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

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ClinicalTrials.gov Identifier: NCT02540538
Recruitment Status : Completed
First Posted : September 4, 2015
Last Update Posted : September 14, 2016
Sponsor:
Collaborator:
CyTuVax
Information provided by (Responsible Party):
Maastricht University Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Hepatitis B Biological: HBVaxPro Biological: HBAI20 Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Safety and Immunogenicity of HBAI20 Hepatitis B Vaccine in Naive Adults and Non-responders
Study Start Date : September 2015
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: HB vaccine naive - HBVaxPro
Subjects have never been vaccinated with a Hepatitis B vaccine. Subjects are vaccinated with Hepatitis B vaccine HBVaxPro-10ug at day 0, 30, and 180.
Biological: HBVaxPro
3 vaccinations with HBVaxPro-10ug at 0, 30, and 180 days.

Experimental: HB vaccine naive - HBAI20
Subjects have never been vaccinated with a Hepatitis B vaccine. Subjects are vaccinated with Hepatitis B vaccine HBAI20 at day 0 and 30, and Hepatitis B vaccine HBVaxPro-10ug at day 180.
Biological: HBAI20
2 vaccinations with HBAI20 at 0 and 30 days and 1 vaccination with HBVaxPro-10ug at 180 days.

Experimental: Non-responders - HBAI20

Subjects have been vaccinated 6 times with a Hepatitis B vaccine without developing a protective immune response, measured as anti Hepatitis B surface antigen antibodies, superior to 10mIU/ml.

Subjects are vaccinated with Hepatitis B vaccine HBAI20 at day 0 and 30, and Hepatitis B vaccine HBVaxPro-10ug at day 180.

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




Primary Outcome Measures :
  1. Number of subjects with adverse events [ Time Frame: Up to 7 months after first vaccination. ]

    Subjects will be given a diary for 4 days after the first and second vaccination.

    Dairy: Local reactions at injection site: Pain (1 to 4), Impaired movement of injected arm (1 to 4), Redness/erythema (cm), Swelling (cm), Induration (cm) General/Systemic adverse events: Fever (temperature measurement), Headache (1 to 4), Fatigue (1 to 4), Muscle pain (1 to 4), Skin rash (1 to 4), Vomiting (1 to 4), Diarrhea (1 to 4).

    Record medication taken during the study (up to 7 months after the first vaccination).

    The laboratory parameters analysed at day 10, 30, 40, 60, 180, and 210 are:

    Hematology: Hematocrit, Hemoglobin, RBC count, WBC count, Platelet count, Neutrophils, Eosinophils, Basophils, Lymphocytes, and Monocytes. Biochemistry: Creatinine, Albumin, Alkaline Phosphatase, Total Bilirubin, ALT (GPT), AST (GOT), Gamma-Gt, C-Reactive Protein, and TSH/FT4.

    Urinalysis (day 10, 40, and 210): Clarity, Color, Specific gravity, Leukocytes, Nitrite, pH, Erythrocytes, Albumin, and Glucose.


  2. Number of adverse events of grade 2 or higher assessed by CTCAE v4.0 [ Time Frame: Up to 7 months after first vaccination ]

Secondary Outcome Measures :
  1. Immunogenicity of Hepatitis B vaccine [ Time Frame: Day 0, 10, 30, 40, 60, 180, and 210 ]
    Anti Hepatitis B surface antigen antibody titer



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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 enrolment
  • Willing and able to adhere to the study regimen
  • Having a signed informed consent form

Non-responders:

- Documented non-responders: Subjects with documented two cycles of Hepatitis B vaccination (total of 6 vaccinations) and titer analysis that show that they have not developed the Hepatitis B antibody titer recommended after standard vaccination: anti-HBsAg antibody titer higher to 10mIU/ml.

Exclusion Criteria:

  • Any infectious disease at the time of screening and/or enrolment
  • Positive HIV, Hepatitis B virus or Hepatitis C virus serology
  • Positive anti-IL-2 antibody titer
  • Known or suspected immune deficiency
  • Known or suspected disease that influences the immune system including chronic allergies that require frequent anti-allergy medication, 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)
  • Any vaccination within 3 months before screening
  • 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, or use of medication for bleeding disorders, and use of anti-coagulants
  • Female subjects planning to become pregnant or breastfeeding babies until visit 7
  • Females: positive urine pregnancy test. Urine test positive at screening date or positive urine pregnancy test on the day of vaccination
  • 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

Exclusion criterion for Hepatitis B naïve subjects (groups 1 and 2):

- Previous vaccination with Hepatitis B vaccine

Exclusion criterion for non-responders (group 3):

- Any Hepatitis B vaccination in the last 6 months

Temporary exclusion criterion for vaccination

- Ear 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): NCT02540538


Locations
Netherlands
Maastricht UMC
Maastricht, Netherlands, 6202 AZ
Sponsors and Collaborators
Maastricht University Medical Center
CyTuVax
Investigators
Principal Investigator: Astrid ML Oude Lashof, PhD, MD Maastricht UMC

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT02540538     History of Changes
Other Study ID Numbers: HBnr01
2014-000913-30 ( EudraCT Number )
First Posted: September 4, 2015    Key Record Dates
Last Update Posted: September 14, 2016
Last Verified: September 2016

Keywords provided by Maastricht University Medical Center:
Adjuvants, immunologic
Interleukin-2
Hepatitis B vaccines
Non-responders

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