Healthy
Conditions
Keywords
Healthy Volunteers
Brief summary
This study was aimed to evaluate the Immunogenicity and Safety response by vaccinating Hantavax in Healthy Adult.
Detailed description
This clinical trial was designed as a multicenter, non-comparative, open-label clinical trial. This trial was conducted, written informed consent form by voluntary agreement, the subjects who have not had the hantavax vaccination history at the time of screening. Investigator product was administrated 0, 1, 2, 13 months. For antibody test, Sampling was conducted pre-dose(T0), 28 days after the 2nd vaccination(before the 3rd vaccination, T1), 28 days after the 3rd vaccination(T2) and 11 months after the 3rd vaccination(before booster vaccination, T3), 28 days after the booster vaccination(T4), 2 months after the booster vaccination(T5) and 4 months after the booster vaccination(T6). Also, after the completion of booster vaccination for antibody retention duration observed for subjects with antibody to conduct a five-year follow-up survey was conducted, and the antibody test every year. In conclusion, sampling was conducted 12 months(T7), 24 months(T8), 36months(T9), 48 months(T10), 60 months(T11) after the booster vaccination. However, follow-up survey was terminated when the antibody titer was determined as a negative by neutralizing antibody test and fluorescent antibody technique.
Interventions
BIOLOGICALHantavax injection
A single 0.5mL dose intramuscular or subcutaneous injection
Sponsors
Green Cross Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Healthy adults ≥ 19years old. * Subjects who have not the hantavax vaccination history at the time of screening.
Exclusion criteria
* Subject who did not passed by 2 weeks after recovering the acute disease. * immunologic dysfunction subjects. * Subjects previously treated with anti-coagulant therapy or hemophiliac patients. * Subjects with severe chronic diseases. * Subjects who had an acute before vaccinating IP. * Subjects who had received another vaccination during the 28 days before vaccinating IP or who were scheduled for another vaccination during the study. * Subjects who were receiving immunosuppressant or immune modifying drug * Subjects who had been administered immunoglobulins or blood-derived products 3 months before vaccinating IP or who were scheduled for the administration during the study. * Subjects of childbearing potential at the time of screening and were scheduled to pregnancy for the study. A female subject who was pregnant or who was breast-feeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Antibody Seroconversion rates by neutralizing antibody test at 28 days after the 3rd vaccination(2month) | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| The Antibody Seroconversion Rates by neutralizing antibody test and fluorescent antibody test at 28 days after the 2nd vaccination(1month) | 2 months |
| The Antibody Seroconversion Rates by neutralizing antibody test and fluorescent antibody test at 28 days after the 4th vaccination(13month) | 14 months |
| The Antibody Seroconversion Rates by neutralizing antibody test and fluorescent antibody test at 2 , 4, 12, 24, 36, 48, 60months after the 4th vaccination(13month) | 15, 17, 25, 37, 49, 61, 73months |
| Geometric Mean Titer(GMT) at 28 days after the 2nd vaccination(1month) | 2 months |
| The Antibody Seroconversion Rates by fluorescent antibody test at 28 days after the 3rd vaccination(2month) | 3 months |
| Geometric Mean Titer(GMT) at 28 days after the 4th vaccination(13month) | 14 months |
| Geometric Mean Titer(GMT) at 2, 4, 12, 24, 36, 48, 60 after the 4th vaccination(13month) | 15, 17, 25, 37, 49, 61, 73months |
| The Antibodies retention duration per the neutralizing antibody test | 5 years |
| The Antibodies retention duration per the fluorescent antibody test | 5 years |
| Geometric Mean Titer(GMT) at 28 days after the 3rd vaccination(2month) | 3 months |
Outcome results
None listed