Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting
Trial record 63 of 347 for:    hepatitis b | Open Studies

Hepatitis B Vaccination in HIV-infected Adults

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:
NCT02713620
First received: March 4, 2016
Last updated: March 18, 2016
Last verified: March 2016
  Purpose
This is a follow up study from the published article entitled "Comparison of immunogenicity and safety of four doses and four double doses vs. standard doses of hepatitis B vaccination in HIV-infected adults: a randomized, controlled trial" by Chaiklang K, Wipasa J, Chaiwarith R, Praparattanapan J, Supparatpinyo K. that was published in PLoS One. 2013 Nov 12;8(11):e80409. doi: 10.1371/journal.pone.0080409. eCollection 2013. ClinicalTrials.gov; NCT1289106. This study aimed to evaluate the efficacy of the HBV vaccination regimens using either four standard doses or four double doses compared with the current standard regimen of three doses in HIV-infected adults in northern Thailand. In addition, the investigators evaluated the efficacy of the HBV vaccination with the current standard regimen of three doses between healthy adults and HIV-infected patients.

Condition Intervention Phase
Hepatitis B
Biological: recombinant HBV vaccine (Hepavax-Gene® Berna, Korea)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Comparison of Immunogenicity of Four Doses and Four Double Doses vs. Standard Doses of Hepatitis B Vaccination in HIV-infected Adults: a Result From Randomized Controlled Trial at 3 Years After Vaccination

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: 36 months after vaccination ] [ Designated as safety issue: No ]
    Comparison of proportion of participants who had protective immunity (anti-HBS titer >=10 mIU/ml) against HBV between "healthy" v.s. "HIV group 1", "HIV group 2" v.s. "HIV group 1", "HIV group 3 v.s. "HIV group 1"


Secondary Outcome Measures:
  • The geometric means of anti-HBs titers [ Time Frame: 36 months after vaccination ] [ Designated as safety issue: No ]
    Comparison of the geometric means of anti-HBS titers between "healthy" v.s. "HIV group 1", "HIV group 2" v.s. "HIV group 1", "HIV group 3 v.s. "HIV group 1"

  • Proportion of participants with high level of immune response against HBV [ Time Frame: 36 months after vaccination ] [ Designated as safety issue: No ]
    Comparison of proportion of participants who had anti-HBS titers >=100 mIU/ml between "healthy" v.s. "HIV group 1", "HIV group 2" v.s. "HIV group 1", "HIV group 3 v.s. "HIV group 1"


Estimated Enrollment: 176
Study Start Date: March 2015
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Healthy
the "Healthy group" receiving three intramuscular injections of 20 μg of recombinant HBV vaccine (Hepavax-Gene® Berna, Korea) at months 0, 1, and 6
Biological: recombinant HBV vaccine (Hepavax-Gene® Berna, Korea)
Different HBV vaccine regimen in each group
Active Comparator: HIV-Group1
the "Standard doses group" receiving three intramuscular injections of 20 μg of recombinant HBV vaccine (Hepavax-Gene® Berna, Korea) at months 0, 1, and 6
Biological: recombinant HBV vaccine (Hepavax-Gene® Berna, Korea)
Different HBV vaccine regimen in each group
Active Comparator: HIV-Group 2
the "Four doses group" receiving four intramuscular doses of 20 μg of recombinant HBV vaccine (Hepavax-Gene® Berna, Korea) at months 0, 1, 2, and 6
Biological: recombinant HBV vaccine (Hepavax-Gene® Berna, Korea)
Different HBV vaccine regimen in each group
Active Comparator: HIV-Group 3
the "Four double doses group" receiving four intramuscular double doses (40 μg) of recombinant HBV vaccine (Hepavax-Gene® Berna, Korea) at months 0, 1, 2, and 6
Biological: recombinant HBV vaccine (Hepavax-Gene® Berna, Korea)
Different HBV vaccine regimen in each group

Detailed Description:

From February 4, 2011 to May 4, 2012, 132 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 three recombinant vaccine (Hepavax-Gene® Berna, Korea) regimens: 20 μg IM at months 0, 1, and 6 (Standard doses group, n=44), 20 μg IM at months 0, 1, 2, 6 (four doses group, n=44), or 40 μg IM at months 0, 1, 2, and 6 (four double doses group, n=44). There was another group of healthy individuals received standard dose of 20 μg IM at months 0, 1, and 6 recruited during the same time and under the same protocol. In brief, at months 7 and 12, the percentages of responders (anti-HBs ≥10 mIU/mL) were 88.6% and 70.4% in the Standard doses group, 93.2% and 86.4% in the four doses group, (P=0.713 and 0.119), and 95.4% and 88.6% in the four double doses group, (P=0.434 and 0.062), respectively.

