The purpose of this study is to evaluate the immunogenicity and safety of two intramuscular vaccinations with BLB-750 in healthy Japanese adults.
The drug being tested in this study is called BLB-750 that is a vaccine for pandemic influenza infection. This study will evaluate 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 first vaccination. Participants will make multiple visits to the clinic, including 21 days after the first vaccination and 21 days after the second vaccination.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
55
BLB-750 Injection
Sekino Rinsho Yakuri Clinic
Toshima-ku, Tokyo, Japan
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.
Time frame: 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.
Time frame: 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.
Time frame: Day 43 (21 days after the second vaccination)
Seroprotection Rate as Measured by SRH Antibody Titer for the Vaccine Strain at 21 Days After the First Vaccination
Seroprotection rate was measured by SRH antibody titer for BLB-750 Qinghai RG strain at 21 days after first vaccination. Seroprotection rate as SRH antibody titer is defined as the percentage of participants with SRH antibody titer ≥25 mm\^2.
Time frame: 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
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Seroconversion rate was measured by SRH antibody titer for BLB-750 Qinghai RG strain at 21 days after first 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.
Time frame: 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
GMFI was measured as geometric mean fold change from baseline in SRH antibody titer for BLB-750 Qinghai RG strain at 21 days after first vaccination.
Time frame: 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
GMT was measured by SRH antibody titer for BLB-750 Qinghai RG strain at 21 days after first and second vaccination.
Time frame: 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)
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
Time frame: Up to Day 43
Number of Participants With Adverse Events Related to Solicited Local and Systemic Adverse Events to be Recorded in the Participant Diary
Local reactions and systemic events were recorded using a diary.
Time frame: Up to Day 43
Change From Baseline in Mean Systolic Blood Pressure at Specific Time Points After Vaccination
Time frame: Baseline, At 30 minutes after the first vaccination and on Day 22 after the first vaccination, and at 30 minutes after the second vaccination and on Day 22 after the second vaccination
Change From Baseline in Mean Diastolic Blood Pressure at Specific Time Points After Vaccination
Time frame: Baseline, At 30 minutes after the first vaccination and on Day 22 after the first vaccination, and at 30 minutes after the second vaccination and on Day 22 after the second vaccination
Change From Baseline in Mean Pulse Rate at Specific Time Points After Vaccination
Time frame: At 30 minutes after the first vaccination and on Day 22 after the first vaccination, and at 30 minutes after the second vaccination and on Day 22 after the second vaccination
Change From Baseline in Mean Respiratory Rate at 30 Minutes After Vaccination
Time frame: Baseline, At 30 minutes after the first vaccination, and at 30 minutes after the second vaccination
Mean Body Temperature at Specific Time Points After Vaccination
Time frame: Baseline, Days 1, 2, 3, 4, 5, 6, 7, and 22 after the first vaccination, Days 1, 2, 3, 4, 5, 6, 7, and 22 after the second vaccination