NCT02540538

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2015

Completed
7 days until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 4, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

November 29, 2018

Completed
Last Updated

December 19, 2018

Status Verified

November 1, 2018

Enrollment Period

10 months

First QC Date

August 25, 2015

Results QC Date

April 24, 2018

Last Update Submit

November 29, 2018

Conditions

Hepatitis B

Keywords

Adjuvants, immunologicInterleukin-2Hepatitis B vaccinesNon-responders

Outcome Measures

Primary Outcomes (2)

  • Subjects With Local and/or General Adverse Events Irrespective of Severity

    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).

    Up to 7 months after first vaccination.

  • Subjects With Local and/or General SEVERE Adverse Events

    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.

    Up to 7 months after first vaccination

Secondary Outcomes (1)

  • Number of Participants With Seroprotection

    Day 0, 10, 30, 40, 60, 180, and 210

Study Arms (3)

HB vaccine naive - HBVaxPro

ACTIVE COMPARATOR

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

HB vaccine naive - HBAI20

EXPERIMENTAL

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

Non-responders - HBAI20

EXPERIMENTAL

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

Interventions

HBVaxProBIOLOGICAL

3 vaccinations with HBVaxPro-10ug at 0, 30, and 180 days.

HB vaccine naive - HBVaxPro
HBAI20BIOLOGICAL

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

HB vaccine naive - HBAI20Non-responders - HBAI20

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht UMC

Maastricht, 6202 AZ, Netherlands

Location

Related Publications (1)

  • Koc OM, Savelkoul PHM, van Loo IHM, Peeters A, Oude Lashof AML. Safety and immunogenicity of HBAI20 Hepatitis B vaccine in healthy naive and nonresponding adults. J Viral Hepat. 2018 Sep;25(9):1048-1056. doi: 10.1111/jvh.12909. Epub 2018 May 9.

    PMID: 29660190RESULT

MeSH Terms

Conditions

Hepatitis B

Interventions

Hepatitis B Vaccines

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Viral Hepatitis VaccinesViral VaccinesVaccinesBiological ProductsComplex Mixtures

Limitations and Caveats

We are aware of the limitations of the small study population when drawing the tentative conclusions from this study.

Results Point of Contact

Title
Astrid ML Oude Lashof, MD, PHD
Organization
MaastrichtUMC
a.oudelashof@mumc.nl
0031433876644

Study Officials

  • Astrid ML Oude Lashof, PhD, MD

    Maastricht UMC

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2015

First Posted

September 4, 2015

Study Start

September 1, 2015

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

December 19, 2018

Results First Posted

November 29, 2018

Record last verified: 2018-11

Locations

NL(1)