- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04075201
Clinical Trial of Recombinant Hepatitis B Vaccine (Hansenula Polymorpha, 10μg)
July 26, 2021 updated by: Sinovac Biotech Co., Ltd
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.
Study Overview
Status
Completed
Conditions
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 Type
Interventional
Enrollment (Actual)
144
Phase
- Phase 1
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
-
-
Henan
-
Zhumadian, Henan, China, 463700
- Biyang County Center for Disease Control and Prevention
-
-
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
No older than 49 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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 ;
Exclusion Criteria (For Adults):
- 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;
- 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.
Exclusion Criteria (For Children):
- 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.
Exclusion Criteria (For Neonates):
- 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.
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 Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Adults-Experimental group
One dose of investigational vaccine
|
One dose of investigational hepatitis B vaccine (10μg/0.5ml)
developed by Sinovac Research & Development Co., Ltd.
|
Experimental: Children-Experimental group
One dose of investigational vaccine
|
One dose of investigational hepatitis B vaccine (10μg/0.5ml)
developed by Sinovac Research & Development Co., Ltd.
|
Active Comparator: Children-Control group
One dose of control vaccine
|
One dose of control hepatitis B vaccine (10μg/0.5ml)
manufactured by Dalian Hissen Bio-pharmInc.
|
Experimental: Neonates-Experimenatal group
Three doses of investigational vaccine
|
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
|
Active Comparator: Neonates-Control group
Three doses of control vaccine
|
Three doses of control hepatitis B vaccine (10μg/0.5ml)
manufactured by Dalian Hissen Bio-pharmInc.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
within 30 days after each dose
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The incidence of the serious adverse events (SAEs)
Time Frame: For adults and children: 30 days; for neonates: 18 months
|
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. |
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
|
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.
|
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
|
Immunogenicity index
|
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
|
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.
|
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
|
Immunogenicity index
|
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
|
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.
|
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
|
Immunogenicity index
|
60 days after the first dose injection
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Shengli Xia, Doctor, Henan Provincial Center for Disease Control and Prevention
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)
July 7, 2019
Primary Completion (Actual)
May 30, 2021
Study Completion (Actual)
July 25, 2021
Study Registration Dates
First Submitted
August 28, 2019
First Submitted That Met QC Criteria
August 28, 2019
First Posted (Actual)
August 30, 2019
Study Record Updates
Last Update Posted (Actual)
July 29, 2021
Last Update Submitted That Met QC Criteria
July 26, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Hepatitis, Viral, Human
- Hepadnaviridae Infections
- DNA Virus Infections
- Enterovirus Infections
- Picornaviridae Infections
- Hepatitis B
- Hepatitis
- Hepatitis A
- Physiological Effects of Drugs
- Immunologic Factors
- Vaccines
Other Study ID Numbers
- PRO-HB-1001
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.
Clinical Trials on Hepatitis B
-
The Affiliated Nanjing Drum Tower Hospital of Nanjing...Gilead SciencesNot yet recruiting
-
Ain Shams UniversityCompleted
-
National Taiwan University HospitalChiayi Christian Hospital; E-DA Hospital; Taipei City Hospital; Taipei Tzu Chi... and other collaboratorsRecruitingChronic Hepatitis b | Hepatitis B ReactivationTaiwan
-
Mahidol UniversityUnknownChronic Hepatitis B, HBsAg, Hepatitis B VaccineThailand
-
Nanfang Hospital of Southern Medical UniversityRecruiting
-
IlDong Pharmaceutical Co LtdRecruitingChronic Hepatitis bKorea, Republic of
-
Antios Therapeutics, IncTerminatedChronic Hepatitis bUnited States
-
Xi'an Xintong Pharmaceutical Research Co.,Ltd.Unknown
-
Third Affiliated Hospital, Sun Yat-Sen UniversityRecruitingChronic Hepatitis b | Cirrhosis Due to Hepatitis BChina
-
Tongji HospitalChia Tai Tianqing Pharmaceutical Group Co., Ltd.UnknownChronic Hepatitis b
Clinical Trials on One dose of investigational vaccine
-
GlaxoSmithKlineActive, not recruitingSexually Transmitted DiseasesUnited States, Germany, Philippines, France, Spain, South Africa, United Kingdom, Brazil
-
Beijing Chaoyang District Centre for Disease Control...UnknownQuadrivalent Influenza Virus Vaccine
-
Institut PasteurCompleted
-
Meissa Vaccines, Inc.RecruitingRespiratory Syncytial Virus (RSV)United States
-
GlaxoSmithKlineBiological E. LimitedRecruiting
-
Meissa Vaccines, Inc.Recruiting
-
Sanofi Pasteur, a Sanofi CompanyCompletedTetanus Immunisation (Healthy Volunteers) | Diphtheria Immunisation (Healthy Volunteers) | Pertussis Immunisation (Healthy Volunteers)Canada
-
GlaxoSmithKlineCompleted
-
Hualan Biological Bacterin Co. Ltd.Completed
-
Sinovac Biotech Co., LtdCompleted