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Completed

NCT Number: NCT02360514

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

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

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Key information

Conditions

Infection Infections

Age range

19 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hantavax injection

Drug

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 outcomes

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

    Time frame: 13 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Green Cross Corporation

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
Feb 10, 2015
Registry last updated
Feb 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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