Hepatitis BPhase 4NCT02713620
Hepatitis B Vaccination in HIV-infected Adults
A Phase 4 study testing recombinant HBV vaccine (Hepavax-Gene® Berna, Korea) in people with Hepatitis B, run by Chiang Mai University at 1 site in Thailand.
Trial summary
This is a follow up study from the published article entitled "Comparison of immunogenicity and safety of four doses and four double doses vs. standard doses of hepatitis B vaccination in HIV-infected adults: a randomized, controlled trial" by Chaiklang K, Wipasa J, Chaiwarith R, Praparattanapan J, Supparatpinyo K. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B
- What is being tested?
- recombinant HBV vaccine (Hepavax-Gene® Berna, Korea)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 154 participants
- Where
- 1 siteThailand
- Study dates
- Jan 2015to Jan 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy Group 1.1 ≥18 years old, 1.2 were negative for hepatitis B surface antigen (HBsAg), antibody to hepatitis B surface antigen (anti-HBs), and antibody to hepatitis B core antigen (anti-HBc), had no history of previous vaccine 1.3 were negative for antibody to hepatitis C virus (anti-HCV) 1.4 received three intramuscular injections of 20 μg of recombinant HBV vaccine (Hepavax-Gene® Berna, Korea) at months 0, 1, and 6 during February 4, 2011 to May 4, 2012, the same time as the study under ClinicalTrials.gov; NCT1289106. were conducted.
- 1.4 and were willing to sign an informed consent
- HIV Group 1 2.1 HIV-1 infection 2.2 ≥18 years old, 2.3 had a CD4+ cell count >200 cells/mm3, 2.4 undetectable plasma HIV-1 RNA, 2.5 were negative for hepatitis B surface antigen (HBsAg), antibody to hepatitis B surface antigen (anti-HBs), and antibody to hepatitis B core antigen (anti-HBc), had no history of previous vaccine, 2.6 were negative for antibody to hepatitis C virus (anti-HCV), 2.7 had no active opportunistic infections (at the time of screening), 2.8 were participated in ClinicalTrials.gov; NCT1289106.and receiving three intramuscular injections of 20 μg of recombinant HBV vaccine (Hepavax-Gene® Berna, Korea) at months 0, 1, and 6 2.9 were willing to sign an informed consent
- HIV-Group 2 3.1 HIV-1 infection 3.2 ≥18 years old, 3.3 had a CD4+ cell count >200 cells/mm3, 3.4 undetectable plasma HIV-1 RNA, 3.5 were negative for hepatitis B surface antigen (HBsAg), antibody to hepatitis B surface antigen (anti-HBs), and antibody to hepatitis B core antigen (anti-HBc), had no history of previous vaccine, 3.6 were negative for antibody to hepatitis C virus (anti-HCV), 3.7 had no active opportunistic infections (at the time of screening), 3.8 were participated in ClinicalTrials.gov; NCT1289106.and receiving four intramuscular doses of 20 μg of the same vaccine at months 0, 1, 2, and 6 3.9 were willing to sign an informed consent
- HIV Group 3 4.1 HIV-1 infection 4.2 ≥18 years old, 4.3 had a CD4+ cell count >200 cells/mm3, 4.4 undetectable plasma HIV-1 RNA, 4.5 were negative for hepatitis B surface antigen (HBsAg), antibody to hepatitis B surface antigen (anti-HBs), and antibody to hepatitis B core antigen (anti-HBc), had no history of previous vaccine, 4.6 were negative for antibody to hepatitis C virus (anti-HCV), 4.7 had no active opportunistic infections (at the time of screening), 4.8 were participated in ClinicalTrials.gov; NCT1289106.and receiving four intramuscular double doses (40 μg) at months 0, 1, 2, and 6 4.9 were willing to sign an informed consent
Who cannot join
- For HIV group 1, 2, and 3
- active malignancy receiving chemotherapy or radiation,
- 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, 4. had renal insufficiency (creatinine clearance <30 mL/min), 5. 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, 50130
About this study
Official title: Comparison of Immunogenicity of Four Doses and Four Double Doses vs. Standard Doses of Hepatitis B Vaccination in HIV-infected Adults: a Result From Randomized Controlled Trial at 3 Years After Vaccination
This is a follow up study from the published article entitled "Comparison of immunogenicity and safety of four doses and four double doses vs. standard doses of hepatitis B vaccination in HIV-infected adults: a randomized, controlled trial" by Chaiklang K, Wipasa J, Chaiwarith R, Praparattanapan J, Supparatpinyo K. that was published in PLoS One. 2013 Nov 12;8(11):e80409. doi: 10.1371/journal.pone.0080409. eCollection 2013. ClinicalTrials.gov; NCT1289106. This study aimed to evaluate the efficacy of the HBV vaccination regimens using either four standard doses or four double doses compared with the current standard regimen of three doses in HIV-infected adults in northern Thailand. In addition, the investigators evaluated the efficacy of the HBV vaccination with the current standard regimen of three doses between healthy adults and HIV-infected patients.
Read the detailed description
From February 4, 2011 to May 4, 2012, 132 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 three recombinant vaccine (Hepavax-Gene® Berna, Korea) regimens: 20 μg IM at months 0, 1, and 6 (Standard doses group, n=44), 20 μg IM at months 0, 1, 2, 6 (four doses group, n=44), or 40 μg IM at months 0, 1, 2, and 6 (four double doses group, n=44). There was another group of healthy individuals received standard dose of 20 μg IM at months 0, 1, and 6 recruited during the same time and under the same protocol. In brief, at months 7 and 12, the percentages of responders (anti-HBs ≥10 mIU/mL) were 88.6% and 70.4% in the Standard doses group, 93.2% and 86.4% in the four doses group, (P=0.713 and 0.119), and 95.4% and 88.6% in the four double doses group, (P=0.434 and 0.062), respectively.
This current study aimed to evaluate the efficacy of the different HBV vaccination regimens at 36 months after vaccination. In addition to compare the group using four standard doses or four double doses with the current standard regimen of three doses in HIV-infected adults in northern Thailand, the investigators also compare the efficacy of the current standard regimen of 3 doses between HIV-infected and healthy individuals.
- Conditions
- Hepatitis B
- Being tested
- recombinant HBV vaccine (Hepavax-Gene® Berna, Korea)
- 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 HBV vaccine (Hepavax-Gene® Berna, Korea)Biological
Different HBV vaccine regimen in each group
| Study group | Role | What they receive |
|---|---|---|
| Healthy | Placebo comparator | the "Healthy group" receiving three intramuscular injections of 20 μg of recombinant HBV vaccine (Hepavax-Gene® Berna, Korea) at months 0, 1, and 6 Receives: Biological: recombinant HBV vaccine (Hepavax-Gene® Berna, Korea) |
| HIV-Group1 | Active comparator | the "Standard doses group" receiving three intramuscular injections of 20 μg of recombinant HBV vaccine (Hepavax-Gene® Berna, Korea) at months 0, 1, and 6 Receives: Biological: recombinant HBV vaccine (Hepavax-Gene® Berna, Korea) |
| HIV-Group 2 | Active comparator | the "Four doses group" receiving four intramuscular doses of 20 μg of recombinant HBV vaccine (Hepavax-Gene® Berna, Korea) at months 0, 1, 2, and 6 Receives: Biological: recombinant HBV vaccine (Hepavax-Gene® Berna, Korea) |
| HIV-Group 3 | Active comparator | the "Four double doses group" receiving four intramuscular double doses (40 μg) of recombinant HBV vaccine (Hepavax-Gene® Berna, Korea) at months 0, 1, 2, and 6 Receives: Biological: recombinant HBV vaccine (Hepavax-Gene® Berna, Korea) |
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 "healthy" v.s. "HIV group 1", "HIV group 2" v.s. "HIV group 1", "HIV group 3 v.s. "HIV group 1"
Measured: 36 months after vaccination
Secondary outcomes (2)
The geometric means of anti-HBs titers
Comparison of the geometric means of anti-HBS titers between "healthy" v.s. "HIV group 1", "HIV group 2" v.s. "HIV group 1", "HIV group 3 v.s. "HIV group 1"
Measured: 36 months 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 "healthy" v.s. "HIV group 1", "HIV group 2" v.s. "HIV group 1", "HIV group 3 v.s. "HIV group 1"
Measured: 36 months after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2016 (estimated)
- Study startJan 2015
- Primary completionJan 2016
- Study completionJan 2016
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 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
- 154 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, Chiang Mai Unviersity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02713620
- Sponsor's protocol ID
- Research ID: 2986
- Status last verified
- Apr 2017
- First submitted
- 4 Mar 2016
- Last updated
- 19 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Chaiwarith R, Praparattanapan J, Kotarathititum W, Wipasa J, Chaiklang K, Supparatpinyo K. Higher rate of long-term serologic response of four double doses vs. standard doses of hepatitis B vaccination in HIV-infected adults: 4-year follow-up of a randomised controlled trial. AIDS Res Ther. 2019 Nov 11;16(1):33. doi: 10.1186/s12981-019-0249-8.
PubMed 31711528
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 of Four Doses and Four Double Doses vs. Standard Doses of Hepatitis B Vaccination in HIV-infected Adults: a Result From Randomized Controlled Trial at 3 Years After Vaccination
- ClinicalTrials.gov ID
- NCT02713620
- Acronym / sponsor ID
- Research ID: 2986
- Conditions
- Hepatitis B
- Keywords
- HBV vaccination, immunity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Chiang Mai UniversityUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 21 Mar 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 is a follow up study from the published article entitled "Comparison of immunogenicity and safety of four doses and four double doses vs. standard doses of hepatitis B vaccination in HIV-infected adults: a randomized, controlled trial" by Chaiklang K, Wipasa J, Chaiwarith R, Praparattanapan J, Supparatpinyo K. that was published in PLoS One. 2013 Nov 12;8(11):e80409. doi: 10.1371/journal.pone.0080409. eCollection 2013. ClinicalTrials.gov; NCT1289106. This study aimed to evaluate the efficacy of the HBV vaccination regimens using either four standard doses or four double doses compared with the current standard regimen of three doses in HIV-infected adults in northern Thailand. In addition, the investigators evaluated the efficacy of the HBV vaccination with the current standard regimen of three doses between healthy adults and HIV-infected patients.
Detailed description
From February 4, 2011 to May 4, 2012, 132 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 three recombinant vaccine (Hepavax-Gene® Berna, Korea) regimens: 20 μg IM at months 0, 1, and 6 (Standard doses group, n=44), 20 μg IM at months 0, 1, 2, 6 (four doses group, n=44), or 40 μg IM at months 0, 1, 2, and 6 (four double doses group, n=44). There was another group of healthy individuals received standard dose of 20 μg IM at months 0, 1, and 6 recruited during the same time and under the same protocol. In brief, at months 7 and 12, the percentages of responders (anti-HBs ≥10 mIU/mL) were 88.6% and 70.4% in the Standard doses group, 93.2% and 86.4% in the four doses group, (P=0.713 and 0.119), and 95.4% and 88.6% in the four double doses group, (P=0.434 and 0.062), respectively.
This current study aimed to evaluate the efficacy of the different HBV vaccination regimens at 36 months after vaccination. In addition to compare the group using four standard doses or four double doses with the current standard regimen of three doses in HIV-infected adults in northern Thailand, the investigators also compare the efficacy of the current standard regimen of 3 doses between HIV-infected and healthy individuals.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy | Placebo comparator | Biological: recombinant HBV vaccine (Hepavax-Gene® Berna, Korea)the "Healthy group" receiving three intramuscular injections of 20 μg of recombinant HBV vaccine (Hepavax-Gene® Berna, Korea) at months 0, 1, and 6 |
| HIV-Group1 | Active comparator | Biological: recombinant HBV vaccine (Hepavax-Gene® Berna, Korea)the "Standard doses group" receiving three intramuscular injections of 20 μg of recombinant HBV vaccine (Hepavax-Gene® Berna, Korea) at months 0, 1, and 6 |
| HIV-Group 2 | Active comparator | Biological: recombinant HBV vaccine (Hepavax-Gene® Berna, Korea)the "Four doses group" receiving four intramuscular doses of 20 μg of recombinant HBV vaccine (Hepavax-Gene® Berna, Korea) at months 0, 1, 2, and 6 |
| HIV-Group 3 | Active comparator | Biological: recombinant HBV vaccine (Hepavax-Gene® Berna, Korea)the "Four double doses group" receiving four intramuscular double doses (40 μg) of recombinant HBV vaccine (Hepavax-Gene® Berna, Korea) at months 0, 1, 2, and 6 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy Group 1.1 ≥18 years old, 1.2 were negative for hepatitis B surface antigen (HBsAg), antibody to hepatitis B surface antigen (anti-HBs), and antibody to hepatitis B core antigen (anti-HBc), had no history of previous vaccine 1.3 were negative for antibody to hepatitis C virus (anti-HCV) 1.4 received three intramuscular injections of 20 μg of recombinant HBV vaccine (Hepavax-Gene® Berna, Korea) at months 0, 1, and 6 during February 4, 2011 to May 4, 2012, the same time as the study under ClinicalTrials.gov; NCT1289106. were conducted.
- 1.4 and were willing to sign an informed consent
- HIV Group 1 2.1 HIV-1 infection 2.2 ≥18 years old, 2.3 had a CD4+ cell count >200 cells/mm3, 2.4 undetectable plasma HIV-1 RNA, 2.5 were negative for hepatitis B surface antigen (HBsAg), antibody to hepatitis B surface antigen (anti-HBs), and antibody to hepatitis B core antigen (anti-HBc), had no history of previous vaccine, 2.6 were negative for antibody to hepatitis C virus (anti-HCV), 2.7 had no active opportunistic infections (at the time of screening), 2.8 were participated in ClinicalTrials.gov; NCT1289106.and receiving three intramuscular injections of 20 μg of recombinant HBV vaccine (Hepavax-Gene® Berna, Korea) at months 0, 1, and 6 2.9 were willing to sign an informed consent
- HIV-Group 2 3.1 HIV-1 infection 3.2 ≥18 years old, 3.3 had a CD4+ cell count >200 cells/mm3, 3.4 undetectable plasma HIV-1 RNA, 3.5 were negative for hepatitis B surface antigen (HBsAg), antibody to hepatitis B surface antigen (anti-HBs), and antibody to hepatitis B core antigen (anti-HBc), had no history of previous vaccine, 3.6 were negative for antibody to hepatitis C virus (anti-HCV), 3.7 had no active opportunistic infections (at the time of screening), 3.8 were participated in ClinicalTrials.gov; NCT1289106.and receiving four intramuscular doses of 20 μg of the same vaccine at months 0, 1, 2, and 6 3.9 were willing to sign an informed consent
- HIV Group 3 4.1 HIV-1 infection 4.2 ≥18 years old, 4.3 had a CD4+ cell count >200 cells/mm3, 4.4 undetectable plasma HIV-1 RNA, 4.5 were negative for hepatitis B surface antigen (HBsAg), antibody to hepatitis B surface antigen (anti-HBs), and antibody to hepatitis B core antigen (anti-HBc), had no history of previous vaccine, 4.6 were negative for antibody to hepatitis C virus (anti-HCV), 4.7 had no active opportunistic infections (at the time of screening), 4.8 were participated in ClinicalTrials.gov; NCT1289106.and receiving four intramuscular double doses (40 μg) at months 0, 1, 2, and 6 4.9 were willing to sign an informed consent
Key exclusion criteria (4 listed)
- For HIV group 1, 2, and 3
- active malignancy receiving chemotherapy or radiation,
- 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, 4. had renal insufficiency (creatinine clearance <30 mL/min), 5. 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 HBV vaccine (Hepavax-Gene® Berna, Korea)Different HBV vaccine regimen in each group | Biological | HIV-Group 2, HIV-Group 3, HIV-Group1, Healthy |
Primary outcome
Proportion of participants with protective immunity against HBV
Time frame: 36 months after vaccination
Comparison of proportion of participants who had protective immunity (anti-HBS titer >=10 mIU/ml) against HBV between "healthy" v.s. "HIV group 1", "HIV group 2" v.s. "HIV group 1", "HIV group 3 v.s. "HIV group 1"
2 secondary outcomes
The geometric means of anti-HBs titers
Time frame: 36 months after vaccination
Proportion of participants with high level of immune response against HBV
Time frame: 36 months 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.
- Derived from this study: PubMed 31711528Chaiwarith R, Praparattanapan J, Kotarathititum W, Wipasa J, Chaiklang K, Supparatpinyo K. Higher rate of long-term serologic response of four double doses vs. standard doses of hepatitis B vaccination in HIV-infected adults: 4-year follow-up of a randomised controlled trial. AIDS Res Ther. 2019 Nov 11;16(1):33. doi: 10.1186/s12981-019-0249-8.
- 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 Unviersity
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 HBV vaccine (Hepavax-Gene® Berna, Korea) 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 5 inclusion and 4 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. Some participants in this study may receive a placebo. 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: 36 months after 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 NCT02713620, 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 19 Apr 2017.