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This study was aimed to evaluate the Immunogenicity and Safety response by vaccinating Hantavax in Healthy Adult.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment only | Experimental | Drug: Hantavax injectionSchedule: The basic vaccination(0, 1, 2months) and The boost vaccination(13months) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hantavax injection | Biological | A single 0.5mL dose intramuscular or subcutaneous injection |
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| Measure | Description | Time Frame |
|---|---|---|
| The Antibody Seroconversion rates by neutralizing antibody test at 28 days after the 3rd vaccination(2month) | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| The Antibody Seroconversion Rates by fluorescent antibody test at 28 days after the 3rd vaccination(2month) | 3 months | |
| The Antibody Seroconversion Rates by neutralizing antibody test and fluorescent antibody test at 28 days after the 2nd vaccination(1month) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Woo Joo Kim, MD | Korea University Guro Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33131933 | Derived | Song JY, Jeong HW, Yun JW, Lee J, Woo HJ, Bae JY, Park MS, Choi WS, Park DW, Noh JY, Cheong HJ, Kim WJ. Immunogenicity and safety of a modified three-dose priming and booster schedule for the Hantaan virus vaccine (Hantavax): A multi-center phase III clinical trial in healthy adults. Vaccine. 2020 Nov 25;38(50):8016-8023. doi: 10.1016/j.vaccine.2020.10.035. Epub 2020 Oct 31. |
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| 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 |
| Geometric Mean Titer(GMT) 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 |