건강한 성인의 COVID-19에 대한 다양한 용량의 백신에 대한 안전성 및 면역 반응 연구

실험적: CoV-2 SAM [LNP] Group

Participants received two 1-microgram (µg) doses of Coronavirus-2 Spike self-amplifying mRNA lipid nanoparticle (CoV-2 SAM [LNP]) vaccine, one at Day 1 and one at Day 31.

생물학적: 1µg CoV2 SAM(LNP)

0.1개월 일정으로 1µg CoV2 SAM(LNP) 백신 2회 투여, 비우세 팔의 삼각근에 IM 투여.

Number of Participants With Solicited Administration Site Adverse Events After Each Vaccination

The solicited administration site adverse events assessed were pain, redness and swelling.

Number of Participants With Solicited Systemic Adverse Events After Each Vaccination

The solicited systemic events assessed were abdominal pain, arthralgia, diarrhea, fatigue, fever, headache, myalgia, nausea, vomiting. Fever is defined as temperature ≥38.0°Celsius (C)/100.4°Fahrenheit (F) regardless the location of measurement.

Number of Participants With Unsolicited Adverse Events (AEs) After Each Vaccination

An unsolicited AE is defined as an AE that was not included in a list of solicited events using a Participant eDiary, or any solicited event with onset after the 7-day period post each vaccination.

Number of Participants With Hematological and Biochemical Laboratory Abnormalities at Day 2 Compared With Baseline (Day 1)

The hematological and biochemical laboratory parameters assessed include alanine aminotransferase (ALT),alkaline phosphatase (ALP),aspartate aminotransferase (AST),bilirubin,creatinine,urea nitrogen,eosinophils,erythrocytes,hemoglobin,leukocytes,lymphocytes,neutrophils,partial thromboplastin time (PTT) and platelets. Categories reported for each parameter when comparing Day 1 baseline and post-baseline hematological and biochemical laboratory results are defined as follows:<range at baseline [Day 1]>, <range at post-baseline time point> for example, Below-Within, where each range is classified as below, within, or above the applicable laboratory reference range. Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.

Number of Participants With Hematological and Biochemical Laboratory Abnormalities at Day 8 Compared With Baseline (Day 1)

The hematological and biochemical laboratory parameters assessed include ALT, ALP, AST, bilirubin, creatinine, urea nitrogen, eosinophils, erythrocytes, hemoglobin, leukocytes, lymphocytes, neutrophils, PTT and platelets.

Categories reported for each parameter when comparing Day 1 (baseline) and post-baseline hematological and biochemical laboratory results are defined as follows: <range at baseline [Day 1]>, <range at post-baseline time point> for example, Below-Within, where each range is classified as below, within, or above the applicable laboratory reference range.

Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter; Unknown = No results are available for the specified visit and laboratory parameter.

Number of Participants With Hematological and Biochemical Laboratory Abnormalities at Day 31 Compared With Baseline (Day 1)

The hematological and biochemical laboratory parameters assessed include ALT, ALP, AST, bilirubin, creatinine, urea nitrogen, eosinophils, erythrocytes, hemoglobin, leukocytes, lymphocytes, neutrophils, PTT and platelets.

Categories reported for each parameter when comparing Day 1 (baseline) and post-baseline hematological and biochemical laboratory results are defined as follows: <range at baseline [Day 1]>, <range at post-baseline time point> for example, Below-Within, where each range is classified as below, within, or above the applicable laboratory reference range.

Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter; Unknown = No results are available for the specified visit and laboratory parameter.

Number of Participants With Hematological and Biochemical Laboratory Abnormalities at Day 32 Compared With Baseline (Day 1)

The hematological and biochemical laboratory parameters assessed include ALT, ALP, AST, bilirubin, creatinine, urea nitrogen, eosinophils, erythrocytes, hemoglobin, leukocytes, lymphocytes, neutrophils, PTT and platelets.

Categories reported for each parameter when comparing Day 1 (baseline) and post-baseline hematological and biochemical laboratory results are defined as follows: <range at baseline [Day 1]>, <range at post-baseline time point> for example, Below-Within, where each range is classified as below, within, or above the applicable laboratory reference range.

Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter; Unknown = No results are available for the specified visit and laboratory parameter.

Number of Participants With Hematological and Biochemical Laboratory Abnormalities at Day 38 Compared With Baseline (Day 1)

The hematological and biochemical laboratory parameters assessed include ALT, ALP, AST, bilirubin, creatinine, urea nitrogen, eosinophils, erythrocytes, hemoglobin, leukocytes, lymphocytes, neutrophils, PTT and platelets.

Categories reported for each parameter when comparing Day 1 (baseline) and post-baseline hematological and biochemical laboratory results are defined as follows: <range at baseline [Day 1]>, <range at post-baseline time point> for example, Below-Within, where each range is classified as below, within, or above the applicable laboratory reference range.

Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter; Unknown = No results are available for the specified visit and laboratory parameter.

Number of Participants With Medically-attended AEs (MAEs) From Day 1 to Day 61

A medically attended adverse event (MAE) is defined as an AE for which the participant received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (i.e., nurse practitioner or physician assistant or medical doctor) for any reason.

Number of Participants With Serious AEs (SAEs) From Day 1 to Day 61

An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, results in abnormal pregnancy outcomes or any other situation based on appropriate medical or scientific judgment.

Number of Participants With Adverse Events of Special Interest (AESIs) [Potential Immune-mediated Diseases (pIMDs) and COVID-19 Cases) From Day 1 to Day 61

AESIs assessed include pIMDs and COVID-19 cases. pIMDs are a subset of AESIs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology. Any suspected, probable or confirmed case of COVID-19 was reported.

Number of Participants With MAEs, SAEs and AESIs (pIMDs and COVID-19 Cases) From Day 1 up to Day 391

Percentage of Participants With Anti-Spike (S) Immunoglobulin G (IgG) Antibody Concentrations at Day 1, Day 31 and Day 61

Anti-S IgG antibody concentrations were measured using Enzyme-linked Immunosorbent Assay (ELISA). The considered cut-off value for this analysis was greater than or equal (>=) 50.3 ELISA units per milliliter (EU/mL).

Number of Participants With Anti-Nucleocapsid (N) IgG Antibody Concentrations at Day 1, Day 31 and Day 61

Anti-N IgG antibody concentrations were measured using ELISA. The considered cut-off value for this analysis was >=47.6 EU/mL.

SARS-CoV-2 Neutralizing Antibody Titers by Live Wild-Type Virus Neutralization at Day 1, Day 31 and Day 61

Neutralizing antibodies against SARS-CoV-2 were measured in serum using a live wild-type virus neutralizing assay and expressed as geometric mean titers (GMT).

Percentage of Participants With Anti-S IgG Antibody Concentrations at Day 8, Day 15, Day 38 and Day 45

Anti-S IgG antibody concentrations were measured using ELISA. The considered cut-off value for this analysis was >= 50.3 EU/mL.

Number of Participants With Anti-N IgG Antibody Concentrations at Day 8, Day 15, Day 38 and Day 45

Anti-N IgG antibody concentrations were measured using ELISA. The considered cut-off value for this analysis was >=47.6 EU/mL.

Cell Mediated Immune (CMI) Response in Terms of Frequency of SARS-CoV-2 Spike-specific Cluster of Differentiation (CD) 4+ T-cells Secreting at Least 2 Markers Including One Cytokine

Frequency of SARS-CoV-2 Spike-specific CD4+ T-cells expressing at least 2 activation markers including at least 1 cytokine (among IL-2, IFN gamma, TNF alpha, IL-13, IL-17, 4-1BB and CD40L) was determined by flow cytometry using intracellular cytokine staining (ICS) and expressed as CD4+ T-cells per million cells (CD4+ T-cells/million cells).

CMI Response in Terms of Frequency of SARS-CoV-2 Spike-specific CD 8+ T-cells Secreting at Least 2 Markers Including One Cytokine

Frequency of SARS-CoV-2 Spike-specific CD8+ T-cells expressing at least 2 activation markers including at least 1 cytokine (among IL-2, IFN gamma, TNF alpha, IL-13, IL-17, 4-1BB and CD40L) was determined by flow cytometry using intracellular cytokine staining (ICS) and expressed as CD8+ T-cells/million cells.