Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| jRCT2051210093 | Registry Identifier | Japan Registry of Clinical Trials (jRCT) |
Not provided
Not provided
Not provided
Public vaccination of approved ancestral strain COVID-19 vaccines will be terminated soon. And boosters must be dosed after ancestral vaccination approved in Japan. The study was terminated for ethical reason to prioritize the ancestral vaccination.
Not provided
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| Name | Class |
|---|---|
| Tanabe Pharma Corporation | INDUSTRY |
Not provided
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The objective of this study is to evaluate the safety and immunogenicity of MT-2766 in Japanese adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MT-2766 High dose (3.75 µg) | Experimental |
| |
| Placebo | Placebo Comparator |
| |
| MT-2766 Low dose | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MT-2766 High dose (3.75 µg) | Biological | Subjects will receive two doses of MT-2766 high dose (3.75 µg) given 21 days apart into the deltoid region of the alternating arm (each arm will be injected once) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Immediate Adverse Events (AEs) According to Severity, and Investigator-assessed Causality | Immediate AEs are defined as any solicited AEs and unsolicited AEs occurring within 30 minutes after vaccination. The causal relationship of all solicited AEs to investigational product was analyzed as related. | Within 30 minutes after each vaccination |
| Percentage of Participants With Solicited AEs According to Severity | Solicited AEs are defined the following; (i) local AEs (injection site erythema, injection site swelling, injection site induration, and injection site pain) and (ii) systemic AEs (fever, headache, fatigue, muscle aches, joint aches, chills, a feeling of general discomfort, swelling in the axilla, and swelling in the neck)． | Within 7 days after each vaccination |
| Percentage of Participants With Unsolicited AEs According to Severity, and Investigator-assessed Causality | Within 21 days after each vaccination | |
| Percentage of Participants With Serious AEs (SAEs), Medically Attended AEs (MAAEs), AEs Leading to Withdrawal, AEs of Special Interest (AESIs), and Deaths | AESIs include vaccine-associated enhanced diseases, hypersensitivity reactions, and potential immune-mediated diseases | Within 21 days after each vaccination |
| SARS-CoV-2 Neutralizing Antibody (Nab) Responses: GMT | Geometric mean neutralizing antibody titer (GMT) | Day 0 (before 1st vaccination), Day 21 (21 days after 1st vaccination and before 2nd vaccination), and Day 42 (21 days after 2nd vaccination) |
| SARS-CoV-2 Neutralizing Antibody (Nab) Responses: GMFR |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Serious AEs (SAEs), Medically Attended AEs (MAAEs), AEs Leading to Withdrawal, AEs of Special Interest (AESIs), and Deaths | AESIs include vaccine-associated enhanced diseases, hypersensitivity reactions, and potential immune-mediated diseases. | Day 0 (after 1st vaccination) to end of study, on average the study duration by the termination is 334 days. |
Not provided
Inclusion Criteria:
- Subjects must meet all of the following inclusion criteria at the Screening visit (Visit 1) and/or 1st vaccination visit (Visit 2) to be eligible for participation in this study. All Investigator assessment-based judgments must be carefully and fully documented in the source documents:
Subjects must have read, understood, and signed the informed consent form (ICF) prior to participating in the study; subjects must also complete study-related procedures and must communicate with the study staff at visits and by phone during the study;
At the Screening visit (Visit 1), Japanese male and female subjects must be ≥20 years of age;
At the Screening visit (Visit 1) and 1st vaccination visit (Visit 2), subject must have a body mass index (BMI) of ≥18.5 kg/m^2 and <30 kg/m^2;
Subjects are considered by the Investigator to be reliable and likely to cooperate with the assessment procedures and be available for the duration of the study;
Female subjects of childbearing potential must have a negative serum pregnancy test result at the Screening visit (Visit 1) and a negative urine pregnancy test result at 1st vaccination visit (Visit 2):
Non-childbearing females are defined as:
Female subjects of childbearing potential must use an effective method of contraception for one month prior to 1st vaccination visit (Visit 2) and agree to continue employing highly effective birth control measures for at least one month after the last study vaccination (or in the case of early termination, she must not plan to become pregnant for at least one month after her last study vaccination);
Subjects must be non-institutionalized (e.g. not living in rehabilitation centers or old-age homes);
Subjects have no acute or evolving medical problems prior to study participation and no clinically relevant abnormalities that could jeopardize subject safety or interfere with study assessments, as assessed by the Principal Investigator or sub-Investigator (thereafter referred as Investigator) and determined by medical history, physical examination, serology, clinical chemistry and hematology tests, urinalysis, and vital signs. Investigator discretion is permitted with this inclusion criterion.
