Viral Hepatitis BPhase 4NCT03854630
Hepatitis B Virus Vaccination in HIV-positive Patients and Individuals at High Risk for HIV Infection
A Phase 4 study testing Engerix-B in people with Viral Hepatitis B and Immunization; Infection, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The primary aim of this open-label, randomized control trial is to compare the immunogenicity at week 28 after 20µg HBV vaccine (at week 0, 4, 24) versus 40µg HBV vaccine (40-µg at week 0, 4, 24 week) among HIV-positive patients or HIV-negative MSM who were born in Taiwan after July 1986 and tested negative for all… Read more about this study
- Who is it for?
- Ages 20 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Viral Hepatitis B, Immunization; Infection, HIV Infections
- What is being tested?
- Engerix-B
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 575 participants
- Where
- 1 siteTaiwan
- Study dates
- 6 Sep 2017to 31 Dec 2023
- Phase
- Phase 4
- 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 20 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men who have sex with men (MSM)
- Birth date after 1986/7/1 and aged 20 years or older
- Seronegative for HBsAg, anti-HBs (<10 mIU/ml), and anti-HBc at screening (within 1 month of the first dose)
- Regularly receiving HIV care for HIV-positive patients over the past 6 months
- Seeking VCT for at least once for HIV-negative patients over the past 12 months
Who cannot join
- Active infection or malignancy within 12 months of screening
- Receiving chemotherapy, immunosuppressant, or IVIG within 12 months of screening
- Received higher than 5 mg of prednisolone, including IV, oral, or topical form, per day for more than 1 weeks within 6 months of screening
- Receiving HBV vaccination within 1 months of screening, or being allergic to HBV vaccine
- Receiving other vaccination within 1 months of screening, such as influenza, pneumococcus, HPV, HAV, varicella vaccine.
- Stage 4 and 5 of chronic kidney disease (GFR<30 mL/min/1.73m), or receiving dialysis.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Chien-Ching Hung, MD, PhD, +886-2-23123456 ext. 67552, hcc0401@ntu.edu.tw
About this study
Official title: Hepatitis B Virus Vaccination in HIV-positive Patients and Individuals at High Risk for HIV Infection: an Open-label Randomized Clinical Trial
The primary aim of this open-label, randomized control trial is to compare the immunogenicity at week 28 after 20µg HBV vaccine (at week 0, 4, 24) versus 40µg HBV vaccine (40-µg at week 0, 4, 24 week) among HIV-positive patients or HIV-negative MSM who were born in Taiwan after July 1986 and tested negative for all HBV serological markers. The secondary aims are to assess the safety of double-dose HBV vaccination, the proportions of high-level responders (anti-HBs antibody >100 mIU/ml) at weeks 28 and 48, the serological responses at week 48, and incident HBV infection (indicated by appearance of anti-HBc and/or HBsAg) at week 48.
Read the detailed description
- Study procedures:
- Well explain, complete inform and consent documents
- A blood test for hepatitis B surface antigen (HBsAg), anti-hepatitis B surface antibody (anti-HBs antibody), anti-hepatitis B core antibody (anti-HBc antibody), anti-HCV and RPR will be performed first.
- The patients with all negative seromarkers (within 1 month) will be allocated to two groups (random blank=4), a standard-dose booster of 20µg and a double-dose booster of 40µg. For patients receiving 40µg, two 20µg of vaccines are injected at both sides of deltoid muscles. The schedules of booster vaccination are the same in two groups, which is at 0, 1, 6 months.
- To detect and manage possible immediate and severe allergic reaction, patients who received vaccination will be observed for 30 minutes after injection.
- The solicited adverse effect will be recorded on the diary card if occurred in 7 days after each dose of vaccination.
- The titer of hepatitis B surface antibody will be examined before booster vaccination, at the 4th week, the 24th week, 28th week, 48th week. By comparing the responses in the two groups, the effect of different doses of booster vaccination can be evaluated. For those HIV-negative individuals at baseline, HIV screening test will be evaluated every 6 months during the study, at the 24th week, the 48th.
