Hepatitis BPhase 4NCT03219203
Immunologic Response of Hepatitis B Vaccine
A Phase 4 study testing Hepatitis B vaccine in people with Hepatitis B, run by Chiang Mai University at 1 site in Thailand.
Trial summary
This study aims to evaluate the immunologic response to the two hepatitis B virus (HBV) vaccination booster strategies in previously vaccinated HIV-infected adults at Maharaj Nakorn Chiang Mai Hospital. Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Hepatitis B
- 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
- 80 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jul 2017to 1 Oct 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 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Document of HIV infection
- Thai nationality
- Age ≥18 years old
- Born after 1 January 1992
- Has been taking antiretroviral drugs for HIV treatment
- CD4 ≥200 cell/mm3 and VL <50 copies/mL for at least 6 months before enrollment
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- Negative for any HBV and HCV serological markers
- Willing to sign informed consent
- Able to follow up
Who cannot join
- Active opportunistic infection
- Pregnancy or breast feeding
- History of previous hepatitis B vaccine booster
- History of hypersensitivity to any component of vaccine
- Malignancy which received chemotherapy or radiation
- Immunocompromised condition such as solid-organ transplantation, chemotherapy in the last 6 months
Show all 11Show fewer
- On Immunosuppressive treatment, immunomodulating treatment or general corticotherapy (equal or above 0.5 mg per kg per day )
- Renal failure (creatinine clearance <30 mL/min)
- Transaminitis in the past 3 months (≥ 5 UNL)
- Decompensated cirrhosis (child-Pugh class C)
- Unable or not willing to return for follow up
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: Immunologic Response of Hepatitis B Single Dose Versus 3-dose Series in Previously Vaccinated HIV-infected Adults at Maharaj Nakorn Chiang Mai Hospital: A Randomized Controlled Trial
This study aims to evaluate the immunologic response to the two hepatitis B virus (HBV) vaccination booster strategies in previously vaccinated HIV-infected adults at Maharaj Nakorn Chiang Mai Hospital.
Read the detailed description
This study intended to evaluate the immunologic response to the two hepatitis B virus (HBV) vaccination strategies in previously vaccinated HIV-infected adults at Maharaj Nakorn Chiang Mai Hospital.
As a part of HBV prevention program, HBV vaccine has been included in Thailand expanded program on immunization (EPI) since 1992. HBV vaccine has been shown to be safe, effective, and has a prolonged protective immunity to HBV infection. Despite the immunity from HBV vaccination could wane overtime, the previous data in general population revealed that HBV vaccine booster could raise the immune in very well. However, the data about booster effects for HBV vaccine among HIV-infected population who previously received a vaccination during their childhood is lagging. Based on previous data of vaccination response in HIV-infected population, the investigators estimate that the protective antibody will rise up to 60% with HBV vaccine one dose booster versus 90% with 3-dose series. Eighty participants, HIV-infected person who were born after HBV vaccine were born after HBV has been included in Thai EPI without evidence of HBV infection nor protective immunity, will be enrolled to this study (with estimation of 5% loss follow up rate). The participants will be randomized in 1:1. The immune response and vaccine safety will be evaluated at 1,7 and 12 months after the first dose HBV vaccine.
