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Trial record 8 of 351 for:    hepatitis b | Open Studies

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2016 by Chiang Mai University
Sponsor:
Information provided by (Responsible Party):
Romanee Chaiwarith, Chiang Mai University
ClinicalTrials.gov Identifier:
NCT02732054
First received: March 31, 2016
Last updated: April 7, 2016
Last verified: March 2016
  Purpose
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 Intervention Phase
Hepatitis B
Biological: Recombinant Hepatitis B vaccine [(CIGB) La Habana, Cuba]
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Chiang Mai University:

Primary Outcome Measures:
  • 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:
  • 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

  • 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


Estimated Enrollment: 16
Study Start Date: May 2015
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02732054

Contacts
Contact: Romanee Chaiwarith, MD +66-5393-6457 rchaiwar@gmail.com
Contact: Rathakarn Kawila, MD +66-5393-6457 ticy_rk@yahoo.com

Locations
Thailand
Maharaj Nakorn Chiang Mai Hospital, Department of Medicine, Chiang Mai University Recruiting
Muang, Chiang Mai, Thailand, 50200
Contact: Romanee Chaiwarith, MD, MHS    +6653936457    rchaiwar@gmail.com   
Contact: Rathakarn Kawila, MD    +6653936457    ticy_rk@yahoo.com   
Sponsors and Collaborators
Chiang Mai University
Investigators
Principal Investigator: Romanee Chaiwarith, MD Thailand Maharaj Nakorn Chiang Mai Hospital, Department of Medicine, Chiang Mai University Muang, Chiang Mai Thailand
  More Information

Responsible Party: Romanee Chaiwarith, Associate Professor, Chiang Mai University
ClinicalTrials.gov Identifier: NCT02732054     History of Changes
Other Study ID Numbers: Research ID: 02891
Study First Received: March 31, 2016
Last Updated: April 7, 2016
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Chiang Mai University:
HBV vaccination, immunity

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on March 29, 2017