This current study aimed to evaluate the efficacy of the different HBV vaccination regimens at 36 months after vaccination. In addition to compare the group using four standard doses or four double doses with the current standard regimen of three doses in HIV-infected adults in northern Thailand, the investigators also compare the efficacy of the current standard regimen of 3 doses between HIV-infected and healthy individuals.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy Group 1.1 ≥18 years old, 1.2 were 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 vaccine 1.3 were negative for antibody to hepatitis C virus (anti-HCV) 1.4 received three intramuscular injections of 20 μg of recombinant HBV vaccine (Hepavax-Gene® Berna, Korea) at months 0, 1, and 6 during February 4, 2011 to May 4, 2012, the same time as the study under ClinicalTrials.gov; NCT1289106. were conducted.

    1.4 and were willing to sign an informed consent

  2. HIV Group 1 2.1 HIV-1 infection 2.2 ≥18 years old, 2.3 had a CD4+ cell count >200 cells/mm3, 2.4 undetectable plasma HIV-1 RNA, 2.5 were 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 vaccine, 2.6 were negative for antibody to hepatitis C virus (anti-HCV), 2.7 had no active opportunistic infections (at the time of screening), 2.8 were participated in ClinicalTrials.gov; NCT1289106.and receiving three intramuscular injections of 20 μg of recombinant HBV vaccine (Hepavax-Gene® Berna, Korea) at months 0, 1, and 6 2.9 were willing to sign an informed consent
  3. HIV-Group 2 3.1 HIV-1 infection 3.2 ≥18 years old, 3.3 had a CD4+ cell count >200 cells/mm3, 3.4 undetectable plasma HIV-1 RNA, 3.5 were 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 vaccine, 3.6 were negative for antibody to hepatitis C virus (anti-HCV), 3.7 had no active opportunistic infections (at the time of screening), 3.8 were participated in ClinicalTrials.gov; NCT1289106.and receiving four intramuscular doses of 20 μg of the same vaccine at months 0, 1, 2, and 6 3.9 were willing to sign an informed consent
  4. HIV Group 3 4.1 HIV-1 infection 4.2 ≥18 years old, 4.3 had a CD4+ cell count >200 cells/mm3, 4.4 undetectable plasma HIV-1 RNA, 4.5 were 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 vaccine, 4.6 were negative for antibody to hepatitis C virus (anti-HCV), 4.7 had no active opportunistic infections (at the time of screening), 4.8 were participated in ClinicalTrials.gov; NCT1289106.and receiving four intramuscular double doses (40 μg) at months 0, 1, 2, and 6 4.9 were willing to sign an informed consent

Exclusion Criteria:

For HIV group 1, 2, and 3

  1. active malignancy receiving chemotherapy or radiation,
  2. other immunocompromised conditions besides HIV (e.g., solid organ transplant),
  3. received immunosuppressive (e.g., corticosteroid ≥ 0•5 mg/kg/day) or immunomodulating treatment in the last six months before screening visit, 4. had 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: NCT02713620

Contacts
Contact: Romanee Chaiwarith, MD +66-5393-6457 rchaiwar@gmail.com
Contact: Jutarat Praparattanapan, PhD +66-5393-8879 jutarat.praparattanapan@gmail.com

Locations
Thailand
Maharaj Nakorn Chiang Mai Hospital, Department of Medicine, Chiang Mai University Recruiting
Muang, Chiang Mai, Thailand, 50130
Contact: Romanee Chaiwarith, MD, MHS         
Sponsors and Collaborators
Chiang Mai University
Investigators
Principal Investigator: Romanee Chaiwarith, MD Chiang Mai Unviersity
  More Information

Responsible Party: Romanee Chaiwarith, Associate Professor, Chiang Mai University
ClinicalTrials.gov Identifier: NCT02713620     History of Changes
Other Study ID Numbers: Research ID: 2986 
Study First Received: March 4, 2016
Last Updated: March 18, 2016
Health Authority: Thailand: Research Institute for Health Sciences
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 December 08, 2016