Hepatitis BPhase 1NCT04075201
Clinical Trial of Recombinant Hepatitis B Vaccine (Hansenula Polymorpha, 10μg)
A Phase 1 study testing One dose of investigational vaccine and Three doses of investigational vaccine in people with Hepatitis B, run by Sinovac Biotech Co., Ltd at 1 site in China.
Trial summary
The purpose of this study is to evaluate the safety and immunogenicity of the recombinant hepatitis B vaccine (Hansenula polymorpha, 10μg), with an open-labelled design in adults and randomized, double-blinded, and positive controlled design in children and neonates. Read more about this study
- Who is it for?
- Ages Up to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B
- What is being tested?
- One dose of investigational vaccine and Three doses of investigational vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteChina
- Study dates
- 7 Jul 2019to 25 Jul 2021
- 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 Up to 49 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Adults aged 18~49 years, or children aged 1~15 years, or neonates within 24 hours of birth;
- Proven legal identity;
- Participants or guardians of the participants should be capable of understanding the written consent form, and such form should be signed prior to enrollment ;
Who cannot join
- Breast feeding, pregnant, or expected to conceive in the next 60 days;
- History of allergy to any vaccine or vaccine ingredient, or serious adverse reaction(s) to vaccination, such as urticaria, difficulty in breathing, angioneurotic edema, abdominal pain, etc;
- Congenital malformation, developmental disorders, genetic defects;
- Autoimmune disease or immunodeficiency/immunosuppressive;
- Severe chronic diseases, severe cardiovascular disease, hypertension and diabetes that cannot be controlled by drugs, liver Kidney disease, malignant tumor;
- Severe nervous system disease or mental illness;
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- Asplenia or functional asplenia;
- Diagnosed coagulation function abnormal (e.g., coagulation factor deficiency, coagulation disorder, or platelet abnormalities) , or obvious bruising or coagulation disorders;
- Any immunosuppressant, cytotoxic medicine, or inhaled corticosteroids (except corticosteroid spray for treatment of allergic rhinitis or corticosteroid treatment on surface for acute non-complicated dermatitis) within 6 month prior to study entry;
- Long term history of alcoholism or drug abuse;
- Administration of blood product within 3 months prior to the entry;
- Administration of any other investigational drugs within 30 days prior to the entry;
- Receipt of any attenuated live vaccine within 14 days prior to study entry;
- Receipt of any subunit vaccine or inactivated vaccine within 7 days prior to study entry;
- Any acute disease within 7 days prior to the study entry;
- Axillaty temperature > 37.0 °C;
- Any other factor that suggesting the volunteer is unsuitable for this study based on the opinions of investigators.
- History of extra vaccination of Hepatitis B vaccine or vaccine containing hepatitis B except for the primary vaccination in the immunization planning program;
- History of allergy to any vaccine or vaccine ingredient, or serious adverse reaction(s) to vaccination, such as urticaria, difficulty in breathing, angioneurotic edema, abdominal pain, etc;
- Congenital malformation, developmental disorders, genetic defects;
- Autoimmune disease or immunodeficiency/immunosuppressive;
- Severe chronic diseases, severe cardiovascular disease, hypertension and diabetes that cannot be controlled by drugs, liver Kidney disease, malignant tumor;
- Severe nervous system disease or mental illness;
- Asplenia or functional asplenia;
- Diagnosed coagulation function abnormal (e.g., coagulation factor deficiency, coagulation disorder, or platelet abnormalities) , or obvious bruising or coagulation disorders;
- Any immunosuppressant, cytotoxic medicine, or inhaled corticosteroids (except corticosteroid spray for treatment of allergic rhinitis or corticosteroid treatment on surface for acute non-complicated dermatitis) within 6 month prior to study entry; Long term history of alcoholism or drug abuse;
- Administration of blood product within 3 months prior to the entry;
- Administration of any other investigational drugs within 30 days prior to the entry;
- Receipt of any attenuated live vaccine within 14 days prior to study entry;
- Receipt of any subunit vaccine or inactivated vaccine within 7 days prior to study entry;
- Any acute disease within 7 days prior to the study entry;
- Axillaty temperature > 37.0 °C;
- Any other factor that suggesting the volunteer is unsuitable for this study based on the opinions of investigators.
