CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 133 enrolled
Drug / intervention
HBVaxPro +1 morebiological
Likely dose
HBVaxPro 10μgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03415672
NCT03415672Phase 2Completed
CompareCT.gov

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

Maastricht University Medical Center·interventional·Posted Jan 30, 2018·Updated Jan 31, 2019

In Brief

A Phase 2 clinical trial evaluating HBVaxPro and HBAI20 for Hepatitis B. Completed, enrolled 133 participants across 3 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis B
CountriesBelgium, Netherlands
CollaboratorsCyTuVax

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedJan 30, 2018
Enrollment StartOct 11, 2017
Primary CompletionJan 9, 2019
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 8.4 years ago

Interventions

HBVaxProbiological

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.

HBAI20biological

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.