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Hepatitis B Vaccine for Non-responders

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ClinicalTrials.gov Identifier: NCT03415672
Recruitment Status : Active, not recruiting
First Posted : January 30, 2018
Last Update Posted : December 5, 2018
Sponsor:
Collaborator:
CyTuVax
Information provided by (Responsible Party):
Maastricht University Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Hepatitis B Biological: HBVaxPro Biological: HBAI20 Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 133 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety of HBAI20 Hepatitis B Vaccine in Non-responders
Actual Study Start Date : October 11, 2017
Estimated Primary Completion Date : January 15, 2019
Estimated Study Completion Date : March 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Group 1
Subjects included in Group 1 are adults who are non-responders (did not achieve seroprotection after 3 or more vaccinations with a Hepatitis B vaccine. They will receive 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: 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.

Experimental: Group 2

Subjects included in Group 2 are adults who are non-responders (did not achieve seroprotection after 3 or more vaccinations with a Hepatitis B vaccine). They will receive 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.

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.




Primary Outcome Measures :
  1. Immunogenicity of the HBAI20 [ Time Frame: Six weeks after the third vaccination. ]
    Anti Hepatitis B surface antigen antibody titer.


Secondary Outcome Measures :
  1. Safety of the HBAI20 Hepatitis B vaccine: Percentage of subjects reporting adverse events after being vaccinated. [ Time Frame: The whole duration of the study protocol (102 days) ]
    Percentage of subjects reporting adverse events after being vaccinated.



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Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • In good health as determined by the outcome of medical history, physical examination screening/baseline labs and clinical judgment of the clinical investigator
  • Age 18 to 59 years, inclusive at the time of enrollment
  • Willing and able to adhere to the study regimen
  • Willing to adhere to a highly effective birth control method during the duration of the study
  • Having a signed informed consent form
  • Documented non-responders: Subjects with documented one or more cycles of Hepatitis B vaccination (total of 3 or more vaccinations) and titer analysis 1 to 3 months after the last vaccination that show that they have not developed the Hepatitis B antibody titer recommended after standard vaccination: HBsAg antibody titer superior to 10mIU/ml. In case the subjects do not have a titer analysis performed 1 to 3 months after their last recorded vaccination, the potential subject can be included after permission from the project leader after analysis of the case file.

Exclusion Criteria:

  • Any infectious disease at the time of screening and/or enrollment
  • Positive HIV, Hepatitis B virus or Hepatitis C virus serology
  • Known or suspected immune deficiency
  • Known or suspected disease that influences the immune system including chronic allergies that require frequent anti-allergy medication - excluding anti-histaminics -, cancer and transplantation recipients
  • Known or suspected allergy to any of the vaccine components
  • Dialysis patient
  • History of unusual or severe reactions to any previous vaccination
  • History of any neurologic disorder, including epilepsy and autism
  • Use of medication that influences the immune system (immune suppressive treatment or daily use of corticosteroids, including chronic use of local corticosteroids)
  • Any vaccination within 3 months before screening excluding flu vaccination
  • Blood donation within 1 month before screening
  • Administration of plasma (incl. immunoglobulins) or blood products within 12 months before screening
  • Participation in another clinical trial within 3 months before screening
  • Abnormal pre-treatment laboratory parameters which are clinically relevant according to the investigator
  • Bleeding disorders. Participants on coumadins anticoagulants and participants receiving 2 platelet aggregation inhibitors can not be included in the study. People on the direct oral anticoagulant dabigatran, apixaban, edoxaban, and rivaroxaban and participants using only one platelet aggregation inhibitor can be included.
  • Female subjects planning to become pregnant or breastfeeding babies until visit 4
  • Females: positive pregnancy test at screening date
  • Excessive alcohol or controlled drug use - More than 2 alcohol measures per day (one alcohol measure is a beer (250ml) or one glass of wine (125ml) or one strong measure (35ml) or one port/sherry (75ml)). Regular use of controlled drugs
  • Any Hepatitis B vaccination in the last 3 months Temporary exclusion criterion for vaccination
  • Temperature > 38.4°C will lead to postponement of participation and vaccination.

Screening may continue when the temperature has normalized.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03415672


Locations
Belgium
Vaxinfectio - Antwerp University
Antwerp, Belgium
Ziekenhuis Oost-Limburg
Genk, Belgium
Netherlands
Maastricht UMC
Maastricht, Netherlands, 6202 AZ
Sponsors and Collaborators
Maastricht University Medical Center
CyTuVax
Investigators
Principal Investigator: Pierre van Damme, MD, PhD Vaxinfectio - Antwerp University
Principal Investigator: Geert Robaeys, MD, PhD Ziekenhuis Oost-Limburg

Publications:

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT03415672     History of Changes
Other Study ID Numbers: HBnr02
2016-002720-91 ( EudraCT Number )
First Posted: January 30, 2018    Key Record Dates
Last Update Posted: December 5, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Maastricht University Medical Center:
Interleukin-2
Hepatitis B Vaccines
Non-responders
Liver Diseases
Digestive system
Vaccines

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs