Hepatitis B Vaccine for Non-responders
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|ClinicalTrials.gov Identifier: NCT03415672|
Recruitment Status : Completed
First Posted : January 30, 2018
Last Update Posted : January 31, 2019
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|Condition or disease||Intervention/treatment||Phase|
|Hepatitis B||Biological: HBVaxPro Biological: HBAI20||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||133 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Immunogenicity and Safety of HBAI20 Hepatitis B Vaccine in Non-responders|
|Actual Study Start Date :||October 11, 2017|
|Actual Primary Completion Date :||January 9, 2019|
|Actual Study Completion Date :||January 9, 2019|
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.
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.
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.
- Immunogenicity of the HBAI20 [ Time Frame: Six weeks after the third vaccination. ]Anti Hepatitis B surface antigen antibody titer.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 59 Years (Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- 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.
- 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.
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
|Vaxinfectio - Antwerp University|
|Maastricht, Netherlands, 6202 AZ|
|Principal Investigator:||Pierre van Damme, MD, PhD||Vaxinfectio - Antwerp University|
|Principal Investigator:||Geert Robaeys, MD, PhD||Ziekenhuis Oost-Limburg|
|Responsible Party:||Maastricht University Medical Center|
|Other Study ID Numbers:||
2016-002720-91 ( EudraCT Number )
|First Posted:||January 30, 2018 Key Record Dates|
|Last Update Posted:||January 31, 2019|
|Last Verified:||January 2019|
|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|
Hepatitis B Vaccines
Digestive System Diseases
Hepatitis, Viral, Human
RNA Virus Infections
DNA Virus Infections