Exclusion Criteria:
Subjects who meet any of the following exclusion criteria at the Screening visit (Visit 1) and/or 1st vaccination visit (Visit 2) will not be eligible for participation in this study. All Investigator assessment-based judgments must be carefully and fully documented in the source documents:
Acute disease is defined as presence of any moderate or severe acute illness with or without a fever within 48 hours prior to the Screening visit (Visit 1) and/or 1st vaccination visit (Visit 2).
'Uncontrolled' is defined as:
Investigator discretion is permitted with this exclusion criterion. 2. Any confirmed or suspected current immunosuppressive condition or immunodeficiency, including cancer, HIV, hepatitis B or C infection (subjects with a history of cured hepatitis B or C infection without any signs of immunodeficiency at present time are allowed). Investigator discretion is permitted with this exclusion criterion; 3. Current autoimmune disease (such as rheumatoid arthritis, systemic lupus erythematosus or multiple sclerosis). Investigator discretion is permitted with this exclusion criterion. Subjects may be eligible to participate with appropriate written justification in the source document. For example, subjects with a history of autoimmune disease who are disease-free without treatment for three years or more, subjects receiving stable thyroid replacement therapy, and subjects with mild psoriasis (i.e. a small number of minor plaques requiring no systemic treatment) are eligible for participation; 4. Administration of any medication or treatment that may alter the vaccine immune responses, such as:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Medicago | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Corporation Heishinkai OPHAC Hospital | Osaka | Osaka | 532-0003 | Japan | ||
| Medical Corporation Heishinkai OCROM Clinic |
Not provided
Not provided
Not provided
Not provided
Not provided
Low dose arm is open-label, not randomized arm and was not enrolled. It was described in the protocol that the study may be completed even if fewer than planned number of subjects in Low dose arm are enrolled.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | MT-2766 High Dose (3.75 µg) | Subjects received two doses of MT-2766 high dose (3.75 µg) given 21 days apart into the deltoid region of the alternating arm (each arm will be injected once). |
| FG001 | Placebo | Subjects received two doses of placebo given 21 days apart into the deltoid region of the alternating arm (each arm will be injected once). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Up to Day 42 |
|
| |||||||||||||||||||||
| After Day 43 |
|
Safety population included all randomized subjects who received at least 1 dose of the investigational product.
After randomization, one subject withdrew before receiving investigational product at the subject's request.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | MT-2766 High Dose (3.75 µg) | Subjects received two doses of MT-2766 high dose (3.75 µg) given 21 days apart into the deltoid region of the alternating arm (each arm will be injected once). |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Immediate Adverse Events (AEs) According to Severity, and Investigator-assessed Causality | Immediate AEs are defined as any solicited AEs and unsolicited AEs occurring within 30 minutes after vaccination. The causal relationship of all solicited AEs to investigational product was analyzed as related. | Safety population included all randomized subjects who received at least 1 dose of the investigational product. | Posted | Number | percentage of participants | Within 30 minutes after each vaccination |
|
Day 0 (after 1st vaccination) to end of study, on average the study duration by the termination is 334 days.
Data were collected based on regular investigator assessment and laboratory testing, self-reporting by participants and subject diary. For solicited AEs, prespecified AEs were collected up to 7 days after each administration using the subject diary.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MT-2766 High Dose (3.75 µg) | Subjects received two doses of MT-2766 high dose (3.75 µg) given 21 days apart into the deltoid region of the alternating arm (each arm will be injected once). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Induration | General disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Medicago | +1 418-658-9393 | clinicaltrialinquiries@medicago.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 16, 2021 | Mar 9, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 12, 2023 | Jul 30, 2023 | SAP_002.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| C000720497 | MT-2766 vaccine |
| C550253 | AS03 adjuvant |
Not provided
Not provided
Not provided
Not provided
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Not provided
MT-2766 High dose group and placebo group are randomized and observer-blinded. MT-2766 Low dose group is open label.
|
| Placebo | Drug | Subjects will receive two doses of placebo given 21 days apart into the deltoid region of the alternating arm (each arm will be injected once) |
|
| MT-2766 Low dose | Biological | Subjects will receive two doses of MT-2766 low dose given 21 days apart into the deltoid region of the alternating arm (each arm will be injected once) |
|
|
Geometric mean fold rise (GMFR) is defined as the ratio of geometric mean antibody titer (GMT) based on that of Day 0 (i.e. Day 21/Day 0 and Day 42/Day 0).
| Day 21 (21 days after 1st vaccination and before 2nd vaccination), and Day 42 (21 days after 2nd vaccination) |
| SARS-CoV-2 Neutralizing Antibody (Nab) Responses | Seroconversion (SC) rate. SC rate is defined as the proportion of subjects achieving SC in the analysis set i.e. subjects with:
| Day 0 (before 1st vaccination), Day 21 (21 days after 1st vaccination and before 2nd vaccination), and Day 42 (21 days after 2nd vaccination) |
| SARS-CoV-2-specific T Helper 1 (Th1) Cell-mediated Immune (CMI) Responses | Using the interferon-γ enzyme-linked immunospot (ELISpot) assay. Unit of Measure: Spot-Forming Cell (SFC)/10^6 Peripheral Blood Mononuclear Cells (PBMC) | Day 0 (before 1st vaccination), Day 21 (21 days after 1st vaccination and before 2nd vaccination), and Day 42 (21 days after 2nd vaccination) |
| SARS-CoV-2-specific T Helper 2 (Th2) CMI Responses | Using the interleukin-4 ELISpot assay | Day 0 (before 1st vaccination), Day 21 (21 days after 1st vaccination and before 2nd vaccination), and Day 42 (21 days after 2nd vaccination) |
| SARS-CoV-2 Neutralizing Antibody (Nab) Responses: GMT | Geometric mean neutralizing antibody titer (GMT) | Day 128 and Day 201 |
| SARS-CoV-2 Neutralizing Antibody (Nab) Responses: GMFR | Geometric mean fold rise (GMFR) | Day 128 and Day 201 |
| Seroconversion (SC) Rate of SARS-CoV-2 Neutralizing Antibody | SC rate is defined as the proportion of subjects achieving SC in the analysis set i.e. subjects with:
| Day 128 and Day 201 |
| SARS-CoV-2-specific T Helper 1 (Th1) Cell-mediated Immune (CMI) Responses | Using the interferon-γ enzyme-linked immunospot (ELISpot) assay. | Days 201 |
| SARS-CoV-2-specific T Helper 2 (Th2) CMI Responses | Using the interleukin-4 ELISpot assay | Days 201 |
| SARS-CoV-2-specific Antibody Responses (Total IgG): GMT | Geometric mean neutralizing antibody titer (GMT) | Day 0，Day 21，Day 42，Day 128 and Day 201 |
| SARS-CoV-2-specific Antibody Responses (Total IgG): GMFR | Geometric mean fold rise (GMFR) | Day 0，Day 21，Day 42，Day 128 and Day 201 |
| Seroconversion (SC) Rate of SARS-CoV-2-specific Antibody Responses (Total IgG): | SC rate is defined as the proportion of subjects achieving SC in the analysis set i.e. subjects with:
| Day 0，Day 21，Day 42，Day 128 and Day 201 |
| Suita-shi |
| Osaka |
| 565-0853 |
| Japan |
| Medical Corporation Heishinkai ToCROM Clinic | Shinjuku-ku | Tokyo | 160-0008 | Japan |
| NOT COMPLETED |
|
|
Subjects received two doses of placebo given 21 days apart into the deltoid region of the alternating arm (each arm will be injected once).
