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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02553837
• Other study ID #: GC3101B_P3
• Status: Active, not recruiting
• Phase: Phase 3
• First received: September 13, 2015
• Last updated: January 31, 2016
• Start date: November 2015
• Est. completion date: July 2022

Study information

• Verified date: September 2015
• Source: Green Cross Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 317
• Est. completion date: July 2022
• Est. primary completion date: August 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Healthy

Intervention

Biological:
• Hantavax injection
A single 0.5mL dose intramuscular or subcutaneous injection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Green Cross Corporation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Antibody Seroconversion rates by neutralizing antibody test at 28 days after the 3rd vaccination(2month)		3 months	No
Secondary	The Antibody Seroconversion Rates by fluorescent antibody test at 28 days after the 3rd vaccination(2month)		3 months	No
Secondary	The Antibody Seroconversion Rates by neutralizing antibody test and fluorescent antibody test at 28 days after the 2nd vaccination(1month)		2 months	No
Secondary	The Antibody Seroconversion Rates by neutralizing antibody test and fluorescent antibody test at 28 days after the 4th vaccination(13month)		14 months	No
Secondary	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)		15, 17, 25, 37, 49, 61, 73months	No
Secondary	Geometric Mean Titer(GMT) at 28 days after the 2nd vaccination(1month)		2 months	No
Secondary	Geometric Mean Titer(GMT) at 28 days after the 3rd vaccination(2month)		3 months	No
Secondary	Geometric Mean Titer(GMT) at 28 days after the 4th vaccination(13month)		14 months	No
Secondary	Geometric Mean Titer(GMT) at 2, 4, 12, 24, 36, 48, 60 after the 4th vaccination(13month)		15, 17, 25, 37, 49, 61, 73months	No
Secondary	The Antibodies retention duration per the neutralizing antibody test		5 years	No
Secondary	The Antibodies retention duration per the fluorescent antibody test		5 years	No

External Links

•   Genetic and Rare Diseases Information Center resources: Hantavirus Pulmonary Syndrome Hemorrhagic FeverViral Hemorrhagic Fever U.S. FDA Resources