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The purposes of this study include 1) to compare the seroconversion rate of an intensive standard-dose regimen (0, 1, 2 and 6 months) to a standard-dose regimen (0,1 and 6 months), and 2) to compare the seroconversion rate of an intensive double-dose regimen (40 μg at 0,1,2 and 6 months) to a standard-dose regimen (20 μg at 0,1 and 6 months) of HBV vaccine in HIV-infected adult patients.
HIV and HBV share similar risk factors and routes of transmission. HIV/HBV coinfection is associated with greater chance of chronic HBV carrier state, higher level of HBV replication and increasing its potential for transmission. Currently, there are no concrete data to determine the best HBV vaccination schedule in HIV-infected patients. Standard HBV vaccination (20 μg at 0, 1 and 6 months) gives seroconversion rate of 33-63% in HIV-infected individuals compared with >90% in healthy individuals. This study aims to compare the efficacy of an intensive standard-dose regimen (0, 1, 2 and 6 months) to a standard-dose regimen (0,1 and 6 months) and to compare the seroconversion rate of an intensive double-dose regimen (40 μg at 0,1,2 and 6 months) to a standard-dose regimen (20 μg at 0,1 and 6 months) of HBV vaccine in HIV-infected adult patients with CD4 level above 200 permm3 and suppressed viral load.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Active Comparator | 20 μg of Hepavax-gene intramuscularly injections at deltoid region at 0,1 and 6 months |
|
| Arm B | Experimental | 20 μg of Hepavax-gene intramuscularly injections at deltoid region at 0,1,2 and 6 months |
|
| Arm C | Experimental | 40 μg of Hepavax-gene intramuscularly injections at deltoid region at 0,1,2 and 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hepavax-Gene | Biological | 20 μg of Hepavax-gene intramuscularly injections at deltoid region at 0,1 and 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Seroconversion rate (percentage of subjects with anti-HBs antibody titer >= 10 IU/L) at day 210 |
| Day 210 |
| Measure | Description | Time Frame |
|---|---|---|
| Seroprotective rate (percentage of subjects with anti-HBs antibody titer >= 10 IU/L) at 1 year | To determine the seroprotective rate at 1 year of each of the vaccination regimens. | 1 year |
| Number of subjects with adverse events after vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kanokporn Chaiklang, MD | Contact | +66 89 8539864 | kanokpornk@rihes.org |
| Name | Affiliation | Role |
|---|---|---|
| Kanokporn Chaiklang, MD | Faculty of Medicine, Chiang Mai University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maharaj Nakorn Chiang Mai Hospital, Department of Medicine, Chiang Mai University | Recruiting | Muang | Chiang Mai | 50200 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31711528 | Derived | 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. | |
| 29682590 |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| Hepavax-Gene | Biological | 20 μg of Hepavax-gene intramuscularly injections at deltoid region at 0,1,2 and 6 months |
|
|
| Hepavax-Gene | Biological | 40 μg of Hepavax-gene intramuscularly injections at deltoid region at 0,1,2 and 6 months |
|
|
Adverse events include pain at injected site, swelling at injected site, redness at injected site, fever, headache, fatique and anaphylaxis
| 180 days |
| Chawansuntati K, Chaiklang K, Chaiwarith R, Praparattanapan J, Supparatpinyo K, Wipasa J. Hepatitis B Vaccination Induced TNF-alpha- and IL-2-Producing T Cell Responses in HIV- Healthy Individuals Higher than in HIV+ Individuals Who Received the Same Vaccination Regimen. J Immunol Res. 2018 Feb 27;2018:8350862. doi: 10.1155/2018/8350862. eCollection 2018. |
| 24265819 | Derived | Chaiklang K, Wipasa J, Chaiwarith R, Praparattanapan J, Supparatpinyo K. 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. PLoS One. 2013 Nov 12;8(11):e80409. doi: 10.1371/journal.pone.0080409. eCollection 2013. |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |