ImmunogenicityPhase 2/3NCT03919578
Protectivity and Safety Following Recombinant Hepatitis B Vaccine
A Phase 2/3 study testing Recombinant Hepatitis B vaccine and Recombinant Hepatitis B (Bio Farma) in people with Immunogenicity, run by PT Bio Farma at 1 site in Indonesia.
Trial 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 Read more about this study
- Who is it for?
- Ages 10 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Immunogenicity
- What is being tested?
- Recombinant Hepatitis B vaccine and Recombinant Hepatitis B (Bio Farma)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 536 participants
- Where
- 1 siteIndonesia
- Study dates
- 11 Sep 2019to 28 Feb 2020
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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.
- Conditions
- Immunogenicity
- Being tested
- Recombinant Hepatitis B vaccine, Recombinant Hepatitis B (Bio Farma)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Hepatitis B vaccineBiological
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.
Recombinant Hepatitis B (Bio Farma)Biological
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.
| Study group | Role | What they receive |
|---|---|---|
| Hep B Batch 1 | Experimental | 1 dose of 1 mL Hepatitis B Batch 1 Receives: Biological: Recombinant Hepatitis B vaccine |
| Hep B Batch 2 | Experimental | 1 dose of 1 mL Hepatitis B Batch 2 Receives: Biological: Recombinant Hepatitis B vaccine |
| Hep B Batch 3 | Experimental | 1 dose of 1 mL Hepatitis B Batch 3 Receives: Biological: Recombinant Hepatitis B vaccine |
| Hep B (Bio Farma) | Active comparator | 1 dose of 1 mL Hepatitis B (Bio Farma) Receives: Biological: Recombinant Hepatitis B (Bio Farma) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 28 days after the last dose immunization
Secondary outcomes (7)
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
Measured: 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
Measured: 28 days after the last dose immunization
Percentage of subjects with at least one immediate reaction
Immediate reaction (local reaction or systemic event)
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 28 days after each dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2019
- Study start11 Sep 2019
- Primary completion30 Jan 2020
- Study completion28 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ImmunogenicityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experimental, randomized, double blind, four arm parallel group study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 536 participants (actual)
Sponsor and investigators
- Lead sponsor
- PT Bio Farma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yetty M Nency, MD, Principal investigator, Universitas Diponegoro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03919578
- Sponsor's protocol ID
- Hep B 0218
- Status last verified
- Sep 2022
- First submitted
- 11 Apr 2019
- Last updated
- 19 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03919578
- Acronym / sponsor ID
- Hep B 0218
- Conditions
- Immunogenicity
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 536 participants (actual)
- Lead sponsor
- PT Bio FarmaIndustry (pharma, biotech, devices)
- Study start
- 11 Sep 2019 (actual)
- Primary completion
- 30 Jan 2020 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 18 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Experimental, randomized, double blind, four arm parallel group study
| Arm | Type | Receives |
|---|---|---|
| Hep B Batch 1 | Experimental | Biological: Recombinant Hepatitis B vaccine1 dose of 1 mL Hepatitis B Batch 1 |
| Hep B Batch 2 | Experimental | Biological: Recombinant Hepatitis B vaccine1 dose of 1 mL Hepatitis B Batch 2 |
| Hep B Batch 3 | Experimental | Biological: Recombinant Hepatitis B vaccine1 dose of 1 mL Hepatitis B Batch 3 |
| Hep B (Bio Farma) | Active comparator | Biological: Recombinant Hepatitis B (Bio Farma)1 dose of 1 mL Hepatitis B (Bio Farma) |
Who may qualify
- Ages
- 10 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recombinant Hepatitis B vaccineRecombinant 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. | Biological | Hep B Batch 1, Hep B Batch 2, Hep B Batch 3 |
| Recombinant 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. | Biological | Hep B (Bio Farma) |
Primary outcome
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
7 secondary outcomes
Geometric Mean Titer (GMT)
Time frame: 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 at least one immediate reaction
Time frame: 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
Serious adverse event after vaccination
Time frame: 28 days after the last dose immunization
Comparison adverse events between Investigational Products (Hepatitis B) and Control
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yetty M Nency, MD principal investigator
Universitas Diponegoro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Recombinant Hepatitis B vaccine and Recombinant Hepatitis B (Bio Farma) in people with Immunogenicity, run by PT Bio Farma at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of subjects with increasing antibody titer >= 4 times (time frame: 28 days after the last dose immunization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2022.