A Single Heterologous Booster Vaccination Study of TAK-019 in Healthy Japanese Adults (COVID-19)

NCT05299359 | Completed Phase 3 Results FDA Drug

• 3 other identifiers: TAK-019-3001jRCT2071210141U1111-1281-3948
• Study Type: interventional
• Target: 150
• 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 for participants who will receive TAK-019 as heterologous booster vaccination. This study consists of two parts, main part and extension part. Firstly, participants who completed 2 doses primary vaccinations 6 to 12 months prior to the trial vaccination can take part in main study. At the first visit of main part of this study, 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 main part, 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. Participants who received the first single booster vaccination of TAK-019 in the main part and remained in study follow-up at least 5 months will be able to decide to take part in the extension part of this study. At the first visit of extension part of this study, the study doctor will check if each person can take part. Participants who can take part will receive an injection of TAK-019 as a second booster vaccination at the first visit of extension part. The participants will stay in the main part of this study for up to 12 months after they have had their injection or up to the start of extension part. For participants who will take part in the extension part, they will stay in the extension part for up to 12 months from the start of extension part. 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.

Conditions

Coronavirus Disease (COVID-19)

Outcome Measures

Primary Outcomes (9)

• Main Part: 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

  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 20. GMT for each group and 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 participants from the TAK-019-1501 study (NCT04712110) were reported. GMT ratio was calculated with GMT of TAK-019-3001 on Day 15 divided by GMT of TAK-019-1501 study on Day 36. Here, ELISA is Enzyme-linked immunosorbent assay.

  Day 15 for this study (14 days after the vaccination); Day 36 for TAK-019-1501 study (14 days after the second vaccination)

• Main Part: Percentage of Participants With Reported Solicited Local Adverse Events (AEs) for 7 Days Following the First Single Booster Vaccination

  AE was defined as any untoward medical occurrence in a clinical investigation participant administered an investigational medicinal product (IMP); it did not necessarily have to have a causal relationship with IMP administration. Reported solicited local AEs were defined as injection site pain, tenderness, erythema/redness, induration, and swelling.

  Main Part: 7 days after the first single booster vaccination

• Main Part: Percentage of Participants With Solicited Systemic AEs for 7 Days Following the First Single Booster Vaccination

  Solicited systemic AEs were defined as fever, fatigue, malaise, myalgia, arthralgia, nausea/vomiting, and headache.

  Main Part: 7 days after the first single booster vaccination

• Main Part: Percentage of Participants With Unsolicited AEs for 28 Days Following the First Single Booster Vaccination

  Unsolicited AEs defines as other AEs than solicited local AEs and solicited systemic AEs.

  Main Part: 28 days after the first single booster vaccination

• Main Part: Percentage of Participants With Solicited and Unsolicited Serious Adverse Events (SAE) Until Day 29

  An SAE was 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. Solicited SAEs and unsolicited SAEs were reported.

  Main Part: Up to Day 29

• Main Part: Percentage of Participants With Adverse Event of Special Interest (AESI) Until Day 29

  An AESI was defined as AEs that will be specifically highlighted to the Investigator. AESIs for the study included 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.

  Main Part: Up to Day 29

• Main Part: Percentage of Participants With Medically-Attended Adverse Events (MAAEs) Until Day 29

  MAAEs were 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.

  Main Part: Up to Day 29

• Main Part: Percentage of Participants With Any AE Leading to Withdrawal From the Trial Until Day 29

  Percentage of participants with any AE leading to withdrawal from the trial until Day 29 was reported.

  Main Part: Up to Day 29

• Main Part: Percentage of Participants With Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Infection Until Day 29

  Percentage of participants with SARS-CoV-2 infection until Day 29 of the main part of the trial were reported in this outcome measure.

