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

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

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.

Study Overview

• Status: Completed
• Conditions: Hepatitis B
• Intervention / Treatment: Biological: Recombinant Hepatitis B vaccine [(CIGB) La Habana, Cuba]

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.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 4

Contacts and Locations

Study Locations

• Thailand
  • Chiang Mai
    • Muang, Chiang Mai, Thailand, 50200
      • Maharaj Nakorn Chiang Mai Hospital, Department of Medicine, Chiang Mai University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Biological: Recombinant Hepatitis B vaccine [(CIGB) La Habana, Cuba]; Different HBV vaccine regimen in each group
Experimental: 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	Biological: Recombinant Hepatitis B vaccine [(CIGB) La Habana, Cuba]; Different HBV vaccine regimen in each group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants with protective immunity against HBV	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	1 month after vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The geometric means of anti-HBs titers	Comparison of the geometric means of anti-HBS titers between HIV group 2 v.s. HIV group 1	1 month after vaccination
Proportion of participants with high level of immune response against HBV	Comparison of proportion of participants who had anti-HBS titers >= 100 mIU/ml between HIV group 2 v.s. HIV group 1	1 month after vaccination

Collaborators and Investigators

• Sponsor: Chiang Mai University
• Investigators: Principal Investigator: Romanee Chaiwarith, MD, Thailand Maharaj Nakorn Chiang Mai Hospital, Department of Medicine, Chiang Mai University Muang, Chiang Mai Thailand

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2015
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: March 31, 2016
• First Submitted That Met QC Criteria: April 7, 2016
• First Posted (Estimate): April 8, 2016

Study Record Updates

• Last Update Posted (Actual): April 19, 2017
• Last Update Submitted That Met QC Criteria: April 17, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: HBV vaccination, immunity
• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Enterovirus Infections; Picornaviridae Infections; Hepatitis B; Hepatitis; Hepatitis A
• Other Study ID Numbers: Research ID: 02891

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO