Hepatitis BPhase 4NCT02732054
Hepatitis B Vaccination in HIV-infected Adults With Low CD4 Cell Counts
A Phase 4 study testing Recombinant Hepatitis B vaccine [(CIGB) La Habana, Cuba] in people with Hepatitis B, run by Chiang Mai University at 1 site in Thailand.
Trial summary
This study aimed to evaluate the efficacy of different hepatitis B vaccination regimens in HIV-infected adults with low CD4 cell count in northern Thailand. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hepatitis B
- What is being tested?
- Recombinant Hepatitis B vaccine [(CIGB) La Habana, Cuba]
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteThailand
- Study dates
- Mar 2015to Feb 2016
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- HIV-infection
- ≥18 years old
- Received combination antiretroviral therapy for at least 1 year
- Had a CD4+ cell count < 200 cells/mm3 for at least 1 year
- Undetectable plasma HIV-1 RNA for at least 1 year
- Negative for hepatitis B surface antigen (HBsAg), antibody to hepatitis B surface antigen (anti-HBs), and antibody to hepatitis B core antigen (anti-HBc),
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- Had no history of previous HBV vaccine
- Negative for antibody to hepatitis C virus (anti-HCV)
- No active opportunistic infections (at the time of screening)
- Willing to sign an informed consent
- Able to return for follow-up.
Who cannot join
- Pregnancy or lactation
- History of hypersensitivity to any component of the vaccine
- Active malignancy receiving chemotherapy or radiation, or other immunocompromised conditions besides HIV (e.g., solid organ transplant), received immunosuppressive (e.g., corticosteroid ≥ 0.5 mg/kg/day) or immunomodulating treatment in the last six months before screening visit
- Renal insufficiency (creatinine clearance <30 mL/min)
- Decompensated cirrhosis (Child-Pugh class C)
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Maharaj Nakorn Chiang Mai Hospital, Department of Medicine, Chiang Mai University
Muang, Chiang Mai, 50200
About this study
Official title: Comparison of Immunogenicity and Safety of 4 Standard Doses and 3 Standard Doses of Hepatitis B Vaccination in HIV-infected Adults Who Have CD4 < 200 Cells/mm3
This study aimed to evaluate the efficacy of different hepatitis B vaccination regimens in HIV-infected adults with low CD4 cell count in northern Thailand.
Read the detailed description
HIV-infected adults with CD4+ cell counts < 200 cells/mm3, undetectable plasma HIV-1 RNA, and negative for all HBV markers were randomly assigned to receive one of these 2 regimens of recombinant hepatitis B vaccine (Centro De Ingenieria Genetica Y Biotecnologia, La Habana, Cuba); 1) 20 μg IM at months 0, 1, and 6 (3-standard doses group), and 2) 20 μg IM at months 0, 1, 2, 6 (4-standard doses group).
This study aimed to evaluate the efficacy and safety of these 2 hepatitis B vaccination regimens at month 7 after vaccination.
- Conditions
- Hepatitis B
- Being tested
- Recombinant Hepatitis B vaccine [(CIGB) La Habana, Cuba]
- 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.
Recombinant Hepatitis B vaccine [(CIGB) La Habana, Cuba]Biological
Different HBV vaccine regimen in each group
| Study group | Role | What they receive |
|---|---|---|
| HIV-Group 1 | Active comparator | Receiving three intramuscular injections of 20 µg of recombinant hepatitis B vaccine [(CIGB) La Habana, Cuba] at months 0, 1, and 6 Receives: Biological: Recombinant Hepatitis B vaccine [(CIGB) La Habana, Cuba] |
| HIV-Group 2 | Experimental | Receiving four intramuscular injections of 20 µg of recombinant hepatitis B vaccine [(CIGB) La Habana, Cuba] at months 0, 1, 2, and 6 Receives: Biological: Recombinant Hepatitis B vaccine [(CIGB) La Habana, Cuba] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with protective immunity against HBV
comparison of proportion of participants who had protective immunity (anti-HBS titer >=10 mIU/ml) against HBV between HIV group 2 v.s. HIV group 1
Measured: 1 month after vaccination
Secondary outcomes (2)
The geometric means of anti-HBs titers
Comparison of the geometric means of anti-HBS titers between HIV group 2 v.s. HIV group 1
Measured: 1 month after vaccination
Proportion of participants with high level of immune response against HBV
Comparison of proportion of participants who had anti-HBS titers >= 100 mIU/ml between HIV group 2 v.s. HIV group 1
Measured: 1 month after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2016 (estimated)
- Study startMar 2015
- Primary completionFeb 2016
- Study completionFeb 2016
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
- 16 participants (actual)
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, Thailand Maharaj Nakorn Chiang Mai Hospital, Department of Medicine, Chiang Mai University Muang, Chiang Mai Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02732054
- Sponsor's protocol ID
- Research ID: 02891
- Status last verified
- Apr 2017
- First submitted
- 31 Mar 2016
- Last updated
- 19 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Immunogenicity and Safety of 4 Standard Doses and 3 Standard Doses of Hepatitis B Vaccination in HIV-infected Adults Who Have CD4 < 200 Cells/mm3
- ClinicalTrials.gov ID
- NCT02732054
- Acronym / sponsor ID
- Research ID: 02891
- Conditions
- Hepatitis B
- Keywords
- HBV vaccination, immunity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Chiang Mai UniversityUniversity, hospital or other
- Study start
- Mar 2015 (actual)
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 8 Apr 2016 (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.
