Prevention of Infection Disease Caused by Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2)Phase 1/2NCT04712110
A Study of TAK-019 in Healthy Japanese Adults (COVID-19)
A Phase 1/2 study testing TAK-019 in people with Prevention of Infection Disease Caused by Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2), run by Takeda at 2 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Prevention of Infection Disease Caused by Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2)
- What is being tested?
- TAK-019
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 2 sitesJapan
- Study dates
- 12 Feb 2021to 28 Mar 2022
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy Japanese male and female adult participants aged >= 20 years of age at the time of signing of informed consent.
- Participants who understand and are willing to comply with trial procedures and are available for the duration of follow-up.
Who cannot join
- Participants who received any other SARS-CoV-2 or other experimental novel coronavirus vaccine prior to the trial.
- Participants who have close contact of anyone known to have COVID-19 within 30 days prior to the trial vaccination.
- Participants who were tested positive for SARS-CoV-2 prior to the trial or before the trial vaccination.
- Participants who are on current treatment with other investigational agents for prophylaxis of COVID-19.
- Participants who have traveled outside of Japan in the 30 days prior to the trial participation.
- 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.
Show all 19Show fewer
- Participants with known hypersensitivity or allergy to any of the investigational vaccine components.
- 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.
- Participants with known or suspected impairment/alteration of immune function, including history of any autoimmune disease or neuro-inflammatory disease.
- Abnormalities of splenic or thymic function.
- Participants with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
- Participants with any serious chronic or progressive disease (eg, neoplasm, insulin dependent diabetes, cardiac, renal or hepatic disease).
- Participants with body mass index (BMI) greater than or equal to 30 kg/m^2 (BMI= weight in kg/ height in meters^2).
- 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.
- 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.
- Participants with acute or chronic clinically significant disease including pulmonary, cardiovascular, hepatic or renal abnormality evaluated by physical examination.
- Participants involved in the trial conduct or their first degree relatives.
- Participants who have history or infection of hepatitis B, hepatitis C, and human immunodeficiency virus infection.
- Female participants who are pregnant or breastfeeding.
Trial locations and contacts
2 sites in 1 country.
About this study
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)
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.
Read more
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.
Read the 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.
- Being tested
- TAK-019, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAK-019Biological
TAK-019 intramuscular injection
PlaceboBiological
Placebo intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| TAK-019 | Experimental | TAK-019 0.5 mL, intramuscular injection in the upper arm Receives: Biological: TAK-019 |
| Placebo | Placebo comparator | TAK-019 Matching Placebo, intramuscular injection in the upper arm Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Solicited Local Adverse Events (AEs) for Six Subsequent Days Following First Vaccination
Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their diary for six subsequent days following first vaccination. Solicited local AEs included injection site pain, tenderness, erythema/redness, induration, and swelling.
Measured: Up to Day 7 (6 subsequent days after first vaccination on Day 1)
Percentage of Participants With Solicited Local AEs for Six Subsequent Days Following Second Vaccination
Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their diary for six subsequent days following second vaccination. Solicited local AEs included injection site pain, tenderness, erythema/redness, induration, and swelling.
Measured: Up to Day 28 (6 subsequent days after second vaccination on Day 22)
Percentage of Participants With Solicited Systemic AEs for Six Subsequent Days Following First Vaccination
Solicited systemic AEs were pre-defined AEs for which participants were specifically questioned and which were noted by participants in their diary for six subsequent days following first vaccination. Solicited systemic AEs included fever, fatigue, malaise, myalgia, arthralgia, nausea/vomiting and headache.
Measured: Up to Day 7 (6 subsequent days after first vaccination on Day 1)
Percentage of Participants With Solicited Systemic AEs for Six Subsequent Days Following Second Vaccination
Solicited systemic AEs were pre-defined AEs for which participants were specifically questioned and which were noted by participants in their diary for six subsequent days following second vaccination. Solicited systemic AEs included fever, fatigue, malaise, myalgia, arthralgia, nausea/vomiting and headache.
