JRCT ID: jRCT2071200084
Registered date:18/01/2021
A Study of TAK-019 in Healthy Japanese Adults (COVID-19)
Basic Information
Recruitment status | Complete |
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Health condition(s) or Problem(s) studied | Prevention of infection disease caused by SARS-CoV-2 |
Date of first enrollment | 12/02/2021 |
Target sample size | 200 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | TAK-019 0.5 mL or TAK-019 Matching Placebo, intramuscular injection in the upper arm |
Outcome(s)
Primary Outcome | 1. Percentage of Participants with Solicited Local Adverse Events (AEs) for Six Subsequent Days Following First Vaccination Time Frame: Up to Day 7 (6 subsequent days after first vaccination on Day 1) Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their diary for six subsequent days following first vaccination. Solicited local AEs included injection site pain, tenderness, erythema/redness, induration, and swelling. 2.Percentage of Participants With Solicited Local AEs for Six Subsequent Days Following Second Vaccination Time Frame: Up to Day 28 (6 subsequent days after second vaccination on Day 22) Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their diary for six subsequent days following second vaccination. Solicited local AEs included injection site pain, tenderness, erythema/redness, induration, and swelling. 3.Percentage of Participants with Solicited Systemic AEs for Six Subsequent Days Following First Vaccination Time Frame: Up to Day 7 (6 subsequent days after first vaccination on Day 1) Solicited systemic AEs were pre-defined AEs for which participants were specifically questioned and which were noted by participants in their diary for six subsequent days following first vaccination. Solicited systemic AEs included fever, fatigue, malaise, myalgia, arthralgia, nausea/vomiting, and headache. 4.Percentage of Participants With Solicited Systemic AEs for Six Subsequent Days Following Second Vaccination Time Frame: Up to Day 28 (6 subsequent days after second vaccination on Day 22) Solicited systemic AEs were pre-defined AEs for which participants were specifically questioned and which were noted by participants in their diary for six subsequent days following second vaccination. Solicited systemic AEs included fever, fatigue, malaise, myalgia, arthralgia, nausea/vomiting and headache. 5.Percentage of Participants with Unsolicited AEs for 20 Days Following First Vaccination Time Frame: Up to Day 21 (20 days after first vaccination on Day 1) Unsolicited AEs were all AEs that were not pre-defined for which the participant was not specifically questioned in the participant diary. 6.Percentage of Participants With Unsolicited AEs for 27 Days Following Second Vaccination Time Frame: Up to Day 49 (27 days after second vaccination on Day 22) Unsolicited AEs were all AEs that were not pre-defined for which the participant was not specifically questioned in the participant diary. 7.Percentage of Participants with Serious Adverse Events (SAEs) until Day 50 Time Frame: Day 1 up to Day 50 Only unsolicited SAEs data was planned to be collected and assessed for the assessment of this OM and solicited SAE was out of the scope of assessment. Unsolicited SAEs were those AEs that were not pre-defined for which the participant was not specifically questioned in the participant diary. Percentage of participants with unsolicited SAEs until Day 50 were reported in this outcome measure. 8.Percentage of Participants with Adverse Events of Special Interest (AESI) until Day 50 Time Frame: Day 1 up to Day 50 AESIs were defined as AEs that were specifically highlighted to the Investigator. Only unsolicited AESI data was planned to be collected and assessed for the assessment of this OM and solicited AESI was out of the scope of assessment. Unsolicited AESIs were those AEs that were not pre-defined for which the participant was not specifically questioned in the participant diary. Percentage of participants with unsolicited AESIs until Day 50 were reported in this outcome measure. 9.Percentage of Participants with Medically-Attended Adverse Events (MAAEs) until Day 50 Time Frame: Day 1 up to Day 50 MAAEs are defined as AEs leading to an unscheduled visit to or by a healthcare professional including visits to an emergency department, but not fulfilling seriousness criteria. Only unsolicited MAAEs data was planned to be collected and assessed for the assessment of this OM and solicited AESI was out of the scope of assessment. Unsolicited MAAEs were those AEs that were not pre-defined for which the participant was not specifically questioned in the participant diary. Percentage of participants with unsolicited MAAEs until Day 50 were reported in this outcome measure. 10.Percentage of Participants with Any AE Leading to Discontinuation of Vaccination Time Frame: Day 1 up to Day 22 Only unsolicited AE leading to discontinuation of vaccination data was planned to be collected and assessed for the assessment of this OM and solicited AE leading to discontinuation of vaccination was out of the scope of assessment. Unsolicited AEs were those AEs that were not pre-defined for which the participant was not specifically questioned in the participant diary. Percentage of participants with any unsolicited AE leading to discontinuation of vaccination until Day 22 were reported in this outcome measure. 11.Percentage of Participants with Any AE Leading to Participant's Withdrawal from the Trial until Day 50 Time Frame: Day 1 up to Day 50 Only unsolicited AE leading to participant's withdrawal from the trial data was planned to be collected and assessed for the assessment of this OM and solicited AE leading to participant's withdrawal from the trial was out of the scope of assessment. Unsolicited AEs were those AEs that were not pre-defined for which the participant was not specifically questioned in the participant diary. Percentage of participants with any unsolicited AE leading to participant's withdrawal from the trial until Day 50 were reported in this outcome measure. 