- Conditions
- Hepatitis B
- Being tested
- Hepatitis B vaccine
- Keywords
- HBV vaccination, immunity
- Medical subject headings
- Hepatitis B
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 µg/ml) 1 ml intramuscular injection in single (at 0 month) or 3-dose series (at 0, 1, 6 months)
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Single dose hepatitis B vaccine | Experimental | Single dose of hepatitis B vaccine group will receive a 20 µg recombinant HBV vaccine intramuscular at entry Receives: Biological: Hepatitis B vaccine |
| Arm B: 3-dose series of hepatitis B vaccine | Active comparator | 3-dose series of hepatitis B vaccine group will receive a 20 µg recombinant HBV vaccine intramuscular at month 0, 1, and 6 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 single dose versus 3-dose series of HBV vaccination in HIV-infected adults
Immunologic response to single versus 3-dose series of HBV vaccination in HIV-infected adults, 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 (3)
Anamnestic response at week 4
Anamnestic response at week 4, demonstrated by percentage of responders (with anti-HBs Ab ≥ 10 mIU/mL )
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]
Intensity and frequency of vaccine adverse event (AE)
Intensity and frequency of vaccine adverse event (AE)
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 posted17 Jul 2017
- Study start1 Jul 2017
- Primary completion1 Jul 2018 (estimated)
- Study completion1 Oct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis BStudies 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
- Masking
- None (open label)
- Enrolment
- 80 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
- NCT03219203
- Sponsor's protocol ID
- 4564
- Status last verified
- Jul 2017
- First submitted
- 6 Jul 2017
- Last updated
- 17 Jul 2017
- 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 17 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunologic Response of Hepatitis B Single Dose Versus 3-dose Series in Previously Vaccinated HIV-infected Adults at Maharaj Nakorn Chiang Mai Hospital: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03219203
- Acronym / sponsor ID
- 4564
- Conditions
- Hepatitis B
- Keywords
- HBV vaccination, immunity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Chiang Mai UniversityUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 1 Jul 2018 (estimated)
- Study completion
- 1 Oct 2018 (estimated)
- First posted
- 17 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.
This study aims to evaluate the immunologic response to the two hepatitis B virus (HBV) vaccination booster strategies in previously vaccinated HIV-infected adults at Maharaj Nakorn Chiang Mai Hospital.
Detailed description
This study intended to evaluate the immunologic response to the two hepatitis B virus (HBV) vaccination strategies in previously vaccinated HIV-infected adults at Maharaj Nakorn Chiang Mai Hospital.
As a part of HBV prevention program, HBV vaccine has been included in Thailand expanded program on immunization (EPI) since 1992. HBV vaccine has been shown to be safe, effective, and has a prolonged protective immunity to HBV infection. Despite the immunity from HBV vaccination could wane overtime, the previous data in general population revealed that HBV vaccine booster could raise the immune in very well. However, the data about booster effects for HBV vaccine among HIV-infected population who previously received a vaccination during their childhood is lagging. Based on previous data of vaccination response in HIV-infected population, the investigators estimate that the protective antibody will rise up to 60% with HBV vaccine one dose booster versus 90% with 3-dose series. Eighty participants, HIV-infected person who were born after HBV vaccine were born after HBV has been included in Thai EPI without evidence of HBV infection nor protective immunity, will be enrolled to this study (with estimation of 5% loss follow up rate). The participants will be randomized in 1:1. The immune response and vaccine safety will be evaluated at 1,7 and 12 months after the first dose HBV vaccine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: Single dose hepatitis B vaccine | Experimental | Biological: Hepatitis B vaccineSingle dose of hepatitis B vaccine group will receive a 20 µg recombinant HBV vaccine intramuscular at entry |
| Arm B: 3-dose series of hepatitis B vaccine | Active comparator | Biological: Hepatitis B vaccine3-dose series of hepatitis B vaccine group will receive a 20 µg recombinant HBV vaccine intramuscular at month 0, 1, and 6 |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Document of HIV infection
- Thai nationality
- Age ≥18 years old
- Born after 1 January 1992
- Has been taking antiretroviral drugs for HIV treatment
Key exclusion criteria (11 listed)
- Active opportunistic infection
- Pregnancy or breast feeding
- History of previous hepatitis B vaccine booster
- History of hypersensitivity to any component of vaccine
- Malignancy which received chemotherapy or radiation
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 µg/ml) 1 ml intramuscular injection in single (at 0 month) or 3-dose series (at 0, 1, 6 months) | Biological | Arm A: Single dose hepatitis B vaccine, Arm B: 3-dose series of hepatitis B vaccine |
Primary outcome
Immunologic response to single dose versus 3-dose series of HBV vaccination in HIV-infected adults
Time frame: 28 weeks after the first dose of HBV vaccination
Immunologic response to single versus 3-dose series of HBV vaccination in HIV-infected adults, demonstrated by percentage of responders (with anti-HBs Ab ≥ 10 mIU/mL ) at week 28
3 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]
Intensity and frequency of vaccine adverse event (AE)
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 17 Jul 2017.
- 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, 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 9 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 17 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 single dose versus 3-dose series of HBV vaccination in HIV-infected adults (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?
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 17 Jul 2017.