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CompletedNCT03307902Updated Oct 22, 2019

ID HBV Vaccination With Imiquimod in OBI

A Phase 2/3 interventional study of Imiquimod + ID HBVv and Aqueous + ID HBVv in Hepatitis B, sponsored by The University of Hong Kong. Completed at 1 site in Hong Kong. Open to participants aged 27 Years and older. Per ClinicalTrials.gov, last updated 2019-10-22.

Sponsored by The University of Hong Kong · Phase 2/3, Interventional, and Prevention

Phase
Phase 2/3
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
27 Years and older
Sex
All
01

Study summary

During the course of chronic hepatitis B infection, patients may undergo hepatitis B surface antigen (HBsAg) seroclearance, resulting in undetectable circulating HBsAg. With the advance of sensitive nucleic acid detection techniques, HBsAg-negative subjects with detectable HBV DNA in sera or liver tissues can be identified. Patients who have undetectable HBsAg and yet detectable HBV DNA in sera or liver tissues are defined as having occult HBV infection (OBI). OBI as a cause of liver disease in HBsAg-negative patients remains clinically important [1,2]. Studies conducted by our research group had demonstrated that patients with HBsAg seroclearance could still develop flare of hepatitis B, advanced liver diseases and HCC [3-6]. Prevention of these complications in OBI patients by conventional intramuscular hepatitis B vaccination (HBVv) remains elusive with poor amnestic anti-HBs response [7].

The objective of this prospective double-blind randomized controlled trial is to evaluate the effect and safety of topical treatment with imiquimod immediately before intradermal vaccination with Sci-B-Vac™ in patients with OBI. Our a priori hypothesis is that imiquimod pretreatment would improve immune responses to Sci-B-Vac™ further in OBI patients, resulting in HBsAb conversion. Thereby preventing subsequent complications including flare of hepatitis, cirrhosis and HCC in these patients.

Read the detailed description

This randomized double-blind placebo-controlled trial will compare the safety, immunogenicity and clinical efficacy of Sci-B-Vac™ with topical ointment pretreatment among 5 groups. Group 1: Intradermal Sci-B-Vac™ with topical imiquimod ointment pretreatment; Group 2: Intradermal Sci-B-Vac™ with topical aqueous cream (placebo) pretreatment; Group 3: Intramuscular Sci-B-Vac™ with topical imiquimod ointment pretreatment.

Vaccination Regimen and Data Collection Enrolled patients will be randomized into 3 groups after written informed consent. Each patient will receive a 3 doses Sci-B-Vac™ regime at 0, 1 and 6 months. Group 1 will receive a total of 10μg intradermal HBsAg each time with topical imiquimod ointment pretreatment; Group 2 will receive a total of 10μg intradermal HBsAg each time with topical aqueous cream pretreatment. Group 3 will receive a total of 10μg intramuscular HBsAg each time with topical imiquimod ointment pretreatment.

The primary outcome measurement will be the seroprotection rate of the HBVv at 12 months after the first dose of vaccination and the secondary outcome measurements will include the seroconversion rate, the GMT fold increase and the safety of the intradermal Sci-B-Vac™ with topical imiquimod treatment at other time points.

02

Conditions studied

  • Hepatitis B

Keywords

  • Vaccination
03

Who can participate

Ages eligible
27 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Subjects recruited have to be aged ≥27 years (born before the universal hepatitis B immunization program for newborns introduced in Hong Kong in 1988), with documentation of loss of HBsAg without anti-HBs production during follow-up of the chronic hepatitis B infection in our clinics in Queen Mary Hospital. These patients should have normal liver function tests.
  • Subjects have to give written informed consent.
  • Subjects must be available to complete the study and comply with study procedures.
  • Subjects are willing to allow for serum samples to be stored beyond the study period, for potential additional future testing to better characterize immune response.

Exclusion criteria

Exclusion Criteria:

  • Subjects with a history or any illness that might interfere with the results of the study or participation in the study may pose additional risk to the subjects.
  • Subjects have a recent history (documented, confirmed or suspected) of a flu-like disease within a week of vaccination.
  • Subjects have a known allergy to components of the study vaccine Sci-B-Vac™.
  • Subjects have a positive urine or serum pregnancy test within 24 hours prior to vaccination, or women who are breastfeeding.
  • Subjects have an active neoplastic disease or a history of any hematologic malignancy.
  • Subjects have known chronic active hepatitis C (anti-HCV+ve), autoimmune hepatitis or cirrhosis.
  • Subjects have known active human immunodeficiency virus infection (anti-HIV+ve).
  • Subjects have known chronic liver disease due to primary biliary cirrhosis, metabolic or hereditary causes.
  • Subjects have received an experimental agent (vaccine, drug, biologic, device, blood product, or medication) within 1 month prior to vaccination in this study or expect to receive an experimental agent during this study.
  • Subjects participate in another clinical study during the current study.
  • Subjects have axillary temperature ≥38°C or oral temperature ≥38.5°C within 3 days of intended study vaccination
  • Subjects have a history of alcohol or drug abuse in the last 5 years.
  • Subjects have any condition that the investigator believes may interfere with successful completion of the study.
04

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
120 participants (actual)

Study arms

  • Experimental
    Imiquimod + ID HBVv

    topical imiquimod + intradermal hepatitis B vaccination

    Biological: Imiquimod + ID HBVv

  • Active comparator
    Aqueous + ID HBVv

    topical aqueous + intradermal hepatitis B vaccination

    Biological: Aqueous + ID HBVv

  • Active comparator
    Imiquimod + IM HBVv

    topical imiquimod + intramuscular hepatitis B vaccination

    Biological: Imiquimod + IM HBVv

Interventions

  • BiologicalImiquimod + ID HBVv

    Imiquimod ointment + intradermal 10μg Sci-B-Vac vaccine

  • BiologicalAqueous + ID HBVv

    Aqueous ointment + intradermal 10μg Sci-B-Vac vaccine

  • BiologicalImiquimod + IM HBVv

    Imiquimod ointment + intramuscular 10μg Sci-B-Vac vaccine

05

What researchers measure

Primary outcomes

  1. Seroprotection rate to HBV at 12 month

    Percentage of recruited subjects with anti-HBs antibody titre \>10mIU/mL

    Time frame: 12 month

Secondary outcomes

  1. Seroprotection rate to HBV at 1 month

    Percentage of recruited subjects with anti-HBs antibody titre \>10mIU/mL

    Time frame: 1 month

  2. Seroprotection rate to HBV at 6 month

    Percentage of recruited subjects with anti-HBs antibody titre \>10mIU/mL

    Time frame: 6 month

  3. GMT of anti-HBs at 1 month

    Geometric mean titre of anti-HBs antibody at 1 month after vaccination

    Time frame: 1 month

  4. GMT of anti-HBs at 6 month

    Geometric mean titre of anti-HBs antibody at 6 month after vaccination

    Time frame: 6 month

  5. GMT of anti-HBs at 12 month

    Geometric mean titre of anti-HBs antibody at 12 month after vaccination

    Time frame: 12 month

06

Study locations

1 site
  • University of Hong Kong
    Hong Kong, Hong Kong
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03307902
Lead sponsor
The University of Hong Kong
Responsible party
Sponsor
First posted
Oct 12, 2017
Start date
Oct 1, 2016
Primary completion
Mar 31, 2019
Completion
Jul 31, 2019
Last update
Oct 22, 2019

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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