Hepatitis B Vaccination in HIV-infected Adults With Low CD4 Cell Counts

Chiang Mai University

Status and phase: Completed; Phase 4

Conditions: Hepatitis B

Treatments: Biological: Recombinant Hepatitis B vaccine [(CIGB) La Habana, Cuba]

Study type: Interventional

Funder types: Other

Identifiers

NCT02732054

Research ID: 02891

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

HIV-Group 1

Active Comparator group

Description:

Receiving three intramuscular injections of 20 µg of recombinant hepatitis B vaccine \[(CIGB) La Habana, Cuba\] at months 0, 1, and 6

Treatment:

Biological: Recombinant Hepatitis B vaccine [(CIGB) La Habana, Cuba]

HIV-Group 2

Experimental group

Description:

Receiving four intramuscular injections of 20 µg of recombinant hepatitis B vaccine \[(CIGB) La Habana, Cuba\] at months 0, 1, 2, and 6

Treatment:

Biological: Recombinant Hepatitis B vaccine [(CIGB) La Habana, Cuba]