Change at Day 113 | -7.5 Spot Forming Unit (SFU) per 10^6 cells | Standard Deviation 17.18 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 5_6 : Change at Day 29 | 17.5 Spot Forming Unit (SFU) per 10^6 cells | Standard Deviation 68.54 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 1_2 : Change at Day 293 | -2.5 Spot Forming Unit (SFU) per 10^6 cells | Standard Deviation 33.63 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 7_8 : Change at Day 142 | 0.0 Spot Forming Unit (SFU) per 10^6 cells | Standard Deviation 15.25 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 1_2 : Change at Day 365 | 40.0 Spot Forming Unit (SFU) per 10^6 cells | — |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 1_2 : Change at Day 478 | 20.0 Spot Forming Unit (SFU) per 10^6 cells | — |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 1_2 : Baseline | 62.5 Spot Forming Unit (SFU) per 10^6 cells | Standard Deviation 61.35 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 3_4 : Baseline | 30.9 Spot Forming Unit (SFU) per 10^6 cells | Standard Deviation 19.86 |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 7_8 : Change at Day 113 | -0.8 Spot Forming Unit (SFU) per 10^6 cells | Standard Deviation 11.58 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 1_2 : Change at Day 478 | 82.5 Spot Forming Unit (SFU) per 10^6 cells | — |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 1_2 : Baseline | 62.5 Spot Forming Unit (SFU) per 10^6 cells | Standard Deviation 53.93 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 1_2 : Change at Day 8 | -5.7 Spot Forming Unit (SFU) per 10^6 cells | Standard Deviation 31.38 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 1_2 : Change at Day 29 | 20.7 Spot Forming Unit (SFU) per 10^6 cells | Standard Deviation 37.1 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 1_2 : Change at Day 113 | 1.3 Spot Forming Unit (SFU) per 10^6 cells | Standard Deviation 38.65 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 1_2 : Change at Day 142 | 6.7 Spot Forming Unit (SFU) per 10^6 cells | Standard Deviation 11.55 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 1_2 : Change at Day 180 | 30.0 Spot Forming Unit (SFU) per 10^6 cells | — |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 1_2 : Change at Day 293 | 40.0 Spot Forming Unit (SFU) per 10^6 cells | — |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 3_4 : Baseline | 51.1 Spot Forming Unit (SFU) per 10^6 cells | Standard Deviation 37.16 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 3_4 : Change at Day 8 | 10.4 Spot Forming Unit (SFU) per 10^6 cells | Standard Deviation 23.25 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 3_4 : Change at Day 29 | 16.1 Spot Forming Unit (SFU) per 10^6 cells | Standard Deviation 31.72 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 3_4 : Change at Day 113 | -15.0 Spot Forming Unit (SFU) per 10^6 cells | Standard Deviation 36.97 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 3_4 : Change at Day 142 | -25.0 Spot Forming Unit (SFU) per 10^6 cells | Standard Deviation 43.3 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 3_4 : Change at Day 180 | 62.5 Spot Forming Unit (SFU) per 10^6 cells | — |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 3_4 : Change at Day 293 | 0.0 Spot Forming Unit (SFU) per 10^6 cells | — |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 3_4 : Change at Day 478 | 0.0 Spot Forming Unit (SFU) per 10^6 cells | — |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 5_6 : Baseline | 33.9 Spot Forming Unit (SFU) per 10^6 cells | Standard Deviation 40.51 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 5_6 : Change at Day 8 | 11.4 Spot Forming Unit (SFU) per 10^6 cells | Standard Deviation 32.56 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 5_6 : Change at Day 29 | 9.6 Spot Forming Unit (SFU) per 10^6 cells | Standard Deviation 25.31 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 5_6 : Change at Day 113 | 0.0 Spot Forming Unit (SFU) per 10^6 cells | Standard Deviation 0 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 5_6 : Change at Day 142 | 17.5 Spot Forming Unit (SFU) per 10^6 cells | Standard Deviation 30.31 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 5_6 : Change at Day 180 | 25.0 Spot Forming Unit (SFU) per 10^6 cells | — |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 5_6 : Change at Day 293 | 32.5 Spot Forming Unit (SFU) per 10^6 cells | — |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 5_6 : Change at Day 478 | 67.5 Spot Forming Unit (SFU) per 10^6 cells | — |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 7_8 : Baseline | 25.7 Spot Forming Unit (SFU) per 10^6 cells | Standard Deviation 13.13 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 7_8 : Change at Day 29 | 80.4 Spot Forming Unit (SFU) per 10^6 cells | Standard Deviation 148.42 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 7_8 : Change at Day 113 | 15.0 Spot Forming Unit (SFU) per 10^6 cells | Standard Deviation 42.62 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 7_8 : Change at Day 142 | 169.2 Spot Forming Unit (SFU) per 10^6 cells | Standard Deviation 308.28 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 7_8 : Change at Day 180 | 20.0 Spot Forming Unit (SFU) per 10^6 cells | — |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 7_8 : Change at Day 293 | -32.5 Spot Forming Unit (SFU) per 10^6 cells | — |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 7_8 : Change at Day 478 | 27.5 Spot Forming Unit (SFU) per 10^6 cells | — |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 7_8 : Change at Day 8 | 52.1 Spot Forming Unit (SFU) per 10^6 cells | Standard Deviation 88.04 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 1_2 : Change at Day 8 | -19.4 Spot Forming Unit (SFU) per 10^6 cells | Standard Deviation 30.81 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 1_2 : Change at Day 58 | 29.4 Spot Forming Unit (SFU) per 10^6 cells | Standard Deviation 34.6 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 7_8 : Change at Day 209 | 13.8 Spot Forming Unit (SFU) per 10^6 cells | Standard Deviation 19.45 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 7_8 : Change at Day 29 | 9.2 Spot Forming Unit (SFU) per 10^6 cells | Standard Deviation 29.18 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 5_6 : Change at Day 29 | 36.7 Spot Forming Unit (SFU) per 10^6 cells | Standard Deviation 36.11 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 1_2 : Baseline | 75.0 Spot Forming Unit (SFU) per 10^6 cells | Standard Deviation 82.22 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 5_6 : Baseline | 37.2 Spot Forming Unit (SFU) per 10^6 cells | Standard Deviation 41.18 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 7_8 : Baseline | 30.9 Spot Forming Unit (SFU) per 10^6 cells | Standard Deviation 22.83 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 7_8 : Change at Day 8 | -11.6 Spot Forming Unit (SFU) per 10^6 cells | Standard Deviation 17.27 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 1_2 : Change at Day 29 | 30.0 Spot Forming Unit (SFU) per 10^6 cells | Standard Deviation 46.61 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 5_6 : Change at Day 58 | 62.5 Spot Forming Unit (SFU) per 10^6 cells | Standard Deviation 45.55 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 3_4 : Baseline | 69.7 Spot Forming Unit (SFU) per 10^6 cells | Standard Deviation 56.35 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 3_4 : Change at Day 8 | 5.9 Spot Forming Unit (SFU) per 10^6 cells | Standard Deviation 27.35 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 1_2 : Change at Day 209 | 52.5 Spot Forming Unit (SFU) per 10^6 cells | Standard Deviation 84.85 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 3_4 : Change at Day 209 | 61.3 Spot Forming Unit (SFU) per 10^6 cells | Standard Deviation 76.01 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 7_8 : Change at Day 58 | 8.8 Spot Forming Unit (SFU) per 10^6 cells | Standard Deviation 17.5 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 3_4 : Change at Day 29 | 34.2 Spot Forming Unit (SFU) per 10^6 cells | Standard Deviation 52.65 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 5_6 : Change at Day 8 | 3.4 Spot Forming Unit (SFU) per 10^6 cells | Standard Deviation 20.09 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 3_4 : Change at Day 58 | 23.8 Spot Forming Unit (SFU) per 10^6 cells | Standard Deviation 29.26 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 5_6 : Change at Day 209 | 75.0 Spot Forming Unit (SFU) per 10^6 cells | Standard Deviation 106.07 |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 5_6 : Baseline | 34.6 Spot Forming Unit (SFU) per 10^6 cells | Standard Deviation 29.34 |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 5_6 : Change at Day 8 | -4.6 Spot Forming Unit (SFU) per 10^6 cells | Standard Deviation 11.23 |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 1_2 : Change at Day 209 | 7.5 Spot Forming Unit (SFU) per 10^6 cells | Standard Deviation 12.99 |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 