People living with HIV with viral load suppressed and CD4 equal to more than 500 cells/mm3 HIV HBV vaccine
Conditions
Interventions
40 mcg of HBV vaccine (Recombinant HEPATITIS B VACCINE, SERUM INSTITUTE OF INDIA),20 mcg of HBV vaccine (Recombinant HEPATITIS B VACCINE, SERUM INSTITUTE OF INDIA)
Active Comparator Drug,Experimental Drug
Double-dose HBV vaccine,Standard-dose HBV vaccine
Sponsors
Faculty of Medicine, Chiang Mai University
Eligibility
Sex/Gender
All
Age
20 Years to No maximum
Inclusion criteria
Inclusion criteria: (1) PLWH with age equal to more than 20 years old (2) CD4 cell count equal to more than 500 cells/mm3 (3) HIV-1 RNA less than 20 copies/mL (4) HBV serostatus at baseline shows HBsAg negative, anti-HBc total negative and anti-HBs less than 10 mIU/mL
Exclusion criteria
Exclusion criteria: 1. Documented non-responder to HBV vaccination or previous documented anti-HBs more than 10 mIU/mL 2. HCV co-infection (anti-HCV positive and documented plasma HCV viral load) 3. Pregnancy or lactation 4. History of severe allergy to any component of vaccine 5. Active malignancy receiving chemotherapy or radiation 6. Received immunosuppressive (e.g., corticosteroid equal to more than 0.5 mg/kg/day) or immunomodulating treatment in the last six months before screening visit 7. Renal insufficiency (CrCl less than 30 mL/min) 8. Decompensated cirrhosis (Child-Pugh class C)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| seroprotection rate 1 month after last dose of vaccine anti-HBs level more than 10 mIU/mL | — |
Secondary
| Measure | Time frame |
|---|---|
| safety assessment 1 week after each vaccination side effect from vaccine included local reactions (pain, tenderness, swelling, and redness) and systemic reactions (fever, fatigue, headache, myalgia, nausea/vomiting, and diarrhea) | — |
Countries
Thailand
Contacts
Public ContactDitsaruj Srijiranon
Faculty of Medicine, Chiang Mai University
Outcome results
None listed