Renal FailurePhase 2/3NCT02621112
HBV Vaccine in Renal Failure Patients
A Phase 2/3 study testing Intradermal HBVv with imiquimod, Intradermal HBVv with aqueous cream and Intramuscular HBVv with aqueous cream in people with Renal Failure, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
Hepatitis B virus infection remains an important clinical issue among patients on renal replacement therapy. Seroconversion rate as defined by an anti-HBs Ab titer > 10 IU/L after intramuscular hepatitis B vaccination (HBVv) remains poor in this cohort. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Renal Failure
- What is being tested?
- Intradermal HBVv with imiquimod, Intradermal HBVv with aqueous cream and Intramuscular HBVv with aqueous cream
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteHong Kong
- Study dates
- Jan 2016to Mar 2019
- Phase
- Phase 2/3
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients recruited have to be aged ≥ 21 years, with history of chronic renal failure and on renal replacement therapy (continuous ambulatory peritoneal dialysis or hemodialysis).
- All patients have to give written informed consent and will have up to 1 week period to decide.
- Subjects must be available to complete the study and comply with study procedures.
- Patients are willing to allow for serum samples to be stored beyond the study period, for potential additional future testing to better characterize immune response.
- All recruited subjects have to be HBsAg, anti-HBs and anti-HIV negative before recruitment.
Who cannot join
- Inability to comprehend and to follow all required study procedures
- History or any illness that might interfere with the results of the study or pose additional risk to the subjects due to participation in the study.
- Have a recent history (documented, confirmed or suspected) of a flu-like disease within a week of vaccination.
- Have a known allergy to components of the Study Vaccines.
- Have a positive urine or serum pregnancy test within 24 hours prior to vaccination, or women who are breastfeeding.
- Have an active neoplastic disease or a history of any hematologic malignancy.
Show all 13Show fewer
- Have known chronic active hepatitis B and hepatitis C (HBsAg+ve and anti-HCV+ve).
- Have known active human immunodeficiency virus (HIV).
- 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.
- Unwilling to refuse participation in another clinical study through the end of this study.
- Axillary temperature ≥ 38°C or oral temperature ≥ 38.5°C within 3 days of intended study vaccination.
- Have a history of alcohol or drug abuse in the last 5 years.
- Have any condition that the investigator believes may interfere with successful completion of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Intradermal Hepatitis B Vaccine in Renal Failure Patients
Hepatitis B virus infection remains an important clinical issue among patients on renal replacement therapy. Seroconversion rate as defined by an anti-HBs Ab titer > 10 IU/L after intramuscular hepatitis B vaccination (HBVv) remains poor in this cohort. Factors associated with inadequate anti-HBs response include older age, diabetes mellitus, obesity and low hepatitis B vaccine dose. Various small-scale studies including multiple high dose intramuscular vaccination or multiple small dose intradermal vaccination were attempted with variable response. Recent study on dose sparing seasonal influenza vaccine delivered via a novel intradermal microneedle has demonstrated good immunogenic responses similar to full-dose intramuscular vaccination. Imiquimod, a synthetic TLR7 agonist useful for the treatment of DNA virus infection, has been shown to improve vaccine immunogenicity. The investigators therefore propose a prospective, randomized study to compare the safety and immunogenicity of intradermal hepatitis B vaccination with this novel device with intramuscular in patients on renal replacement therapy.
Read the detailed description
The investigators aim to recruit at least 120 subjects on renal replacement therapy in this prospective double blind randomized controlled trial. All recruited subjects have to be HBsAg and anti-HBs negative before recruitment. Subjects were randomly assigned to three groups.
All patients received 4 doses of hepatitis B vaccine at 0,1,3 and 6 months: Group 1: to receive intradermal 10mcg of recombinant hepatitis B vaccine at two separate sites (5mcg) with topical imiquimod ointment pretreatment 5 minutes before injection. Group 2: to receive intradermal 10mcg of recombinant hepatitis B vaccine at two separate sites (5mcg) with topical placebo aqueous cream pretreatment 5 minutes before injection. Group 3: to receive intramuscular 10mcg (1mL) of recombinant hepatitis B vaccine at two separate sites (5mcg) with topical placebo aqueous cream pretreatment 5 minutes before injection.
Subjects will be advised not to wash the topical treatment for 8 hours after vaccination. Patients and investigators will be blinded to the type of topical treatment applied. Anti-HBs titre will be measured at baseline, before each vaccination, and at 12 and 18 months after the first dose of vaccination.
The primary end point is the seroprotection rate of the HBVv at 12 months after the first dose of vaccination. The secondary end points are the seroprotection rate of HBVv and the geometric mean titre (GMT) fold increase of the anti-HBs at 1, 3, 6, 12 (GMT only) and 18 months after the first dose of vaccination. Adverse reactions of the vaccine will also be assessed immediately and for 1 month after vaccination.
- Conditions
- Renal Failure
- Being tested
- Intradermal HBVv with imiquimod, Intradermal HBVv with aqueous cream, Intramuscular HBVv with aqueous cream
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intradermal HBVv with imiquimodBiological
Intradermal hepatitis B vaccine with imiquimod pretreatment
Intradermal HBVv with aqueous creamBiological
Intradermal hepatitis B vaccine with aqueous cream pretreatment
Intramuscular HBVv with aqueous creamBiological
Intramuscular hepatitis B vaccine with aqueous cream pretreatment
| Study group | Role | What they receive |
|---|---|---|
| Intradermal HBVv with imiquimod | Experimental | Intradermal hepatitis B vaccination with topical imiquimod pretreatment. Subjects to receive intradermal 10mcg of recombinant hepatitis B vaccine at two separate sites (5mcg) with topical imiquimod ointment pretreatment 5 minutes before injection at 0, 1, 3, 6 months Receives: Biological: Intradermal HBVv with imiquimod |
| Intradermal HBVv with aqueous cream | Active comparator | Intradermal hepatitis B vaccination with topical aqueous cream. Subjects to receive intradermal 10mcg of recombinant hepatitis B vaccine at two separate sites (5mcg) with topical aqueous cream pretreatment 5 minutes before injection at 0, 1, 3, 6 months Receives: Biological: Intradermal HBVv with aqueous cream |
| Intramuscular HBVv with aqueous cream | Active comparator | Intramuscular hepatitis B vaccination with topical aqueous cream. Subjects to receive intramuscular 10mcg of recombinant hepatitis B vaccine at two separate sites (5mcg) with topical aqueous cream pretreatment 5 minutes before injection at 0, 1, 3, 6 months Receives: Biological: Intramuscular HBVv with aqueous cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroprotection rate to HBV
percentage of recruited subjects with anti-HBs >10 mIU/mL
Measured: 12 months after first dose of hepatitis B vaccine
Secondary outcomes (3)
Adverse reaction to hepatitis B vaccine
Measured: 1 month
Seroprotection rate to HBV
percentage of recruited subjects with anti-HBs >10 mIU/mL
Measured: 1, 3, 6 and 18 months after first dose of hepatitis B vaccine
GMT fold increase of anti-HBs
Measured: 1, 3, 6, 12 and 18 months after first dose of hepatitis B vaccine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2015 (estimated)
- Study startJan 2016
- Primary completionDec 2018
- Study completionMar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal FailureStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ivan FN Hung, MD FRCP, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02621112
- Sponsor's protocol ID
- UW 11-209
- Status last verified
- Oct 2019
- First submitted
- 1 Dec 2015
- Last updated
- 22 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hung IF, Yap DY, Yip TP, Zhang RR, To KK, Chan KH, Tang SC, Lui SL, Levin Y, Kochba E, Lau JY, Yuen MF, Chan TM, Yuen KY. A Double-blind, Randomized Phase 2 Controlled Trial of Intradermal Hepatitis B Vaccination With a Topical Toll-like Receptor 7 Agonist Imiquimod, in Patients on Dialysis. Clin Infect Dis. 2021 Jul 15;73(2):e304-e311. doi: 10.1093/cid/ciaa804.
PubMed 32556176
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Intradermal Hepatitis B Vaccine in Renal Failure Patients
- ClinicalTrials.gov ID
- NCT02621112
- Acronym / sponsor ID
- UW 11-209
- Conditions
- Renal Failure
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Dec 2018 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 3 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hepatitis B virus infection remains an important clinical issue among patients on renal replacement therapy. Seroconversion rate as defined by an anti-HBs Ab titer > 10 IU/L after intramuscular hepatitis B vaccination (HBVv) remains poor in this cohort. Factors associated with inadequate anti-HBs response include older age, diabetes mellitus, obesity and low hepatitis B vaccine dose. Various small-scale studies including multiple high dose intramuscular vaccination or multiple small dose intradermal vaccination were attempted with variable response. Recent study on dose sparing seasonal influenza vaccine delivered via a novel intradermal microneedle has demonstrated good immunogenic responses similar to full-dose intramuscular vaccination. Imiquimod, a synthetic TLR7 agonist useful for the treatment of DNA virus infection, has been shown to improve vaccine immunogenicity. The investigators therefore propose a prospective, randomized study to compare the safety and immunogenicity of intradermal hepatitis B vaccination with this novel device with intramuscular in patients on renal replacement therapy.
Detailed description
The investigators aim to recruit at least 120 subjects on renal replacement therapy in this prospective double blind randomized controlled trial. All recruited subjects have to be HBsAg and anti-HBs negative before recruitment. Subjects were randomly assigned to three groups.
All patients received 4 doses of hepatitis B vaccine at 0,1,3 and 6 months: Group 1: to receive intradermal 10mcg of recombinant hepatitis B vaccine at two separate sites (5mcg) with topical imiquimod ointment pretreatment 5 minutes before injection. Group 2: to receive intradermal 10mcg of recombinant hepatitis B vaccine at two separate sites (5mcg) with topical placebo aqueous cream pretreatment 5 minutes before injection. Group 3: to receive intramuscular 10mcg (1mL) of recombinant hepatitis B vaccine at two separate sites (5mcg) with topical placebo aqueous cream pretreatment 5 minutes before injection.