5_6 : Change at Day 29 | 23.1 Spot Forming Unit (SFU) per 10^6 cells | Standard Deviation 36.93 |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 5_6 : Change at Day 58 | -3.0 Spot Forming Unit (SFU) per 10^6 cells | Standard Deviation 4.47 |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 1_2 : Change at Day 58 | 9.5 Spot Forming Unit (SFU) per 10^6 cells | Standard Deviation 15.25 |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 5_6 : Change at Day 209 | -10.0 Spot Forming Unit (SFU) per 10^6 cells | Standard Deviation 10 |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 7_8 : Change at Day 209 | 1.7 Spot Forming Unit (SFU) per 10^6 cells | Standard Deviation 2.89 |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 1_2 : Change at Day 29 | 1.5 Spot Forming Unit (SFU) per 10^6 cells | Standard Deviation 3.35 |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 1_2 : Baseline | 17.9 Spot Forming Unit (SFU) per 10^6 cells | Standard Deviation 7.14 |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 7_8 : Change at Day 8 | -1.3 Spot Forming Unit (SFU) per 10^6 cells | Standard Deviation 3.06 |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 7_8 : Baseline | 16.3 Spot Forming Unit (SFU) per 10^6 cells | Standard Deviation 3.06 |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 3_4 : Change at Day 29 | 21.3 Spot Forming Unit (SFU) per 10^6 cells | Standard Deviation 47.63 |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 3_4 : Change at Day 58 | 2.0 Spot Forming Unit (SFU) per 10^6 cells | Standard Deviation 9.25 |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 7_8 : Change at Day 29 | -1.9 Spot Forming Unit (SFU) per 10^6 cells | Standard Deviation 3.75 |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 3_4 : Change at Day 8 | -22.5 Spot Forming Unit (SFU) per 10^6 cells | Standard Deviation 41.35 |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 3_4 : Change at Day 209 | -17.5 Spot Forming Unit (SFU) per 10^6 cells | Standard Deviation 30.31 |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 7_8 : Change at Day 58 | -1.5 Spot Forming Unit (SFU) per 10^6 cells | Standard Deviation 3.35 |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 3_4 : Baseline | 94.6 Spot Forming Unit (SFU) per 10^6 cells | Standard Deviation 180.45 |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 1_2 : Change at Day 8 | -0.4 Spot Forming Unit (SFU) per 10^6 cells | Standard Deviation 1.02 |
| Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 1_2 : Baseline | 15.0 Spot Forming Unit (SFU) per 10^6 cells | — |
| Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 3_4 : Baseline | 15.0 Spot Forming Unit (SFU) per 10^6 cells | — |
| Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 3_4 : Change at Day 8 | 0.0 Spot Forming Unit (SFU) per 10^6 cells | — |
| Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 7_8 : Change at Day 29 | 0.0 Spot Forming Unit (SFU) per 10^6 cells | — |
| Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 7_8 : Change at Day 58 | 0.0 Spot Forming Unit (SFU) per 10^6 cells | — |
| Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 1_2 : Change at Day 58 | 0.0 Spot Forming Unit (SFU) per 10^6 cells | — |
| Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 7_8 : Baseline | 15.0 Spot Forming Unit (SFU) per 10^6 cells | — |
| Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 7_8 : Change at Day 8 | 0.0 Spot Forming Unit (SFU) per 10^6 cells | — |
| Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 1_2 : Change at Day 8 | 0.0 Spot Forming Unit (SFU) per 10^6 cells | — |
| Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 5_6 : Change at Day 29 | 0.0 Spot Forming Unit (SFU) per 10^6 cells | — |
| Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 1_2 : Change at Day 29 | 0.0 Spot Forming Unit (SFU) per 10^6 cells | — |
| Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 5_6 : Change at Day 58 | 0.0 Spot Forming Unit (SFU) per 10^6 cells | — |
| Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 3_4 : Change at Day 29 | 0.0 Spot Forming Unit (SFU) per 10^6 cells | — |
| Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 5_6 : Baseline | 15.0 Spot Forming Unit (SFU) per 10^6 cells | — |
| Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 5_6 : Change at Day 8 | 0.0 Spot Forming Unit (SFU) per 10^6 cells | — |
| Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot) | Spike pool 3_4 : Change at Day 58 | 0.0 Spot Forming Unit (SFU) per 10^6 cells | — |
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.