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Placebo |
Subjects received two doses of placebo given 21 days apart into the deltoid region of the alternating arm (each arm will be injected once). |
|
|
| Primary | Percentage of Participants With Solicited AEs According to Severity | Solicited AEs are defined the following; (i) local AEs (injection site erythema, injection site swelling, injection site induration, and injection site pain) and (ii) systemic AEs (fever, headache, fatigue, muscle aches, joint aches, chills, a feeling of general discomfort, swelling in the axilla, and swelling in the neck)． | Safety population included all randomized subjects who received at least 1 dose of the investigational product. | Posted | Number | percentage of participants | Within 7 days after each vaccination |
|
|
|
| Primary | Percentage of Participants With Unsolicited AEs According to Severity, and Investigator-assessed Causality | Safety population included all randomized subjects who received at least 1 dose of the investigational product. | Posted | Number | percentage of participants | Within 21 days after each vaccination |
|
|
|
| Primary | Percentage of Participants With Serious AEs (SAEs), Medically Attended AEs (MAAEs), AEs Leading to Withdrawal, AEs of Special Interest (AESIs), and Deaths | AESIs include vaccine-associated enhanced diseases, hypersensitivity reactions, and potential immune-mediated diseases | Safety population included all randomized subjects who received at least 1 dose of the investigational product. | Posted | Number | percentage of participants | Within 21 days after each vaccination |
|
|
|
| Primary | SARS-CoV-2 Neutralizing Antibody (Nab) Responses: GMT | Geometric mean neutralizing antibody titer (GMT) | Immunogenicity Per Protocol population included all randomized subjects who do not have any major protocol violations, and who received the investigational product. For the Day 21 analysis, this included the subjects who received the first vaccine dose and had Day 0 and Day 21 immunogenicity sample collections. For the Day 42 analysis, this included the subjects who received both vaccine doses and had Day 0 and Day 42 immunogenicity sample collections. | Posted | Geometric Mean | 95% Confidence Interval | titer | Day 0 (before 1st vaccination), Day 21 (21 days after 1st vaccination and before 2nd vaccination), and Day 42 (21 days after 2nd vaccination) |
|
|
|
| Primary | SARS-CoV-2 Neutralizing Antibody (Nab) Responses: GMFR | Geometric mean fold rise (GMFR) is defined as the ratio of geometric mean antibody titer (GMT) based on that of Day 0 (i.e. Day 21/Day 0 and Day 42/Day 0). | Immunogenicity Per Protocol population included all randomized subjects who do not have any major protocol violations, and who received the investigational product. For the Day 21 analysis, this included the subjects who received the first vaccine dose and had Day 0 and Day 21 immunogenicity sample collections. For the Day 42 analysis, this included the subjects who received both vaccine doses and had Day 0 and Day 42 immunogenicity sample collections. | Posted | Geometric Mean | 95% Confidence Interval | fold rise | Day 21 (21 days after 1st vaccination and before 2nd vaccination), and Day 42 (21 days after 2nd vaccination) |
|
|
|
| Primary | SARS-CoV-2 Neutralizing Antibody (Nab) Responses | Seroconversion (SC) rate. SC rate is defined as the proportion of subjects achieving SC in the analysis set i.e. subjects with:
| Immunogenicity Per Protocol population included all randomized subjects who do not have any major protocol violations, and who received the investigational product. For the Day 21 analysis, this included the subjects who received the first vaccine dose and had Day 0 and Day 21 immunogenicity sample collections. For the Day 42 analysis, this included the subjects who received both vaccine doses and had Day 0 and Day 42 immunogenicity sample collections. | Posted | Number | 95% Confidence Interval | percentage of subjects achieving SC | Day 0 (before 1st vaccination), Day 21 (21 days after 1st vaccination and before 2nd vaccination), and Day 42 (21 days after 2nd vaccination) |
|
|
|
| Primary | SARS-CoV-2-specific T Helper 1 (Th1) Cell-mediated Immune (CMI) Responses | Using the interferon-γ enzyme-linked immunospot (ELISpot) assay. Unit of Measure: Spot-Forming Cell (SFC)/10^6 Peripheral Blood Mononuclear Cells (PBMC) | Immunogenicity Per Protocol population included all randomized subjects who do not have any major protocol violations, and who received the investigational product. For the Day 21 analysis, this included the subjects who received the first vaccine dose and had Day 0 and Day 21 immunogenicity sample collections. For the Day 42 analysis, this included the subjects who received both vaccine doses and had Day 0 and Day 42 immunogenicity sample collections. | Posted | Median | 95% Confidence Interval | SFC/10^6 PBMC | Day 0 (before 1st vaccination), Day 21 (21 days after 1st vaccination and before 2nd vaccination), and Day 42 (21 days after 2nd vaccination) |
