HIV Infection
Conditions
Keywords
Hepatitis B vaccine, HIV infection, Modified HBV vaccine dose, Modified HBV vaccine schedule
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALHepavax-Gene
20 μg of Hepavax-gene intramuscularly injections at deltoid region at 0,1 and 6 months
Sponsors
Chiang Mai University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Positive for anti-HIV antibody * At least 18 years of age * CD4 \> 200 cell/mm3 * On antiretroviral therapy * Viral load \< 50 copies/ml * Negative for any HBV serological marker (HBsAg, Anti-HBs, Anti-HBc) * No history of previous hepatitis B vaccination * Anti-HCV negative * No active opportunistic infection at the time of screening * Willing to sign informed consent * Able to follow up
Exclusion criteria
* Pregnancy or breast feeding * History of hypersensitivity to any component of vaccine * Diagnosis of malignancy and receiving chemotherapy or radiation * Other immunocompromised conditions not related to HIV infection (solid-organ transplantation, chemotherapy in the last 6 months) * On Immunosuppressive treatment, immunomodulating treatment or corticosteroid (equal or above 0.5 mg per kg per day of prednisolone) * Renal failure (creatinine clearance \< 30 mL/min) * Decompensated cirrhosis (child-pugh C) * Not able to follow up
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Seroconversion rate (percentage of subjects with anti-HBs antibody titer >= 10 IU/L) at day 210 | Day 210 | 1. To compare the seroconversion rate at day 210 of an intensive standard-dose regimen (0, 1, 2 and 6 months) to a standard-dose regimen (0,1 and 6 months) 2. To compare the seroconversion rate at day 210 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Seroprotective rate (percentage of subjects with anti-HBs antibody titer >= 10 IU/L) at 1 year | 1 year | To determine the seroprotective rate at 1 year of each of the vaccination regimens. |
| Number of subjects with adverse events after vaccination | 180 days | Adverse events include pain at injected site, swelling at injected site, redness at injected site, fever, headache, fatique and anaphylaxis |
Countries
Thailand
Contacts
Primary ContactKanokporn Chaiklang, MD
Outcome results
None listed