A S ingle Heterologous Booster Vaccination Study of TAK-019 in Healthy Japanese Adults (COVID-19)

JRCT ID: jRCT2071210141

Registered date:30/03/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Coronavirus Disease (COVID-19)
• Date of first enrollment: 15/04/2022
• Target sample size: 150
• Study type: Interventional

Intervention(s)

MAIN PART:
TAK-019 0.5 mL, intramuscular injection in the mid deltoid, preferable in the non-dominant upper arm

EXTENSION PART:
TAK-019 0.5 mL, intramuscular injection in the mid deltoid, preferable in the non-dominant upper arm. The participants who received the first single booster vaccination of TAK-019 in the main part and remained in study follow-up at least 5 months will receive a second single booster vaccination of TAK-019 by intramuscular injection.

Outcome(s)

Primary Outcome

1.Main Part: Geometric Mean Titers (GMT) Ratio of Neutralizing Antibody Titers to the Ancestral Strain (Wild-type Virus) on Day 15 Compared with that Observed on Day 36 in Participants from the TAK-019-1501 Study
Time Frame: Day 15 (14 days after the vaccination)
GMT ratio of neutralizing antibody titers to the ancestral strain (wild-type virus) on Day15 after a single booster vaccination (14 days after the booster vaccination) compared with that observed on Day 36 (14 days after the second vaccination) in participants from the TAK-019-1501 study (NCT04712110) was reported. GMT ratio was calculated with GMT of TAK-019-3001 on Day 15 divided by GMT of TAK-019-1501 study on Day 36.

2.Main Part: Percentage of Participants with Reported Solicited Local Adverse Events (AEs) for 7 Days Following the First Single Booster Vaccination
Time Frame: 7 days after the first single booster vaccination
AE was defined as any untoward medical occurrence in a clinical investigation participant administered an investigational medicinal product (IMP); it did not necessarily have to have a causal relationship with IMP administration. Reported solicited local AEs were defined as injection site pain, tenderness, erythema/redness, induration, and swelling.

3.Main Part: Percentage of Participants with Solicited Systemic AEs for 7 Days Following the First Single Booster Vaccination
Time Frame: 7 days after the first single booster vaccination
Solicited systemic AEs were defined as fever, fatigue, malaise, myalgia, arthralgia, nausea/vomiting, and headache.

4.Main Part: Percentage of Participants with Unsolicited AEs for 28 Days Following the First Single Booster Vaccination
Time Frame: 28 days after the first single booster vaccination
Unsolicited AEs defines as other AEs than solicited local AEs and solicited systemic AEs.

5.Main Part: Percentage of Participants with Serious Adverse Events (SAE) until Day 29
Time Frame: Up to Day 29
An SAE was defined as any untoward medical occurrence that: Results in death, Is life-threatening, Requires inpatient hospitalization or prolongation of existing hospitalization, Results in persistent or significant disability/incapacity, Leads to a congenital anomaly/birth defect in the offspring of a participant, or Is an important medical event. Solicited SAEs and Unsolicited SAEs were reported.

6.Main Part: Percentage of Participants with Adverse Event of Special Interest (AESI) until Day 29
Time Frame: Up to Day 29
An AESI was defined as AEs that will be specifically highlighted to the Investigator. AESIs for the study include the Potential Immune Mediated Medical Conditions (PIMMC) and AEs specific to COVID-19. PIMMC is categorized as following; Neuroinflammatory Disorders, Musculoskeletal and Connective Tissue Disorders, Vasculitides, Gastrointestinal Disorders, Hepatic Disorders, Renal Disorders, Cardiac Disorders, Skin Disorder, Hematologic Disorders, Metabolic Disorders, and Other Disorders.

7.Main Part: Percentage of Participants with Medically-Attended Adverse Events (MAAEs) until Day 29
Time Frame: Up to Day 29

8.Main Part: Percentage of Participants with Any AE Leading to Participant's Withdrawal from the Trial until Day 29
Time Frame: Up to Day 29

9.Main Part: Percentage of Participants with SARS-CoV-2 Infection until Day 29
Time Frame: Up to Day 29

Secondary Outcome

1.Main Part: GMT of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Day 8, 15, 29, 91, 181, and 366
Time Frame: Day 8, 15, 29, 91, 181, and 366

2.Main Part: Geometric Mean Fold Rise (GMFR) of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Day 8, 15, 29, 91, 181, and 366
Time Frame: Day 8, 15, 29, 91, 181, and 366

3.Main Part: Seroconversion Rate (SCR) of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Day 8, 15, 29, 91, 181, and 366
Time Frame: Day 8, 15, 29, 91, 181, and 366
SCR is defined at percentage of participants with >= 4-fold rises from baseline (Day 1).

4.Main Part: GMT of Serum Neutralizing Antibody Titters to the Ancestral Strain (Wild-type Virus) on Day 8, 15, 29, 91, 181, and 366
Time Frame: Day 8, 15, 29, 91, 181, and 366

5.Main Part: GMFR of Serum Neutralizing Antibody Titters to the Ancestral Strain (Wild-type Virus) on Day 8, 15, 29, 91, 181, and 366
Time Frame: Day 8, 15, 29, 91, 181, and 366

6.Main Part: SCR of Serum Neutralizing Antibody Titters to the Ancestral Strain (Wild-type Virus) on Day 8, 15, 29, 91, 181, and 366
Time Frame: Day 8, 15, 29, 91, 181, and 366
SCR is defined at percentage of participants with >= 4-fold rises from baseline (Day 1).

7.Main Part: Percentage of Participants with SAE throughout the Trial
Time Frame: Up to Day 366

8.Main Part: Percentage of Participants with AESI throughout the Trial
Time Frame: Up to Day 366

9.Main Part: Percentage of Participants with MAAEs throughout the Trial
Time Frame: Up to Day 366

10.Main Part: Percentage of Participants with Any AE Leading to Participant's Withdrawal from the Trial from the Day of the First Single Booster Vaccination throughout the Trial
Time Frame: Up to Day 366

11.Main Part: Percentage of Participants with SARS-CoV-2 Infection throughout the Trial
Time Frame: Up to Day 366

12.Extension Part: GMT of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Extension Part Day 15, Day 29, Day 91, Day 181, and Day 366
Time Frame: Day 15, 29, 91, 181, and 366

13.Extension Part: GMFR of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Extension Part Day 15, Day 29, Day 91, Day 181, and Day 366
Time Frame: Day 15, 29, 91, 181, and 366

14.Extension Part: SCR of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Extension Part Day 15, Day 29, Day 91, Day 181, and Day 366
Time Frame: Day 15, 29, 91, 181, and 366
SCR is defined at percentage of participants with >= 4-fold rises from baseline (Extension Part Day 1).

15.Extension Part: GMT of Serum Neutralizing Antibody Titers to the Ancestral Strain (Wild-type Virus) on Extension Part Day 15, Day 29, Day 91, Day 181, and Day 366.
Time Frame: Day 15, 29, 91, 181, and 366

16.Extension Part: GMFR of Serum Neutralizing Antibody Titers to the Ancestral Strain (Wild-type Virus) on Extension Part Day 15, Day 29, Day 91, Day 181, and Day 366.
Time Frame: Day 15, 29, 91, 181, and 366

17.Extension Part: SCR of Serum Neutralizing Antibody Titers to the Ancestral Strain (Wild-type Virus) on Extension Part Day 15, Day 29, Day 91, Day 181, and Day 366.
Time Frame: Day 15, 29, 91, 181, and 366
SCR is defined at percentage of participants with >= 4-fold rises from baseline (Extension Part Day 1).

18.Extension Part: Percentage of Participants with Reported Solicited Local AEs for 7 Days Following the Second Single Booster Vaccination
Time Frame: 7 days

19.Extension Part: Percentage of Participants with Solicited Systemic AEs for 7 Days Following the Second Single Booster Vaccination
Time Frame: 7 days

20.Extension Part: Percentage of Participants with Unsolicited AEs for 28 Days Following the Second Single Booster Vaccination
Time Frame: 28 days

21.Extension Part: Percentage of Participants with SAEs until Extension Part Day 29
Time Frame: From Day 1 to Day 29

22.Extension Part: Percentage of Participants with AESIs until Extension Part Day 29
Time Frame: From Day 1 to Day 29

23.Extension Part: Percentage of Participants with MAAEs until Extension Part Day 29
Time Frame: From Day 1 to Day 29

24.Extension Part: Percentage of Participants with any AEs Leading to Participant's Withdrawal from the Trial until Extension Part Day 29
Time Frame: From Day 1 to Day 29

25.Extension Part: Percentage of Participants with SARS-CoV-2 Infection until Extension Part Day 29.
Time Frame: From Day 1 to Day 29

26.Extension Part: Percentage of Participants with SAEs throughout the Extension Part
Time Frame: From Day 1 to Day 366

27.Extension Part: Percentage of Participants with AESIs throughout the Extension Part
Time Frame: From Day 1 to Day 366

28.Extension Part: Percentage of Participants with MAAEs throughout the Extension Part
Time Frame: From Day 1 to Day 366

29.Extension Part: Percentage of Participants with any AEs Leading to Participant's Withdrawal from the Trial from the Day of the Second Single Booster Vaccination throughout the Extension Part
Time Frame: From Day 1 to Day 366

30.Extension Part: Percentage of Participants with SARS-CoV-2 infection throughout the Extension Part
Time Frame: From Day 1 to Day 366

Key inclusion & exclusion criteria

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

Include criteria

MAIN PART:
1.Healthy Japanese male and female adult participants aged >= 20 years of age at the time of signing of informed consent.
2.Participant who completed 2 doses primary vaccinations with another specified mRNA vaccine (SARS-CoV-2) which is available in Japan 6 to 12 months prior to the trial vaccination.

EXTENSION PART:
3.Participants who received the first trial vaccination at least 5 months earlier and are currently enrolled in the Main Part (ie, not have withdrawn or discontinued early).

Exclude criteria

MAIN PART:
1.Participants who received any other SARS-CoV-2 vaccine (except for the specified mRNA vaccine) or other experimental novel coronavirus vaccine prior to the trial.
2.Participant who received a booster vaccination (i.e. 3rd dose)
3.Participants who have close contact of anyone known to have COVID-19 within 14 days prior to the trial vaccination.
4.Participants who were tested positive for SARS-CoV-2 prior to the trial.
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 or oral temperature >= 38 degree Celsius within 3 days of the intended date of the first single booster vaccination.
7.Participants with body mass index (BMI) greater than or equal to 30 kg/m^2 (BMI= weight in kg/ height in meters^2).

EXTENSION PART:
8.Participants with a clinically significant active infection or oral temperature >=38 degree Celsius within 3 days of the intended date of the second single booster vaccination.

Related Information

• Primary Sponsor: Kuriyama Kenji
• Source(s) of Monetary Support: Ministry of Health, Labour and Welfare
• Secondary ID(s): NCT05299359