Clinical trial NCT02732054: Hepatitis B Vaccination in HIV-infected Adults With Low CD4 Cell Counts
Official title: Comparison of Immunogenicity and Safety of 4 Standard Doses and 3 Standard Doses of Hepatitis B Vaccination in HIV-infected Adults Who Have CD4 < 200 Cells/mm3
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis B
Keywords: HBV vaccination, immunity
Lead sponsor: Chiang Mai University
Sponsor class: OTHER
First posted: 2016-04-08
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Proportion of participants with protective immunity against HBV
timeFrame: 1 month after vaccination
Secondary outcomes:
measure: The geometric means of anti-HBs titers
timeFrame: 1 month after vaccination
measure: Proportion of participants with high level of immune response against HBV
timeFrame: 1 month after vaccination
Other outcomes:
Locations:
city: Muang
country: Thailand
facility: Maharaj Nakorn Chiang Mai Hospital, Department of Medicine, Chiang Mai University
state: Chiang Mai
Study officials:
affiliation: Thailand Maharaj Nakorn Chiang Mai Hospital, Department of Medicine, Chiang Mai University Muang, Chiang Mai Thailand
name: Romanee Chaiwarith, MD
role: PRINCIPAL_INVESTIGATOR
References: