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Study to Evaluate the Immunogenicity and Safety of Hantavax in Healthy Adult

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ClinicalTrials.gov Identifier: NCT02553837
Recruitment Status : Active, not recruiting
First Posted : September 18, 2015
Last Update Posted : February 2, 2016
Sponsor:
Information provided by (Responsible Party):
Green Cross Corporation

Brief Summary:
This study was aimed to evaluate the Immunogenicity and Safety response by vaccinating Hantavax in Healthy Adult.

Condition or disease Intervention/treatment Phase
Healthy Biological: Hantavax injection Phase 3

Detailed Description:

This clinical trial was designed as a multicenter, non-comparative, open-label clinical trial. This trial was conducted, written informed consent form by voluntary agreement, the subjects who have not had the hantavax vaccination history at the time of screening. Investigator product was administrated 0, 1, 2, 13 months.

For antibody test, Sampling was conducted pre-dose(T0), 28 days after the 2nd vaccination(before the 3rd vaccination, T1), 28 days after the 3rd vaccination(T2) and 11 months after the 3rd vaccination(before booster vaccination, T3), 28 days after the booster vaccination(T4), 2 months after the booster vaccination(T5) and 4 months after the booster vaccination(T6). Also, after the completion of booster vaccination for antibody retention duration observed for subjects with antibody to conduct a five-year follow-up survey was conducted, and the antibody test every year. In conclusion, sampling was conducted 12 months(T7), 24 months(T8), 36months(T9), 48 months(T10), 60 months(T11) after the booster vaccination.

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)
Estimated Enrollment : 317 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Study to Evaluate the Immunogenicity and Safety of Hantavax in Healthy Adult
Study Start Date : November 2015
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : July 2022

Arm Intervention/treatment
Experimental: Treatment only
Drug: Hantavax injectionSchedule: The basic vaccination(0, 1, 2months) and The boost vaccination(13months)
Biological: Hantavax injection
A single 0.5mL dose intramuscular or subcutaneous injection




Primary Outcome Measures :
  1. The Antibody Seroconversion rates by neutralizing antibody test at 28 days after the 3rd vaccination(2month) [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. The Antibody Seroconversion Rates by fluorescent antibody test at 28 days after the 3rd vaccination(2month) [ Time Frame: 3 months ]
  2. The Antibody Seroconversion Rates by neutralizing antibody test and fluorescent antibody test at 28 days after the 2nd vaccination(1month) [ Time Frame: 2 months ]
  3. The Antibody Seroconversion Rates by neutralizing antibody test and fluorescent antibody test at 28 days after the 4th vaccination(13month) [ Time Frame: 14 months ]
  4. The Antibody Seroconversion Rates by neutralizing antibody test and fluorescent antibody test at 2 , 4, 12, 24, 36, 48, 60months after the 4th vaccination(13month) [ Time Frame: 15, 17, 25, 37, 49, 61, 73months ]
  5. Geometric Mean Titer(GMT) at 28 days after the 2nd vaccination(1month) [ Time Frame: 2 months ]
  6. Geometric Mean Titer(GMT) at 28 days after the 3rd vaccination(2month) [ Time Frame: 3 months ]
  7. Geometric Mean Titer(GMT) at 28 days after the 4th vaccination(13month) [ Time Frame: 14 months ]
  8. Geometric Mean Titer(GMT) at 2, 4, 12, 24, 36, 48, 60 after the 4th vaccination(13month) [ Time Frame: 15, 17, 25, 37, 49, 61, 73months ]
  9. The Antibodies retention duration per the neutralizing antibody test [ Time Frame: 5 years ]
  10. The Antibodies retention duration per the fluorescent antibody test [ Time Frame: 5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy adults ≥ 19years old.
  • Subjects who have not the hantavax vaccination history at the time of screening.

Exclusion Criteria:

  • Subject who did not passed by 2 weeks after recovering the acute disease.
  • immunologic dysfunction subjects.
  • Subjects previously treated with anti-coagulant therapy or hemophiliac patients.
  • Subjects with severe chronic diseases.
  • Subjects who had an acute before vaccinating IP.
  • Subjects who had received another vaccination during the 28 days before vaccinating IP or who were scheduled for another vaccination during the study.
  • Subjects who were receiving immunosuppressant or immune modifying drug
  • Subjects who had been administered immunoglobulins or blood-derived products 3 months before vaccinating IP or who were scheduled for the administration during the study.
  • Subjects of childbearing potential at the time of screening and were scheduled to pregnancy for the study. A female subject who was pregnant or who was breast-feeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02553837


Sponsors and Collaborators
Green Cross Corporation
Investigators
Principal Investigator: Woo Joo Kim, MD Korea University Guro Hospital

Additional Information:
Responsible Party: Green Cross Corporation
ClinicalTrials.gov Identifier: NCT02553837     History of Changes
Other Study ID Numbers: GC3101B_P3
First Posted: September 18, 2015    Key Record Dates
Last Update Posted: February 2, 2016
Last Verified: September 2015

Keywords provided by Green Cross Corporation:
Healthy Volunteers