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

Phase 4

Completed

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

• Registration Number: NCT02732054
• Lead Sponsor: Chiang Mai University

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.

Study Timeline

• Study Start: 2015-03
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Study First Submitted: 2016-03-31
• Study First Submitted QC: 2016-04-07
• Study First Posted: 2016-04-08
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-17
• Last Update Posted: 2017-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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)

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HIV-Group 1	Recombinant Hepatitis B vaccine [(CIGB) La Habana, Cuba]	Receiving three intramuscular injections of 20 µg of recombinant hepatitis B vaccine \[(CIGB) La Habana, Cuba\] at months 0, 1, and 6
HIV-Group 2	Recombinant Hepatitis B vaccine [(CIGB) La Habana, Cuba]	Receiving four intramuscular injections of 20 µg of recombinant hepatitis B vaccine \[(CIGB) La Habana, Cuba\] at months 0, 1, 2, and 6

Primary Outcome Measures

Name	Time	Method
Proportion of participants with protective immunity against HBV	1 month after vaccination	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

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