|
|
|
| Primary | SARS-CoV-2-specific T Helper 2 (Th2) CMI Responses | Using the interleukin-4 ELISpot assay | Immunogenicity Per Protocol population included all randomized subjects who do not have any major protocol violations, and who received the investigational product. For the Day 21 analysis, this included the subjects who received the first vaccine dose and had Day 0 and Day 21 immunogenicity sample collections. For the Day 42 analysis, this included the subjects who received both vaccine doses and had Day 0 and Day 42 immunogenicity sample collections. | Posted | Median | 95% Confidence Interval | SFC/10^6 PBMC | Day 0 (before 1st vaccination), Day 21 (21 days after 1st vaccination and before 2nd vaccination), and Day 42 (21 days after 2nd vaccination) |
|
|
|
| Secondary | Percentage of Participants With Serious AEs (SAEs), Medically Attended AEs (MAAEs), AEs Leading to Withdrawal, AEs of Special Interest (AESIs), and Deaths | AESIs include vaccine-associated enhanced diseases, hypersensitivity reactions, and potential immune-mediated diseases. | Safety population included all randomized subjects who received at least 1 dose of the investigational product. | Posted | Number | percentage of participants | Day 0 (after 1st vaccination) to end of study, on average the study duration by the termination is 334 days. |
|
|
|
| Secondary | SARS-CoV-2 Neutralizing Antibody (Nab) Responses: GMT | Geometric mean neutralizing antibody titer (GMT) | This analysis population included randomized subjects who had no major protocol violations and received investigational drug (MT-2766 n=100, Placebo n=26). For the Day 128, analysis included the subjects who received both doses and had Day 0 and 128 sample collections (MT-2766 n=94, Placebo n=25). For the Day 201, analysis included the subjects who received both doses and had Day 0 and 201 sample collections (MT-2766 n=90, Placebo n=22). | Posted | Geometric Mean | 95% Confidence Interval | titer | Day 128 and Day 201 |
|
|
|
| Secondary | SARS-CoV-2 Neutralizing Antibody (Nab) Responses: GMFR | Geometric mean fold rise (GMFR) | This analysis population included randomized subjects who had no major protocol violations and received investigational drug (MT-2766 n=100, Placebo n=26). For the Day 128, analysis included the subjects who received both doses and had Day 0 and 128 sample collections (MT-2766 n=94, Placebo n=25). For the Day 201, analysis included the subjects who received both doses and had Day 0 and 201 sample collections (MT-2766 n=90, Placebo n=22). | Posted | Geometric Mean | 95% Confidence Interval | fold rise | Day 128 and Day 201 |
|
|
|
| Secondary | Seroconversion (SC) Rate of SARS-CoV-2 Neutralizing Antibody | SC rate is defined as the proportion of subjects achieving SC in the analysis set i.e. subjects with:
| This analysis population included randomized subjects who had no major protocol violations and received investigational drug (MT-2766 n=100, Placebo n=26). For the Day 128, analysis included the subjects who received both doses and had Day 0 and 128 sample collections (MT-2766 n=94, Placebo n=25). For the Day 201, analysis included the subjects who received both doses and had Day 0 and 201 sample collections (MT-2766 n=90, Placebo n=22). | Posted | Geometric Mean | 95% Confidence Interval | ï¼… | Day 128 and Day 201 |
|
|
|
| Secondary | SARS-CoV-2-specific T Helper 1 (Th1) Cell-mediated Immune (CMI) Responses | Using the interferon-γ enzyme-linked immunospot (ELISpot) assay. | Immunogenicity Per Protocol population included all randomized subjects who do not have any major protocol violations, and who received the investigational product. For the Day 128 analysis, this should include the subjects who received both vaccine doses and had Day 0 and Day 128 immunogenicity sample collections. For the Day 201 analysis, this should include the subjects who received both vaccine doses and had Day 0 and Day 201 immunogenicity sample collections. | Posted | Median | 95% Confidence Interval | SFC/10^6 PBMC | Days 201 |
|
|
|
| Secondary | SARS-CoV-2-specific T Helper 2 (Th2) CMI Responses | Using the interleukin-4 ELISpot assay | Immunogenicity Per Protocol population included all randomized subjects who do not have any major protocol violations, and who received the investigational product. For the Day 128 analysis, this should include the subjects who received both vaccine doses and had Day 0 and Day 128 immunogenicity sample collections. For the Day 201 analysis, this should include the subjects who received both vaccine doses and had Day 0 and Day 201 immunogenicity sample collections. | Posted | Median | 95% Confidence Interval | SFC/10^6 PBMC | Days 201 |
|
|
|
