Hepatitis B Vaccination, HIVPhase 4NCT03212911
HBV Vaccination in HIV-infected Adults
A Phase 4 study testing Hepatitis B vaccine in people with Hepatitis B Vaccination, HIV, run by Chiang Mai University at 1 site in Thailand.
Trial summary
The finding of isolated hepatitis B core antibody (isolated HBc) in absent of recent active hepatitis could cause by several scenarios, including false positive, remote infection without viremia, and occult infection with low viremia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis B Vaccination, HIV
- What is being tested?
- Hepatitis B vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jul 2017to 1 Jul 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥ 18 years
- On combination antiretroviral therapy (cART)
- CD4 ≥ 200 cell/mm3 for ≥ 1 year
- HIV viral load < 20 copies/ml for ≥ 1 year
- Isolated anti-HBc Ab (negative HBsAg, anti-HBs Ab) and negative anti-HCV at screening
Who cannot join
- Pregnancy
- Previous HBV vaccination
- Intolerance to any component of HBV vaccine
- Transaminitis in the past 3 months (≥ 5 UNL)
- Ongoing opportunistic infection (OI)
- Active malignancy, with current chemotherapy or radiotherapy
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- Systemic steroid therapy (≥ 0.5 mg/kg/day) or any immunomodulating therapy in the last 6 months
- Other immunocompromised disorders (e.g. solid organ transplant)
- Asplenism
- Renal insufficiency (CrCl ≤ 30 mL/min)
- Decompensated cirrhosis (Child-Pugh C)
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Maharaj Nakorn Chiang Mai Hospital, Department of medicine, Chiang Mai University
Muang, Chiang Mai, Chiang Mai, 50200
Romanee Chaiwarith, MD, +66-5393-6457, rchaiwar@gmail.com
Quanhathai Kaewpoowat, MD, +66-5393-6457, quanhathai@rihes.org
About this study
Official title: Immunogenicity and Safety of 4- vs. 3-standard Doses HBV Vaccination in HIV-infected Adults With Isolated Anti-HBc Antibody
The finding of isolated hepatitis B core antibody (isolated HBc) in absent of recent active hepatitis could cause by several scenarios, including false positive, remote infection without viremia, and occult infection with low viremia. Hepatitis B virus (HBV) vaccine booster could be a great prevention strategy for those who do not have HBV viremia. There is no standard consensus for management of this issue especially among HIV infected population. In addition, prior studies revealed that HIV-infected individuals had lower immunologic response to HBV vaccine than general population. This study intends to compare the immune response and safety of 4- versus 3-standard dose of hepatitis B virus vaccination in HIV-infected adults who has isolated HBc. The immunologic response will be evaluated after the participants receive vaccination.
Read the detailed description
- A randomized controlled trial to evaluate differences in immunogenicity and safety of the two hepatitis B vaccination regimens, including the percentage of responders, high-level responders, anamnestic response, geometric mean titers of anti-HBs antibody, adverse events and predictive factors associated with vaccine responsiveness
- After participant enrollment, data on baseline characteristics, time since HIV diagnosis, CD4 counts, HIV viral load, antiretroviral treatment regimen and duration will be collected, then the participants will be randomized into 2 groups to receive either 3- or 4-standard doses (20 mcg per dose) of HBV vaccination, and follow-up blood test for anti-HBs titers at multiple pre-specified time points to evaluate outcomes
- Conditions
- Hepatitis B Vaccination, HIV
- Being tested
- Hepatitis B vaccine
- Keywords
- HBV vaccination, HIV, isolated anti-HBc
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hepatitis B vaccineBiological
Hepatitis B vaccine (20 mcg/ml) 1 ml intramuscular injection in 3 (at 0, 1, 6 months) or 4 doses (0, 1, 2, 6 months)
| Study group | Role | What they receive |
|---|---|---|
| 3-standard dose HBV vaccination group | Active comparator | participants will receive 3 standard doses of HBV vaccination at 0, 1, 6 months Receives: Biological: Hepatitis B vaccine |
| 4-standard dose HBV vaccination group | Active comparator | participants will receive 4 standard doses of HBV vaccination at 0, 1, 2, 6 months Receives: Biological: Hepatitis B vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunologic response to 4 versus 3 doses of HBV vaccination in HIV-infected adults with isolated anti-HBc antibody, demonstrated by percentage of responders (with anti-HBs Ab ≥ 10 mIU/mL ) at week 28
Immunologic response to 4 versus 3 doses of HBV vaccination in HIV-infected adults with isolated anti-HBc antibody, demonstrated by percentage of responders (with anti-HBs Ab ≥ 10 mIU/mL ) at week 28
Measured: 28 weeks after the first dose of HBV vaccination
Secondary outcomes (6)
Anamnestic response at week 4
Anamnestic response at week 4
Measured: 4 weeks after the first dose of HBV vaccination
Percentage of responders (with anti-HBs Ab ≥ 10 mIU/mL) at month 12
Percentage of responders (with anti-HBs Ab ≥ 10 mIU/mL) at month 12
Measured: 12 months after the first dose of HBV vaccination
Percentage of high-level responders (with anti-HBs Ab ≥ 100 mIU/mL) at week 28 and month 12
Percentage of high-level responders (with anti-HBs Ab ≥ 100 mIU/mL) at week 28 and month 12
Measured: 28 weeks and 12 months after the first dose of HBV vaccination
Intensity and frequency of vaccine adverse event (AE)
Intensity and frequency of vaccine adverse event (AE)
Measured: 1 year
Geometric mean titers of anti-HBs Ab at week 28 and month 12
Geometric mean titers of anti-HBs Ab at week 28 and month 12
Measured: 28 weeks and 12 months after the first dose of HBV vaccination
Predictive factors associated with response to vaccine (age, sex, CD4 count)
Predictive factors associated with response to vaccine (age, sex, CD4 count)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study start1 Jul 2017
- Primary completion1 Feb 2018 (estimated)
- Study completion1 Jul 2018 (estimated)
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 Hepatitis B Vaccination, HIVStudies of the same condition, open and under way.
- 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
- Model description
- Open-label, randomized controlled trial (RCT) with 1:1 allocation in parallel arms
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chiang Mai University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Romanee Chaiwarith, Chiang Mai University
- Investigators
- Romanee Chaiwarith, MD, Principal investigator, Chiang Mai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03212911
- Sponsor's protocol ID
- 04565
- Status last verified
- Jul 2017
- First submitted
- 6 Jul 2017
- Last updated
- 11 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Laksananun N, Praparattanapan J, Kotarathititum W, Supparatpinyo K, Chaiwarith R. Immunogenicity and safety of 4 vs. 3 standard doses of HBV vaccination in HIV-infected adults with isolated anti-HBc antibody. AIDS Res Ther. 2019 May 3;16(1):10. doi: 10.1186/s12981-019-0225-3.
PubMed 31053142
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety of 4- vs. 3-standard Doses HBV Vaccination in HIV-infected Adults With Isolated Anti-HBc Antibody
- ClinicalTrials.gov ID
- NCT03212911
- Acronym / sponsor ID
- 04565
- Conditions
- Hepatitis B Vaccination, HIV
- Keywords
- HBV vaccination, HIV, isolated anti-HBc
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Chiang Mai UniversityUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 1 Feb 2018 (estimated)
- Study completion
- 1 Jul 2018 (estimated)
- First posted
- 11 Jul 2017 (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 finding of isolated hepatitis B core antibody (isolated HBc) in absent of recent active hepatitis could cause by several scenarios, including false positive, remote infection without viremia, and occult infection with low viremia. Hepatitis B virus (HBV) vaccine booster could be a great prevention strategy for those who do not have HBV viremia. There is no standard consensus for management of this issue especially among HIV infected population. In addition, prior studies revealed that HIV-infected individuals had lower immunologic response to HBV vaccine than general population. This study intends to compare the immune response and safety of 4- versus 3-standard dose of hepatitis B virus vaccination in HIV-infected adults who has isolated HBc. The immunologic response will be evaluated after the participants receive vaccination.
Detailed description
- A randomized controlled trial to evaluate differences in immunogenicity and safety of the two hepatitis B vaccination regimens, including the percentage of responders, high-level responders, anamnestic response, geometric mean titers of anti-HBs antibody, adverse events and predictive factors associated with vaccine responsiveness
- After participant enrollment, data on baseline characteristics, time since HIV diagnosis, CD4 counts, HIV viral load, antiretroviral treatment regimen and duration will be collected, then the participants will be randomized into 2 groups to receive either 3- or 4-standard doses (20 mcg per dose) of HBV vaccination, and follow-up blood test for anti-HBs titers at multiple pre-specified time points to evaluate outcomes
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open-label, randomized controlled trial (RCT) with 1:1 allocation in parallel arms
| Arm | Type | Receives |
|---|---|---|
| 3-standard dose HBV vaccination group | Active comparator | Biological: Hepatitis B vaccineparticipants will receive 3 standard doses of HBV vaccination at 0, 1, 6 months |
| 4-standard dose HBV vaccination group | Active comparator | Biological: Hepatitis B vaccineparticipants will receive 4 standard doses of HBV vaccination at 0, 1, 2, 6 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged ≥ 18 years
- On combination antiretroviral therapy (cART)
- CD4 ≥ 200 cell/mm3 for ≥ 1 year
- HIV viral load < 20 copies/ml for ≥ 1 year
- Isolated anti-HBc Ab (negative HBsAg, anti-HBs Ab) and negative anti-HCV at screening
Key exclusion criteria (11 listed)
- Pregnancy
- Previous HBV vaccination
- Intolerance to any component of HBV vaccine
- Transaminitis in the past 3 months (≥ 5 UNL)
- Ongoing opportunistic infection (OI)
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 |
|---|---|---|
| Hepatitis B vaccineHepatitis B vaccine (20 mcg/ml) 1 ml intramuscular injection in 3 (at 0, 1, 6 months) or 4 doses (0, 1, 2, 6 months) | Biological | 3-standard dose HBV vaccination group, 4-standard dose HBV vaccination group |
Primary outcome
Immunologic response to 4 versus 3 doses of HBV vaccination in HIV-infected adults with isolated anti-HBc antibody, demonstrated by percentage of responders (with anti-HBs Ab ≥ 10 mIU/mL ) at week 28
Time frame: 28 weeks after the first dose of HBV vaccination
Immunologic response to 4 versus 3 doses of HBV vaccination in HIV-infected adults with isolated anti-HBc antibody, demonstrated by percentage of responders (with anti-HBs Ab ≥ 10 mIU/mL ) at week 28
6 secondary outcomes
Anamnestic response at week 4
Time frame: 4 weeks after the first dose of HBV vaccination
Percentage of responders (with anti-HBs Ab ≥ 10 mIU/mL) at month 12
Time frame: 12 months after the first dose of HBV vaccination
Percentage of high-level responders (with anti-HBs Ab ≥ 100 mIU/mL) at week 28 and month 12
Time frame: 28 weeks and 12 months after the first dose of HBV vaccination
Intensity and frequency of vaccine adverse event (AE)
Time frame: 1 year
Geometric mean titers of anti-HBs Ab at week 28 and month 12
Time frame: 28 weeks and 12 months after the first dose of HBV vaccination
Predictive factors associated with response to vaccine (age, sex, CD4 count)
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2017.
- Derived from this study: PubMed 31053142Laksananun N, Praparattanapan J, Kotarathititum W, Supparatpinyo K, Chaiwarith R. Immunogenicity and safety of 4 vs. 3 standard doses of HBV vaccination in HIV-infected adults with isolated anti-HBc antibody. AIDS Res Ther. 2019 May 3;16(1):10. doi: 10.1186/s12981-019-0225-3.
- 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.
Romanee Chaiwarith, MD principal investigator
Chiang Mai University
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 Hepatitis B vaccine in people with Hepatitis B Vaccination, HIV, run by Chiang Mai University at 1 site in Thailand.
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 11 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 11 Jul 2017. 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 Thailand. 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 Romanee Chaiwarith, MD (+66-5393-6457, rchaiwar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immunologic response to 4 versus 3 doses of HBV vaccination in HIV-infected adults with isolated anti-HBc antibody, demonstrated by percentage of responders (with anti-HBs Ab ≥ 10 mIU/mL ) at week 28 (time frame: 28 weeks after the first dose of HBV vaccination). 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 NCT03212911, 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 11 Jul 2017.