- Neonates gestational age <37 weeks or >42 weeks;
- Birth weight <2500g for boy, <2300g for girl;
- Apgar score at birth <8;
- Positive for any of the mother's HBsAg, HBeAg, HBeAb, and HBcAb (check the laboratory report of the birth hospital);
- Parents have family history of convulsions, epilepsy, encephalopathy, etc.;
- Mother's immune function is low or history of organ transplantation or hemodialysis;
- Mother has history of allergy to any vaccine or vaccine ingredient, or serious adverse reaction(s) to vaccination, such as urticaria, difficulty in breathing, angioneurotic edema, abdominal pain, etc;
- Family history of coagulation function abnormal (e.g., coagulation factor deficiency, coagulation disorder, or platelet abnormalities) , or obvious bruising or coagulation disorders;
- Immune system function damage, or parents have autoimmune diseases or immunodeficiency/immunosuppression;
- Congenital malformation, developmental disorders, genetic defects;
- Diognosed or suspected of active infection, cardiovascular disease, etc.;
- Axillaty temperature > 37.0 °C;
- Any other factor that suggesting the volunteer is unsuitable for this study based on the opinions of investigators.
Trial locations and contacts
1 site in 1 country.
China1 site
Biyang County Center for Disease Control and Prevention
Zhumadian, Henan, 463700
About this study
Official title: A Phase ⅠClinical Trial of Recombinant Hepatitis B Vaccine (Hansenula Polymorpha, 10μg) With an Open-labelled Design in Adults and a Randomized, Double-blinded, Positive Controlled Design in Children and Neonates
The purpose of this study is to evaluate the safety and immunogenicity of the recombinant hepatitis B vaccine (Hansenula polymorpha, 10μg), with an open-labelled design in adults and randomized, double-blinded, and positive controlled design in children and neonates.
Read the detailed description
This is a phase Ⅰ clinical trial of recombinant hepatitis B vaccine (Hansenula polymorpha,10μg) with an open-labelled design in adults and randomized, double-blinded, and positive controlled design in children and neonates. The control vaccine was the commercialized recombinant hepatitis B vaccine (Hansenula polymorpha,10μg) manufactured by Dalian Hissen Bio-pharm Lnc. Twenty four adults aged from 18 to 49 years will be vaccinated with one dose of investigational vaccine. Sixty children aged from 1 to 15 years will be randomly assigned in a 1:1 ratio to receive one dose of in investigational vaccine or control vaccine. Sixty neonates will be randomly assigned in a 1:1 ratio to receive three doses of investigational vaccine or control vaccine on the schedule of month 0,1,2. Safety profiles 30 days after each dose will be assessed based on all the participants, and immunogenicity will be assessed based on the enrolled chidren and neonates.
- Conditions
- Hepatitis B
- Being tested
- One dose of investigational vaccine, One dose of control vaccine, Three doses of investigational vaccine, Three doses of control vaccine
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One dose of investigational vaccineBiological
One dose of investigational hepatitis B vaccine (10μg/0.5ml) developed by Sinovac Research \& Development Co., Ltd.
One dose of control vaccineBiological
One dose of control hepatitis B vaccine (10μg/0.5ml) manufactured by Dalian Hissen Bio-pharmInc.
Three doses of investigational vaccineBiological
Three doses of investigational hepatitis B vaccine (10μg/0.5ml) developed by Sinovac Research \& Development Co., Ltd. on the schedule of month 0,1,2
Three doses of control vaccineBiological
Three doses of control hepatitis B vaccine (10μg/0.5ml) manufactured by Dalian Hissen Bio-pharmInc.
| Study group | Role | What they receive |
|---|---|---|
| Adults-Experimental group | Experimental | One dose of investigational vaccine Receives: Biological: One dose of investigational vaccine |
| Children-Experimental group | Experimental | One dose of investigational vaccine Receives: Biological: One dose of investigational vaccine |
| Children-Control group | Active comparator | One dose of control vaccine Receives: Biological: One dose of control vaccine |
| Neonates-Experimenatal group | Experimental | Three doses of investigational vaccine Receives: Biological: Three doses of investigational vaccine |
| Neonates-Control group | Active comparator | Three doses of control vaccine Receives: Biological: Three doses of control vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The overall incidence of the adverse reactions after each dose vaccination
Safety index-After each dose, a 30-minute safety observation will be conducted immediately. The body temperature, solicited local and general adverse events (AE) on day 0-7 were reported. The solicited local symptoms include pain, induration, redness, swelling, rash, and pruritus. The solicited general adverse symptoms include allergy, fatigue, irritability, inappetence, vomiting, diarrhea, and fever. Unsolicited adverse events on day 0-30 were also reported, which include the unsolicited symptoms happened within 0-7 days, and any symptoms happened within the 8-28 days. Each AE case will be reviewed by the investigator to determine whether it was an adverse reaction (The vaccination-related AE). The incidence of adverse reactions=Number of subjects who have adverse reactions of any symptoms/number of all the subjects whose safety information are collected.
Measured: within 30 days after each dose
Secondary outcomes (7)
The incidence of the serious adverse events (SAEs)
Safety index-After each dose, the serious adverse events in the safety observation period will be reported.
The SAE incidence=Number of subjects who have SAE of any symptoms/Number of subjects whose safety information are collected.
Measured: For adults and children: 30 days; for neonates: 18 months
The seroconversion rate (SCR) of anti-HBs 1 months after the single dose injection in Children aged 1-15 years
Immunogenicity index-Subjects whose pre-immune anti-HBs concentration <10mIU/ml, and post-immune anti-HBs concentration ≥10mIU/ml, or those whose pre-immune anti-HBs concentration ≥10mIU/ml and the increase of post-immune anti-HBs level ≥4 folds are considered seroconverted.
Measured: 30 days after the injection
The geometric mean concentration (GMC) of anti-HBs 1 months after the single dose injection in Children aged 1-15 years
Immunogenicity index
Measured: 30 days after the injection
The SCR of anti-HBs 7 months after the first dose injection in neonates
Immunogenicity index-Subjects whose pre-immune anti-HBs concentration <10mIU/ml, and post-immune anti-HBs concentration ≥10mIU/ml, or those whose pre-immune anti-HBs concentration ≥10mIU/ml and the increase of post-immune anti-HBs level ≥4 folds are considered seroconverted.
Measured: 210 days after the first dose injection
The GMC of anti-HBs 7 months after the first dose injection in neonates
Immunogenicity index
Measured: 210 days after the first dose injection
The SCR of anti-HBs 2 months after the first dose injection in neonates
Immunogenicity index-Subjects whose pre-immune anti-HBs concentration <10mIU/ml, and post-immune anti-HBs concentration ≥10mIU/ml, or those whose pre-immune anti-HBs concentration ≥10mIU/ml and the increase of post-immune anti-HBs level ≥4 folds are considered seroconverted.
Measured: 60 days after the first dose injection
The GMC of anti-HBs 7 months after the first dose injection in neonates
Immunogenicity index
Measured: 60 days after the first dose injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2019
- Study start7 Jul 2019
- Primary completion30 May 2021
- Study completion25 Jul 2021
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.
- More trials run by Sinovac Biotech Co., LtdThe sponsor's other registered studies.
- 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
- Parallel groups
- Model description
- Single group in the adults participants, and parallel groups in the children and neonates participants.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sinovac Biotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shengli Xia, Doctor, Principal investigator, Henan Provincial Center for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04075201
- Sponsor's protocol ID
- PRO-HB-1001
- Status last verified
- Jul 2021
- First submitted
- 28 Aug 2019
- Last updated
- 29 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase ⅠClinical Trial of Recombinant Hepatitis B Vaccine (Hansenula Polymorpha, 10μg) With an Open-labelled Design in Adults and a Randomized, Double-blinded, Positive Controlled Design in Children and Neonates
- ClinicalTrials.gov ID
- NCT04075201
- Acronym / sponsor ID
- PRO-HB-1001
- Conditions
- Hepatitis B
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Sinovac Biotech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 7 Jul 2019 (actual)
- Primary completion
- 30 May 2021 (actual)
- Study completion
- 25 Jul 2021 (actual)
- First posted
- 30 Aug 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.
The purpose of this study is to evaluate the safety and immunogenicity of the recombinant hepatitis B vaccine (Hansenula polymorpha, 10μg), with an open-labelled design in adults and randomized, double-blinded, and positive controlled design in children and neonates.
Detailed description
This is a phase Ⅰ clinical trial of recombinant hepatitis B vaccine (Hansenula polymorpha,10μg) with an open-labelled design in adults and randomized, double-blinded, and positive controlled design in children and neonates. The control vaccine was the commercialized recombinant hepatitis B vaccine (Hansenula polymorpha,10μg) manufactured by Dalian Hissen Bio-pharm Lnc. Twenty four adults aged from 18 to 49 years will be vaccinated with one dose of investigational vaccine. Sixty children aged from 1 to 15 years will be randomly assigned in a 1:1 ratio to receive one dose of in investigational vaccine or control vaccine. Sixty neonates will be randomly assigned in a 1:1 ratio to receive three doses of investigational vaccine or control vaccine on the schedule of month 0,1,2. Safety profiles 30 days after each dose will be assessed based on all the participants, and immunogenicity will be assessed based on the enrolled chidren and neonates.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
- Model description
- Single group in the adults participants, and parallel groups in the children and neonates participants.
| Arm | Type | Receives |
|---|---|---|
| Adults-Experimental group | Experimental | Biological: One dose of investigational vaccineOne dose of investigational vaccine |
| Children-Experimental group | Experimental | Biological: One dose of investigational vaccineOne dose of investigational vaccine |
| Children-Control group | Active comparator | Biological: One dose of control vaccineOne dose of control vaccine |
| Neonates-Experimenatal group | Experimental | Biological: Three doses of investigational vaccineThree doses of investigational vaccine |
| Neonates-Control group | Active comparator | Biological: Three doses of control vaccineThree doses of control vaccine |
Who may qualify
- Ages
- Up to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Adults aged 18~49 years, or children aged 1~15 years, or neonates within 24 hours of birth;
- Proven legal identity;
- Participants or guardians of the participants should be capable of understanding the written consent form, and such form should be signed prior to enrollment ;
Key exclusion criteria (46 listed)
- Breast feeding, pregnant, or expected to conceive in the next 60 days;
- History of allergy to any vaccine or vaccine ingredient, or serious adverse reaction(s) to vaccination, such as urticaria, difficulty in breathing, angioneurotic edema, abdominal pain, etc;
- Congenital malformation, developmental disorders, genetic defects;
- Autoimmune disease or immunodeficiency/immunosuppressive;
- Severe chronic diseases, severe cardiovascular disease, hypertension and diabetes that cannot be controlled by drugs, liver Kidney disease, malignant tumor;
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 |
|---|---|---|
| One dose of investigational vaccineOne dose of investigational hepatitis B vaccine (10μg/0.5ml) developed by Sinovac Research \& Development Co., Ltd. | Biological | Adults-Experimental group, Children-Experimental group |
| One dose of control vaccineOne dose of control hepatitis B vaccine (10μg/0.5ml) manufactured by Dalian Hissen Bio-pharmInc. | Biological | Children-Control group |
| Three doses of investigational vaccineThree doses of investigational hepatitis B vaccine (10μg/0.5ml) developed by Sinovac Research \& Development Co., Ltd. on the schedule of month 0,1,2 | Biological | Neonates-Experimenatal group |
| Three doses of control vaccineThree doses of control hepatitis B vaccine (10μg/0.5ml) manufactured by Dalian Hissen Bio-pharmInc. | Biological | Neonates-Control group |
Primary outcome
The overall incidence of the adverse reactions after each dose vaccination
Time frame: within 30 days after each dose
Safety index-After each dose, a 30-minute safety observation will be conducted immediately. The body temperature, solicited local and general adverse events (AE) on day 0-7 were reported. The solicited local symptoms include pain, induration, redness, swelling, rash, and pruritus. The solicited general adverse symptoms include allergy, fatigue, irritability, inappetence, vomiting, diarrhea, and fever. Unsolicited adverse events on day 0-30 were also reported, which include the unsolicited symptoms happened within 0-7 days, and any symptoms happened within the 8-28 days. Each AE case will be reviewed by the investigator to determine whether it was an adverse reaction (The vaccination-related AE). The incidence of adverse reactions=Number of subjects who have adverse reactions of any symptoms/number of all the subjects whose safety information are collected.
7 secondary outcomes
The incidence of the serious adverse events (SAEs)
Time frame: For adults and children: 30 days; for neonates: 18 months
The seroconversion rate (SCR) of anti-HBs 1 months after the single dose injection in Children aged 1-15 years
Time frame: 30 days after the injection
The geometric mean concentration (GMC) of anti-HBs 1 months after the single dose injection in Children aged 1-15 years
Time frame: 30 days after the injection
The SCR of anti-HBs 7 months after the first dose injection in neonates
Time frame: 210 days after the first dose injection
The GMC of anti-HBs 7 months after the first dose injection in neonates
Time frame: 210 days after the first dose injection
The SCR of anti-HBs 2 months after the first dose injection in neonates
Time frame: 60 days after the first dose injection
The GMC of anti-HBs 7 months after the first dose injection in neonates
Time frame: 60 days after the first dose injection
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 29 Jul 2021.
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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.
Shengli Xia, Doctor principal investigator
Henan Provincial Center for Disease Control and Prevention
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 One dose of investigational vaccine and Three doses of investigational vaccine in people with Hepatitis B, run by Sinovac Biotech Co., Ltd at 1 site in China.
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 46 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 29 Jul 2021. 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 China. 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?
The overall incidence of the adverse reactions after each dose vaccination (time frame: within 30 days after each dose). 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 29 Jul 2021.