  Main Part: Up to Day 29

Secondary Outcomes (30)

• Main Part: GMT of Serum Immunoglobulin G (IgG) Antibody Levels to SARS-CoV-2 Recombinant Spike (rS) Protein on Day 8, 15, 29, 91, 181, and 366

  Main Part: Day 8, 15, 29, 91, 181, and 366

• Main Part: 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

  Main Part: Day 8, 15, 29, 91, 181, and 366

• Main Part: Seroconversion Rate (SCR) of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Day 8, 15, 29, 91, 181, and 366

  Main Part: Day 8, 15, 29, 91, 181, and 366

• Main Part: GMT of Serum Neutralizing Antibody Titers to the Ancestral Strain (Wild-type Virus) on Day 8, 15, 29, 91, 181, and 366

  Main Part: Day 8, 15, 29, 91, 181, and 366

• Main Part: GMFR of Serum Neutralizing Antibody Titers to the Ancestral Strain (Wild-type Virus) on Day 8, 15, 29, 91, 181, and 366

  Main Part: Day 8, 15, 29, 91, 181, and 366

Study Arms (2)

TAK-019 Main Part

EXPERIMENTAL

TAK-019 0.5 mL, intramuscular injection in the mid deltoid, preferable in the non-dominant upper arm

Biological: TAK-019

TAK-019 Extension Part

EXPERIMENTAL

TAK-019 0 .5 mL, intramuscular injection in the mid deltoid, preferable in the non-dominant upper arm. The participants who received the first single booster vaccination of TAK-019 in the main part and remained in study follow-up at least 5 months will receive a second single booster vaccination of TAK-019 by intramuscular injection.

Biological: TAK-019

Interventions

TAK-019 BIOLOGICAL

TAK-019 intramuscular injection

TAK-019 Extension Part; TAK-019 Main Part

Eligibility Criteria

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

You may qualify if:

• MAIN PART:
• Healthy Japanese male and female adult participants aged \>= 20 years of age at the time of signing of informed consent.
• 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.
• EXTENSION PART:
• Participants who received the first trial vaccination at least 5 months earlier and are currently enrolled in the Main Part (ie, not have withdrawn or discontinued early).

You may not qualify if:

• MAIN PART:
• 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.
• Participant who received a booster vaccination (i.e. 3rd dose)
• Participants who have close contact of anyone known to have COVID-19 within 14 days prior to the trial vaccination.
• Participants who were tested positive for SARS-CoV-2 prior to the trial.
• Participants who have traveled outside of Japan in the 30 days prior to the trial participation.
• Participants with a clinically significant active infection or oral temperature \>= 38 degree Celsius within 3 days of the intended date of the first single booster vaccination.
• Participants with body mass index (BMI) greater than or equal to 30 kg/m\^2 (BMI= weight in kg/ height in meters\^2)
• EXTENSION PART:
• Participants with a clinically significant active infection or oral temperature \>=38 degree Celsius within 3 days of the intended date of the second single booster vaccination.

Sponsors & Collaborators

• Takeda: lead

Study Sites (2)

Sumida Hospital

Sumida-ku, Tokyo, Japan

Location

PS Clinic

Fukuoka, Japan

Location

Related Publications (2)

• Kuriyama K, Murakami K, Sugiura K, Sakui S, Schuring RP, Mori M. Immunogenicity and safety of a second heterologous booster dose of NVX-CoV2373 (TAK-019) in healthy Japanese adults who had previously received a primary series of COVID-19 mRNA vaccine: Interim analysis report of a phase 3 open-label trial. Vaccine. 2024 Jan 25;42(3):662-670. doi: 10.1016/j.vaccine.2023.12.036. Epub 2023 Dec 21.

  PMID: 38129286 DERIVED

• Kuriyama K, Murakami K, Masuda T, Sugiura K, Sakui S, Schuring RP, Mori M. Immunogenicity and safety of a single booster dose of NVX-CoV2373 (TAK-019) in healthy Japanese adults who had previously received a primary series of COVID-19 mRNA vaccine: Primary analysis report of a phase 3 open-label trial. Vaccine. 2023 Jun 7;41(25):3763-3771. doi: 10.1016/j.vaccine.2023.05.001. Epub 2023 May 8.

  PMID: 37198021 DERIVED

Related Links

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

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

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
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2022
• First Posted: March 29, 2022
• Study Start: April 15, 2022
• Primary Completion: June 11, 2022
• Study Completion: October 18, 2023
• Last Updated: October 21, 2024
• Results First Posted: July 28, 2023

Record last verified: 2024-10

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)