Clinical trial NCT04712110: A Study of TAK-019 in Healthy Japanese Adults (COVID-19)
Official title: A Phase 1/2, Randomized, Observer-Blind, Placebo-Controlled Trial to Evaluate the Safety and Immunogenicity of TAK-019 by Intramuscular Injection in Healthy Japanese Male and Female Adults Aged 20 Years and Older (COVID-19)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Prevention of Infection Disease Caused by Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2)
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2021-01-15
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.

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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants With Solicited Local Adverse Events (AEs) for Six Subsequent Days Following First Vaccination
timeFrame: Up to Day 7 (6 subsequent days after first vaccination on Day 1)
measure: Percentage of Participants With Solicited Local AEs for Six Subsequent Days Following Second Vaccination
timeFrame: Up to Day 28 (6 subsequent days after second vaccination on Day 22)
measure: Percentage of Participants With Solicited Systemic AEs for Six Subsequent Days Following First Vaccination
timeFrame: Up to Day 7 (6 subsequent days after first vaccination on Day 1)
measure: Percentage of Participants With Solicited Systemic AEs for Six Subsequent Days Following Second Vaccination
timeFrame: Up to Day 28 (6 subsequent days after second vaccination on Day 22)
measure: Percentage of Participants With Unsolicited AEs for 20 Days Following First Vaccination
timeFrame: Up to Day 21 (20 days after first vaccination on Day 1)
measure: Percentage of Participants With Unsolicited AEs for 27 Days Following Second Vaccination
timeFrame: Up to Day 49 (27 days after second vaccination on Day 22)
measure: Percentage of Participants With Serious Adverse Events (SAEs) Until Day 50
timeFrame: Day 1 up to Day 50
measure: Percentage of Participants With Adverse Events of Special Interest (AESI) Until Day 50
timeFrame: Day 1 up to Day 50
measure: Percentage of Participants With Medically-Attended Adverse Events (MAAEs) Until Day 50
timeFrame: Day 1 up to Day 50
measure: Percentage of Participants With Any AE Leading to Discontinuation of Vaccination
timeFrame: Day 1 up to Day 22
measure: Percentage of Participants With Any AE Leading to Participant's Withdrawal From the Trial Until Day 50
timeFrame: Day 1 up to Day 50
measure: Percentage of Participants With Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Infection Until Day 50
timeFrame: Day 1 up to Day 50
measure: Geometric Mean Titers (GMT) of Serum Immunoglobulin G (IgG) Antibody Levels to SARS-CoV-2 Recombinant Spike (rS) Protein on Day 36
timeFrame: At Day 36
measure: Geometric Mean Fold Rise (GMFR) of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Day 36
timeFrame: At Day 36
measure: Seroconversion Rate (SCR) of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Day 36
timeFrame: At Day 36
measure: Seroresponse Rate (SRR) of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Day 36
timeFrame: At Day 36
Secondary outcomes:
measure: Percentage of Participants With SAE Throughout the Trial
timeFrame: Day 1 up to Day 387
measure: Percentage of Participants With AESI Throughout the Trial
timeFrame: Day 1 up to Day 387
measure: Percentage of Participants With MAAEs Throughout the Trial
timeFrame: Day 1 up to Day 387
measure: 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 387
measure: Percentage of Participants With SARS-CoV-2 Infection Throughout the Trial
timeFrame: Day 1 up to Day 387
measure: GMT of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Days 22, 50, 202, and 387
timeFrame: At Days 22, 50, 202, and 387
measure: GMFR of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Days 22, 50, 202, and 387
timeFrame: At Days 22, 50, 202, and 387
measure: SCR of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Days 22, 50, 202, and 387
timeFrame: At Days 22, 50, 202, and 387
measure: SRR of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Days 22, 50, 202, and 387
timeFrame: At Days 22, 50, 202, and 387
measure: GMT of Serum Neutralizing Antibody (nAb) Titers to Wild Type Virus on Days 22, 36, 50, 202 and Day 387
timeFrame: At Days 22, 36, 50, 202 and 387
measure: GMFR of Serum nAb Titers to Wild Type Virus on Days 22, 36, 50, 202 and 387
timeFrame: At Days 22, 36, 50, 202 and 387
measure: SCR to Serum nAb Titers to Wild Type Virus on Days 22, 36, 50, 202 and 387
timeFrame: At Days 22, 36, 50, 202 and 387
measure: SRR to Serum nAb Titers to Wild Type Virus on Days 22, 36, 50, 202 and 387
timeFrame: At Days 22, 36, 50, 202 and 387
Other outcomes:
Locations:
city: Sumida-ku
country: Japan
facility: Sumida Hospital
state: Tokyo
city: Kumamoto
country: Japan
facility: Nishi Kumamoto Hospital
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
citation: Masuda T, Murakami K, Sugiura K, Sakui S, Schuring RP, Mori M. Safety and immunogenicity of NVX-CoV2373 (TAK-019) vaccine in healthy Japanese adults: Interim report of a phase I/II randomized controlled trial. Vaccine. 2022 May 26;40(24):3380-3388. doi: 10.1016/j.vaccine.2022.04.035. Epub 2022 Apr 29.