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

IDENTIFIERS
Trial Protocol: TAK-919-1501
Clinicaltrials.gov: NCT04677660
JapicCTI: jRCT2071200069
PURPOSE

TAK-919 is a vaccine in development to protect people against Covid-19. The main aims of the study are to learn if TAK-919 can protect people from Covid-19 and to check for side effects from TAK-919. At the first visit, the study doctor will check if each person can take part. Those who can take part will be chosen for 1 of 2 treatments by chance. Participants will either receive an injection of TAK-919 or a placebo in their arm. In this study, a placebo will look like the TAK-919 vaccine but will not have any medicine in it. 3 times as many participants will receive TAK-919 than placebo. Participants will receive 2 injections of TAK-919 or placebo, 28 days apart. Participants will be asked to record their temperature and any medical problems in an electronic diary for up to 7 days after each injection. During the study, participants will visit the clinic for regular check-ups, blood tests, and sometimes for nose swab samples. When all participants have visited their clinic 28 days after their 2nd injection, the study sponsor (Takeda) will check how many participants have made enough antibodies to protect them against Covid-19. The participants will stay in the study for up to 12 months after they have had their 2nd injection. During this time, the study doctors will continue to check how many participants have made enough antibodies to protect them against Covid-19. Also, they will check if participants have any more side effects from TAK-919 or the placebo.

Recruitment Complete
JP

Trial at a glance

What medical condition is being studied?   Prevention of Infectious Disease Caused by Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2)
What is the trial testing?   TAK-919, Placebo
Are placebos part of the trial?   Yes
How many participants are being enrolled?   200
When is the trial being conducted?    - 
How long is participation in the trial?   This study will take place in Japan. Each participant will be in the study for up to 394 days (just over 12 months). This will include the time for the 2 injections. Participants will visit the clinic 7 times. There might be more clinic visits for extra nose swabs if required.

Key requirements

Sex   
All
Age   
From 20 Years
Accepts Healthy Volunteers?   

Trial Details / Participation Requirements

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Trial Phase:   Phase 1/Phase 2
Trial Type:   Interventional
Trial Arms/Groups or Cohorts:   
TAK-919: TAK-919 0.5 mL, intramuscular injection in the upper arm
Placebo: TAK-919 Matching Placebo, intramuscular injection in the upper arm
Intervention:   TAK-919, Placebo
Primary Outcome Measure(s):   
Percentage of Participants with Reported Solicited Local Adverse Events (AEs) for 7 Days Following Each Vaccination [Time Frame: Up to Day 7 after each vaccination]
Percentage of Participants with Solicited Systemic AEs for 7 Days Following Each Vaccination [Time Frame: Up to Day 7 after each vaccination]
Percentage of Participants with Unsolicited AEs for 28 Days After Each Vaccination [Time Frame: Up to Day 28 after each vaccination]
Percentage of Participants with Serious AE (SAE) until Day 57 [Time Frame: Up to Day 57]
Percentage of Participants with Medically-Attended Adverse Events (MAAEs) until Day 57 [Time Frame: Up to Day 57]
Percentage of Participants with Any AE Leading to Discontinuation of Vaccination [Time Frame: Up to Day 57 (up to discontinuation of vaccination)]
Percentage of Participants with Any AE Leading to Participant's Withdrawal from the Trial until Day 57 [Time Frame: Up to Day 57]
Percentage of Participants with SARS-CoV-2 Infection until Day 57 [Time Frame: Up to Day 57]
Geometric Mean Titers (GMT) of Serum binding antibody (bAb) Against SARS-CoV-2 on Day 57 [Time Frame: Day 57]
Geometric Mean Fold Rise (GMFR) of Serum bAb Against SARS-CoV-2 on Day 57 [Time Frame: Day 57]
Seroconversion Rate (SCR) of Serum bAb Against SARS-CoV-2 on Day 57 [Time Frame: Day 57]
Secondary Outcome Measure(s):   
Percentage of Participants with SAE throughout the Trial [Time Frame: Up to Day 394]
Percentage of Participants with MAAEs throughout the Trial [Time Frame: Up to Day 394]
Percentage of Participants with Any AE Leading to Participant's Withdrawal from the Trial from the Day of Vaccination throughout the Trial [Time Frame: Up to Day 394]
Percentage of Participants with SARS-CoV-2 Infection throughout the Trial [Time Frame: Up to Day 394]
GMT of Serum bAb Against SARS-CoV-2 on Day 29, Day 43, Day 209 and Day 394 [Time Frame: Day 29, Day 43, Day 209 and Day 394]
GMFR of Serum bAb Against SARS-CoV-2 on Day 29, Day 43, Day 209 and Day 394 [Time Frame: Day 29, Day 43, Day 209 and Day 394]
SCR of Serum bAb Against SARS-CoV-2 on Day 29, Day 43, Day 209 and Day 394 [Time Frame: Day 29, Day 43, Day 209 and Day 394]
GMT of serum neutralizing antibody (nAb) against SARS-CoV-2 on Day 29, Day 43, Day 57, Day 209, and Day 394 [Time Frame: Day 29, Day 43, Day 57, Day 209, and Day 394]
GMFR of serum nAb against SARS-CoV-2 on Day 29, Day 43, Day 57, Day 209, and Day 394 [Time Frame: Day 29, Day 43, Day 57, Day 209, and Day 394]
SCR of serum nAb against SARS-CoV-2 on Day 29, Day 43, Day 57, Day 209, and Day 394 [Time Frame: Day 29, Day 43, Day 57, Day 209, and Day 394]
Entry Criteria:
- Must be healthy Japanese men or women aged 20 years or older. - If men could conceive children or women could become pregnant, they must be willing to use birth control from when they join the study until 3 months after the 2nd injection. - Cannot have received any other vaccine to prevent Covid-19. - Cannot have been in close contact with anyone who has COVID-19 in the last 30 days. - Cannot have previously tested positive for Covid-19. - Cannot have traveled outside of Japan in the last 30 days. - Cannot have an infection that the study doctor thinks is medically important. - Cannot have any known reactions to any component of the vaccine. - Cannot have an immune system that is not working properly. - Cannot have received any blood or plasma products in the last 3 months. - Women cannot be pregnant or be breastfeeding.

Trial Locations

Any
Recruiting
Any
RESULTS
Sumida Hospital

Japan, 〒130-0004 Tōkyō-to, Sumida City, Honjo, 1-chōme−29−1 ランダムスクウエア本所ビル

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PS Clinic

Japan, 〒810-0005 Fukuoka, 福岡市中央区Chūō-ku, Kiyokawa, 1-chōme−9, −20 テングッッド 渡辺 通 3 階

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Trial Protocol ID: TAK-919-1501
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