Protectivity and Safety Following Recombinant Hepatitis B Vaccine
September 15, 2022 updated by: PT Bio Farma
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
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 Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
536
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Central Java
-
Semarang, Central Java, Indonesia
- RSND
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years to 40 years (ADULT, CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Hep B Batch 1
1 dose of 1 mL Hepatitis B Batch 1
|
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.
|
|
EXPERIMENTAL: Hep B Batch 2
1 dose of 1 mL Hepatitis B Batch 2
|
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.
|
|
EXPERIMENTAL: Hep B Batch 3
1 dose of 1 mL Hepatitis B Batch 3
|
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.
|
|
ACTIVE_COMPARATOR: Hep B (Bio Farma)
1 dose of 1 mL Hepatitis B (Bio Farma)
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage of subjects with increasing antibody titer >= 4 times
Time Frame: 28 days after the last dose immunization
|
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 |
|---|---|---|
|
Percentage of subjects with at least one immediate reaction
Time Frame: 30 minutes after each vaccination
|
Immediate reaction (local reaction or systemic event)
|
30 minutes after each vaccination
|
|
Percentage of subjects with at least one of these adverse events
Time Frame: within 72 hours, between 72 hours to 28 days after vaccination
|
At least one of these adverse events, expected or not
|
within 72 hours, between 72 hours to 28 days after vaccination
|
|
Geometric Mean Titer (GMT)
Time Frame: 28 days after the last dose immunization
|
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
Time Frame: 28 days after the last dose immunization
|
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
|
|
Serious adverse event after vaccination
Time Frame: 28 days after the last dose immunization
|
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
Time Frame: 28 days after each dose
|
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
Time Frame: 28 days after each dose
|
Adverse events occuring until 28 days after vaccination
|
28 days after each dose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Yetty M Nency, MD, Universitas Diponegoro
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
September 11, 2019
Primary Completion (ACTUAL)
January 30, 2020
Study Completion (ACTUAL)
February 28, 2020
Study Registration Dates
First Submitted
April 11, 2019
First Submitted That Met QC Criteria
April 15, 2019
First Posted (ACTUAL)
April 18, 2019
Study Record Updates
Last Update Posted (ACTUAL)
September 19, 2022
Last Update Submitted That Met QC Criteria
September 15, 2022
Last Verified
September 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Hep B 0218
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.