NCT04075201

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 144 (actual)
• Sponsor: Sinovac Biotech Co., Ltd · Industry
• Sex: All
• Age: 49 Years
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
BIOLOGICAL	One dose of investigational vaccine	One dose of investigational hepatitis B vaccine (10μg/0.5ml) developed by Sinovac Research \& Development Co., Ltd.
BIOLOGICAL	One dose of control vaccine	One dose of control hepatitis B vaccine (10μg/0.5ml) manufactured by Dalian Hissen Bio-pharmInc.
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
BIOLOGICAL	Three doses of control vaccine	Three doses of control hepatitis B vaccine (10μg/0.5ml) manufactured by Dalian Hissen Bio-pharmInc.

Timeline

• Start date: 2019-07-07
• Primary completion: 2021-05-30
• Completion: 2021-07-25
• First posted: 2019-08-30
• Last updated: 2021-07-29

Locations

1 site across 1 country: China