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A Phase ⅠClinical Trial of Recombinant Hepatitis B Vaccine (Hansenula Polymorpha, 10μg)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04075201
Recruitment Status : Recruiting
First Posted : August 30, 2019
Last Update Posted : August 30, 2019
Sponsor:
Information provided by (Responsible Party):
Sinovac Biotech Co., Ltd

Brief 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.

Condition or disease Intervention/treatment Phase
Hepatitis B Biological: One dose of investigational vaccine Biological: One dose of control vaccine Biological: Three doses of investigational vaccine Biological: Three doses of control vaccine Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Single group in the adults participants, and parallel groups in the children and neonates participants.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Open-labelled in the adults participants, and double-blinded in the children ans neonates participants.
Primary Purpose: Prevention
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
Actual Study Start Date : July 7, 2019
Estimated Primary Completion Date : May 30, 2021
Estimated Study Completion Date : July 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Adults-Experimental group
One dose of investigational vaccine
Biological: 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
Biological: 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
Biological: 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
Biological: 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
Biological: Three doses of control vaccine
Three doses of control hepatitis B vaccine (10μg/0.5ml) manufactured by Dalian Hissen Bio-pharmInc.




Primary Outcome Measures :
  1. The overall incidence of the adverse reactions after each dose vaccination [ Time Frame: 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.


Secondary Outcome Measures :
  1. 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.


  2. 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.

  3. 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

  4. 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.

  5. 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

  6. 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.

  7. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 49 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04075201


Contacts
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Contact: Yanxia Wang, Bachelor 86-13613816598 wangyanxia99@163.com

Locations
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China, Henan
Biyang County Center for Disease Control and Prevention Recruiting
Zhumadian, Henan, China, 463700
Contact: Dongmei Liu    86-13783315561    939145972@qq.com   
Sponsors and Collaborators
Sinovac Biotech Co., Ltd
Investigators
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Principal Investigator: Shengli Xia, Doctor Henan Provincial Center for Disease Control and Prevention
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Responsible Party: Sinovac Biotech Co., Ltd
ClinicalTrials.gov Identifier: NCT04075201    
Other Study ID Numbers: PRO-HB-1001
First Posted: August 30, 2019    Key Record Dates
Last Update Posted: August 30, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs