Hepatitis BPhase 1NCT04188223
Safety and Immunogenicity Following Recombinant Hepatitis B (Bio Farma) Vaccine in Adults & Children
A Phase 1 study testing Recombinant Hepatitis B (Bio Farma) Vaccine and Recombinant Hepatitis B (Bio Farma) Vaccine® in people with Hepatitis B, run by PT Bio Farma at 1 site in Indonesia.
Trial summary
This trial is an experimental, randomized, double blind, prospective intervention study Approximately 100 subjects will be enrolled in this trial, divided into 2 arms, as follow: For adult (18-40 years old) Read more about this study
- Who is it for?
- Ages 10 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B
- What is being tested?
- Recombinant Hepatitis B (Bio Farma) Vaccine and Recombinant Hepatitis B (Bio Farma) Vaccine®
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIndonesia
- Study dates
- 3 Dec 2019to 16 Jul 2020
- Phase
- Phase 1
- 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
- Adult
- Healthy individu as determined by clinical judgment, including a medical history, physical exam, rontgen thorax and laboratory results, which confirms the absence of a current or past disease state considered significant by the investigator.
- Subjects have been informed properly regarding the study and signed the informed consent form
- Subjects will commit to comply with the instructions of the investigator and the schedule of the trial
- Children:
- Healthy individu as determined by clinical judgment, including a medical history, physical exam and rontgen thorax 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 and
- 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
- Any direct relatives relationship with the study team.
- Evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature ³ 37.5°C) within the 48 hours preceding enrollment.
- Known history of allergy to any component of the vaccines (based on anamnesis)
- Known history of immunodeficiency disorder (HIV infection, leukemia, lymphoma, or malignancy)
- History of uncontrolled coagulopathy or blood disorders contraindicating for phlebotomy.
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- 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).
- Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives.
- Pregnancy or planning a pregnancy within the next 3 months \& lactation. (for Adults)
- Subject already immunized with any vaccine within 4 weeks prior and expects to receive other vaccines within 4 weeks following immunization.
- HbsAg positive
- Subjects with known history of Hepatitis B infection.
- Subjects who have received Hepatitis B vaccination which proven by vaccination records.
- Subject planning to move from the study area before the end of study period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Preliminary of Immunogenicity Following Recombinant Hepatitis B (Bio Farma) Vaccine in Adults & Children (Phase I)
This trial is an experimental, randomized, double blind, prospective intervention study
Approximately 100 subjects will be enrolled in this trial, divided into 2 arms, as follow:
For adult (18-40 years old)
Read the detailed description
Each study age group/arm will be divided into two groups of treatment. One group will receive investigational product and one other group will receive active comparator. This Study is sequential age de-escalation. To be conducted in heathy adults (18-40 years old) and followed by children (10-17 years old) ). Before the study started, the subjects will be assessed for anti HBs Antibody. For subjects with anti-HBs not protective (< 10mIU/mL) before immunization, additional 2 doses will be required with 1 month interval.
- Conditions
- Hepatitis B
- Being tested
- Recombinant Hepatitis B (Bio Farma) Vaccine, Recombinant Hepatitis B (Bio Farma) Vaccine®
- Keywords
- vaccine, hepatitis b, infection, virus
- Medical subject headings
- Hepatitis B, Infections, Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Hepatitis B (Bio Farma) VaccineBiological
Recombinant Hepatitis B vaccine produced by Bio Farma
Recombinant Hepatitis B (Bio Farma) Vaccine®Biological
Registered Recombinant Hepatitis B vaccine produced by Bio Farma
| Study group | Role | What they receive |
|---|---|---|
| Recombinant Hepatitis B (Bio Farma) Vaccine | Experimental | 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 and purified and inactivated by several physicochemical steps such as ultracentrifugation, column chromatography and formaldehyde treatment. Receives: Biological: Recombinant Hepatitis B (Bio Farma) Vaccine |
| Control Product: Recombinant Hepatitis B (Bio Farma) Vaccine® | Active comparator | Registered 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 and purified and inactivated by several physicochemical steps such as ultracentrifugation, column chromatography and formaldehyde treatment. Receives: Biological: Recombinant Hepatitis B (Bio Farma) Vaccine® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with Immediate reaction
Number of subjects with at least one immediate reaction (local reaction or systemic event) within 30 minutes after one dose or three doses of Hepatits B vaccination
Measured: 3 months
percentage of subjects with Immediate reaction
Percentage of subjects with at least one immediate reaction (local reaction or systemic event) within 30 minutes after one dose or three doses of Hepatits B vaccination
Measured: 3 months
Secondary outcomes (10)
Number of subjects with Adverse Events from 1 day to 28 days after vaccination
Number of subjects with at least one of these adverse events, solicited or not, within 24 h, 48h, 72h and 28 days after each dose vaccination
Measured: 3 months
Percentage of subjects with Adverse Events from 1 day to 28 days after vaccination
Percentage of subjects with at least one of these adverse events, solicited or not, within 24 h, 48h, 72h and 28 days after each dose vaccination
Measured: 3 months
Number of subjects with Serious Adverse Events from 1 day to 28 days after vaccination
Number of subjects with serious adverse event from inclusion until 28 day after each dose vaccination.
Measured: 3 Months
Percentage of subjects with serious Adverse Events from 1 day to 28 days after vaccination
Percentage of subjects with serious adverse event from inclusion until 28 day after each dose vaccination.
Measured: 3 Months
Number of Lab Deviation for adults subjects in 7 days of immunization
Number of deviation from routine biochemical (SGOT, SGPT, Ureum, Creatinine) and Hematological (Hb, Hct, Dif, Leucocyte count, Total Leucocyte, total Eryhrocyte, total Thrombocyte) laboratory evaluation that probably related to the vaccination (adults subject).
Measured: 7 Days After 1st Vaccination
Safety Comparison between each intervention group
incidence of any adverse event, compared between two intervention arms
Measured: 3 months
Protectivity of Hepatitis B vaccine (number of subject with protective anti HbsAg)
Number of subjects with anti-HbsAg more than 10mIU/ml, 28 days after 1 dose or three doses of vaccination.
Measured: 3 months
Protectivity of Hepatitis B vaccine (4 times increasing antibody)
- Number and percentage of subjects with more than 4 folds increasing antibody
Measured: 3 months
Protectivity of Hepatitis B vaccine (Geometic Mean Titers)
- Geometric Mean Titers (GMT) following immunization
Measured: 3 months
Anti-HBs description between groups
Number of subjects with protective Anti-HBs value, compared between intervention groups after vaccination.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2019
- Study start3 Dec 2019
- Primary completion16 Jul 2020
- Study completion16 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis BStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- This Study is sequential age de-escalation. To be conducted in heathy adults (18-40 years old) and followed by children (10-17 years old) )
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- PT Bio Farma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kusnandi Rusmil, Professor, Principal investigator, Padjadjaran University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04188223
- Sponsor's protocol ID
- Hep B 0119
- Status last verified
- Jul 2022
- First submitted
- 27 Nov 2019
- Last updated
- 1 Aug 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 1 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Preliminary of Immunogenicity Following Recombinant Hepatitis B (Bio Farma) Vaccine in Adults & Children (Phase I)
- ClinicalTrials.gov ID
- NCT04188223
- Acronym / sponsor ID
- Hep B 0119
- Conditions
- Hepatitis B
- Keywords
- vaccine, hepatitis b, infection, virus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- PT Bio FarmaIndustry (pharma, biotech, devices)
- Study start
- 3 Dec 2019 (actual)
- Primary completion
- 16 Jul 2020 (actual)
- Study completion
- 16 Jul 2020 (actual)
- First posted
- 5 Dec 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.
