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A Single Heterologous Booster Vaccination Study of TAK-019 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: NCT05299359
Recruitment Status : Active, not recruiting
First Posted : March 29, 2022
Last Update Posted : June 6, 2022
Sponsor:
Information provided by (Responsible Party):
Takeda

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 for participants who will receive TAK-019 as heterologous booster vaccination.

Participants who completed 2 doses primary vaccinations 6 to 12 months prior to the trial vaccination can take part in this study. At the first visit, the study doctor will check if each person can take part. Participants who can take part will receive an injection of TAK-019 as booster vaccination.

Participants will be asked to record their temperature and any medical problems in an electronic diary for up to 7 days after the 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 the 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 injection. During this time, the doctors will continue to collect blood samples to check immune response. Also, they will check if participants have any more side effects from TAK-019.


Condition or disease Intervention/treatment Phase
Coronavirus Disease (COVID-19) Biological: TAK-019 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Phase 3, Single Arm, Open-Label Trial to Evaluate the Immunogenicity and Safety of a Single Heterologous Booster Vaccination of TAK-019 in Healthy Japanese Male and Female Adults Aged 20 Years and Older (COVID-19)
Actual Study Start Date : April 15, 2022
Estimated Primary Completion Date : May 29, 2023
Estimated Study Completion Date : May 29, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: TAK-019
TAK-019 0.5 mL, intramuscular injection in the mid deltoid, preferable in the non-dominant upper arm
Biological: TAK-019
TAK-019 intramuscular injection




Primary Outcome Measures :
  1. Geometric Mean Titers (GMT) Ratio of Neutralizing Antibody Titers to the Ancestral Strain (Wild-type Virus) on Day 15 Compared with that Observed on Day 36 in Participants from the TAK-019-1501 Study [ Time Frame: Day 15 ]
    GMT ratio of neutralizing antibody titers to the ancestral strain (wild-type virus) on Day15 after a single booster vaccination (14 days after the booster vaccination) compared with that observed on Day 36 (14 days after the second vaccination) in subjects from the TAK-019-1501 study (NCT04712110) will be reported.

  2. Percentage of Participants with Reported Solicited Local Adverse Events (AEs) for 7 Days Following Booster Vaccination [ Time Frame: 7 days after booster vaccination ]
    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.

  3. Percentage of Participants with Solicited Systemic AEs for 7 Days Following Booster Vaccination [ Time Frame: 7 days after booster vaccination ]
    Solicited systemic AEs are defined as fever, fatigue, malaise, myalgia, arthralgia, nausea/vomiting, and headache.

  4. Percentage of Participants with Unsolicited AEs for 28 Days Following Booster Vaccination [ Time Frame: 28 days after booster vaccination ]
    Unsolicited AEs defines as other AEs than solicited local AEs and solicited systemic AEs.

  5. Percentage of Participants with Serious Adverse Events (SAE) until Day 29 [ Time Frame: Up to Day 29 ]
    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.

  6. Percentage of Participants with Adverse Event of Special Interest (AESI) until Day 29 [ Time Frame: Up to Day 29 ]
    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.

  7. Percentage of Participants with Medically-Attended Adverse Events (MAAEs) until Day 29 [ Time Frame: Up to Day 29 ]
  8. Percentage of Participants with Any AE Leading to Participant's Withdrawal from the Trial until Day 29 [ Time Frame: Up to Day 29 ]
  9. Percentage of Participants with SARS-CoV-2 Infection until Day 29 [ Time Frame: Up to Day 29 ]

Secondary Outcome Measures :
  1. GMT of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Day 8, 15, 29, 91, 181, and 366 [ Time Frame: Day 8, 15, 29, 91, 181, and 366 ]
  2. Geometric Mean Fold Rise (GMFR) of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Day 8, 15, 29, 91, 181, and 366 [ Time Frame: Day 8, 15, 29, 91, 181, and 366 ]
  3. Seroconversion Rate (SCR) of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Day 8, 15, 29, 91, 181, and 366 [ Time Frame: Day 8, 15, 29, 91, 181, and 366 ]
    SCR is defined at percentage of participants with >= 4-fold rises from baseline (Day 1).

  4. GMT of Serum Neutralizing Antibody Titters to the Ancestral Strain (Wild-type Virus) on Day 8, 15, 29, 91, 181, and 366 [ Time Frame: Day 8, 15, 29, 91, 181, and 366 ]
  5. GMFR of Serum Neutralizing Antibody Titters to the Ancestral Strain (Wild-type Virus) on Day 8, 15, 29, 91, 181, and 366 [ Time Frame: Day 8, 15, 29, 91, 181, and 366 ]
  6. SCR of Serum Neutralizing Antibody Titters to the Ancestral Strain (Wild-type Virus) on Day 8, 15, 29, 91, 181, and 366 [ Time Frame: Day 8, 15, 29, 91, 181, and 366 ]
    SCR is defined at percentage of participants with >= 4-fold rises from baseline (Day 1).

  7. Percentage of Participants with SAE throughout the Trial [ Time Frame: Up to Day 366 ]
  8. Percentage of Participants with AESI throughout the Trial [ Time Frame: Up to Day 366 ]
  9. Percentage of Participants with MAAEs throughout the Trial [ Time Frame: Up to Day 366 ]
  10. Percentage of Participants with Any AE Leading to Participant's Withdrawal from the Trial from the Day of Booster Vaccination throughout the Trial [ Time Frame: Up to Day 366 ]
  11. Percentage of Participants with SARS-CoV-2 Infection throughout the Trial [ Time Frame: Up to Day 366 ]


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.


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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 adult subjects aged >= 20 years of age at the time of signing of informed consent.
  2. Participant who completed 2 doses primary vaccinations with another specified mRNA vaccine which is available in Japan 6 to 12 months prior to the trial vaccination.

Exclusion Criteria:

  1. Participants who received any other SARS-CoV-2 vaccine (except for the specified mRNA vaccine) or other experimental novel coronavirus vaccine prior to the trial.
  2. Participant who received a booster vaccination (i.e. 3rd dose)
  3. Participants who have close contact of anyone known to have COVID-19 within 14 days prior to the trial vaccination.
  4. Participants who were tested positive for SARS-CoV-2 prior to the trial.
  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 or oral temperature >= 38 degree Celsius within 3 days of the intended date of vaccination.
  7. Participants with body mass index (BMI) greater than or equal to 30 kg/m^2 (BMI= weight in kg/ height in meters^2)

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): NCT05299359


Locations
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Japan
Sumida Hospital
Sumida-ku, Tokyo, Japan
PS Clinic
Fukuoka, Japan
Sponsors and Collaborators
Takeda
Investigators
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Study Director: Study Director Takeda
Additional Information:
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Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT05299359    
Other Study ID Numbers: TAK-019-3001
2020-004042-11 ( Registry Identifier: EudraCT )
jRCT2071210141 ( Registry Identifier: jRCT )
First Posted: March 29, 2022    Key Record Dates
Last Update Posted: June 6, 2022
Last Verified: June 2022
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/

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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:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases