Hepatitis B
Conditions
Keywords
HBV vaccination, immunity
Brief 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.
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.
Interventions
BIOLOGICALRecombinant Hepatitis B vaccine [(CIGB) La Habana, Cuba]
Different HBV vaccine regimen in each group
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
1. HIV-infection 2. ≥18 years old 3. Received combination antiretroviral therapy for at least 1 year 4. Had a CD4+ cell count \< 200 cells/mm3 for at least 1 year 5. Undetectable plasma HIV-1 RNA for at least 1 year 6. Negative for hepatitis B surface antigen (HBsAg), antibody to hepatitis B surface antigen (anti-HBs), and antibody to hepatitis B core antigen (anti-HBc), 7. Had no history of previous HBV vaccine 8. Negative for antibody to hepatitis C virus (anti-HCV) 9. No active opportunistic infections (at the time of screening) 10. Willing to sign an informed consent 11. Able to return for follow-up.
Exclusion criteria
1. Pregnancy or lactation 2. History of hypersensitivity to any component of the vaccine 3. 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 4. Renal insufficiency (creatinine clearance \<30 mL/min) 5. Decompensated cirrhosis (Child-Pugh class C)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants with protective immunity against HBV | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The geometric means of anti-HBs titers | 1 month after vaccination | Comparison of the geometric means of anti-HBS titers between HIV group 2 v.s. HIV group 1 |
| Proportion of participants with high level of immune response against HBV | 1 month after vaccination | Comparison of proportion of participants who had anti-HBS titers \>= 100 mIU/ml between HIV group 2 v.s. HIV group 1 |
Countries
Thailand
Outcome results
None listed