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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02360514
Recruitment Status : Completed
First Posted : February 10, 2015
Last Update Posted : February 10, 2015
Information provided by (Responsible Party):
Green Cross Corporation

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

Condition or disease Intervention/treatment Phase
Infection Drug: Hantavax injection Phase 3

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 226 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Study Start Date : December 2007
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Arm Intervention/treatment
Experimental: hantaan virus vaccine Drug: Hantavax injection
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

Primary Outcome Measures :
  1. Antibody seroconversion rates at 1 month after the booster vaccination and its retention rates [ Time Frame: 13 months ]

Secondary Outcome Measures :
  1. The antibody seroconversion rates and its retension rates by neutralizing antibody test [ Time Frame: 13 months ]
    After vaccination (2 times) and booster vaccination (1 time) of Hantavax to adults in high risk population

  2. The antibody seroconversion rates and its retension rates by fluorescent antibody technique [ Time Frame: 13 months ]
    After vaccination (2 times) and booster vaccination (1 time) of Hantavax to adults in high risk population

  3. The antibody titers by neutralizing antibody test and fluorescent antibody technique [ Time Frame: 13 months ]
  4. Number of adverse events after vaccination of Hantavax to adults in high risk population. [ Time Frame: 3 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Responsible Party: Green Cross Corporation Identifier: NCT02360514     History of Changes
Other Study ID Numbers: HTV_P3
First Posted: February 10, 2015    Key Record Dates
Last Update Posted: February 10, 2015
Last Verified: February 2015

Additional relevant MeSH terms:
Hemorrhagic Fever with Renal Syndrome
Hantavirus Infections
Bunyaviridae Infections
RNA Virus Infections
Virus Diseases
Hemorrhagic Fevers, Viral