12.Percentage of Participants with SARS-CoV-2 Infection until Day 50 Time Frame: Day 1 up to Day 50 13.Geometric Mean Titers (GMT) of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Day 36 Time Frame: At Day 36 GMT was the immunogenicity outcome expressed as reciprocal antibody titer with average for each group. Titer values was measured as below lower limit of quantification (LLOQ) were imputed to a value that was half of the LLOQ. LLOQ was equal to 200. Here, ELISA is Enzyme-linked immunosorbent assay. 14.Geometric Mean Fold Rise (GMFR) of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Day 36 Time Frame: At Day 36 GMFR was calculated as the ratio of the post-vaccination titer level to the baseline titer level. Baseline was defined as the last measurement taken before the first dose of study intervention. 15.Seroconversion Rate (SCR) of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Day 36 Time Frame: At Day 36 SCR was defined as percentage of participants with 4-fold or more rises in titer if naive at baseline OR percentage of participants with 2-fold or more rises in titer if seropositive at baseline. Baseline was defined as the last measurement taken before the first dose of study intervention. 16.Seroresponce Rate (SRR) of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Day 36 Time Frame: At Day 36 SRR was defined as percentage of participants with greater than or equal to (>=) 95 percentile in titer at Baseline for all participants. Baseline was defined as the last measurement taken before the first dose of study intervention. |
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Secondary Outcome | 1.Percentage of Participants with SAE throughout the Trial Time Frame: Day 1 up to Day 387 Only unsolicited SAEs data was planned to be collected and assessed for the assessment of this OM and solicited SAE was out of the scope of assessment. Unsolicited SAEs were those AEs that were not pre-defined for which the participant was not specifically questioned in the participant diary. Percentage of participants with unsolicited SAEs throughout the trial were reported in this outcome measure. 2.Percentage of Participants with AESI throughout the Trial Time Frame: Day 1up to Day 387 AESIs were defined as AEs that were specifically highlighted to the Investigator. Only unsolicited AESI data was planned to be collected and assessed for the assessment of this OM and solicited AESI was out of the scope of assessment. Unsolicited AESI were those AEs that were not pre-defined for which the participant was not specifically questioned in the participant diary. Percentage of participants with unsolicited AESIs throughout the trial were reported in this outcome measure. 3.Percentage of Participants with MAAEs throughout the Trial Time Frame: Day 1 up to Day 387 MAAEs are defined as AEs leading to an unscheduled visit to or by a healthcare professional including visits to an emergency department, but not fulfilling seriousness criteria. Only unsolicited MAAEs data was planned to be collected and assessed for the assessment of this OM and solicited MAAE was out of the scope of assessment. Unsolicited MAAEs were those AEs that were not pre-defined for which the participant was not specifically questioned in the participant diary. Percentage of participants with unsolicited MAAEs throughout the trial were reported in this outcome measure. 4.Percentage of Participants with Any AE Leading to Participant's Withdrawal from the Trial from the Day of Vaccination throughout the Trial Time Frame: Day 1 up to Day 387 Only unsolicited AE leading to participant's withdrawal from the trial data was planned to be collected and assessed for the assessment of this OM and solicited AE leading to participant's withdrawal from the trial was out of the scope of assessment. Unsolicited AEs were those AEs that were not pre-defined for which the participant was not specifically questioned in the participant diary. Percentage of participants with any unsolicited AE leading to withdrawal from the trial from the day of vaccination throughout the trial were reported in this outcome measure. 5.Percentage of Participants with SARS-CoV-2 Infection throughout the Trial Time Frame: Day 1 up to Day 387 6.GMT of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Days 22, 50, 202, and 387 Time Frame: At Days 22, 50, 202, and 387 GMT was the immunogenicity outcome expressed as reciprocal antibody titer with average for each group. Titer values was measured as below LLOQ were imputed to a value that was half of the LLOQ. GMT of serum IgG antibody levels to the SARS-CoV-2 rS protein was measured where LLOQ was equal to 200. 7.GMFR of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Days 22, 50, 202, and 387 Time Frame: At Days 22, 50, 202, and 387 GMFR was calculated as the ratio of the post-vaccination titer level to the baseline titer level. Where baseline was defined as the last measurement taken before the first dose of study intervention. 8.SCR of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Days 22, 50, 202, and 387 Time Frame: At Days 22, 50, 202, and 387 SCR was defined as percentage of participants with 4-fold or more rises in titer if naive at baseline OR percentage of participants with 2-fold or more rises in titer if seropositive at baseline. Baseline was defined as the last measurement taken before the first dose of study intervention. 9.SRR of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Days 22, 50, 202, and 387 Time Frame: At Days 22, 50, 202, and 387 SRR was defined as percentage of participants with >=95 percentile in titer at Baseline for all participants. Baseline was defined as the last measurement taken before the first dose of study intervention. 