Time frame: Baseline, Days 8, 29, 58, 113, 142, 180, 209, 293, 365, 478
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in T Cell Response by T Cell Epitope (TCE) Pools (ex Vivo ELISpot) | ORF3a/Membrane OLP : Change at Day 293 | 0.0 SFU per 10^6 cells | — |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in T Cell Response by T Cell Epitope (TCE) Pools (ex Vivo ELISpot) | Nuc OLP : Change at Day 8 | 3.6 SFU per 10^6 cells | Standard Deviation 9.45 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in T Cell Response by T Cell Epitope (TCE) Pools (ex Vivo ELISpot) | Nuc OLP : Change at Day 29 | 1.1 SFU per 10^6 cells | Standard Deviation 2.83 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in T Cell Response by T Cell Epitope (TCE) Pools (ex Vivo ELISpot) | Nuc OLP : Change at Day 113 | 0.0 SFU per 10^6 cells | Standard Deviation 0 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in T Cell Response by T Cell Epitope (TCE) Pools (ex Vivo ELISpot) | Nuc OLP : Change at Day 142 | 0.0 SFU per 10^6 cells | Standard Deviation 0 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in T Cell Response by T Cell Epitope (TCE) Pools (ex Vivo ELISpot) | Nuc OLP : Change at Day 180 | 0.0 SFU per 10^6 cells | — |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in T Cell Response by T Cell Epitope (TCE) Pools (ex Vivo ELISpot) | Nuc OLP : Change at Day 293 | 0.0 SFU per 10^6 cells | — |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in T Cell Response by T Cell Epitope (TCE) Pools (ex Vivo ELISpot) | ORF3a/Membrane OLP : Baseline | 17.9 SFU per 10^6 cells | Standard Deviation 7.56 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in T Cell Response by T Cell Epitope (TCE) Pools (ex Vivo ELISpot) | ORF3a/Membrane OLP : Change at Day 8 | -0.4 SFU per 10^6 cells | Standard Deviation 0.94 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in T Cell Response by T Cell Epitope (TCE) Pools (ex Vivo ELISpot) | ORF3a/Membrane OLP : Change at Day 29 | 15.4 SFU per 10^6 cells | Standard Deviation 26.24 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in T Cell Response by T Cell Epitope (TCE) Pools (ex Vivo ELISpot) | ORF3a/Membrane OLP : Change at Day 113 | 0.0 SFU per 10^6 cells | Standard Deviation 0 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in T Cell Response by T Cell Epitope (TCE) Pools (ex Vivo ELISpot) | ORF3a/Membrane OLP : Change at Day 142 | 0.0 SFU per 10^6 cells | Standard Deviation 0 |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in T Cell Response by T Cell Epitope (TCE) Pools (ex Vivo ELISpot) | ORF3a/Membrane OLP : Change at Day 180 | 47.5 SFU per 10^6 cells | — |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Change From Baseline in T Cell Response by T Cell Epitope (TCE) Pools (ex Vivo ELISpot) | Nuc OLP : Baseline | 15.0 SFU per 10^6 cells | Standard Deviation 0 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in T Cell Response by T Cell Epitope (TCE) Pools (ex Vivo ELISpot) | ORF3a/Membrane OLP : Change at Day 29 | 0.0 SFU per 10^6 cells | Standard Deviation 6.32 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in T Cell Response by T Cell Epitope (TCE) Pools (ex Vivo ELISpot) | Nuc OLP : Change at Day 209 | 0.0 SFU per 10^6 cells | Standard Deviation 0 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in T Cell Response by T Cell Epitope (TCE) Pools (ex Vivo ELISpot) | ORF3a/Membrane OLP : Change at Day 58 | 4.4 SFU per 10^6 cells | Standard Deviation 16.12 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in T Cell Response by T Cell Epitope (TCE) Pools (ex Vivo ELISpot) | ORF3a/Membrane OLP : Baseline | 19.4 SFU per 10^6 cells | Standard Deviation 9.04 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in T Cell Response by T Cell Epitope (TCE) Pools (ex Vivo ELISpot) | ORF3a/Membrane OLP : Change at Day 8 | 0.8 SFU per 10^6 cells | Standard Deviation 2.04 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in T Cell Response by T Cell Epitope (TCE) Pools (ex Vivo ELISpot) | Nuc OLP : Baseline | 15.0 SFU per 10^6 