Measured: Up to Day 28 (6 subsequent days after second vaccination on Day 22)
Percentage of Participants With Unsolicited AEs for 20 Days Following First Vaccination
Unsolicited AEs were all AEs that were not pre-defined for which the participant was not specifically questioned in the participant diary.
Measured: Up to Day 21 (20 days after first vaccination on Day 1)
Percentage of Participants With Unsolicited AEs for 27 Days Following Second Vaccination
Unsolicited AEs were all AEs that were not pre-defined for which the participant was not specifically questioned in the participant diary.
Measured: Up to Day 49 (27 days after second vaccination on Day 22)
Percentage of Participants With Serious Adverse Events (SAEs) Until Day 50
Only unsolicited SAEs data was planned to be collected and assessed for the assessment of this outcome measure (OM) and solicited SAE was out of the scope of assessment. Unsolicited SAEs were those AEs that were not pre-defined for which the participant was not specifically questioned in the participant diary. Percentage of participants with unsolicited SAEs until Day 50 were reported in this outcome measure.
Measured: Day 1 up to Day 50
Percentage of Participants With Adverse Events of Special Interest (AESI) Until Day 50
AESIs were defined as AEs that were specifically highlighted to the Investigator. Only unsolicited AESI data was planned to be collected and assessed for the assessment of this OM and solicited AESI was out of the scope of assessment. Unsolicited AESIs were those AEs that were not pre-defined for which the participant was not specifically questioned in the participant diary. Percentage of participants with unsolicited AESIs until Day 50 were reported in this outcome measure.
Measured: Day 1 up to Day 50
Percentage of Participants With Medically-Attended Adverse Events (MAAEs) Until Day 50
MAAEs are defined as AEs leading to an unscheduled visit to or by a healthcare professional including visits to an emergency department, but not fulfilling seriousness criteria. Only unsolicited MAAEs data was planned to be collected and assessed for the assessment of this OM and solicited MAAE was out of the scope of assessment. Unsolicited MAAEs were those AEs that were not pre-defined for which the participant was not specifically questioned in the participant diary. Percentage of participants with unsolicited MAAEs until Day 50 were reported in this outcome measure.
Measured: Day 1 up to Day 50
Percentage of Participants With Any AE Leading to Discontinuation of Vaccination
Only any unsolicited AE leading to discontinuation of vaccination data was planned to be collected and assessed for the assessment of this OM and solicited AE leading to discontinuation of vaccination was out of the scope of assessment. Unsolicited AEs were those AEs that were not pre-defined for which the participant was not specifically questioned in the participant diary. Percentage of participants with any unsolicited AE leading to discontinuation of vaccination until Day 22 were reported in this outcome measure.
Measured: Day 1 up to Day 22
Percentage of Participants With Any AE Leading to Participant's Withdrawal From the Trial Until Day 50
Only any unsolicited AE leading to participant's withdrawal from the trial data was planned to be collected and assessed for the assessment of this OM and solicited AE leading to participant's withdrawal from the trial was out of the scope of assessment. Unsolicited AEs were those AEs that were not pre-defined for which the participant was not specifically questioned in the participant diary. Percentage of participants with any unsolicited AE leading to participant's withdrawal from the trial until Day 50 were reported in this outcome measure.
Measured: Day 1 up to Day 50
Percentage of Participants With Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Infection Until Day 50
Measured: Day 1 up to Day 50
Geometric Mean Titers (GMT) of Serum Immunoglobulin G (IgG) Antibody Levels to SARS-CoV-2 Recombinant Spike (rS) Protein on Day 36
GMT was the immunogenicity outcome expressed as reciprocal antibody titer with average for each group. Titer values was measured as below lower limit of quantification (LLOQ) were imputed to a value that was half of the LLOQ. LLOQ was equal to 200. Here, ELISA is Enzyme-linked immunosorbent assay.
Measured: At Day 36
Geometric Mean Fold Rise (GMFR) of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Day 36
GMFR was calculated as the ratio of the post-vaccination titer level to the baseline titer level. Baseline was defined as the last measurement taken before the first dose of study intervention.
