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This study was aimed evaluate long-term immunity response by neutralizing antibody test of adults in high risk population of HFRS .
This clinical trial was designed as a multicenter, non-comparable, open-label clinical trial.This trial was conducted written informed consent form by voluntary agreement, negative result of hantaanvirus antubidy by neutralizaing antibody test, test drug was administrated 0, 1, 13 months according to drug label.
For antibody test, Sampling was conducted pre-dose(T0), 1 month after vaccination(T1), 1 year after vaccination(before booster vaccination, T2) and 1 month after vaccination(T3). Also, 1 month after vaccination (T3) after completion of booster vaccination for antibody retension duration observed for subjects with antibody to conduct a three-year follow-up survey was conducted, and the antibody test every year.In conclusion, sampling was conducted 12 months(T4), 24 months(T5), 36months(T6) after the booster vaccionation.
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 |
|---|---|---|---|
| hantaan virus vaccine | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hantavax injection | Drug | Intramuscular or hypodermic injection of 0.5ml per time twice at interval of 1 month for adults. For more immune, inoculate muscle or subcutaneous once mor 12 months after the completion of the initial immune |
| Measure | Description | Time Frame |
|---|---|---|
| Antibody seroconversion rates at 1 month after the booster vaccination and its retention rates | 13 months |
| Measure | Description | Time Frame |
|---|---|---|
| The antibody seroconversion rates and its retension rates by neutralizing antibody test | After vaccination (2 times) and booster vaccination (1 time) of Hantavax to adults in high risk population | 13 months |
| The antibody seroconversion rates and its retension rates by fluorescent antibody technique |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D007239 | Infections |
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After vaccination (2 times) and booster vaccination (1 time) of Hantavax to adults in high risk population |
| 13 months |
| The antibody titers by neutralizing antibody test and fluorescent antibody technique | 13 months |
| Number of adverse events after vaccination of Hantavax to adults in high risk population. | 3 years |