10.GMT of Serum Neutralizing Antibody (nAb) Titters to Wild-type Virus on Days 22, 36, 50, 202, and 387 Time Frame: At Days 22, 36, 50, 202, and 387 The neutralization titer was expressed as the reciprocal of the highest dilution at which greater than or equal to (>=) 50% of the replicate wells were protected from infection (MN50). GMT was the immunogenicity outcome expressed as reciprocal antibody titer with average for each group. Titer values was measured as below LLOQ were imputed to a value that was half of the LLOQ. GMT of serum IgG antibody levels to the SARS-CoV-2 rS protein was measured where LLOQ was equal to 200. 11.GMFR of Serum nAb Titters to Wild-type Virus on Days 22, 36, 50, 202, and 387 Time Frame: At Days 22, 36, 50, 202, and 387 The neutralization titer was expressed as the reciprocal of the highest dilution at which >=50% of the replicate wells were protected from infection (MN50). GMFR was calculated as the ratio of the post-vaccination titer level to the baseline titer level. Baseline was defined as the last measurement taken before the first dose of study intervention. 12.SCR to Serum nAb Titters to Wild-type Virus on Days 22, 36, 50, 202, and 387 Time Frame: At Days 22, 36, 50, 202, and 387 The neutralization titer was expressed as the reciprocal of the highest dilution at which >=50% of the replicate wells were protected from infection (MN50). SCR was defined as percentage of participants with 4-fold or more rises in titer if naive at baseline OR percentage of participants with 2-fold or more rises in titer if seropositive at baseline. Baseline was defined as the last measurement taken before the first dose of study intervention. 13.SRR to Serum nAb Titters to Wild-type Virus on Days 22, 36, 50, 202, and 387 Time Frame: At Days 22, 36, 50, 202, and 387 The neutralization titer was expressed as the reciprocal of the highest dilution at which >=50% of the replicate wells were protected from infection (MN50). SRR was defined as percentage of participants with >=95 percentile in titer at Baseline for all participants. Baseline was defined as the last measurement taken before the first dose of study intervention. |
Key inclusion & exclusion criteria
Age minimum | >= 20age old |
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Age maximum | Not applicable |
Gender | Both |
Include criteria | 1. Healthy Japanese male and female adult participants aged >= 20 years of age at the time of signing of informed consent. 2. Participants who understand and are willing to comply with trial procedures and are available for the duration of follow-up. |
Exclude criteria | 1. Participants who received any other SARS-CoV-2 or other experimental novel coronavirus vaccine prior to the trial. 2. Participants who have close contact of anyone known to have COVID-19 within 30 days prior to the trial vaccination. 3. Participants who were tested positive for SARS-CoV-2 prior to the trial or before the trial vaccination. 4. Participants who are on current treatment with other investigational agents for prophylaxis of COVID-19. 5. Participants who have traveled outside of Japan in the 30 days prior to the trial participation. 6. Participants with a clinically significant active infection (as assessed by the Investigator) or oral temperature >= 38 degree Celsius within 3 days of the intended date of vaccination. 7. Participants with known hypersensitivity or allergy to any of the investigational vaccine components. 8. Participants with history or any illness that, in the opinion of the Investigator, might interfere with the results of the trial or pose additional risk to the participants due to participation in the trial. 9. Participants with known or suspected impairment/alteration of immune function, including history of any autoimmune disease or neuro-inflammatory disease. 10. Abnormalities of splenic or thymic function. 11. Participants with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time. 12. Participants with any serious chronic or progressive disease (eg, neoplasm, insulin dependent diabetes, cardiac, renal or hepatic disease). 13. Participants with body mass index (BMI) greater than or equal to 30 kg/m^2 (BMI= weight in kg/ height in meters^2). 14. Participants participating in any clinical trial with another investigational product within 30 days prior to the trial vaccination or intend to participate in another clinical trial at any time during the conduct of this trial. 15. Participants who received or plan to receive any other licensed vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to trial dose administration. 16. Participants with acute or chronic clinically significant disease including pulmonary, cardiovascular, hepatic or renal abnormality evaluated by physical examination. 17. Participants involved in the trial conduct or their first degree relatives. 18. Participants who have history or infection of hepatitis B, hepatitis C, and human immunodeficiency virus infection. 19. Female participants who are pregnant or breastfeeding. |
Related Information
Primary Sponsor | Kuriyama Kenji |
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Secondary Sponsor | |
Source(s) of Monetary Support | Japan Agency for Medical Research and Development |
Secondary ID(s) | U1111-1262-6244,NCT04712110 |
Contact
Public contact | |
Name | Trial Information Contact for Clinical |
Address | 1-1, Doshomachi 4-chome, Chuo-ku, Osaka Osaka Japan 540-8645 |
Telephone | +81-662042111 |
smb.Japanclinicalstudydisclosure@takeda.com | |
Affiliation | Takeda Pharmaceutical Company Limited |
Scientific contact | |
Name | Kenji Kuriyama |
Address | 1-1, Doshomachi 4-chome, Chuo-ku, Osaka Osaka Japan 540-8645 |
Telephone | +81-662042111 |
smb.Japanclinicalstudydisclosure@takeda.com | |
Affiliation | Takeda Pharmaceutical Company Limited |