This trial is an experimental, randomized, double blind, prospective intervention study
Approximately 100 subjects will be enrolled in this trial, divided into 2 arms, as follow:
For adult (18-40 years old)
Detailed description
Each study age group/arm will be divided into two groups of treatment. One group will receive investigational product and one other group will receive active comparator. This Study is sequential age de-escalation. To be conducted in heathy adults (18-40 years old) and followed by children (10-17 years old) ). Before the study started, the subjects will be assessed for anti HBs Antibody. For subjects with anti-HBs not protective (< 10mIU/mL) before immunization, additional 2 doses will be required with 1 month interval.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This Study is sequential age de-escalation. To be conducted in heathy adults (18-40 years old) and followed by children (10-17 years old) )
| Arm | Type | Receives |
|---|---|---|
| Recombinant Hepatitis B (Bio Farma) Vaccine | Experimental | Biological: Recombinant Hepatitis B (Bio Farma) 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 and purified and inactivated by several physicochemical steps such as ultracentrifugation, column chromatography and formaldehyde treatment. |
| Control Product: Recombinant Hepatitis B (Bio Farma) Vaccine® | Active comparator | Biological: Recombinant Hepatitis B (Bio Farma) Vaccine®Registered 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 and purified and inactivated by several physicochemical steps such as ultracentrifugation, column chromatography and formaldehyde treatment. |
Who may qualify
- Ages
- 10 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Adult
- Healthy individu as determined by clinical judgment, including a medical history, physical exam, rontgen thorax and laboratory results, which confirms the absence of a current or past disease state considered significant by the investigator.
- Subjects have been informed properly regarding the study and signed the informed consent form
- Subjects will commit to comply with the instructions of the investigator and the schedule of the trial
- Healthy individu as determined by clinical judgment, including a medical history, physical exam and rontgen thorax which confirms the absence of a current or past disease state considered significant by the investigator.
Key exclusion criteria (14 listed)
- Subject concomitantly enrolled or scheduled to be enrolled in another trial
- Any direct relatives relationship with the study team.
- Evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature ³ 37.5°C) within the 48 hours preceding enrollment.
- Known history of allergy to any component of the vaccines (based on anamnesis)
- Known history of immunodeficiency disorder (HIV infection, leukemia, lymphoma, or malignancy)
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 (Bio Farma) VaccineRecombinant Hepatitis B vaccine produced by Bio Farma | Biological | Recombinant Hepatitis B (Bio Farma) Vaccine |
| Recombinant Hepatitis B (Bio Farma) Vaccine®Registered Recombinant Hepatitis B vaccine produced by Bio Farma | Biological | Control Product: Recombinant Hepatitis B (Bio Farma) Vaccine® |
Primary outcome
Number of subjects with Immediate reaction
Time frame: 3 months
Number of subjects with at least one immediate reaction (local reaction or systemic event) within 30 minutes after one dose or three doses of Hepatits B vaccination
percentage of subjects with Immediate reaction
Time frame: 3 months
Percentage of subjects with at least one immediate reaction (local reaction or systemic event) within 30 minutes after one dose or three doses of Hepatits B vaccination
10 secondary outcomes
Number of subjects with Adverse Events from 1 day to 28 days after vaccination
Time frame: 3 months
Percentage of subjects with Adverse Events from 1 day to 28 days after vaccination
Time frame: 3 months
Number of subjects with Serious Adverse Events from 1 day to 28 days after vaccination
Time frame: 3 Months
Percentage of subjects with serious Adverse Events from 1 day to 28 days after vaccination
Time frame: 3 Months
Number of Lab Deviation for adults subjects in 7 days of immunization
Time frame: 7 Days After 1st Vaccination
Safety Comparison between each intervention group
Time frame: 3 months
Protectivity of Hepatitis B vaccine (number of subject with protective anti HbsAg)
Time frame: 3 months
Protectivity of Hepatitis B vaccine (4 times increasing antibody)
Time frame: 3 months
Protectivity of Hepatitis B vaccine (Geometic Mean Titers)
Time frame: 3 months
Anti-HBs description between groups
Time frame: 3 months
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 1 Aug 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.
Kusnandi Rusmil, Professor principal investigator
Padjadjaran University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Recombinant Hepatitis B (Bio Farma) Vaccine and Recombinant Hepatitis B (Bio Farma) Vaccine® in people with Hepatitis B, 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 8 inclusion and 14 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 1 Aug 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 phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Number of subjects with Immediate reaction (time frame: 3 months). The study lists 2 primary outcomes in all. 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 1 Aug 2022.