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

Primary Purpose

Hepatitis B

Status

Completed

Phase

Phase 4

Locations

Thailand

Study Type

Interventional

Intervention

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

About this trial

This is an interventional prevention trial for Hepatitis B focused on measuring HBV vaccination, immunity

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

HIV-infection
≥18 years old
Received combination antiretroviral therapy for at least 1 year
Had a CD4+ cell count < 200 cells/mm3 for at least 1 year
Undetectable plasma HIV-1 RNA for at least 1 year
Negative for hepatitis B surface antigen (HBsAg), antibody to hepatitis B surface antigen (anti-HBs), and antibody to hepatitis B core antigen (anti-HBc),
Had no history of previous HBV vaccine
Negative for antibody to hepatitis C virus (anti-HCV)
No active opportunistic infections (at the time of screening)
Willing to sign an informed consent
Able to return for follow-up.

Exclusion criteria

Pregnancy or lactation
History of hypersensitivity to any component of the vaccine
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
Renal insufficiency (creatinine clearance <30 mL/min)
Decompensated cirrhosis (Child-Pugh class C)

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

HIV-Group 1

HIV-Group 2

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

Full Information

NCT ID

NCT02732054

First Posted

March 31, 2016

Last Updated

April 17, 2017

Sponsor

Chiang Mai University

1. Study Identification

Unique Protocol Identification Number

NCT02732054

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Completed

Study Start Date

March 2015 (Actual)

Primary Completion Date

February 2016 (Actual)

Study Completion Date

February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chiang Mai University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatitis B

Keywords

HBV vaccination, immunity

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

HIV-Group 1

Arm Type

Active Comparator

Arm Description

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

Arm Title

HIV-Group 2

Arm Type

Experimental

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

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

Intervention Description

Different HBV vaccine regimen in each group

Primary Outcome Measure Information:

Title

Proportion of participants with protective immunity against HBV

Description

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

Time Frame

1 month after vaccination

Secondary Outcome Measure Information:

Title

The geometric means of anti-HBs titers

Description

Comparison of the geometric means of anti-HBS titers between HIV group 2 v.s. HIV group 1

Time Frame

1 month after vaccination

Title

Proportion of participants with high level of immune response against HBV

Description

Comparison of proportion of participants who had anti-HBS titers >= 100 mIU/ml between HIV group 2 v.s. HIV group 1

Time Frame

1 month after vaccination

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: HIV-infection ≥18 years old Received combination antiretroviral therapy for at least 1 year Had a CD4+ cell count < 200 cells/mm3 for at least 1 year Undetectable plasma HIV-1 RNA for at least 1 year Negative for hepatitis B surface antigen (HBsAg), antibody to hepatitis B surface antigen (anti-HBs), and antibody to hepatitis B core antigen (anti-HBc), Had no history of previous HBV vaccine Negative for antibody to hepatitis C virus (anti-HCV) No active opportunistic infections (at the time of screening) Willing to sign an informed consent Able to return for follow-up. Exclusion criteria Pregnancy or lactation History of hypersensitivity to any component of the vaccine 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 Renal insufficiency (creatinine clearance <30 mL/min) Decompensated cirrhosis (Child-Pugh class C)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Romanee Chaiwarith, MD

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Muang

State/Province

Chiang Mai

ZIP/Postal Code

50200

Country

Thailand

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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