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Hepatitis B Vaccine for Non-responders

NCT03415672 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 133

Last updated 2019-01-31

No results posted yet for this study

Summary

In the current study, the investigators study the efficacy of the HBAI20 vaccine to induce seroprotection in registered non-responders (adults who were previously vaccinated with the HBVaxPro-10μg but did not achieve seroprotection). The study will further assess the safety of the HBAI20 vaccine in comparison with HBVaxPro-10μg.

Conditions

Interventions

BIOLOGICAL

HBVaxPro

Three doses of HBVaxPro-10μg at 0, 1, and 2 months. The HBVaxPro-10μg vaccines are administered strictly intramuscularly in the deltoid muscle and must not be injected intravascularly.

BIOLOGICAL

HBAI20

Three doses of HBAI20 at 0, 1, and 2 months. The HBAI20 vaccines are administered strictly intramuscularly in the deltoid muscle and must not be injected intravascularly.

Sponsors & Collaborators

  • CyTuVax

    collaborator OTHER

  • Maastricht University Medical Center

    lead OTHER

Principal Investigators

  • Pierre van Damme, MD, PhD · Vaxinfectio - Antwerp University

  • Geert Robaeys, MD, PhD · Ziekenhuis Oost-Limburg

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
2017-10-11
Primary Completion
2019-01-09
Completion
2019-01-09

Countries

  • Belgium
  • 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 NCT03415672 on ClinicalTrials.gov