Measured: At Day 36
Seroconversion Rate (SCR) of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Day 36
SCR was defined as percentage of participants with 4-fold or more rises in titer if naive at baseline OR percentage of participants with 2-fold or more rises in titer if seropositive at baseline. Baseline was defined as the last measurement taken before the first dose of study intervention.
Measured: At Day 36
Seroresponse Rate (SRR) of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Day 36
SRR was defined as percentage of participants with greater than or equal to (>=) 95 percentile in titer at Baseline for all participants. Baseline was defined as the last measurement taken before the first dose of study intervention.
Measured: At Day 36
Secondary outcomes (13)
Percentage of Participants With SAE Throughout the Trial
Only unsolicited SAEs data was planned to be collected and assessed for the assessment of this OM and solicited SAE was out of the scope of assessment. Unsolicited SAEs were those AEs that were not pre-defined for which the participant was not specifically questioned in the participant diary. Percentage of participants with unsolicited SAEs throughout the trial were reported in this outcome measure.
Measured: Day 1 up to Day 387
Percentage of Participants With AESI Throughout the Trial
AESIs were defined as AEs that were specifically highlighted to the Investigator. Only unsolicited AESI data was planned to be collected and assessed for the assessment of this OM and solicited AESI was out of the scope of assessment. Unsolicited AESI were those AEs that were not pre-defined for which the participant was not specifically questioned in the participant diary. Percentage of participants with unsolicited AESIs throughout the trial were reported in this outcome measure.
Measured: Day 1 up to Day 387
Percentage of Participants With MAAEs Throughout the Trial
MAAEs are defined as AEs leading to an unscheduled visit to or by a healthcare professional including visits to an emergency department, but not fulfilling seriousness criteria. Only unsolicited MAAEs data was planned to be collected and assessed for the assessment of this OM and solicited MAAE was out of the scope of assessment. Unsolicited MAAEs were those AEs that were not pre-defined for which the participant was not specifically questioned in the participant diary. Percentage of participants with unsolicited MAAEs throughout the trial were reported in this outcome measure.
Measured: Day 1 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
Only any unsolicited AE leading to participant's withdrawal from the trial data was planned to be collected and assessed for the assessment of this OM and solicited AE leading to participant's withdrawal from the trial was out of the scope of assessment. Unsolicited AEs were those AEs that were not pre-defined for which the participant was not specifically questioned in the participant diary. Percentage of participants with any unsolicited AE leading to withdrawal from the trial from the day of vaccination throughout the trial were reported in this outcome measure.
Measured: Day 1 up to Day 387
Percentage of Participants With SARS-CoV-2 Infection Throughout the Trial
Measured: Day 1 up to Day 387
GMT of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Days 22, 50, 202, and 387
GMT was the immunogenicity outcome expressed as reciprocal antibody titer with average for each group. Titer values was measured as below LLOQ were imputed to a value that was half of the LLOQ. GMT of serum IgG antibody levels to the SARS-CoV-2 rS protein was measured where LLOQ was equal to 200.
Measured: At Days 22, 50, 202, and 387
GMFR of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Days 22, 50, 202, and 387
GMFR was calculated as the ratio of the post-vaccination titer level to the baseline titer level. Where baseline was defined as the last measurement taken before the first dose of study intervention.
Measured: At Days 22, 50, 202, and 387
SCR of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Days 22, 50, 202, and 387
SCR was defined as percentage of participants with 4-fold or more rises in titer if naive at baseline OR percentage of participants with 2-fold or more rises in titer if seropositive at baseline. Baseline was defined as the last measurement taken before the first dose of study intervention.
Measured: At Days 22, 50, 202, and 387
SRR of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Days 22, 50, 202, and 387
SRR was defined as percentage of participants with >=95 percentile in titer at Baseline for all participants. Baseline was defined as the last measurement taken before the first dose of study intervention.
Measured: At Days 22, 50, 202, and 387
GMT of Serum Neutralizing Antibody (nAb) Titers to Wild Type Virus on Days 22, 36, 50, 202 and Day 387
The neutralization titer was expressed as the reciprocal of the highest dilution at which greater than or equal to (>=) 50% of the replicate wells were protected from infection (MN50). GMT was the immunogenicity outcome expressed as reciprocal antibody titer with average for each group. Titer values was measured as below LLOQ were imputed to a value that was half of the LLOQ. GMT of serum IgG antibody levels to the SARS-CoV-2 rS protein was measured where LLOQ was equal to 20.
Measured: At Days 22, 36, 50, 202 and 387
GMFR of Serum nAb Titers to Wild Type Virus on Days 22, 36, 50, 202 and 387
The neutralization titer was expressed as the reciprocal of the highest dilution at which >=50% of the replicate wells were protected from infection (MN50). GMFR was calculated as the ratio of the post-vaccination titer level to the baseline titer level. Baseline was defined as the last measurement taken before the first dose of study intervention.
Measured: At Days 22, 36, 50, 202 and 387
SCR to Serum nAb Titers to Wild Type Virus on Days 22, 36, 50, 202 and 387
The neutralization titer was expressed as the reciprocal of the highest dilution at which >=50% of the replicate wells were protected from infection (MN50). SCR was defined as percentage of participants with 4-fold or more rises in titer if naive at baseline OR percentage of participants with 2-fold or more rises in titer if seropositive at Baseline. Baseline was defined as the last measurement taken before the first dose of study intervention.
Measured: At Days 22, 36, 50, 202 and 387
SRR to Serum nAb Titers to Wild Type Virus on Days 22, 36, 50, 202 and 387
The neutralization titer was expressed as the reciprocal of the highest dilution at which >=50% of the replicate wells were protected from infection (MN50). SRR was defined as percentage of participants with >=95 percentile in titer at Baseline for all participants. Baseline was defined as the last measurement taken before the first dose of study intervention.
Measured: At Days 22, 36, 50, 202 and 387
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2021
- Study start12 Feb 2021
- Primary completion28 Mar 2022
- Study completion28 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prevention of Infection Disease Caused by Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2)Studies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04712110
- Sponsor's protocol ID
- TAK-019-1501
- Other IDs
- U1111-1262-6244, jRCT2071200084
- Status last verified
- May 2023
- First submitted
- 14 Jan 2021
- Last updated
- 6 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Publications
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.
PubMed 35501178
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04712110
- Acronym / sponsor ID
- TAK-019-1501
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 12 Feb 2021 (actual)
- Primary completion
- 28 Mar 2022 (actual)
- Study completion
- 28 Mar 2022 (actual)
- First posted
- 15 Jan 2021 (actual)
- Results
- Posted 6 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAK-019 | Experimental | Biological: TAK-019TAK-019 0.5 mL, intramuscular injection in the upper arm |
| Placebo | Placebo comparator | Biological: PlaceboTAK-019 Matching Placebo, intramuscular injection in the upper arm |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy Japanese male and female adult participants aged >= 20 years of age at the time of signing of informed consent.
- Participants who understand and are willing to comply with trial procedures and are available for the duration of follow-up.
Key exclusion criteria (19 listed)
- Participants who received any other SARS-CoV-2 or other experimental novel coronavirus vaccine prior to the trial.
- Participants who have close contact of anyone known to have COVID-19 within 30 days prior to the trial vaccination.
- Participants who were tested positive for SARS-CoV-2 prior to the trial or before the trial vaccination.
- Participants who are on current treatment with other investigational agents for prophylaxis of COVID-19.
- Participants who have traveled outside of Japan in the 30 days prior to the trial participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAK-019TAK-019 intramuscular injection | Biological | TAK-019 |
| PlaceboPlacebo intramuscular injection | Biological | Placebo |
Primary outcome
Percentage of Participants With Solicited Local Adverse Events (AEs) for Six Subsequent Days Following First Vaccination
Time frame: Up to Day 7 (6 subsequent days after first vaccination on Day 1)
Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their diary for six subsequent days following first vaccination. Solicited local AEs included injection site pain, tenderness, erythema/redness, induration, and swelling.
