Protectivity and Safety Following Recombinant Hepatitis B Vaccine

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Immunogenicity

Intervention / Treatment
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* Biological: Recombinant Hepatitis B vaccine
* Biological: Recombinant Hepatitis B (Bio Farma)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Experimental, randomized, double blind, four arm parallel group study
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hep B Batch 1<br>1 dose of 1 mL Hepatitis B Batch 1 | Biological: Recombinant Hepatitis B vaccine<br>* 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.<br>|
| Experimental: Hep B Batch 2<br>1 dose of 1 mL Hepatitis B Batch 2 | Biological: Recombinant Hepatitis B vaccine<br>* 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.<br>|
| Experimental: Hep B Batch 3<br>1 dose of 1 mL Hepatitis B Batch 3 | Biological: Recombinant Hepatitis B vaccine<br>* 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.<br>|
| Active Comparator: Hep B (Bio Farma)<br>1 dose of 1 mL Hepatitis B (Bio Farma) | Biological: Recombinant Hepatitis B (Bio Farma)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 28 days after the last dose immunization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 28 days after the last dose immunization | 
| 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 | 28 days after the last dose immunization | 
| Percentage of subjects with at least one immediate reaction | Immediate reaction (local reaction or systemic event) | 30 minutes after each vaccination | 
| Percentage of subjects with at least one of these adverse events | At least one of these adverse events, expected or not | within 72 hours, between 72 hours to 28 days after vaccination | 
| Serious adverse event after vaccination | Serious adverse event occurring from inclusion until 28 days after vaccination. | 28 days after the last dose immunization | 
| Comparison adverse events between Investigational Products (Hepatitis B) and Control | Adverse events occuring until 28 days after vaccination | 28 days after each dose | 
| Comparison of adverse events between each lot number of Recombinant Hepatitis B vaccine | Adverse events occuring until 28 days after vaccination | 28 days after each dose |