Back to resultsProtectivity and Safety Following Recombinant Hepatitis B Vaccine
Primary Purpose
Immunogenicity
Status
Completed
Phase
Phase 2
Locations
Indonesia
Study Type
Interventional
Intervention
Recombinant Hepatitis B vaccine
Recombinant Hepatitis B (Bio Farma)
Sponsored by
About this trial
This is an interventional prevention trial for Immunogenicity
Eligibility Criteria
Inclusion Criteria:
- Healthy individu as determined by clinical judgment, including a medical history and physical exam which confirms the absence of a current or past disease state considered significant by the investigator.
- Subjects/parents/guardian(s) have been informed properly regarding the study and signed the informed consent form/ informed assent form.
- Subject/parents/guardian(s) will commit to comply with the instructions of the investigator and the schedule of the trial.
Exclusion Criteria:
- Subject concomitantly enrolled or scheduled to be enrolled in another trial.
- Subjects with known history of Hepatitis B contained vaccination in the last 10 years
- Evolving severe illness and/or chronic disease and fever (axillary temperature more than37.5oC) within the 48 hours preceding enrollment.
- Known history of allergy to any component of the vaccines (based on anamnesis)
- HBsAg positive
- Known history of immunodeficiency disorder (HIV infection, leukemia, lymphoma, or malignancy).
- History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection.
- Subject who has received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products or corticosteroid therapy and other immunosuppresant.
- Pregnancy & Lactation (Adult)
- Subject already immunized with any vaccine within 4 weeks prior and expects to receive other vaccines within 4 weeks following immunization.
Sites / Locations
- RSND
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Arm Label
Hep B Batch 1
Hep B Batch 2
Hep B Batch 3
Hep B (Bio Farma)
Arm Description
1 dose of 1 mL Hepatitis B Batch 1
1 dose of 1 mL Hepatitis B Batch 2
1 dose of 1 mL Hepatitis B Batch 3
1 dose of 1 mL Hepatitis B (Bio Farma)
Outcomes
Primary Outcome Measures
Percentage of subjects with increasing antibody titer >= 4 times
Percentage of subjects with increasing antibody titer >= 4 times: in all subjects; comparison between investigational product and control and between each lot number of Recombinant Hepatitis B
Secondary Outcome Measures
Geometric Mean Titer (GMT)
GMT in all subjects; comparison of GMT between investigational products and control and comparison of GMT between each lot number of Recombinant Hepatitis B
Percentage of subjects with transition of seronegative to seropositive
Percentage of subjects with transition of seronegative to seropositive: in all subjects; Subjets which get investigational products and control and each lot number of Recombinant Hepatitis B
Percentage of subjects with at least one immediate reaction
Immediate reaction (local reaction or systemic event)
Percentage of subjects with at least one of these adverse events
At least one of these adverse events, expected or not
Serious adverse event after vaccination
Serious adverse event occurring from inclusion until 28 days after vaccination.
Comparison adverse events between Investigational Products (Hepatitis B) and Control
Adverse events occuring until 28 days after vaccination
Comparison of adverse events between each lot number of Recombinant Hepatitis B vaccine
Adverse events occuring until 28 days after vaccination
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03919578
Brief Title
Protectivity and Safety Following Recombinant Hepatitis B Vaccine
Official Title
Protectivity and Safety Following Recombinant Hepatitis B Vaccine With Different Source of Hepatitis B Bulk Compared to Hepatitis B (Bio Farma) Vaccine in Indonesian Population
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
September 11, 2019 (Actual)
Primary Completion Date
January 30, 2020 (Actual)
Study Completion Date
February 28, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PT Bio Farma
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Protectivity and Safety Following Recombinant Hepatitis B Vaccine with different source of Hepatitis B bulk compared to Hepatitis B (Bio Farma) vaccine in Indonesian Population
Detailed Description
Protectivity and Safety Following Recombinant Hepatitis B Vaccine with different source of Hepatitis B bulk compared to Hepatitis B (Bio Farma) vaccine in Indonesian Population.
