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Safety and Immunogenicity of HBAI20 Hepatitis B Vaccine in Naive Adults and Non-responders

NCT02540538 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2018-12-19

Study results available
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Summary

The purpose of this study is to determine whether the HBAI20 vaccine is safe and more immunogenic than the HBVaxPro-10µg in people who have never been vaccinated with a hepatitis B vaccine and in people who have been vaccinated 6 times with hepatitis B vaccine but do not have a protective anti hepatitis B antibody titer.

Conditions

Interventions

BIOLOGICAL

HBVaxPro

3 vaccinations with HBVaxPro-10ug at 0, 30, and 180 days.

BIOLOGICAL

HBAI20

2 vaccinations with HBAI20 at 0 and 30 days and 1 vaccination with HBVaxPro-10ug at 180 days.

Sponsors & Collaborators

  • CyTuVax

    collaborator OTHER

  • Maastricht University Medical Center

    lead OTHER

Principal Investigators

  • Astrid ML Oude Lashof, PhD, MD · Maastricht UMC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2016-07-31
Completion
2016-07-31

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02540538 on ClinicalTrials.gov