This study aimed to evaluate the efficacy of different hepatitis B vaccination regimens in HIV-infected adults with low CD4 cell count in northern Thailand.
Detailed description
HIV-infected adults with CD4+ cell counts < 200 cells/mm3, undetectable plasma HIV-1 RNA, and negative for all HBV markers were randomly assigned to receive one of these 2 regimens of recombinant hepatitis B vaccine (Centro De Ingenieria Genetica Y Biotecnologia, La Habana, Cuba); 1) 20 μg IM at months 0, 1, and 6 (3-standard doses group), and 2) 20 μg IM at months 0, 1, 2, 6 (4-standard doses group).
This study aimed to evaluate the efficacy and safety of these 2 hepatitis B vaccination regimens at month 7 after vaccination.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIV-Group 1 | Active comparator | Biological: Recombinant Hepatitis B vaccine [(CIGB) La Habana, Cuba]Receiving three intramuscular injections of 20 µg of recombinant hepatitis B vaccine [(CIGB) La Habana, Cuba] at months 0, 1, and 6 |
| HIV-Group 2 | Experimental | Biological: Recombinant Hepatitis B vaccine [(CIGB) La Habana, Cuba]Receiving four intramuscular injections of 20 µg of recombinant hepatitis B vaccine [(CIGB) La Habana, Cuba] at months 0, 1, 2, and 6 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- HIV-infection
- ≥18 years old
- Received combination antiretroviral therapy for at least 1 year
- Had a CD4+ cell count < 200 cells/mm3 for at least 1 year
- Undetectable plasma HIV-1 RNA for at least 1 year
Key exclusion criteria (5 listed)
- Pregnancy or lactation
- History of hypersensitivity to any component of the vaccine
- Active malignancy receiving chemotherapy or radiation, or other immunocompromised conditions besides HIV (e.g., solid organ transplant), received immunosuppressive (e.g., corticosteroid ≥ 0.5 mg/kg/day) or immunomodulating treatment in the last six months before screening visit
- Renal insufficiency (creatinine clearance <30 mL/min)
- Decompensated cirrhosis (Child-Pugh class C)
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 |
|---|---|---|
| Recombinant Hepatitis B vaccine [(CIGB) La Habana, Cuba]Different HBV vaccine regimen in each group | Biological | HIV-Group 1, HIV-Group 2 |
Primary outcome
Proportion of participants with protective immunity against HBV
Time frame: 1 month after vaccination
comparison of proportion of participants who had protective immunity (anti-HBS titer >=10 mIU/ml) against HBV between HIV group 2 v.s. HIV group 1
2 secondary outcomes
The geometric means of anti-HBs titers
Time frame: 1 month after vaccination
Proportion of participants with high level of immune response against HBV
Time frame: 1 month after vaccination
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 19 Apr 2017.
- Individual participant dataSharing planned: No
Related trials for Hepatitis B
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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
Thailand Maharaj Nakorn Chiang Mai Hospital, Department of Medicine, Chiang Mai University Muang, Chiang Mai Thailand
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 Recombinant Hepatitis B vaccine [(CIGB) La Habana, Cuba] 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 11 inclusion and 5 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 19 Apr 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?
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?
Proportion of participants with protective immunity against HBV (time frame: 1 month after 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 19 Apr 2017.