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

Hepatitis B Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02732054
• Other study ID #: Research ID: 02891
• Status: Completed
• Phase: Phase 4
• First received: March 31, 2016
• Last updated: April 17, 2017
• Start date: March 2015
• Est. completion date: February 2016

Study information

• Verified date: April 2017
• Source: Chiang Mai University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B

Intervention

Biological:
• Recombinant Hepatitis B vaccine [(CIGB) La Habana, Cuba]
Different HBV vaccine regimen in each group

Locations

Country	Name	City	State
Thailand	Maharaj Nakorn Chiang Mai Hospital, Department of Medicine, Chiang Mai University	Muang	Chiang Mai

Sponsors (1)

Lead Sponsor	Collaborator
Chiang Mai University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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