Subjects will be advised not to wash the topical treatment for 8 hours after vaccination. Patients and investigators will be blinded to the type of topical treatment applied. Anti-HBs titre will be measured at baseline, before each vaccination, and at 12 and 18 months after the first dose of vaccination.
The primary end point is the seroprotection rate of the HBVv at 12 months after the first dose of vaccination. The secondary end points are the seroprotection rate of HBVv and the geometric mean titre (GMT) fold increase of the anti-HBs at 1, 3, 6, 12 (GMT only) and 18 months after the first dose of vaccination. Adverse reactions of the vaccine will also be assessed immediately and for 1 month after vaccination.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intradermal HBVv with imiquimod | Experimental | Biological: Intradermal HBVv with imiquimodIntradermal hepatitis B vaccination with topical imiquimod pretreatment. Subjects to receive intradermal 10mcg of recombinant hepatitis B vaccine at two separate sites (5mcg) with topical imiquimod ointment pretreatment 5 minutes before injection at 0, 1, 3, 6 months |
| Intradermal HBVv with aqueous cream | Active comparator | Biological: Intradermal HBVv with aqueous creamIntradermal hepatitis B vaccination with topical aqueous cream. Subjects to receive intradermal 10mcg of recombinant hepatitis B vaccine at two separate sites (5mcg) with topical aqueous cream pretreatment 5 minutes before injection at 0, 1, 3, 6 months |
| Intramuscular HBVv with aqueous cream | Active comparator | Biological: Intramuscular HBVv with aqueous creamIntramuscular hepatitis B vaccination with topical aqueous cream. Subjects to receive intramuscular 10mcg of recombinant hepatitis B vaccine at two separate sites (5mcg) with topical aqueous cream pretreatment 5 minutes before injection at 0, 1, 3, 6 months |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients recruited have to be aged ≥ 21 years, with history of chronic renal failure and on renal replacement therapy (continuous ambulatory peritoneal dialysis or hemodialysis).
- All patients have to give written informed consent and will have up to 1 week period to decide.
- Subjects must be available to complete the study and comply with study procedures.
- Patients are willing to allow for serum samples to be stored beyond the study period, for potential additional future testing to better characterize immune response.
- All recruited subjects have to be HBsAg, anti-HBs and anti-HIV negative before recruitment.
Key exclusion criteria (13 listed)
- Inability to comprehend and to follow all required study procedures
- History or any illness that might interfere with the results of the study or pose additional risk to the subjects due to participation in the study.
- Have a recent history (documented, confirmed or suspected) of a flu-like disease within a week of vaccination.
- Have a known allergy to components of the Study Vaccines.
- Have a positive urine or serum pregnancy test within 24 hours prior to vaccination, or women who are breastfeeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intradermal HBVv with imiquimodIntradermal hepatitis B vaccine with imiquimod pretreatment | Biological | Intradermal HBVv with imiquimod |
| Intradermal HBVv with aqueous creamIntradermal hepatitis B vaccine with aqueous cream pretreatment | Biological | Intradermal HBVv with aqueous cream |
| Intramuscular HBVv with aqueous creamIntramuscular hepatitis B vaccine with aqueous cream pretreatment | Biological | Intramuscular HBVv with aqueous cream |
Primary outcome
Seroprotection rate to HBV
Time frame: 12 months after first dose of hepatitis B vaccine
percentage of recruited subjects with anti-HBs >10 mIU/mL
3 secondary outcomes
Adverse reaction to hepatitis B vaccine
Time frame: 1 month
Seroprotection rate to HBV
Time frame: 1, 3, 6 and 18 months after first dose of hepatitis B vaccine
GMT fold increase of anti-HBs
Time frame: 1, 3, 6, 12 and 18 months after first dose of hepatitis B vaccine
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2019.
- Derived from this study: PubMed 32556176Hung IF, Yap DY, Yip TP, Zhang RR, To KK, Chan KH, Tang SC, Lui SL, Levin Y, Kochba E, Lau JY, Yuen MF, Chan TM, Yuen KY. A Double-blind, Randomized Phase 2 Controlled Trial of Intradermal Hepatitis B Vaccination With a Topical Toll-like Receptor 7 Agonist Imiquimod, in Patients on Dialysis. Clin Infect Dis. 2021 Jul 15;73(2):e304-e311. doi: 10.1093/cid/ciaa804.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ivan FN Hung, MD FRCP principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Intradermal HBVv with imiquimod, Intradermal HBVv with aqueous cream and Intramuscular HBVv with aqueous cream in people with Renal Failure, run by The University of Hong Kong at 1 site in Hong Kong.
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 5 inclusion and 13 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: finished, as of the sponsor's last update on 22 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seroprotection rate to HBV (time frame: 12 months after first dose of hepatitis B vaccine). 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 NCT02621112, which also lists 1 linked publication.
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 22 Oct 2019.