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

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ClinicalTrials.gov Identifier: NCT02732054
Recruitment Status : Completed
First Posted : April 8, 2016
Last Update Posted : April 19, 2017
Sponsor:
Information provided by (Responsible Party):
Romanee Chaiwarith, 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.

Condition or disease Intervention/treatment Phase
Hepatitis B Biological: Recombinant Hepatitis B vaccine [(CIGB) La Habana, Cuba] Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : March 2015
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Proportion of participants with protective immunity against HBV [ Time Frame: 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 :
  1. The geometric means of anti-HBs titers [ Time Frame: 1 month after vaccination ]
    Comparison of the geometric means of anti-HBS titers between HIV group 2 v.s. HIV group 1

  2. Proportion of participants with high level of immune response against HBV [ Time Frame: 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



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02732054


Locations
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Thailand
Maharaj Nakorn Chiang Mai Hospital, Department of Medicine, Chiang Mai University
Muang, Chiang Mai, Thailand, 50200
Sponsors and Collaborators
Chiang Mai University
Investigators
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Principal Investigator: Romanee Chaiwarith, MD Thailand Maharaj Nakorn Chiang Mai Hospital, Department of Medicine, Chiang Mai University Muang, Chiang Mai Thailand

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Responsible Party: Romanee Chaiwarith, Associate Professor, Chiang Mai University
ClinicalTrials.gov Identifier: NCT02732054     History of Changes
Other Study ID Numbers: Research ID: 02891
First Posted: April 8, 2016    Key Record Dates
Last Update Posted: April 19, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Romanee Chaiwarith, Chiang Mai University:
HBV vaccination, immunity
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs