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. 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-019 or a placebo in their arm. In this study, a placebo will look like the TAK-019 vaccine but will not have any medicine in it. 3 times as many participants will receive TAK-019 than placebo. Participants will receive 2 injections of TAK-019 or placebo, 21 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 attended a clinic visit 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-019 or the placebo.
The drug being tested in this study is called TAK-019. TAK-019 is being tested to prevent
infectious disease caused by Severe Acute Respiratory Syndrome coronavirus-2 (SARS-CoV-2).
This study will look at the evaluate the safety and immunogenicity of 2 doses of TAK-019 by
intramuscular (IM) injection 21 days apart in healthy Japanese male and female adults.
The study will enroll approximately 200 healthy volunteers. Participants will be randomly
assigned (by chance, like flipping a coin) to one of the two treatment groups-which will
remain undisclosed to the participant and study doctor during the study (unless there is an
urgent medical need):
- TAK-019 0.5 mL
- Placebo- this is an injection that looks like the study drug but has no active
ingredient
All participants will be asked to take intramuscular injection in the upper arm twice
throughout the study.
This multi-center trial will be conducted in Japan. The overall time to participate in this
study is 12 months from the second vaccination (totally 387 days). Participants will make
multiple visits to the clinic and will be contacted by telephone or a final visit after the
last vaccination for a follow-up assessment.
Biological: TAK-019
TAK-019 intramuscular injection
Biological: Placebo
Placebo intramuscular injection
Inclusion 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.
Exclusion 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.
Sumida Hospital
Sumida-ku, Tokyo, Japan
Nishi Kumamoto Hospital
Kumamoto, Japan
Study Director, Study Director
Takeda