A Study of TAK-019 in Healthy Japanese Adults (COVID-19)

NCT04712110 | Completed Phase 1 Results FDA Drug

• 3 other identifiers: TAK-019-1501U1111-1262-6244jRCT2071200084
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

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.

Conditions

Prevention of Infection Disease Caused by Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2)

Outcome Measures

Primary Outcomes (16)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  Day 1 up to Day 50

• Percentage of Participants With Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Infection Until Day 50

  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.

  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.

  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.

  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.

  At Day 36

Secondary Outcomes (13)

• Percentage of Participants With SAE Throughout the Trial

  Day 1 up to Day 387

• Percentage of Participants With AESI Throughout the Trial

  Day 1 up to Day 387

• Percentage of Participants With MAAEs Throughout the Trial

  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

  Day 1 up to Day 387

• Percentage of Participants With SARS-CoV-2 Infection Throughout the Trial

  Day 1 up to Day 387

Study Arms (2)

TAK-019

EXPERIMENTAL

TAK-019 0.5 mL, intramuscular injection in the upper arm

Biological: TAK-019

Placebo

PLACEBO COMPARATOR

TAK-019 Matching Placebo, intramuscular injection in the upper arm

Biological: Placebo

Interventions

TAK-019 BIOLOGICAL

TAK-019 intramuscular injection

TAK-019

Placebo BIOLOGICAL

Placebo intramuscular injection

Placebo

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Takeda: lead

Study Sites (2)

Sumida Hospital

Sumida-ku, Tokyo, Japan

Location

Nishi Kumamoto Hospital

Kumamoto, Japan

Location

Related Publications (1)

• 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.

  PMID: 35501178 DERIVED

Related Links

• To obtain more information on the study, click here/on this link

Results Point of Contact

• Title: Study Director
• Organization: Takeda

TrialDisclosures@takeda.com

+1-877-825-3327

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2021
• First Posted: January 15, 2021
• Study Start: February 12, 2021
• Primary Completion: March 28, 2022
• Study Completion: March 28, 2022
• Last Updated: June 6, 2023
• Results First Posted: June 6, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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.

Locations

JP (2)