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Hepatitis BPhase 2NCT03625934

Study to Evaluate Induction of HBV Virus Neutralizing Antibodies Using VVX001

A Phase 2 study testing VVX001 in people with Hepatitis B, run by Viravaxx AG at 2 sites in Austria.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Hepatitis B
What is being tested?
VVX001
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
84 participants
Where
2 sitesAustria
Study dates
6 Aug 2018to 31 Dec 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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
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  • 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
  • 5x ULN at screening

Who cannot join

  • 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)
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  • 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

Trial locations and contacts

2 sites in 1 country.

Helmut Brunar, PhD contact

+43 664 415 9511

h.brunar@viravaxx.com

Ghazaleh Gouya, MD contact

+43 650 470 4206

gouya@gouya-insights.com

Austria2 sites, 2 recruiting

  • Medical University of Graz

    Graz, 8036

    Rudolf Stauber, MD, +43 316 385 80268, rudolf.stauber@medunigraz.at

    Recruiting

  • Medical University of Vienna

    Vienna, 1090

    Ursula Wiedermann, MD, +43 1 40160 38290, ursula.wiedermann@meduniwien.ac.at

    Petra Munda, MD, +43 1 40400 4741, petra.munda@meduniwien.ac.at

    Recruiting

Other trials in Austria

About this study

Official title: Study to Evaluate the Induction of HBV Virus Neutralizing Antibodies in Healthy Vaccine Naive Adults and Non-responders and in Patients Chronically Infected With HBV Using VVX001

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.
Read the detailed 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.

Conditions
Hepatitis B
Being tested
VVX001, Placebo
Medical subject headings
Hepatitis B

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VVX001Biological

    5 s.c. injections of 20 micrograms of VVX001 four weeks apart

  • PlaceboBiological

    5 s.c. injections of matching Placebo four weeks apart

Study groups in NCT03625934
Study groupRoleWhat they receive
VVX001 (20 micrograms)ExperimentalSubjects will receive 5 injections of 20 micrograms each over a period of 4 months
Receives: Biological: VVX001
PlaceboPlacebo comparatorSubjects will receive 5 s.c. injections of matching placebo over a period of 4 months
Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PreS specific IgG antibodies

    Titer of PreS specific IgG antibodies

    Measured: 4 weeks after the last injection of study drug

Secondary outcomes (7)

  1. PreS specific IgG, IgG1 and IgG4 antibodies

    Titers of PreS specific IgG, IgG1 and IgG4 antibodies

    Measured: 4 weeks and 6 months after the last injection of study drug

  2. HbSAg specific antibodies

    Titers of HbSAg specific antibodies

    Measured: 4 weeks and 6 months after the last injection of study drug

  3. Suppression of HBV infection

    Suppression of HBV infection in HepG2-NTCP cells using HBV strain D3 in cell culture with patient sera

    Measured: 4 weeks and 6 months after the last injection of study drug

  4. T cell proliferation

    Proliferation of PreS specific CD4 and CD8 T cells

    Measured: 4 weeks and 6 months after the last injection of study drug

  5. HbSAg titers

    HbS Antigen titers will be measured in chronically infected patients

    Measured: 4 weeks and 6 months after the last injection of study drug

  6. HBV DNA load

    HBV DNA load will be measured by PCR in chronically infected patients

    Measured: 4 weeks and 6 months after the last injection of study drug

  7. HBVcrAg titers

    HBVcrAG titers will be measured in chronically infected patients

    Measured: 4 weeks and 6 months after the last injection of study drug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Aug 2018
  2. Study start6 Aug 2018
  3. Primary completion30 Sep 2023 (estimated)
  4. Study completion31 Dec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
84 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03625934
Sponsor's protocol ID
VVX001-CS001
Status last verified
Apr 2021
First submitted
2 Jul 2018
Last updated
6 Apr 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Cornelius C, Schoneweis K, Georgi F, Weber M, Niederberger V, Zieglmayer P, Niespodziana K, Trauner M, Hofer H, Urban S, Valenta R. Immunotherapy With the PreS-based Grass Pollen Allergy Vaccine BM32 Induces Antibody Responses Protecting Against Hepatitis B Infection. EBioMedicine. 2016 Sep;11:58-67. doi: 10.1016/j.ebiom.2016.07.023. Epub 2016 Aug 8.

    PubMed 27568223

  • Tulaeva I, Cornelius C, Zieglmayer P, Zieglmayer R, Schmutz R, Lemell P, Weber M, Focke-Tejkl M, Karaulov A, Henning R, Valenta R. Quantification, epitope mapping and genotype cross-reactivity of hepatitis B preS-specific antibodies in subjects vaccinated with different dosage regimens of BM32. EBioMedicine. 2020 Sep;59:102953. doi: 10.1016/j.ebiom.2020.102953. Epub 2020 Aug 24.

    PubMed 32855110

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing VVX001 in people with Hepatitis B, run by Viravaxx AG at 2 sites in Austria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Helmut Brunar, PhD (+43 664 415 9511, h.brunar@viravaxx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PreS specific IgG antibodies (time frame: 4 weeks after the last injection of study drug). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03625934, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2021.

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