| Secondary | SARS-CoV-2-specific Antibody Responses (Total IgG): GMT | Geometric mean neutralizing antibody titer (GMT) | This analysis population included randomized subjects who had no major protocol violations and received investigational drug (MT-2766 n=100, Placebo n=26). For the Day 21, analysis included the subjects who received the 1st dose and had Day 0 and 21 sample collections. For the Day 42, 128, and 201, analyses included the subjects who received two doses and had Day 0 and the each time point sample collections. See the table below for the number of analyzed subjects at each time point. | Posted | Geometric Mean | 95% Confidence Interval | titer | Day 0，Day 21，Day 42，Day 128 and Day 201 |
|
|
|
| Secondary | SARS-CoV-2-specific Antibody Responses (Total IgG): GMFR | Geometric mean fold rise (GMFR) | This analysis population included randomized subjects who had no major protocol violations and received investigational drug (MT-2766 n=100, Placebo n=26). For the Day 21, analysis included the subjects who received the 1st dose and had Day 0 and 21 sample collections. For the Day 42, 128, and 201, analyses included the subjects who received two doses and had Day 0 and the each time point sample collections. See the table below for the number of analyzed subjects at each time point. | Posted | Geometric Mean | 95% Confidence Interval | fold rise | Day 0，Day 21，Day 42，Day 128 and Day 201 |
|
|
|
| Secondary | Seroconversion (SC) Rate of SARS-CoV-2-specific Antibody Responses (Total IgG): | SC rate is defined as the proportion of subjects achieving SC in the analysis set i.e. subjects with:
| This analysis population included randomized subjects who had no major protocol violations and received investigational drug (MT-2766 n=100, Placebo n=26). For the Day 21, analysis included the subjects who received the 1st dose and had Day 0 and 21 sample collections. For the Day 42, 128, and 201, analyses included the subjects who received two doses and had Day 0 and the each time point sample collections. See the table below for the number of analyzed subjects at each time point. | Posted | Number | 95% Confidence Interval | percentage of subjects achieving SC | Day 0，Day 21，Day 42，Day 128 and Day 201 |
|
|
|
| 0 |
| 101 |
| 2 |
| 101 |
| 92 |
| 101 |
| EG001 | Placebo | Subjects received two doses of placebo given 21 days apart into the deltoid region of the alternating arm (each arm will be injected once). | 0 | 26 | 2 | 26 | 11 | 26 |
| Cerebral infarction | Nervous system disorders | Systematic Assessment |
|
| Large intestine polyp | Gastrointestinal disorders | Systematic Assessment |
|
| Sternal fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Pain | General disorders | Systematic Assessment |
|
| Redness | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Chills | General disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Feeling of General Discomfort | General disorders | Systematic Assessment |
|
| Feeling of Swelling in the Neck | General disorders | Systematic Assessment |
|
| Fever | General disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Joint Aches | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Muscle Aches | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Swelling | General disorders | Systematic Assessment |
|
Not provided
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| Severity of Solicited AE: Moderate |
|
| Severity of Solicited AE: Severe |
|
| Severity of Solicited AE: Potentially life-threatening |
|
| Percentage of Participants with Solicited Local AE |
|
| Severity of Solicited Local AE: Mild |
|
| Severity of Solicited Local AE: Moderate |
|
| Severity of Solicited Local AE: Severe |
|
| Severity of Solicited Local AE: Potentially life-threatening |
|
| Percentage of Participants with Solicited Systemic AE |
|
| Severity of Solicited Systemic AE: Mild |
|
| Severity of Solicited Systemic AE: Moderate |
|
| Severity of Solicited Systemic AE: Severe |
|
| Severity of Solicited Systemic AE: Potentially life-threatening |
|
| Severity of Unsolicited AE: Moderate |
|
| Severity of Unsolicited AE: Severe |
|
| Severity of Unsolicited AE: Potentially life-threatening |
|
| Percentage of Participants with Related Unsolicited AE |
|
| Percentage of Participants with AEs Leading to Study Withdrawal |
|
| Percentage of Participants with AESIs |
|
| Percentage of Participants with Deaths |
|
| GMT: Day 21 |
|
|
| GMT: Day 42 |
|
|
| GMFR: Day 42/Day 0 |
|
|
| Day 42 |
|
|
| Day 21 |
|
|
| Day 42 |
|
|
| Day 21 |
|
|
| Day 42 |
|
|
| Percentage of Participants with AEs Leading to Study Withdrawal |
|
| Percentage of Participants with AESIs |
|
| Percentage of Participants with Deaths |
|
| GMT: Day 201 |
|
|
| GMFR: Day 201/Day 0 |
|
|
| SC rate: Day 201 |
|
|
| GMT: Day 21 |
|
|
| GMT: Day 42 |
|
|
| GMT: Day 128 |
|
|
| GMT: Day 201 |
|
|
| GMFR: Day 42/Day 0 |
|
|
| GMFR: Day 128/Day 0 |
|
|
| GMFR: Day 201/Day 0 |
|
|
| SC rate: Day 42 |
|
|
| SC rate: Day 128 |
|
|
| SC rate: Day 201 |
|
|