In the Phase 2 clinical study, the efficacy of the vaccine in non-responders and the safety of the vaccine will be studied.
ID
Source
Brief title
Condition
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameter is the efficacy of the HBAI20 vaccination for
non-responders. To this end, the immunogenicity of the HBAI20 vaccine will be
measured by median antibody titre, GMT, GMT gain and seroprotection.
Seroprotection is defined as a fourfold increase in titer or a conversion of
seronegative to a virus antibody titre of * 10 mlU/ml.
Secondary outcome
The secondary study parameter is the safety of the HBAI20 vaccine, in which the
number and intensity of local and systemic side effects is investigated.
Background summary
Worldwide people suffer from infection with hepatitis B virus (HBV). There are
prophylactic vaccines against HBV available that in most cases provide adequate
protection. However a small group (5-7% of the population) reacts not or not
sufficiently, these are so-called non-responders. For persons who are likely to
come into contact with infected blood (healthcare, care-workers, teachers,
police, firefighters and soldiers), CyTuVax has developed a new adjuvant (AI20)
to be mixed with the standard hepatitis B vaccine for an effective vaccination
against Hepatitis B. The HBAI20 vaccine adjuvant consists of depot-bound rhuIL2
adjuvant (InterLeukin 2) aggregates for the slow release of IL-2
nano-aggregates.
In a previous Phase 1 study it has been shown that the vaccine is safe (side
effects between the group of subjects who were vaccinated with the HBAI20
vaccine were similar to the group of subjects who were vaccinated with the
standard Hepatitis B vaccine. Furthermore, it was shown that the group
non-responders who have been vaccinated with HBAI20 vaccine, 90% had become
responders after 3 vaccinations with the HBAI20 vaccine and had developed a
protective titer against Hepatitis B.
Study objective
In the Phase 2 clinical study, the efficacy of the vaccine in non-responders
and the safety of the vaccine will be studied.
Study design
The current study is a multi-centre, double-blinded, randomized and controlled
trial.
The study will be conducted at MUMC+, Maastricht, Ziekenhuis Oost Limburg, Genk
and Antwerp University, Antwerp.
The duration of the study is 5 months from the start (V0) until the end (V4)
for each subject. The expected total duration of the study is 2 years from the
beginning of enrolment to the last visit of the last subject.
Study subjects are healthy subjects that are non-responders for the Hepatitis B
vaccine presenting an anti HBsAg antibody titer *10mIU/ml. Subjects who have
completed at least 1 vaccination series consisting of 3 or more Hepatitis B
vaccinations will be enrolled for participation in groups 1 or 2 after
randomization. All the Hepatitis B vaccinations need to be documented for the
subjects to be enrolled in the study.
132 to 140 Hepatitis B vaccine non-responders are randomized into *Group 1* (33
to 35 subjects) and *Group 2* (99 to 105 subjects). Hepatitis B non-responders
that have received only 3 vaccinations should constitute at least 40% of the
total number of subjects in each group.
*Group 1* subjects will receive the HBVaxPro-10µg and serve as control group.
*Group 2* subjects will receive the HBAI20 vaccine.
Intervention
The subjects are vaccinated three times, in M0, M1 and M2.
Study burden and risks
The study participants will come to the hospital for 5 visits and will be
vaccinated 3 times.
From the Phase 1 study it was found that the risk profile of HBAI20 is similar
to the risk profile of a standard Hepatitis B vaccination.
Oxfordlaan 55
Maastricht 6229EV
NL
Oxfordlaan 55
Maastricht 6229EV
NL
Listed location countries
Age
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
Having a signed informed consent form
Documented non-responders: Subjects with documented one or two cycles of Hepatitis B vaccination (total of 3 or more vaccinations) and titer analysis that show that they have not developed the Hepatitis B antibody titer recommended after standard vaccination: anti-HBsAg antibody titer superior to 10mIU/ml
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, cancer and transplantation recipients
Known or suspected allergy to any of the vaccine components: see IB, IMPD
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)
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 4
Females: positive urine 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 6 months
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2016-002720-91-NL |
| ClinicalTrials.gov | NCT03415672 |
| CCMO | NL58391.000.16 |