Study to Evaluate Induction of HBV Virus Neutralizing Antibodies Using VVX001

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    84
  • sponsor
    Viravaxx AG
Updated on 12 February 2022
hepatitis
vaccination
hepatitis b antigen
hepatitis b core antibody
Accepts healthy volunteers

Summary

The Study will evaluate the effects of VVX001, a novel vaccine for hepatitis B, to

  • elicit a robust protective IgG immune response in vaccine naive subjects
  • in subjects who failed to demonstrate seroconversion after treatment with a licensed hepatitis B vaccine and
  • in patients chronically infected with HBV.

Description

VVX001 is a recombinant fusion Protein composed of PreS from the large surface antigen of HBV and Peptides derived from the grass pollen allergen Phl p 5. In a previous trial in allergic but otherwise healthy subjects the product has been shown to elicit a potent IgG response to the epitope of PreS1, which is responsible for binding to the cellular receptor NTCP. These antibodies prevent infection with HBV in a cell culture model. The present study will evaluate if such an immune response can also be achieved in four different patient populations: 1) vaccine naive subjects; 2) subjects having failed to seroconvert upon vaccination with a licensed HBV vaccine; 3) patients who are chronically infected with HBV, but are classified as inactive carriers; 4) patients with active chronic HBV infection who are HbEAg negative and chronically treated with nucleo(t)side (NUC) antiviral drugs. All subjects will receive 5 s.c. injections of VVX001, the time course of antibody response to PreS1 will be monitored in all of them. In cohort 4) NUC treatment will be withdrawn at different timepoints during the study and the effect of treatment with VVX001 on hepatitis B disease Parameters will be monitored. Subjects will be followed for 6 months after the of treatment for Evaluation of a long-term effect.

Details
Condition Hepatitis B
Treatment Placebo, VVX001
Clinical Study IdentifierNCT03625934
SponsorViravaxx AG
Last Modified on12 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Cohort 1: hepatits B vaccine naive subjects Seronegative for anti-HBs and anti-HBc antibodies and for HBs Antigen
Cohort 2: Subjects who failed to develop a protective immune response upon standard vaccination with a licensed hepatitis B vaccine (<10 IU/L anti HbS antibodies) Seronegative for anti-HbS (<10 IU/L) and anti-HBc antibodies and for HbSAg
Cohort 3: Parameters confirmed at screening during the past 12 months
HBeAg negative
HbSAg positive at screening <3000 IU/ml
HBV viral load <2000 IU/ml
ALT Levels ULN at screening
Cohort 4a: Parameters confirmed at screening during the last 12 months
HBeAg negative
HbSAg positive <1000 IU/ml
HBV DNA not detectable for at least 2 years
History of nucleos(t)die Treatment for at least 3 years
Willingness to discontinue NUC treatment during study
ALT levels ULN at screening
Cohort 4b: in addition to cohort 4a
willingness to discontinue NUC treatment 6 weeks before entering the Study
ALT Levels ULN 6 weeks before entering the study and
x ULN at screening

Exclusion Criteria

Pregnant or breast-feeding females, adequate contraception required during the treatment phase
History of grass pollen allergy
Co-infection with HCV, HDV, HIV
History of auto-immune hepatitis
Elevated Levels of Alpha-Fetoprotein (AFP) >100 ng/ml
Documented history of decompensated liver disease (albumin <3.5 g/dl and bilirubin >1.3 mg/dl)
Autoimmune disorders, transplant recipients, use of immunosuppressive or immune modulating agents
Oral corticosteroids of 20 mg/week within the past 4 weeks prior to screening
History of treatment with PEG-IFN of IFN for at least 1 year prior to screening
History of evidence or conditions associated with chronic liver disease
Acute fever at time of enrolment
History of alcohol abuse
Planned administration of a vaccine not foreseen by study protocol in the period starting 30 days before first product administration and during the entire study period with exception of influenza vaccine
History of Cancer
Other severe co-morbid conditions and concurrent medication making the subject unsuitable for participation
blood or plasma donation within 1 month of study enrolement and during the course of the study
For all patients with chronic HBV infection
Total bilirubin >2x ULN confirmed by repeat testing within 2 weeks, unless historical documentation of Gilbert's syndrome
Documented or suspected hepatocelluar carcinoma
Presence of cholangitis, cholecystitis or bile duct obstruction
Liver cirrhosis assessed by fibroscan with elastography <9kPa within the previous 12 months and FIB-score <3.2 at study entry
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