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

NCT ID: NCT02732054

Last Updated: 2017-04-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2016-02-29

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.

Conditions

Hepatitis B

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

HIV-Group 1

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: BIOLOGICAL

Different HBV vaccine regimen in each group

HIV-Group 2

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

Group Type: EXPERIMENTAL

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

Intervention Type: BIOLOGICAL

Different HBV vaccine regimen in each group

Interventions

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

Different HBV vaccine regimen in each group

Intervention Type: BIOLOGICAL

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chiang Mai University

OTHER

Sponsor Role: lead

Responsible Party

Romanee Chaiwarith

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Romanee Chaiwarith, MD

Role: PRINCIPAL_INVESTIGATOR

Thailand Maharaj Nakorn Chiang Mai Hospital, Department of Medicine, Chiang Mai University Muang, Chiang Mai Thailand

Locations

Maharaj Nakorn Chiang Mai Hospital, Department of Medicine, Chiang Mai University

Muang, Chiang Mai, Thailand

Countries

Thailand

Other Identifiers

Research ID: 02891

Identifier Type: -

Identifier Source: org_study_id