Percentage of Participants With Solicited Local AEs for Six Subsequent Days Following Second Vaccination
Time frame: Up to Day 28 (6 subsequent days after second vaccination on Day 22)
Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their diary for six subsequent days following second vaccination. Solicited local AEs included injection site pain, tenderness, erythema/redness, induration, and swelling.
Percentage of Participants With Solicited Systemic AEs for Six Subsequent Days Following First Vaccination
Time frame: Up to Day 7 (6 subsequent days after first vaccination on Day 1)
Solicited systemic AEs were pre-defined AEs for which participants were specifically questioned and which were noted by participants in their diary for six subsequent days following first vaccination. Solicited systemic AEs included fever, fatigue, malaise, myalgia, arthralgia, nausea/vomiting and headache.
Percentage of Participants With Solicited Systemic AEs for Six Subsequent Days Following Second Vaccination
Time frame: Up to Day 28 (6 subsequent days after second vaccination on Day 22)
Solicited systemic AEs were pre-defined AEs for which participants were specifically questioned and which were noted by participants in their diary for six subsequent days following second vaccination. Solicited systemic AEs included fever, fatigue, malaise, myalgia, arthralgia, nausea/vomiting and headache.
Percentage of Participants With Unsolicited AEs for 20 Days Following First Vaccination
Time frame: Up to Day 21 (20 days after first vaccination on Day 1)
Unsolicited AEs were all AEs that were not pre-defined for which the participant was not specifically questioned in the participant diary.
Percentage of Participants With Unsolicited AEs for 27 Days Following Second Vaccination
Time frame: Up to Day 49 (27 days after second vaccination on Day 22)
Unsolicited AEs were all AEs that were not pre-defined for which the participant was not specifically questioned in the participant diary.
Percentage of Participants With Serious Adverse Events (SAEs) Until Day 50
Time frame: Day 1 up to Day 50
Only unsolicited SAEs data was planned to be collected and assessed for the assessment of this outcome measure (OM) and solicited SAE was out of the scope of assessment. Unsolicited SAEs were those AEs that were not pre-defined for which the participant was not specifically questioned in the participant diary. Percentage of participants with unsolicited SAEs until Day 50 were reported in this outcome measure.
Percentage of Participants With Adverse Events of Special Interest (AESI) Until Day 50
Time frame: Day 1 up to Day 50
AESIs were defined as AEs that were specifically highlighted to the Investigator. Only unsolicited AESI data was planned to be collected and assessed for the assessment of this OM and solicited AESI was out of the scope of assessment. Unsolicited AESIs were those AEs that were not pre-defined for which the participant was not specifically questioned in the participant diary. Percentage of participants with unsolicited AESIs until Day 50 were reported in this outcome measure.
Percentage of Participants With Medically-Attended Adverse Events (MAAEs) Until Day 50
Time frame: Day 1 up to Day 50
MAAEs are defined as AEs leading to an unscheduled visit to or by a healthcare professional including visits to an emergency department, but not fulfilling seriousness criteria. Only unsolicited MAAEs data was planned to be collected and assessed for the assessment of this OM and solicited MAAE was out of the scope of assessment. Unsolicited MAAEs were those AEs that were not pre-defined for which the participant was not specifically questioned in the participant diary. Percentage of participants with unsolicited MAAEs until Day 50 were reported in this outcome measure.
Percentage of Participants With Any AE Leading to Discontinuation of Vaccination
Time frame: Day 1 up to Day 22
Only any unsolicited AE leading to discontinuation of vaccination data was planned to be collected and assessed for the assessment of this OM and solicited AE leading to discontinuation of vaccination was out of the scope of assessment. Unsolicited AEs were those AEs that were not pre-defined for which the participant was not specifically questioned in the participant diary. Percentage of participants with any unsolicited AE leading to discontinuation of vaccination until Day 22 were reported in this outcome measure.
Percentage of Participants With Any AE Leading to Participant's Withdrawal From the Trial Until Day 50
Time frame: Day 1 up to Day 50
Only any unsolicited AE leading to participant's withdrawal from the trial data was planned to be collected and assessed for the assessment of this OM and solicited AE leading to participant's withdrawal from the trial was out of the scope of assessment. Unsolicited AEs were those AEs that were not pre-defined for which the participant was not specifically questioned in the participant diary. Percentage of participants with any unsolicited AE leading to participant's withdrawal from the trial until Day 50 were reported in this outcome measure.
Percentage of Participants With Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Infection Until Day 50
Time frame: Day 1 up to Day 50
Geometric Mean Titers (GMT) of Serum Immunoglobulin G (IgG) Antibody Levels to SARS-CoV-2 Recombinant Spike (rS) Protein on Day 36
Time frame: At Day 36
GMT was the immunogenicity outcome expressed as reciprocal antibody titer with average for each group. Titer values was measured as below lower limit of quantification (LLOQ) were imputed to a value that was half of the LLOQ. LLOQ was equal to 200. Here, ELISA is Enzyme-linked immunosorbent assay.
Geometric Mean Fold Rise (GMFR) of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Day 36
Time frame: At Day 36
GMFR was calculated as the ratio of the post-vaccination titer level to the baseline titer level. Baseline was defined as the last measurement taken before the first dose of study intervention.
Seroconversion Rate (SCR) of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Day 36
Time frame: At Day 36
SCR was defined as percentage of participants with 4-fold or more rises in titer if naive at baseline OR percentage of participants with 2-fold or more rises in titer if seropositive at baseline. Baseline was defined as the last measurement taken before the first dose of study intervention.
Seroresponse Rate (SRR) of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Day 36
Time frame: At Day 36
SRR was defined as percentage of participants with greater than or equal to (>=) 95 percentile in titer at Baseline for all participants. Baseline was defined as the last measurement taken before the first dose of study intervention.
13 secondary outcomes
Percentage of Participants With SAE Throughout the Trial
Time frame: Day 1 up to Day 387
Percentage of Participants With AESI Throughout the Trial
Time frame: Day 1 up to Day 387
Percentage of Participants With MAAEs Throughout the Trial
Time frame: Day 1 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
Time frame: Day 1 up to Day 387
Percentage of Participants With SARS-CoV-2 Infection Throughout the Trial
Time frame: Day 1 up to Day 387
GMT of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Days 22, 50, 202, and 387
Time frame: At Days 22, 50, 202, and 387
GMFR of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Days 22, 50, 202, and 387
Time frame: At Days 22, 50, 202, and 387
SCR of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Days 22, 50, 202, and 387
Time frame: At Days 22, 50, 202, and 387
SRR of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Days 22, 50, 202, and 387
Time frame: At Days 22, 50, 202, and 387
GMT of Serum Neutralizing Antibody (nAb) Titers to Wild Type Virus on Days 22, 36, 50, 202 and Day 387
Time frame: At Days 22, 36, 50, 202 and 387
GMFR of Serum nAb Titers to Wild Type Virus on Days 22, 36, 50, 202 and 387
Time frame: At Days 22, 36, 50, 202 and 387
SCR to Serum nAb Titers to Wild Type Virus on Days 22, 36, 50, 202 and 387
Time frame: At Days 22, 36, 50, 202 and 387
SRR to Serum nAb Titers to Wild Type Virus on Days 22, 36, 50, 202 and 387
Time frame: At Days 22, 36, 50, 202 and 387
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35501178Masuda 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.
- To obtain more information on the study, click here/on this linkLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Takeda
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TAK-019 in people with Prevention of Infection Disease Caused by Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2), run by Takeda at 2 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Solicited Local Adverse Events (AEs) for Six Subsequent Days Following First Vaccination (time frame: Up to Day 7 (6 subsequent days after first vaccination on Day 1)). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04712110, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2023.