Infection Clinical Trial
Official title:
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
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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