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

Green Cross Corporation226 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

226

Conditions

Infection

Interventions

Hantavax injectionDRUG

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

Eligibility

Sex: ALLMin age: 19 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Antibody seroconversion rates at 1 month after the booster vaccination and its retention rates

Time frame: 13 months

Secondary Outcomes

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

Time frame: 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

Time frame: 13 months

The antibody titers by neutralizing antibody test and fluorescent antibody technique

Time frame: 13 months

Number of adverse events after vaccination of Hantavax to adults in high risk population.

Time frame: 3 years

Data from ClinicalTrials.gov

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