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

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ClinicalTrials.gov Identifier: NCT03370289
Recruitment Status : Completed
First Posted : December 12, 2017
Last Update Posted : March 30, 2018
Sponsor:
Information provided by (Responsible Party):
Takeda

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.

Condition or disease Intervention/treatment Phase
Influenza Prevention Biological: BLB-750 Vaccine (Qinghai RG strain) Phase 4

Detailed Description:

The drug being tested in this study is called BLB-750 that is a vaccine for influenza infection. This study will look at immunogenicity and safety of two intramuscular vaccinations with BLB-750 at 3-week intervals in healthy Japanese adults. The study will enroll 55 participants. BLB-750 will be administered in opened manner:

- Two intramuscular vaccinations of BLB-750 at 3-week intervals, 0.5 mL

This trial will be conducted in Japan. The overall time to participate in this study will be 43 days, starting on the day of initial vaccination. Participants will make multiple visits to the clinic, including 21 days after the initial vaccination and 21 days after the second vaccination.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: An Open-label Phase 4 Study to Evaluate the Immunogenicity and Safety of Intramuscular Injections of BLB-750 in Healthy Adult Subjects
Actual Study Start Date : December 14, 2017
Actual Primary Completion Date : February 28, 2018
Actual Study Completion Date : February 28, 2018

Arm Intervention/treatment
Experimental: BLB-750 Qinghai RG strain
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, Day 2 and Day 43).
Biological: BLB-750 Vaccine (Qinghai RG strain)
BLB-750 Injection




Primary Outcome Measures :
  1. Seroprotection Rate as Measured by Single Radial Hemolysis (SRH) Antibody Titer for the Vaccine Strain at 21 days after the Second Vaccination [ Time Frame: Day 43 (21 days after the second vaccination) ]
    Seroprotection rate will be 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.

  2. Seroconversion Rate as Measured by SRH Antibody Titer for the Vaccine Strain at 21 days after the Second Vaccination [ Time Frame: Day 43 (21 days after the second vaccination) ]
    Seroconversion rate will be 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.

  3. Geometric Mean Fold Increase (GMFI) in SRH Antibody Titer from Baseline for the Vaccine Strain at 21 days after the Second Vaccination [ Time Frame: Day 43 (21 days after the second vaccination) ]
    GMFI will be measured by SRH antibody titer for BLB-750 Qinghai RG strain at 21 days after second vaccination.


Secondary Outcome Measures :
  1. Seroprotection Rate as Measured by SRH Antibody Titer for the Vaccine Strain at 21 days after the Initial Vaccination [ Time Frame: Day 22 (21 days after the initial vaccination) ]
    Seroprotection rate will be measured by SRH antibody titer for BLB-750 Qinghai RG strain at 21 days after initial vaccination. Seroprotection rate as SRH antibody titer is defined as the percentage of participants with SRH antibody titer ≥25 mm^2

  2. Seroconversion Rate as Measured by SRH Antibody Titer for the Vaccine Strain at 21 days after the Initial Vaccination [ Time Frame: Day 22 (21 days after the initial vaccination) ]
    Seroconversion rate will be measured by SRH antibody titer for BLB-750 Qinghai RG strain at 21 days after initial 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.

  3. GMFI in SRH Antibody Titer from Baseline for the Vaccine Strain at 21 days after the Initial Vaccination [ Time Frame: Day 22 (21 days after the initial vaccination) ]
    GMFI will be measured by SRH antibody titer for BLB-750 Qinghai RG strain at 21 days after initial vaccination.

  4. Geometric Mean Titer (GMT) of SRH Antibody Titer for the Vaccine Strain at 21 days after each Vaccination [ Time Frame: Day 22, and Day 43 (21 days after the initial and the second vaccination) ]
    GMT will be measured by SRH antibody titer for BLB-750 Qinghai RG strain at 21 days after initial and second vaccination.

  5. Number of Participants with Adverse Events Related to Solicited Local and Systemic Adverse Events to be Recorded in the Participant Diary [ Time Frame: Up to Day 43 ]
    Local reactions and systemic events will be recorded using a diary.