cells | Standard Deviation 0 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in T Cell Response by T Cell Epitope (TCE) Pools (ex Vivo ELISpot) | Nuc OLP : Change at Day 8 | 0.0 SFU per 10^6 cells | Standard Deviation 0 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in T Cell Response by T Cell Epitope (TCE) Pools (ex Vivo ELISpot) | ORF3a/Membrane OLP : Change at Day 209 | 0.0 SFU per 10^6 cells | Standard Deviation 0 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in T Cell Response by T Cell Epitope (TCE) Pools (ex Vivo ELISpot) | Nuc OLP : Change at Day 29 | 3.3 SFU per 10^6 cells | Standard Deviation 5.4 |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Change From Baseline in T Cell Response by T Cell Epitope (TCE) Pools (ex Vivo ELISpot) | Nuc OLP : Change at Day 58 | 3.8 SFU per 10^6 cells | Standard Deviation 7.5 |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in T Cell Response by T Cell Epitope (TCE) Pools (ex Vivo ELISpot) | Nuc OLP : Change at Day 209 | 0.0 SFU per 10^6 cells | Standard Deviation 0 |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in T Cell Response by T Cell Epitope (TCE) Pools (ex Vivo ELISpot) | Nuc OLP : Change at Day 8 | -1.5 SFU per 10^6 cells | Standard Deviation 3.35 |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in T Cell Response by T Cell Epitope (TCE) Pools (ex Vivo ELISpot) | ORF3a/Membrane OLP : Change at Day 58 | 3.5 SFU per 10^6 cells | Standard Deviation 7.83 |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in T Cell Response by T Cell Epitope (TCE) Pools (ex Vivo ELISpot) | ORF3a/Membrane OLP : Change at Day 8 | 0.0 SFU per 10^6 cells | Standard Deviation 0 |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in T Cell Response by T Cell Epitope (TCE) Pools (ex Vivo ELISpot) | ORF3a/Membrane OLP : Baseline | 15.0 SFU per 10^6 cells | Standard Deviation 0 |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in T Cell Response by T Cell Epitope (TCE) Pools (ex Vivo ELISpot) | ORF3a/Membrane OLP : Change at Day 209 | 0.0 SFU per 10^6 cells | Standard Deviation 0 |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in T Cell Response by T Cell Epitope (TCE) Pools (ex Vivo ELISpot) | Nuc OLP : Change at Day 58 | 0.0 SFU per 10^6 cells | Standard Deviation 0 |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in T Cell Response by T Cell Epitope (TCE) Pools (ex Vivo ELISpot) | ORF3a/Membrane OLP : Change at Day 29 | 0.0 SFU per 10^6 cells | Standard Deviation 0 |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in T Cell Response by T Cell Epitope (TCE) Pools (ex Vivo ELISpot) | Nuc OLP : Baseline | 16.3 SFU per 10^6 cells | Standard Deviation 3.06 |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in T Cell Response by T Cell Epitope (TCE) Pools (ex Vivo ELISpot) | Nuc OLP : Change at Day 29 | 0.0 SFU per 10^6 cells | Standard Deviation 0 |
| Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in T Cell Response by T Cell Epitope (TCE) Pools (ex Vivo ELISpot) | ORF3a/Membrane OLP : Baseline | 15.0 SFU per 10^6 cells | — |
| Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in T Cell Response by T Cell Epitope (TCE) Pools (ex Vivo ELISpot) | Nuc OLP : Change at Day 29 | 0.0 SFU per 10^6 cells | — |
| Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in T Cell Response by T Cell Epitope (TCE) Pools (ex Vivo ELISpot) | Nuc OLP : Baseline | 15.0 SFU per 10^6 cells | — |
| Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in T Cell Response by T Cell Epitope (TCE) Pools (ex Vivo ELISpot) | ORF3a/Membrane OLP : Change at Day 8 | 0.0 SFU per 10^6 cells | — |
| Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in T Cell Response by T Cell Epitope (TCE) Pools (ex Vivo ELISpot) | ORF3a/Membrane OLP : Change at Day 29 | 0.0 SFU per 10^6 cells | — |
| Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Change From Baseline in T Cell Response by T Cell Epitope (TCE) Pools (ex Vivo ELISpot) | Nuc OLP : Change at Day 8 | 0.0 SFU per 10^6 cells | — |
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.
Time frame: Baseline to 478 days
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Number of Participants With Immunogenicity Response by Spike IgG and nAb Variants | IgG WT | 9 Participants |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Number of Participants With Immunogenicity Response by Spike IgG and nAb Variants | nAb WT | 9 Participants |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Number of Participants With Immunogenicity Response by Spike IgG and nAb Variants | nAb Alpha | 5 Participants |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Number of Participants With Immunogenicity Response by Spike IgG and nAb Variants | nAb Beta | 6 Participants |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Number of Participants With Immunogenicity Response by Spike IgG and nAb Variants | nAb Delta | 6 Participants |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Number of Participants With Immunogenicity Response by Spike IgG and nAb Variants | nAb Gamma | 6 Participants |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Number of Participants With Immunogenicity Response by Spike IgG and nAb Variants | nAb Delta | 4 Participants |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Number of Participants With Immunogenicity Response by Spike IgG and nAb Variants | nAb Gamma | 5 Participants |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Number of Participants With Immunogenicity Response by Spike IgG and nAb Variants | IgG WT | 6 Participants |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Number of Participants With Immunogenicity Response by Spike IgG and nAb Variants | nAb Alpha | 5 Participants |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Number of Participants With Immunogenicity Response by Spike IgG and nAb Variants | nAb Beta | 5 Participants |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Number of Participants With Immunogenicity Response by Spike IgG and nAb Variants | nAb WT | 5 Participants |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Number of Participants With Immunogenicity Response by Spike IgG and nAb Variants | nAb Beta | 1 Participants |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Number of Participants With Immunogenicity Response by Spike IgG and nAb Variants | nAb Delta | 4 Participants |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Number of Participants With Immunogenicity Response by Spike IgG and nAb Variants | IgG WT | 5 Participants |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Number of Participants With Immunogenicity Response by Spike IgG and nAb Variants | nAb Alpha | 2 Participants |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Number of Participants With Immunogenicity Response by Spike IgG and nAb Variants | nAb WT | 4 Participants |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Number of Participants With Immunogenicity Response by Spike IgG and nAb Variants | nAb Gamma | 2 Participants |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Number of Participants With Immunogenicity Response by Spike IgG and nAb Variants | nAb Beta | 3 Participants |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Number of Participants With Immunogenicity Response by Spike IgG and nAb Variants | nAb WT | 5 Participants |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Number of Participants With Immunogenicity Response by Spike IgG and nAb Variants | nAb Alpha | 1 Participants |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Number of Participants With Immunogenicity Response by Spike IgG and nAb Variants | nAb Gamma | 0 Participants |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Number of Participants With Immunogenicity Response by Spike IgG and nAb Variants | nAb Delta | 1 Participants |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Number of Participants With Immunogenicity Response by Spike IgG and nAb Variants | IgG WT | 4 Participants |
| Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Number of Participants With Immunogenicity Response by Spike IgG and nAb Variants | nAb Delta | 1 Participants |
| Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Number of Participants With Immunogenicity Response by Spike IgG and nAb Variants | nAb Alpha | 2 Participants |
| Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Number of Participants With Immunogenicity Response by Spike IgG and nAb Variants | nAb WT | 1 Participants |
| Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Number of Participants With Immunogenicity Response by Spike IgG and nAb Variants | nAb Gamma | 0 Participants |
| Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Number of Participants With Immunogenicity Response by Spike IgG and nAb Variants | nAb Beta | 1 Participants |
| Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Number of Participants With Immunogenicity Response by Spike IgG and nAb Variants | IgG WT | 0 Participants |
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.
