Clinical trial NCT05299359: A Single Heterologous Booster Vaccination Study of TAK-019 in Healthy Japanese Adults (COVID-19)
Official title: A Phase 3, Single Arm, Open-Label Trial to Evaluate the Immunogenicity and Safety of a Single Heterologous Booster Vaccination of TAK-019 in Healthy Japanese Male and Female Adults Aged 20 Years and Older (COVID-19)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Coronavirus Disease (COVID-19)
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2022-03-29
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: TAK-019 is a vaccine in development to protect people against Covid-19. The main aims of the study are to learn if TAK-019 can protect people from Covid-19 and to check for side effects from TAK-019 for participants who will receive TAK-019 as heterologous booster vaccination.

This study consists of two parts, main part and extension part. Firstly, participants who completed 2 doses primary vaccinations 6 to 12 months prior to the trial vaccination can take part in main study. At the first visit of main part of this study, the study doctor will check if each person can take part. Participants who can take part will receive an injection of TAK-019 as booster vaccination.

Participants will be asked to record their temperature and any medical problems in an electronic diary for up to 7 days after the injection. During the main part, participants will visit the clinic for regular check-ups, blood tests, and sometimes for nose swab samples. When all participants have attended a clinic visit 28 days after the injection, the study sponsor (Takeda) will check how many participants have made enough antibodies to protect them against Covid-19.

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 be able to decide to take part in the extension part of this study. At the first visit of extension part of this study, the study doctor will check if each person can take part. Participants who can take part will receive an injection of TAK-019 as a second booster vaccination at the first visit of extension part.

The participants will stay in the main part of this study for up to 12 months after they have had their injection or up to the start of extension part. For participants who will take part in the extension part, they will stay in the extension part for up to 12 months from the start of extension part. During this time, the doctors will continue to collect blood samples to check immune response. Also, they will check if participants have any more side effects from TAK-019.


Eligibility criteria: Inclusion 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 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).

Exclusion 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.

Primary outcomes:
measure: 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
timeFrame: Day 15 for this study (14 days after the vaccination); Day 36 for TAK-019-1501 study (14 days after the second vaccination)
measure: Main Part: Percentage of Participants With Reported Solicited Local Adverse Events (AEs) for 7 Days Following the First Single Booster Vaccination
timeFrame: Main Part: 7 days after the first single booster vaccination
measure: Main Part: Percentage of Participants With Solicited Systemic AEs for 7 Days Following the First Single Booster Vaccination
timeFrame: Main Part: 7 days after the first single booster vaccination
measure: Main Part: Percentage of Participants With Unsolicited AEs for 28 Days Following the First Single Booster Vaccination
timeFrame: Main Part: 28 days after the first single booster vaccination
measure: Main Part: Percentage of Participants With Solicited and Unsolicited Serious Adverse Events (SAE) Until Day 29
timeFrame: Main Part: Up to Day 29
measure: Main Part: Percentage of Participants With Adverse Event of Special Interest (AESI) Until Day 29
timeFrame: Main Part: Up to Day 29
measure: Main Part: Percentage of Participants With Medically-Attended Adverse Events (MAAEs) Until Day 29
timeFrame: Main Part: Up to Day 29
measure: Main Part: Percentage of Participants With Any AE Leading to Withdrawal From the Trial Until Day 29
timeFrame: Main Part: Up to Day 29
measure: Main Part: Percentage of Participants With Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Infection Until Day 29
timeFrame: Main Part: Up to Day 29
Secondary outcomes:
measure: Main Part: GMT of Serum Immunoglobulin G (IgG) Antibody Levels to SARS-CoV-2 Recombinant Spike (rS) Protein on Day 8, 15, 29, 91, 181, and 366
timeFrame: Main Part: Day 8, 15, 29, 91, 181, and 366
measure: 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
timeFrame: Main Part: Day 8, 15, 29, 91, 181, and 366
measure: 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
timeFrame: Main Part: Day 8, 15, 29, 91, 181, and 366
measure: Main Part: GMT of Serum Neutralizing Antibody Titers to the Ancestral Strain (Wild-type Virus) on Day 8, 15, 29, 91, 181, and 366
timeFrame: Main Part: Day 8, 15, 29, 91, 181, and 366
measure: Main Part: GMFR of Serum Neutralizing Antibody Titers to the Ancestral Strain (Wild-type Virus) on Day 8, 15, 29, 91, 181, and 366
timeFrame: Main Part: Day 8, 15, 29, 91, 181, and 366
measure: Main Part: SCR of Serum Neutralizing Antibody Titters to the Ancestral Strain (Wild-type Virus) on Day 8, 15, 29, 91, 181, and 366
timeFrame: Main Part: Day 8, 15, 29, 91, 181, and 366
measure: Main Part: Percentage of Participants With Solicited and Unsolicited SAEs Throughout the Main Part of Trial
timeFrame: Main Part: Up to Day 366
measure: Main Part: Percentage of Participants With AESI Throughout the Main Part of Trial
timeFrame: Main Part: Up to Day 366
measure: Main Part: Percentage of Participants With MAAEs Throughout the Main Part of Trial
timeFrame: Main Part: Up to Day 366
measure: 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 Main Part of Trial
timeFrame: Main Part: Day 1 up to Day 366
measure: Main Part: Percentage of Participants With SARS-CoV-2 Infection Throughout the Main Part of Trial
timeFrame: Main Part: Day 1 up to Day 366
measure: Extension Part: GMT of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Day 15, 29, 91, 181, and 366
timeFrame: Extension Part: Day 15, 29, 91, 181, and 366
measure: Extension Part: GMFR of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Extension Part Day 15, 29, 91, 181, and 366
timeFrame: Extension Part: Day 15, 29, 91, 181, and 366
measure: Extension Part: Seroconversion Rate (SCR) of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Extension Part Day 15, 29, 91, 181, and 366
timeFrame: Extension Part: Day 15, 29, 91, 181, and 366
measure: Extension Part: GMT of Serum Neutralizing Antibody Titers to the Ancestral Strain (Wild-type Virus) on Extension Part Day 15, 29, 91, 181, and 366
timeFrame: Extension Part: Day 15, 29, 91, 181, and 366
measure: Extension Part: GMFR of Serum Neutralizing Antibody Titers to the Ancestral Strain (Wild-type Virus) on Extension Part Day 15, 29, 91, 181, and 366
timeFrame: Extension Part: Day 15, 29, 91, 181, and 366
measure: Extension Part: SCR of Serum Neutralizing Antibody Titers to the Ancestral Strain (Wild-type Virus) on Extension Part Day 15, 29, 91, 181, and 366
timeFrame: Extension Part: Day 15, 29, 91, 181, and 366
measure: Extension Part: Percentage of Participants With Reported Solicited Local AEs for 7 Days Following the Second Single Booster Vaccination in Extension Part
timeFrame: Extension Part: 7 days after the second single booster vaccination
measure: Extension Part: Percentage of Participants With Solicited Systemic AEs for 7 Days Following the Second Single Booster Vaccination in Extension Part
timeFrame: Extension Part: 7 days after the second single booster vaccination
measure: Extension Part: Percentage of Participants With Unsolicited AEs for 28 Days Following the Second Single Booster Vaccination in Extension Part
timeFrame: Extension Part: 28 days after the second single booster vaccination
measure: Extension Part: Percentage of Participants With Solicited and Unsolicited SAEs Until Extension Part Day 29
timeFrame: Extension Part: Up to Day 29
measure: Extension Part: Percentage of Participants With AESIs Until Extension Part Day 29
timeFrame: Extension Part: Up to Day 29
measure: Extension Part: Percentage of Participants With MAAEs Until Extension Part Day 29
timeFrame: Extension Part: Up to Day 29
measure: Extension Part: Percentage of Participants With Any AEs Leading to Withdrawal From the Trial Until Extension Part Day 29
timeFrame: Extension Part: Up to Day 29
measure: Extension Part: Percentage of Participants With SARS-CoV-2 Infection Until Extension Part Day 29
timeFrame: Extension Part: Up to Day 29
measure: Extension Part: Percentage of Participants With Solicited and Unsolicited SAEs Throughout the Extension Part of the Trial
timeFrame: Extension Part: Up to Day 366
measure: Extension Part: Percentage of Participants With AESIs Throughout the Extension Part of the Trial
timeFrame: Extension Part: Up to Day 366
measure: Extension Part: Percentage of Participants With MAAEs Throughout the Extension Part of the Trial
timeFrame: Extension Part: Up to Day 366
measure: Extension Part: Percentage of Participants With Any AEs Leading to Withdrawal From the Trial From the Day of the Second Single Booster Vaccination Throughout the Extension Part of the Trial
timeFrame: Extension Part: From Day 1 up to Day 366
measure: Extension Part: Percentage of Participants With SARS-CoV-2 Infection Throughout the Extension Part of Trial
timeFrame: Extension Part: Up to Day 366
Other outcomes:
Locations:
city: Sumida-ku
country: Japan
facility: Sumida Hospital
state: Tokyo
city: Fukuoka
country: Japan
facility: PS Clinic
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: