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

NCT04075201 | Completed Phase 1

• 1 other identifier: PRO-HB-1001
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis B

Outcome Measures

Primary Outcomes (1)

• 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.

  within 30 days after each dose

Secondary Outcomes (7)

• The incidence of the serious adverse events (SAEs)

  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

  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

  30 days after the injection

• The SCR of anti-HBs 7 months after the first dose injection in neonates

  210 days after the first dose injection

• The GMC of anti-HBs 7 months after the first dose injection in neonates

  210 days after the first dose injection

Study Arms (5)

Adults-Experimental group

EXPERIMENTAL

One dose of investigational vaccine

Biological: One dose of investigational vaccine

Children-Experimental group

EXPERIMENTAL

One dose of investigational vaccine

Biological: One dose of investigational vaccine

Children-Control group

ACTIVE COMPARATOR

One dose of control vaccine

Biological: One dose of control vaccine

Neonates-Experimenatal group

EXPERIMENTAL

Three doses of investigational vaccine

Biological: Three doses of investigational vaccine

Neonates-Control group

ACTIVE COMPARATOR

Three doses of control vaccine

Biological: Three doses of control vaccine

Interventions

One dose of investigational vaccine BIOLOGICAL

One dose of investigational hepatitis B vaccine (10μg/0.5ml) developed by Sinovac Research \& Development Co., Ltd.

Adults-Experimental group; Children-Experimental group

One dose of control vaccine BIOLOGICAL

One dose of control hepatitis B vaccine (10μg/0.5ml) manufactured by Dalian Hissen Bio-pharmInc.

Children-Control group

Three doses of investigational vaccine BIOLOGICAL

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

Neonates-Experimenatal group

Three doses of control vaccine BIOLOGICAL

Three doses of control hepatitis B vaccine (10μg/0.5ml) manufactured by Dalian Hissen Bio-pharmInc.

Neonates-Control group

Eligibility Criteria

• Age: Up to 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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 ;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Sinovac Biotech Co., Ltd: lead

Study Sites (1)

Biyang County Center for Disease Control and Prevention

Zhumadian, Henan, 463700, China

Location

MeSH Terms

Conditions

Hepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Shengli Xia, Doctor

  Henan Provincial Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Open-labelled in the adults participants, and double-blinded in the children ans neonates participants.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single group in the adults participants, and parallel groups in the children and neonates participants.

Study Record Dates

• First Submitted: August 28, 2019
• First Posted: August 30, 2019
• Study Start: July 7, 2019
• Primary Completion: May 30, 2021
• Study Completion: July 25, 2021
• Last Updated: July 29, 2021

Record last verified: 2021-07

Locations

CN (1)