A Study of TAK-919 in Healthy Japanese Adults (COVID-19)

JRCT ID: jRCT2071200069

Registered date:18/12/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Coronavirus Disease (COVID-19)
• Date of first enrollment: 07/01/2021
• Target sample size: 200
• Study type: Interventional
• Intervention(s): TAK-919 0.5 mL or TAK-919 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, erythema/redness, swelling, induration, and axillary (underarm) swelling or tenderness ipsilateral to the side of injection.

2.Percentage of Participants with Solicited Local Adverse Events (AEs) for Six Subsequent Days Following Second Vaccination
Time Frame: Up to Day 35 (6 subsequent days after second vaccination on Day 29)
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, erythema/redness, swelling, induration, and axillary (underarm) swelling or tenderness ipsilateral to the side of injection.

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 headache, fatigue, myalgia, arthralgia, nausea/ vomiting, chills, fever.

4.Percentage of Participants with Solicited Systemic AEs for Six Subsequent Days Following Second Vaccination
Time Frame: Up to Day 35 (6 subsequent days after second vaccination on Day 29)
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 headache, fatigue, myalgia, arthralgia, nausea/ vomiting, chills, fever.

5.Percentage of Participants with Unsolicited AEs for 28 Days Following First Vaccination
Time Frame: Up to Day 29 (28 days after first vaccination on Day 1)
Unsolicited AEs were all AEs that were not pre-defined for which the participant is not specifically questioned in the participant diary.

6.Percentage of Participants with Unsolicited AEs for 28 Days Following Second Vaccination
Time Frame: Up to Day 57 (28 days after second vaccination on Day 29)
Unsolicited AEs were all AEs that were not pre-defined for which the participant is not specifically questioned in the participant diary.

7.Percentage of Participants with Serious AE (SAE) until Day 57
Time Frame: Day 1 up to Day 57
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 the assessment. Unsolicited SAEs were those AEs that were not pre-defined for which the participant is not specifically questioned in the participant diary. Percentage of participants with unsolicited SAEs until Day 57 was reported in this outcome measure.

8.Percentage of Participants with Medically-Attended Adverse Events (MAAEs) until Day 57
Time Frame: Day 1 up to Day 57
MAAEs were 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 the assessment. Unsolicited MAAEs were those AEs that were not pre-defined for which the participant is not specifically questioned in the participant diary. Percentage of participants with unsolicited MAAEs until Day 57 was reported in this outcome measure.

9.Percentage of Participants with Any AE Leading to Discontinuation of Vaccination
Time Frame: Day 1 up to Day 57
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 the assessment. Unsolicited AEs were those AEs that were not pre-defined for which the participant is not specifically questioned in the participant diary. Percentage of participants with any unsolicited AE leading to discontinuation of vaccination was reported in this outcome measure.

10.Percentage of Participants with Any AE Leading to Participant's Withdrawal from the Trial until Day 57
Time Frame: Day 1 up to Day 57
Only unsolicited AE leading to participant's withdrawal data was planned to be collected and assessed for the assessment of this OM and solicited AE leading to participant's withdrawal was out of the scope of the assessment. Unsolicited AEs were those AEs that were not pre-defined for which the participant is not specifically questioned in the participant diary. Percentage of participants with any unsolicited AE leading to participant's withdrawal was reported in this outcome measure.

11.Percentage of Participants with SARS-CoV-2 Infection until Day 57
Time Frame: Day 1 up to Day 57

12.Geometric Mean Titers (GMT) of Serum binding antibody (bAb) Against SARS-CoV-2 on Day 57
Timeframe: At Day 57
GMT was the immunogenicity outcome expressed as reciprocal antibody titer with average for each group. Titer values measured as below lower limit of quantification (LLOQ) were imputed to a value that is half of the LLOQ. Titer values measured as above upper limit of quantification (ULOQ) were imputed at the ULOQ value. LLOQ=1 and ULOQ= 2052. GMT of serum bAb against SARS-CoV-2 was measured by ligand-binding assay specific to the SARS-CoV-2 S protein.

13.Geometric Mean Fold Rise (GMFR) of Serum bAb Against SARS-CoV-2 on Day 57
Timeframe: At Day 57
The 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. GMFR of serum bAb against SARS-CoV-2 was measured by ligand-binding assay specific to the SARS-CoV-2 S protein.

14.Seroconversion Rate (SCR) of Serum bAb Against SARS-CoV-2 on Day 57
Timeframe: At Day 57
SCR was defined at percentage of participants with a change from below the limit of detection (LOD) or limit of quantification (LLOQ) to equal to or above LOD or LLOQ, OR, >= 4-fold rises from baseline. LLOQ= 1, ULOQ= 2052. Baseline was defined as the last measurement taken before the first dose of study intervention. SCR of serum bAb against SARS-CoV-2 was measured by ligand-binding assay specific to the SARS-CoV-2 S protein.

Secondary Outcome

1.Percentage of Participants with SAE throughout the Trial
Timeframe: Day 1 up to Day 394
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 the assessment. Unsolicited SAEs were those AEs that were not pre-defined for which the participant is not specifically questioned in the participant diary. Percentage of participants with unsolicited SAEs throughout the trial was reported in this outcome measure.

2.Percentage of Participants with MAAEs throughout the Trial
Timeframe: Day 1 up to Day 394
MAAEs were 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 the assessment. Unsolicited MAAEs were those AEs that were not pre-defined for which the participant is not specifically questioned in the participant diary. Percentage of participants with unsolicited MAAEs throughout the trial was reported in this outcome measure.

3.Percentage of Participants with Any AE Leading to Participant's Withdrawal from the Trial from the Day of Vaccination throughout the Trial
Timeframe: Day 1 up to Day 394
Only unsolicited AE leading to participant's withdrawal data was planned to be collected and assessed for the assessment of this OM and solicited AE leading to participant's withdrawal was out of the scope of the assessment. Unsolicited AEs were those AEs that were not pre-defined for which the participant is not specifically questioned in the participant diary. Percentage of participants with any unsolicited AE leading to participant's withdrawal was reported in this outcome measure.

4.Percentage of Participants with SARS-CoV-2 Infection throughout the Trial
Timeframe: Day 1 up to Day 394

5.GMT of Serum bAb Against SARS-CoV-2 on Days 29, 43, 209 and 394
Timeframe: At Days 29, 43, 209 and 394
GMT was the immunogenicity outcome expressed as reciprocal antibody titer with average for each group. Titer values measured as below LLOQ were imputed to a value that is half of the LLOQ. Titer values measured as above ULOQ were imputed at the ULOQ value. LLOQ=1 and ULOQ= 2052 until Day 43; LLOQ= 1 and ULOQ= 20520 from Day 209 and later. GMT of serum bAb against SARS-CoV-2 was measured by ligand-binding assay specific to the SARS-CoV-2 S protein.

6.GMFR of Serum bAb Against SARS-CoV-2 on Days 29, 43, 209 and 394
Timeframe: At Days 29, 43, 209 and 394
The 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. GMFR of serum bAb against SARS-CoV-2 was measured by ligand-binding assay specific to the SARS-CoV-2 S protein.

7.SCR of Serum bAb Against SARS-CoV-2 on Days 29, 43, 209 and 394
Timeframe: At Days 29, 43, 209 and 394
SCR was defined at percentage of participants with a change from below LOD to equal to or above LOD, OR, >= 4-fold rises from baseline. LLOQ= 1 and ULOQ= 2052 until Day 43; LLOQ= 1 and ULOQ= 20520 from Day 209 and later. Baseline was defined as the last measurement taken before the first dose of study intervention. SCR of serum bAb against SARS-CoV-2 was measured by ligand-binding assay specific to the SARS-CoV-2 S protein.

8.GMT of serum neutralizing antibody (nAb) against SARS-CoV-2 on Days 29, 43, 57, 209, and 394
Timeframe: At Days 29, 43, 57, 209, and 394
GMT was the immunogenicity outcome expressed as reciprocal antibody titer with average for each group. Titer values measured as below LLOQ were imputed to a value that is half of the LLOQ. Titer values measured as above ULOQ were imputed at the ULOQ value. LLOQ= 159.79 and ULOQ= 11173.11. GMT of serum nAb against SARS-CoV-2 was measured by assay specific to wild-type virus.

9.GMFR of serum nAb against SARS-CoV-2 on Days 29, 43, 57, 209, and 394
Timeframe: At Days 29, 43, 57, 209, and 394
The 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. GMFR of serum nAb against SARS-CoV-2 was measured by assay specific to wild-type virus.

10.SCR of serum nAb against SARS-CoV-2 on Days 29, 43, 57, 209, and 394
Timeframe: At Days 29, 43, 57, 209, and 394
SCR was defined at percentage of subjects with a change from below the lower limit of quantification (LLOQ) to equal to or above LLOQ, OR, >= 4-fold rises from baseline. LLOQ= 159.79 and ULOQ= 11173.11. Baseline was defined as the last measurement taken before the first dose of study intervention. SCR of serum nAb against SARS-CoV-2 was measured by assay specific to wild-type virus.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Healthy Japanese male and female participants.
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 vaccine administration.
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3. Participants who were tested positive for SARS-CoV-2 prior to the trial or on the test before the vaccination.
4. Participants who are on current treatment with other investigational agents for prophylaxis of COVID 19.
5. Participants who 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 vaccination.
7. Participants with a known hypersensitivity or allergy to any of the IMP components.
8. Participants with any illness or history of 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 BMI >= 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 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 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 are with or have history of hepatitis B and hepatitis C infection.
19. Female participants who are pregnant or breastfeeding.

Related Information

• Primary Sponsor: Kuriyama Kenji
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development
• Secondary ID(s): U1111-1261-9040,NCT04677660