A Phase 4 Post-marketing Study of Intramuscular Injections of BLB-750 in Healthy Adult Subjects

NCT03370289 | Completed Phase 4 Results

• 3 other identifiers: BLB-750/CCT-901U1111-1198-2695JapicCTI-173797
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the immunogenicity and safety of two intramuscular vaccinations with BLB-750 in healthy Japanese adults.

Conditions

Pandemic Influenza Prevention

Outcome Measures

Primary Outcomes (3)

• Seroprotection Rate as Measured by Single Radial Hemolysis (SRH) Antibody Titer for the Vaccine Strain at 21 Days After the Second Vaccination

  Seroprotection rate was measured by SRH antibody titer for BLB-750 Qinghai RG strain at 21 days after second vaccination. Seroprotection rate as SRH antibody titer is defined as the percentage of participants with SRH antibody titer ≥25 mm\^2.

  Day 43 (21 days after the second vaccination)

• Seroconversion Rate as Measured by SRH Antibody Titer for the Vaccine Strain at 21 Days After the Second Vaccination

  Seroconversion rate was measured by SRH antibody titer for BLB-750 Qinghai RG strain at 21 days after second vaccination. Seroconversion rate as SRH antibody titer is defined as the percentage of participants with a 50% or more increase in SRH antibody titer from baseline for those who have a baseline value \>4 mm\^2 or SRH antibody titer ≥25 mm\^2 for those who have a baseline value ≤4 mm\^2.

  Day 43 (21 days after the second vaccination)

• Geometric Mean Fold Increase (GMFI) in SRH Antibody Titer From Baseline for the Vaccine Strain at 21 Days After the Second Vaccination

  GMFI was measured as geometric mean fold change from baseline in SRH antibody titer for BLB-750 Qinghai RG strain at 21 days after second vaccination.

  Day 43 (21 days after the second vaccination)

Secondary Outcomes (11)

• Seroprotection Rate as Measured by SRH Antibody Titer for the Vaccine Strain at 21 Days After the First Vaccination

  Day 22 (21 days after the first vaccination)

• Seroconversion Rate as Measured by SRH Antibody Titer for the Vaccine Strain at 21 Days After the First Vaccination

  Day 22 (21 days after the first vaccination)

• GMFI in SRH Antibody Titer From Baseline for the Vaccine Strain at 21 Days After the First Vaccination

  Day 22 (21 days after the first vaccination)

• Geometric Mean Titer (GMT) of SRH Antibody Titer for the Vaccine Strain at 21 Days After Each Vaccination

  Day 22, and Day 43 (21 days after the first and the second vaccination)

• Number of Participants Reporting Who Had One or More Treatment-emergent Adverse Event (TEAE)

  Up to Day 43

Study Arms (1)

BLB-750 Qinghai RG strain

EXPERIMENTAL

Two doses of BLB-750 Qinghai reverse genetics (RG) strain at a vaccination dose of 0.5 mL (HA antigen level of 7.5 µg per strain) will be injected into the upper arm muscle (the deltoid muscle) at 3-week intervals (Day 1 and Day 22) in a treatment period of 43 days.

Biological: BLB-750 Vaccine (Qinghai RG strain)

Interventions

BLB-750 Vaccine (Qinghai RG strain) BIOLOGICAL

BLB-750 Injection

Also known as: Cell-Culture Influenza Vaccine H5N1 "Takeda"

BLB-750 Qinghai RG strain

Eligibility Criteria

• Age: 20 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
• The participant signs and dates a written, informed consent form prior to the initiation of any study procedures.
• The participant is a healthy Japanese adult man or woman.
• The participant is aged 20 to 49 years, inclusive, at the time of informed consent.
• A female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to use routinely adequate contraception from signing of informed consent throughout the duration of the study.

You may not qualify if:

• The participant has received vaccination with any other investigational products within 4 months prior to vaccination with the study drug.
• The participant has a history of vaccination with an H5N1 influenza vaccine.
• The participant has a history of infection with H5N1 virus.
• The participant is at high risk of contracting H5N1 influenza infection (e.g., poultry workers).
• The participant is an immediate family member, study site employee, or is in a dependant relationship with a study site employee who is involved in conduct of this study (e.g., spouse, parent, child, sibling) or may consent under duress.
• The participant has poorly controlled, clinically significant manifestations of neurological, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, endocrine, or other disorders, which may impact their ability to participate as participants or may potentially confound the study results.
• The participant has a body temperature (oral) ≥37.5°C prior to vaccination with the study drug on Day 1.
• The participant has any medically diagnosed or suspected immune-deficiency condition.
• The participant has an immunocompromising condition or disease, or is currently undergoing a form of treatment or was undergoing a form of treatment that can be expected to influence immune response within 30 days prior to vaccination with the study drug.
• Such treatments include, but are not limited to, systemic or high dose inhaled corticosteroids (\>800 μg/day of beclomethasone dipropionate or equivalent; the use of inhaled and nasal steroids that do not exceed this level will be permitted), radiation treatment or other immunosuppressive or cytotoxic drugs.
• The participant has received antipyretics within 4 hours prior to vaccination with the study drug.
• The participant has a history of Guillain-Barré Syndrome, demyelinating disorders (including acute disseminated encephalomyelitis \[ADEM\] and multiple sclerosis), or convulsions.
• The participant has a functional or anatomic asplenia.
• The participant has a rash, other dermatologic conditions or tattoos that may interfere with the evaluation of local reaction.
• The participant has a past or present history of infection with the Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV).

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Sekino Rinsho Yakuri Clinic

Toshima-ku, Tokyo, Japan

Location

Results Point of Contact

• Title: Medical 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 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2017
• First Posted: December 12, 2017
• Study Start: January 12, 2018
• Primary Completion: February 28, 2018
• Study Completion: February 28, 2018
• Last Updated: July 29, 2019
• Results First Posted: July 29, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will share

Locations

JP (1)