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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02732054
Other study ID # Research ID: 02891
Secondary ID
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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