Time frame: Baseline to 478 days
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Number of Participants With Immunogenicity Response by Spike Pools and TCE Pools (ex Vivo ELISpot) | Spike Pool 7_8 | 3 Participants |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Number of Participants With Immunogenicity Response by Spike Pools and TCE Pools (ex Vivo ELISpot) | Spike Pool 5_6 | 3 Participants |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Number of Participants With Immunogenicity Response by Spike Pools and TCE Pools (ex Vivo ELISpot) | Spike Pool 3_4 | 4 Participants |
| Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Number of Participants With Immunogenicity Response by Spike Pools and TCE Pools (ex Vivo ELISpot) | Spike Pool 1_2 | 4 Participants |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Number of Participants With Immunogenicity Response by Spike Pools and TCE Pools (ex Vivo ELISpot) | TCE Pool : Mem/ORF3a OLP | 2 Participants |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Number of Participants With Immunogenicity Response by Spike Pools and TCE Pools (ex Vivo ELISpot) | TCE Pool : Nuc OLP | 1 Participants |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Number of Participants With Immunogenicity Response by Spike Pools and TCE Pools (ex Vivo ELISpot) | Spike Pool 7_8 | 5 Participants |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Number of Participants With Immunogenicity Response by Spike Pools and TCE Pools (ex Vivo ELISpot) | Spike Pool 5_6 | 2 Participants |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Number of Participants With Immunogenicity Response by Spike Pools and TCE Pools (ex Vivo ELISpot) | Spike Pool 3_4 | 3 Participants |
| Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine) | Number of Participants With Immunogenicity Response by Spike Pools and TCE Pools (ex Vivo ELISpot) | Spike Pool 1_2 | 1 Participants |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Number of Participants With Immunogenicity Response by Spike Pools and TCE Pools (ex Vivo ELISpot) | TCE Pool : Mem/ORF3a OLP | 1 Participants |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Number of Participants With Immunogenicity Response by Spike Pools and TCE Pools (ex Vivo ELISpot) | Spike Pool 1_2 | 1 Participants |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Number of Participants With Immunogenicity Response by Spike Pools and TCE Pools (ex Vivo ELISpot) | Spike Pool 3_4 | 1 Participants |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Number of Participants With Immunogenicity Response by Spike Pools and TCE Pools (ex Vivo ELISpot) | Spike Pool 5_6 | 5 Participants |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Number of Participants With Immunogenicity Response by Spike Pools and TCE Pools (ex Vivo ELISpot) | Spike Pool 7_8 | 3 Participants |
| Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine) | Number of Participants With Immunogenicity Response by Spike Pools and TCE Pools (ex Vivo ELISpot) | TCE Pool : Nuc OLP | 1 Participants |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Number of Participants With Immunogenicity Response by Spike Pools and TCE Pools (ex Vivo ELISpot) | Spike Pool 5_6 | 1 Participants |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Number of Participants With Immunogenicity Response by Spike Pools and TCE Pools (ex Vivo ELISpot) | Spike Pool 3_4 | 0 Participants |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Number of Participants With Immunogenicity Response by Spike Pools and TCE Pools (ex Vivo ELISpot) | Spike Pool 7_8 | 0 Participants |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Number of Participants With Immunogenicity Response by Spike Pools and TCE Pools (ex Vivo ELISpot) | Spike Pool 1_2 | 2 Participants |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Number of Participants With Immunogenicity Response by Spike Pools and TCE Pools (ex Vivo ELISpot) | TCE Pool : Mem/ORF3a OLP | 1 Participants |
| Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Number of Participants With Immunogenicity Response by Spike Pools and TCE Pools (ex Vivo ELISpot) | TCE Pool : Nuc OLP | 0 Participants |
| Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Number of Participants With Immunogenicity Response by Spike Pools and TCE Pools (ex Vivo ELISpot) | Spike Pool 3_4 | 0 Participants |
| Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Number of Participants With Immunogenicity Response by Spike Pools and TCE Pools (ex Vivo ELISpot) | TCE Pool : Nuc OLP | 0 Participants |
| Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Number of Participants With Immunogenicity Response by Spike Pools and TCE Pools (ex Vivo ELISpot) | Spike Pool 1_2 | 0 Participants |
| Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Number of Participants With Immunogenicity Response by Spike Pools and TCE Pools (ex Vivo ELISpot) | TCE Pool : Mem/ORF3a OLP | 0 Participants |
| Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Number of Participants With Immunogenicity Response by Spike Pools and TCE Pools (ex Vivo ELISpot) | Spike Pool 5_6 | 0 Participants |
| Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine) | Number of Participants With Immunogenicity Response by Spike Pools and TCE Pools (ex Vivo ELISpot) | Spike Pool 7_8 | 0 Participants |