- To screen the acquisition of hepatitis B, the anti-HBc antibody and HBsAg will be examined at the 48th week
- To screen the acquisition of hepatitis C and syphilis, anti-HCV and RPR will be examined at the 24th week, the 48th week
- The results of the study will be informed by phone or the physician during the follow-up care.
- The serum/blood samples will be preserved in the research lab of the department of internal medicine and kept for 20 years. During this period, the sample will be applied or used in other studies after the patients and the Research Ethics Committee both agreed.
- During the follow-up care, the treatment or record of hospitalization will be recorded or reviewed.
- The participants will drop out of clinical trial when protocol violation occurred or the participant is not willing to continue.
- Conditions
- Viral Hepatitis B, Immunization; Infection, HIV Infections
- Being tested
- Engerix-B
- Medical subject headings
- Hepatitis B, Infections, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Engerix-BDrug
The vaccine contains HBsAg which was produced by genetic engineering yeast. It stimulates the active immunity generated by human immune system toward the HBsAg.
| Study group | Role | What they receive |
|---|---|---|
| Standard dose (20µg) | Active comparator | Three doses of 20µg HBV vaccine given intramuscularly at week 0, 4, 24. Receives: Drug: Engerix-B |
| Double dose (40µg) | Experimental | Three doses of 40µg HBV vaccine given intramuscularly at week 0, 4, 24. Receives: Drug: Engerix-B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaccine efficacy
The proportion of patients with Anti-HBs antibody higher than 10mIU/ml
Measured: week 28
Secondary outcomes (6)
High-titer response
The proportion of patients with Anti-HBs antibody higher than 100mIU/ml
Measured: week 28
Long-term efficacy
The proportion of anti-HBs antibody titers higher than 10mIU/ml
Measured: 48 weeks
Long-term high-titer response
The proportion of anti-HBs antibody titers higher than 100mIU/ml
Measured: 48 weeks
Hepatitis B incident infection rate
new HBsAg and anti-HBc antibody seroconversion
Measured: 48 weeks,
Hepatitis C infection and syphilis infection rate
new hepatitis C infection and syphilis infection
Measured: at 24 week, 48 weeks
HIV seroconversion among HIV-negative MSM
new HIV seroconversion among HIV-negative MSM
Measured: at 24 weeks, 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2019
- Study start6 Sep 2017
- Primary completion1 Jun 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Viral Hepatitis BStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 575 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Taipei Veterans General Hospital, Taiwan
- Responsible party
- Sponsor
- Investigators
- Chien-Ching Hung, MD, PhD, Principal investigator, Department of Internal Medicine, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03854630
- Sponsor's protocol ID
- 201608051MIPC
- Status last verified
- May 2020
- First submitted
- 7 Sep 2017
- Last updated
- 22 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatitis B Virus Vaccination in HIV-positive Patients and Individuals at High Risk for HIV Infection: an Open-label Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03854630
- Acronym / sponsor ID
- 201608051MIPC
- Conditions
- Viral Hepatitis B, Immunization; Infection, HIV Infections
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 575 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- Taipei Veterans General Hospital, Taiwan
- Study start
- 6 Sep 2017 (actual)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 26 Feb 2019 (actual)
- 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.
The primary aim of this open-label, randomized control trial is to compare the immunogenicity at week 28 after 20µg HBV vaccine (at week 0, 4, 24) versus 40µg HBV vaccine (40-µg at week 0, 4, 24 week) among HIV-positive patients or HIV-negative MSM who were born in Taiwan after July 1986 and tested negative for all HBV serological markers. The secondary aims are to assess the safety of double-dose HBV vaccination, the proportions of high-level responders (anti-HBs antibody >100 mIU/ml) at weeks 28 and 48, the serological responses at week 48, and incident HBV infection (indicated by appearance of anti-HBc and/or HBsAg) at week 48.
Detailed description
- Study procedures:
- Well explain, complete inform and consent documents
- A blood test for hepatitis B surface antigen (HBsAg), anti-hepatitis B surface antibody (anti-HBs antibody), anti-hepatitis B core antibody (anti-HBc antibody), anti-HCV and RPR will be performed first.
- The patients with all negative seromarkers (within 1 month) will be allocated to two groups (random blank=4), a standard-dose booster of 20µg and a double-dose booster of 40µg. For patients receiving 40µg, two 20µg of vaccines are injected at both sides of deltoid muscles. The schedules of booster vaccination are the same in two groups, which is at 0, 1, 6 months.
- To detect and manage possible immediate and severe allergic reaction, patients who received vaccination will be observed for 30 minutes after injection.
- The solicited adverse effect will be recorded on the diary card if occurred in 7 days after each dose of vaccination.
- The titer of hepatitis B surface antibody will be examined before booster vaccination, at the 4th week, the 24th week, 28th week, 48th week. By comparing the responses in the two groups, the effect of different doses of booster vaccination can be evaluated. For those HIV-negative individuals at baseline, HIV screening test will be evaluated every 6 months during the study, at the 24th week, the 48th.
- To screen the acquisition of hepatitis B, the anti-HBc antibody and HBsAg will be examined at the 48th week
- To screen the acquisition of hepatitis C and syphilis, anti-HCV and RPR will be examined at the 24th week, the 48th week
- The results of the study will be informed by phone or the physician during the follow-up care.
- The serum/blood samples will be preserved in the research lab of the department of internal medicine and kept for 20 years. During this period, the sample will be applied or used in other studies after the patients and the Research Ethics Committee both agreed.
- During the follow-up care, the treatment or record of hospitalization will be recorded or reviewed.
- The participants will drop out of clinical trial when protocol violation occurred or the participant is not willing to continue.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard dose (20µg) | Active comparator | Drug: Engerix-BThree doses of 20µg HBV vaccine given intramuscularly at week 0, 4, 24. |
| Double dose (40µg) | Experimental | Drug: Engerix-BThree doses of 40µg HBV vaccine given intramuscularly at week 0, 4, 24. |
Who may qualify
- Ages
- 20 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men who have sex with men (MSM)
- Birth date after 1986/7/1 and aged 20 years or older
- Seronegative for HBsAg, anti-HBs (<10 mIU/ml), and anti-HBc at screening (within 1 month of the first dose)
- Regularly receiving HIV care for HIV-positive patients over the past 6 months
- Seeking VCT for at least once for HIV-negative patients over the past 12 months
Key exclusion criteria (6 listed)
- Active infection or malignancy within 12 months of screening
- Receiving chemotherapy, immunosuppressant, or IVIG within 12 months of screening
- Received higher than 5 mg of prednisolone, including IV, oral, or topical form, per day for more than 1 weeks within 6 months of screening
- Receiving HBV vaccination within 1 months of screening, or being allergic to HBV vaccine
- Receiving other vaccination within 1 months of screening, such as influenza, pneumococcus, HPV, HAV, varicella vaccine.
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 |
|---|---|---|
| Engerix-BThe vaccine contains HBsAg which was produced by genetic engineering yeast. It stimulates the active immunity generated by human immune system toward the HBsAg. | Drug | Double dose (40µg), Standard dose (20µg) |
Primary outcome
Vaccine efficacy
Time frame: week 28
The proportion of patients with Anti-HBs antibody higher than 10mIU/ml
6 secondary outcomes
High-titer response
Time frame: week 28
Long-term efficacy
Time frame: 48 weeks
Long-term high-titer response
Time frame: 48 weeks
Hepatitis B incident infection rate
Time frame: 48 weeks,
Hepatitis C infection and syphilis infection rate
Time frame: at 24 week, 48 weeks
HIV seroconversion among HIV-negative MSM
Time frame: at 24 weeks, 48 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2020.
- Individual participant dataSharing planned: No
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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.
Chien-Ching Hung, MD, PhD principal investigator
Department of Internal Medicine, National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Engerix-B in people with Viral Hepatitis B and Immunization; Infection, run by National Taiwan University Hospital at 1 site in Taiwan.
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 6 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 22 May 2020. 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 Taiwan. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Chien-Ching Hung, MD, PhD (+886-2-23123456 ext. 67552, hcc0401@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vaccine efficacy (time frame: week 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 May 2020.