NCT02692170

Brief Summary

A single center, randomized, double blinded phase I/IIa exploratory study to evaluate reactogenicity, safety, immunogenicity and dose-response of a new hepatitis B vaccine in human adult

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Dec 2012

Longer than P75 for phase_1 healthy

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 7, 2012

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 28, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 28, 2015

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 18, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 25, 2016

Completed
Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

2.5 years

First QC Date

February 18, 2016

Last Update Submit

November 16, 2023

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Safety and reactogenicity (including incidence of adverse events and expected adverse reactions for vaccine treatment) measured for 7 days after each vaccination

    Occurrence of severe local and/or systemic reactogenicity signs and symptoms measured for 7 days after each vaccination

    7 days after each vaccination

Secondary Outcomes (2)

  • Seroprotection rate

    4 weeks after vaccination

  • Antibody titers to HBsAg

    4 weeks after vaccination

Study Arms (5)

CVI-HBV-001 (5 μg)

EXPERIMENTAL

* HBV surface antigen 5 μg/dose * Intramuscular injection at 0, 1, 6th month

Biological: CVI-HBV-001

CVI-HBV-001 (10 μg)

EXPERIMENTAL

* HBV surface antigen 10 μg/dose * Intramuscular injection at 0, 1, 6th month

Biological: CVI-HBV-001

CVI-HBV-001 (20 μg)

EXPERIMENTAL

* HBV surface antigen 20 μg/dose * Intramuscular injection at 0, 1, 6th month

Biological: CVI-HBV-001

CVI-HBV-001 (40 μg)

EXPERIMENTAL

* HBV surface antigen 40 μg/dose * Intramuscular injection at 0, 1, 6th month

Biological: CVI-HBV-001

Conventional Hepatitis B vaccine (20 μg)

ACTIVE COMPARATOR

* HBV surface antigen 20 μg/dose * Intramuscular injection at 0, 1, 6th month

Biological: Conventional Hepatitis B vaccine (20 μg)

Interventions

CVI-HBV-001BIOLOGICAL

Investigational Product

CVI-HBV-001 (10 μg)CVI-HBV-001 (20 μg)CVI-HBV-001 (40 μg)CVI-HBV-001 (5 μg)
Conventional Hepatitis B vaccine (20 μg)BIOLOGICAL

Investigational Product

Conventional Hepatitis B vaccine (20 μg)

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Adults between 20 and 50 years of age
  • Anti-HBs titers \< 10 mIU/mL
  • Subject is able to provide written informed consent by oneself or legal representative

You may not qualify if:

  • Hepatitis B core antibodies positive patient
  • Patient has abnormal results in liver-function test
  • Patient has active microbial, viral, or fungal infections in need of systemic treatment
  • Patient has history of serious heart disease (NYHA Functional Class III or IV heart failure, myocardial infarction within 6 months, treatment required ventricular tachyarrhythmias, or unstable angina etc.)
  • Patient has seizure disorder required anticonvulsants treatment
  • Serious chronic obstructive pulmonary disease patient accompanied hypoxemia
  • Uncontrollable diabetic patient
  • Uncontrollable hypertension patient
  • Patient with known history of HIV, HBV, or HCV infection
  • Subject had experience of participating other clinical study or clinical treatment within 30 days before screening
  • Subject has hypersensitivity or anaphylactic reaction for HBV vaccine components
  • Patient being treated for prolonged immunosuppressive therapy (including steroids)
  • Hemodialysis patient
  • Subject has continuous drinking (\>21 units/week, 1 unit = 10g of pure alcohol) or dependence on alcohol
  • Subject is pregnant or breastfeeding or intending to become pregnant during the study
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Seong Gyu Hwang, M.D., Ph.D.

    Bundang CHA General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2016

First Posted

February 25, 2016

Study Start

December 7, 2012

Primary Completion

May 28, 2015

Study Completion

May 28, 2015

Last Updated

November 18, 2023

Record last verified: 2023-11