Study to Evalutate Long-term Immunity of Hantavax in High Risk Population of HFRS

Study Overview
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Brief Summary
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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 .

Detailed Description
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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.

Official Title
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Non-comparable and Open Clinical Research to Evaluate Long-term Immunity by Neutralizing Antibody Test of Adults in High Risk Population of HFRS (Hemorrhagic Fever With Renal Syndrome) After Vaccination and Booster Vaccination of Hantavax

Conditions
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Infection

Intervention / Treatment
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* Drug: Hantavax injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The subjects who have the vaccination history of ah the time of screening The subjects whose Hantaan virus virus's antibody shows negative using Neutralizing antibody test at the time of screening Exclusion Criteria: The subjects who have a history of hemorrhagic fever with renal syndrome The subjects who have a fever or significant dystrophy

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: hantaan virus vaccine<br> | Drug: Hantavax injection<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibody seroconversion rates at 1 month after the booster vaccination and its retention rates |  | 13 months | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |