A Study of TAK-019 in Healthy Japanese Adults (COVID-19)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
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):
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TAK-019 0.5 mL
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: TAK-019 TAK-019 0.5 mL, intramuscular injection in the upper arm |
Biological: TAK-019
TAK-019 intramuscular injection
|
| Placebo Comparator: Placebo TAK-019 Matching Placebo, intramuscular injection in the upper arm |
Biological: Placebo
Placebo intramuscular injection
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants with Reported Solicited Local Adverse Events (AEs) for 7 Days Following Each Vaccination [7 days after each vaccination]
An AE is defined as any untoward medical occurrence in a clinical investigation subject administered an investigational medicinal product (IMP); it does not necessarily have to have a causal relationship with IMP administration. Reported solicited local AEs are defined as injection site pain, tenderness, erythema/redness, induration, and swelling.
- Percentage of Participants with Solicited Systemic AEs for 7 Days Following Each Vaccination [7 days after each vaccination]
Solicited systemic AEs are defined as fever, fatigue, malaise, myalgia, arthralgia, nausea/vomiting, and headache.
- Percentage of Participants with Unsolicited AEs for 49 Days Following First Vaccination (Day 1) [49 days after first vaccination (Day 1)]
Unsolicited AEs defines as other AEs than solicited local AEs and solicited systemic AEs.
- Percentage of Participants with Serious Adverse Events (SAE) until Day 50 [Up to Day 50]
An SAE is 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.
- Percentage of Participants with Adverse Event of Special Interest (AESI) until Day 50 [Up to Day 50]
An AESI is 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.
- Percentage of Participants with Medically-Attended Adverse Events (MAAEs) until Day 50 [Up to Day 50]
- Percentage of Participants with Any AE Leading to Discontinuation of Vaccination [Up to Day 50 (up to discontinuation of vaccination)]
- Percentage of Participants with Any AE Leading to Participant's Withdrawal from the Trial until Day 50 [Up to Day 50]
- Percentage of Participants with SARS-CoV-2 Infection until Day 50 [Up to Day 50]
- Geometric Mean Titers (GMT) of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Day 36 [Day 36]
- Geometric Mean Fold Rise (GMFR) of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Day 36 [Day 36]
- Seroconversion Rate (SCR) of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Day 36 [Day 36]
SCR is defined at proportion of participants with 4-fold or more rises in titer if naive at baseline OR proportion of participants with 2-fold or more rises in titer if seropositive at baseline.
- Seroresponce Rate (SRR) of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Day 36 [Day 36]
SRR is defined at proportion of participants with 95 percentile or more in titer at baseline (Day 1) for all participants.
Secondary Outcome Measures
- Percentage of Participants with SAE throughout the Trial [Up to Day 387]
- Percentage of Participants with AESI throughout the Trial [Up to Day 387]
- Percentage of Participants with MAAEs throughout the Trial [Up to Day 387]
- Percentage of Participants with Any AE Leading to Participant's Withdrawal from the Trial from the Day of Vaccination throughout the Trial [Up to Day 387]
- Percentage of Participants with SARS-CoV-2 Infection throughout the Trial [Up to Day 387]
- GMT of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Day 22, 50, 202, and 387 [Day 22, 50, 202, and 387]
- GMFR of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Day 22, 50, 202, and 387 [Day 22, 50, 202, and 387]
- SCR of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Day 22, 50, 202, and 387 [Day 22, 50, 202, and 387]
SCR is defined at proportion of participants with 4-fold or more rises in titer if naive at baseline OR proportion of participants with 2-fold or more rises in titer if seropositive at baseline.
- SRR of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Day 22, 50, 202, and 387 [Day 22, 50, 202, and 387]
SRR is defined at proportion of participants with 95 percentile or more in titer at baseline (Day 1) for all participants.
- GMT of Serum Neutralizing Antibody Titters to Wild-type Virus on Day 22, 36, 50, 202, and 387 [Day 22, 36, 50, 202, and 387]
- GMFR of Serum Neutralizing Antibody Titters to Wild-type Virus on Day 22, 36, 50, 202, and 387 [Day 22, 36, 50, 202, and 387]
- SCR of Serum Neutralizing Antibody Titters to Wild-type Virus on Day 22, 36, 50, 202, and 387 [Day 22, 36, 50, 202, and 387]
SCR is defined at proportion of participants with 4-fold or more rises in titer if naive at baseline OR proportion of participants with 2-fold or more rises in titer if seropositive at baseline.
- SRR of Serum Neutralizing Antibody Titters to Wild-type Virus on Day 22, 36, 50, 202, and 387 [Day 22, 36, 50, 202, and 387]
SRR is defined at proportion of participants with 95 percentile or more in titer at baseline (Day 1) for all participants.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Healthy Japanese male and female adult participants aged >= 20 years of age at the time of signing of informed consent.
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Participants who understand and are willing to comply with trial procedures and are available for the duration of follow-up.
Exclusion Criteria:
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Participants who received any other SARS-CoV-2 or other experimental novel coronavirus vaccine prior to the trial.
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Participants who have close contact of anyone known to have COVID-19 within 30 days prior to the trial vaccination.
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Participants who were tested positive for SARS-CoV-2 prior to the trial or before the trial vaccination.
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Participants who are on current treatment with other investigational agents for prophylaxis of COVID-19.
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Participants who have traveled outside of Japan in the 30 days prior to the trial participation.
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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.
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Participants with known hypersensitivity or allergy to any of the investigational vaccine components.
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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.
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Participants with known or suspected impairment/alteration of immune function, including history of any autoimmune disease or neuro-inflammatory disease.
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Abnormalities of splenic or thymic function.
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Participants with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
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Participants with any serious chronic or progressive disease (eg, neoplasm, insulin dependent diabetes, cardiac, renal or hepatic disease).
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Participants with body mass index (BMI) greater than or equal to 30 kg/m2 (BMI= weight in kg/ height in meters2).
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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.
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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.
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Participants with acute or chronic clinically significant disease including pulmonary, cardiovascular, hepatic or renal abnormality evaluated by physical examination.
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Participants involved in the trial conduct or their first degree relatives.
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Participants who have history or infection of hepatitis B, hepatitis C, and human immunodeficiency virus infection.
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Female participants who are pregnant or breastfeeding.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sumida Hospital | Sumida-ku | Tokyo | Japan | |
| 2 | Nishi Kumamoto Hospital | Kumamoto | Japan |
Sponsors and Collaborators
- Takeda
Investigators
- Study Director: Study Director, Takeda
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- TAK-019-1501
- U1111-1262-6244
- jRCT2071200084