Experimental, randomized, double blind, four arm parallel group study, lot to lot consistency study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immunogenicity
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Experimental, randomized, double blind, four arm parallel group study
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Investigational product was masking with control
Allocation
Randomized
Enrollment
536 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hep B Batch 1
Arm Type
Experimental
Arm Description
1 dose of 1 mL Hepatitis B Batch 1
Arm Title
Hep B Batch 2
Arm Type
Experimental
Arm Description
1 dose of 1 mL Hepatitis B Batch 2
Arm Title
Hep B Batch 3
Arm Type
Experimental
Arm Description
1 dose of 1 mL Hepatitis B Batch 3
Arm Title
Hep B (Bio Farma)
Arm Type
Active Comparator
Arm Description
1 dose of 1 mL Hepatitis B (Bio Farma)
Intervention Type
Biological
Intervention Name(s)
Recombinant Hepatitis B vaccine
Intervention Description
Recombinant Hepatitis B vaccine is an inactivated HbsAg produced in yeast cells (Hansenula polymorpha) using recombinant DNA technology. It is a whitish liquid produced by culture genetically engineered yeast cell which carry the relevant gene of the HbsAg. The inactivated HbsAg (bulk) is imported from Serum Institute of India and then formulated and filled at Bio Farma.
Intervention Type
Biological
Intervention Name(s)
Recombinant Hepatitis B (Bio Farma)
Intervention Description
Recombinant Hepatitis B vaccine is an inactivated HbsAg produced in yeast cells (Hansenula polymorpha) using recombinant DNA technology. It is a whitish liquid produced by culture genetically engineered yeast cell which carry the relevant gene of the HbsAg. The inactivated HbsAg (bulk) is imported from The Janssen Vaccine Corp and then formulated and filled at Bio Farma.
Primary Outcome Measure Information:
Title
Percentage of subjects with increasing antibody titer >= 4 times
Description
Percentage of subjects with increasing antibody titer >= 4 times: in all subjects; comparison between investigational product and control and between each lot number of Recombinant Hepatitis B
Time Frame
28 days after the last dose immunization
Secondary Outcome Measure Information:
Title
Geometric Mean Titer (GMT)
Description
GMT in all subjects; comparison of GMT between investigational products and control and comparison of GMT between each lot number of Recombinant Hepatitis B
Time Frame
28 days after the last dose immunization
Title
Percentage of subjects with transition of seronegative to seropositive
Description
Percentage of subjects with transition of seronegative to seropositive: in all subjects; Subjets which get investigational products and control and each lot number of Recombinant Hepatitis B
Time Frame
28 days after the last dose immunization
Title
Percentage of subjects with at least one immediate reaction
Description
Immediate reaction (local reaction or systemic event)
Time Frame
30 minutes after each vaccination
Title
Percentage of subjects with at least one of these adverse events
Description
At least one of these adverse events, expected or not
Time Frame
within 72 hours, between 72 hours to 28 days after vaccination
Title
Serious adverse event after vaccination
Description
Serious adverse event occurring from inclusion until 28 days after vaccination.
Time Frame
28 days after the last dose immunization
Title
Comparison adverse events between Investigational Products (Hepatitis B) and Control
Description
Adverse events occuring until 28 days after vaccination
Time Frame
28 days after each dose
Title
Comparison of adverse events between each lot number of Recombinant Hepatitis B vaccine
Description
Adverse events occuring until 28 days after vaccination
Time Frame
28 days after each dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy individu as determined by clinical judgment, including a medical history and physical exam which confirms the absence of a current or past disease state considered significant by the investigator.
Subjects/parents/guardian(s) have been informed properly regarding the study and signed the informed consent form/ informed assent form.
Subject/parents/guardian(s) will commit to comply with the instructions of the investigator and the schedule of the trial.
Exclusion Criteria:
Subject concomitantly enrolled or scheduled to be enrolled in another trial.
Subjects with known history of Hepatitis B contained vaccination in the last 10 years
Evolving severe illness and/or chronic disease and fever (axillary temperature more than37.5oC) within the 48 hours preceding enrollment.
Known history of allergy to any component of the vaccines (based on anamnesis)
HBsAg positive
Known history of immunodeficiency disorder (HIV infection, leukemia, lymphoma, or malignancy).
History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection.
Subject who has received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products or corticosteroid therapy and other immunosuppresant.
Pregnancy & Lactation (Adult)
Subject already immunized with any vaccine within 4 weeks prior and expects to receive other vaccines within 4 weeks following immunization.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yetty M Nency, MD
Organizational Affiliation
Universitas Diponegoro
Official's Role
Principal Investigator
Facility Information:
Facility Name
RSND
City
Semarang
State/Province
Central Java
Country
Indonesia
12. IPD Sharing Statement
Plan to Share IPD
No
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Protectivity and Safety Following Recombinant Hepatitis B Vaccine
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