  6. Number of Participants who Experience at Least One Adverse Events [ Time Frame: Up to Day 43 ]
  7. Number of Participants with Adverse Events Related to Vital Signs [ Time Frame: Up to Day 43 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
  2. The participant signs and dates a written, informed consent form prior to the initiation of any study procedures.
  3. The participant is a healthy Japanese adult man or woman.
  4. The participant is aged 20 to 49 years, inclusive, at the time of informed consent.
  5. 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.

Exclusion Criteria:

  1. The participant has received vaccination with any other investigational products within 4 months prior to vaccination with the study vaccine.
  2. The participant has a history of vaccination with an H5N1 influenza vaccine.
  3. The participant has a history of infection with H5N1 virus.
  4. The participant is at high risk of contracting H5N1 influenza infection (e.g., poultry workers).
  5. 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.
  6. 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.
  7. The participant has a body temperature (oral) ≥37.5°C prior to vaccination with the study vaccine on Day 1.
  8. The participant has any medically diagnosed or suspected immune-deficiency condition.
  9. 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 vaccine.

    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.

  10. The participant has received antipyretics within 4 hours prior to vaccination with the study vaccine.
  11. The participant has a history of Guillain-Barré Syndrome, demyelinating disorders (including acute disseminated encephalomyelitis [ADEM] and multiple sclerosis), or convulsions.
  12. The participant has a functional or anatomic asplenia.
  13. The participant has a rash, other dermatologic conditions or tattoos that may interfere with the evaluation of local reaction.
  14. 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).
  15. The participant has a known hypersensitivity to any component of BLB-750.
  16. The participant has a history of severe allergic reactions or anaphylaxis.
  17. The participant has a history of drug abuse (defined as any illicit drug use) or a history of alcohol dependence within 1 year prior to vaccination with the study vaccine or is unwilling to agree to abstain from excessive alcohol and drugs throughout the study.
  18. The participant has received any blood product (e.g., blood transfusion or immunoglobulin) within 90 days prior to vaccination with the study vaccine.
  19. The participant has received any live vaccine within 4 weeks (28 days) prior to vaccination with the study vaccine or any inactivated vaccine within 2 weeks (14 days) prior to vaccination with the study vaccine.
  20. The participant is a pregnant or lactating woman or wishes to become pregnant before signing informed consent, during, or within 12 weeks after the last vaccination with the study vaccine or intends to donate ova during such time period.
  21. For males: The participant has donated whole blood ≥200 mL within 4 weeks (28 days) or ≥400 mL within 12 weeks (84 days) prior to the first vaccination with the study vaccine.

    For females: The participant has donated whole blood ≥200 mL within 4 weeks (28 days) or ≥400 mL within 16 weeks (112 days) prior to the first vaccination with the study vaccine.

  22. For males: The participant has donated whole blood ≥800 mL in total within 52 weeks (364 days) prior to the first vaccination with the study vaccine.

    For females: The participant has donated whole blood ≥400 mL in total within 52 weeks (364 days) prior to the first vaccination with the study vaccine.

  23. The participant has donated blood components within 2 weeks (14 days) prior to the first vaccination with the study vaccine.
  24. In the opinion of the investigator, the participant is unlikely to comply with protocol requirements or is considered ineligible for any other reason.
  25. The participant has presence of thrombocytopenia or coagulopathy, or has received anticoagulant therapy within 30 days prior to the first vaccination with the study vaccine.

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): NCT03370289


Locations
Japan
Sekino Rinsho Yakuri Clinic
Toshima-ku, Tokyo, Japan
Sponsors and Collaborators
Takeda
Investigators
Study Director: Study Director Takeda

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT03370289     History of Changes
Other Study ID Numbers: BLB-750/CCT-901
U1111-1198-2695 ( Other Identifier: WHO )
JapicCTI-173797 ( Registry Identifier: JapicCTI )
First Posted: December 12, 2017    Key Record Dates
Last Update Posted: March 30, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No