Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04677660
Recruitment Status : Active, not recruiting
First Posted : December 21, 2020
Last Update Posted : May 19, 2021
Sponsor:
Information provided by (Responsible Party):
Takeda

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Prevention of Infectious Disease Caused by Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Biological: TAK-919 Biological: Placebo Phase 1 Phase 2

Detailed Description:

The drug being tested in this study is called TAK-919. TAK-919 is being tested to prevent infectious disease caused by Severe Acute Respiratory Syndrome coronavirus-2 (SARS-CoV-2). This study will look at the safety and immunogenicity of 2 doses of TAK-919 by intramuscular (IM) injection in healthy Japanese male and female adults, given 28 days apart.

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-919 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. 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase 1/2, Randomized, Observer-Blind, Placebo-Controlled Trial to Evaluate the Safety and Immunogenicity of TAK-919 by Intramuscular Injection in Healthy Japanese Male and Female Adults Aged 20 Years and Older (COVID-19)
Actual Study Start Date : January 21, 2021
Estimated Primary Completion Date : March 3, 2022
Estimated Study Completion Date : March 3, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: TAK-919
TAK-919 0.5 mL, intramuscular injection in the upper arm
Biological: TAK-919
TAK-919 intramuscular injection

Placebo Comparator: Placebo
TAK-919 Matching Placebo, intramuscular injection in the upper arm
Biological: Placebo
Placebo intramuscular injection




Primary Outcome Measures :
  1. 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 ]
    An Adverse Event (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, erythema/redness, swelling, induration, and axillary (underarm) swelling or tenderness ipsilateral to the side of injection.

  2. Percentage of Participants with Solicited Systemic AEs for 7 Days Following Each Vaccination [ Time Frame: Up to Day 7 after each vaccination ]
    Solicited systemic AEs are defined as headache, fatigue, myalgia, arthralgia, nausea/vomiting, chills, and fever.

  3. Percentage of Participants with Unsolicited AEs for 28 Days After Each Vaccination [ Time Frame: Up to Day 28 after each vaccination ]
    Unsolicited AEs defines as other AEs than solicited local AEs and solicited systemic AEs.

  4. Percentage of Participants with Serious AE (SAE) until Day 57 [ Time Frame: Up to Day 57 ]
    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.

  5. Percentage of Participants with Medically-Attended Adverse Events (MAAEs) until Day 57 [ Time Frame: Up to Day 57 ]
  6. Percentage of Participants with Any AE Leading to Discontinuation of Vaccination [ Time Frame: Up to Day 57 (up to discontinuation of vaccination) ]
  7. Percentage of Participants with Any AE Leading to Participant's Withdrawal from the Trial until Day 57 [ Time Frame: Up to Day 57 ]
  8. Percentage of Participants with SARS-CoV-2 Infection until Day 57 [ Time Frame: Up to Day 57 ]
  9. Geometric Mean Titers (GMT) of Serum binding antibody (bAb) Against SARS-CoV-2 on Day 57 [ Time Frame: Day 57 ]
    GMT of serum bAb against SARS-CoV-2 will be measured by ligand-binding assay specific to the SARS-CoV-2 S protein.

  10. Geometric Mean Fold Rise (GMFR) of Serum bAb Against SARS-CoV-2 on Day 57 [ Time Frame: Day 57 ]
    GMFR of serum bAb against SARS-CoV-2 will be measured by ligand-binding assay specific to the SARS-CoV-2 S protein.

  11. Seroconversion Rate (SCR) of Serum bAb Against SARS-CoV-2 on Day 57 [ Time Frame: Day 57 ]
    SCR of serum bAb against SARS-CoV-2 will be measured by ligand-binding assay specific to the SARS-CoV-2 S protein. SCR is defined at percentage of participants with a change from below the limit of detection (LOD) or limit of quantification (LLOQ) to equal to or above LOD or LLOQ, OR, >= 4-fold rises from baseline.


Secondary Outcome Measures :
  1. Percentage of Participants with SAE throughout the Trial [ Time Frame: Up to Day 394 ]
  2. Percentage of Participants with MAAEs throughout the Trial [ Time Frame: Up to Day 394 ]
  3. 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 ]
  4. Percentage of Participants with SARS-CoV-2 Infection throughout the Trial [ Time Frame: Up to Day 394 ]
  5. 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 ]
    GMT of serum bAb against SARS-CoV-2 will be measured by ligand-binding assay specific to the SARS-CoV-2 S protein.

  6. 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 ]
    GMFR of serum bAb against SARS-CoV-2 will be measured by ligand-binding assay specific to the SARS-CoV-2 S protein.

  7. 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 ]
    SCR of serum bAb against SARS-CoV-2 will be measured by ligand-binding assay specific to the SARS-CoV-2 S protein. SCR is defined at percentage of participants with a change from below the LOD to equal to or above LOD, OR, >= 4-fold rises from baseline.

  8. 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 ]
    GMT of serum nAb against SARS-CoV-2 will be measured by assay specific to wild-type virus.

  9. 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 ]
    GMFR of serum nAb against SARS-CoV-2 will be measured by assay specific to wild-type virus.

  10. 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 ]
    SCR of serum nAb against SARS-CoV-2 will be measured by assay specific to wild-type virus. SCR is defined at percentage of subjects with a change from below the lower limit of quantification (LLOQ) to equal to or above LLOQ, OR, >= 4-fold rises from baseline.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy Japanese male and female participants.
  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 vaccine administration.
  3. Participants who were tested positive for SARS-CoV-2 prior to the trial or on the test before the vaccination.
  4. Participants who are on current treatment with other investigational agents for prophylaxis of COVID 19.
  5. Participants who 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 vaccination.
  7. Participants with a known hypersensitivity or allergy to any of the IMP components.
  8. Participants with any illness or history of 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 BMI >= 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 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 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 are with or have history of hepatitis B and hepatitis C infection, or with known human immunodeficiency virus (HIV) infection or HIV-related disease..
  19. Female participants who are pregnant or breastfeeding.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04677660


Locations
Layout table for location information
Japan
Sumida Hospital
Sumida-ku, Tokyo, Japan
PS Clinic
Fukuoka, Japan
Sponsors and Collaborators
Takeda
Investigators
Layout table for investigator information
Study Director: Study Director Takeda
Additional Information:
Layout table for additonal information
Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT04677660    
Other Study ID Numbers: TAK-919-1501
U1111-1261-9040 ( Other Identifier: WHO )
jRCT2071200069 ( Registry Identifier: jRCT )
First Posted: December 21, 2020    Key Record Dates
Last Update Posted: May 19, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
URL: https://vivli.org/ourmember/takeda/

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
Layout table for MeSH terms
Communicable Diseases
Infections
Severe Acute Respiratory Syndrome
COVID-19
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Disease Attributes
Pathologic Processes
Respiratory Tract Infections
Respiratory Tract Diseases
Pneumonia, Viral
Pneumonia
Lung Diseases