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

Green Cross Corporation

Status and phase

Completed

Phase 3

Conditions

Infection

Treatments

Drug: Hantavax injection

Study type

Interventional

Funder types

Industry

Identifiers

NCT02360514

HTV_P3

Details and patient eligibility

About

This study was aimed evaluate long-term immunity response by neutralizing antibody test of adults in high risk population of HFRS .

Full description

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.

Enrollment

226 patients

Sex

All

Ages

19 to 75 years old

Volunteers

Accepts Healthy Volunteers

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