Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Immunogenicity of Hepatitis B Vaccination in Hemodialysis Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02963714
Recruitment Status : Unknown
Verified November 2016 by Suping Wang, Shanxi Medical University.
Recruitment status was:  Active, not recruiting
First Posted : November 15, 2016
Last Update Posted : November 15, 2016
Sponsor:
Collaborator:
Centers for Disease Control and Prevention, China
Information provided by (Responsible Party):
Suping Wang, Shanxi Medical University

Brief Summary:

Intramuscular injection of 40 μg hepatitis B vaccine in a standard three-dose schedule or a four-dose schedule is recommended for hemodialysis patients. However, seroconversion rates are inadequate and persistence of immunity remains a challenge.

This is a randomized, controlled trial. The study will evaluate the immunogenicity, immune persistence, and safety of 20 µg and 60 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6 in hemodialysis patients.


Condition or disease Intervention/treatment Phase
Hepatitis B Vaccine Biological: 60 µg dose hepatitis B vaccine Biological: 20 µg dose hepatitis B vaccine Phase 4

Detailed Description:
Participants are randomized in a ratio of 1:1 into 20 µg recombinant hepatitis B vaccine group or 60µg recombinant hepatitis B vaccine group.The 20 µg group will receive three intramuscular injections of the 20 µg recombinant hepatitis B vaccine, while the 60 µg group will receive three intramuscular injections of the 60 µg dose at months 0, 1 and 6, respectively. HBsAg and anti-HBs will be tested during the study period. Adverse reactions will be recorded after vaccination.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 352 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Immunogenicity and Persistence of Intramuscular High Dose Recombinant Hepatitis B Vaccine in Hemodialysis Patients in China: a Multicenter Randomized Controlled Trial
Study Start Date : April 2014
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 60 µg dose hepatitis B vaccine
60 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6
Biological: 60 µg dose hepatitis B vaccine
three-dose, 60 µg per dose

Experimental: 20 µg dose hepatitis B vaccine
20 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6
Biological: 20 µg dose hepatitis B vaccine
three-dose, 20 µg per dose




Primary Outcome Measures :
  1. Anti-HBs seroconversion rate at month 7 [ Time Frame: Month 7 ]
    Anti-HBs seroconversion rate at month 7


Secondary Outcome Measures :
  1. Anti-HBs concentration at month 7 [ Time Frame: Month 7 ]
    Anti-HBs concentration at month 7 as measured by CMIA

  2. Anti-HBs concentration at month 12 [ Time Frame: Month 12 ]
    Anti-HBs concentration at month 12 as measured by CMIA

  3. Anti-HBs seroconversion rate at month 12 [ Time Frame: Month 12 ]
    Anti-HBs seroconversion rate at month 12

  4. Occurrence of adverse events after vaccination [ Time Frame: Within 7 days after the vaccination ]
    Occurrence of adverse reactions within 7 days after vaccination with the hepatitis B vaccine

  5. Occurrence of adverse events after vaccination [ Time Frame: Within 28 days after the vaccination ]
    Occurrence of adverse reactions within 28 days after vaccination with the hepatitis B vaccine

  6. Serious adverse events (SAE) occurred during 42 month [ Time Frame: Month 0-42 ]
    Serious adverse events (SAE) occurred during 42 month


Other Outcome Measures:
  1. High-level response rate at month 7 [ Time Frame: Month 7 ]
    High-level response rate at month 7

  2. High-level response rate at month 12 [ Time Frame: Month 12 ]
    High-level response rate at month 12

  3. Anti-HBs concentration at month 6 before the third injection [ Time Frame: Month 6 before the third injection ]
    Anti-HBs concentration as measured by CMIA

  4. Anti-HBs seroconversion rate at month 6 before the third injection [ Time Frame: Month 6 before the third injection ]
    Anti-HBs seroconversion rate at month 6 before the third injection.

  5. High-level response rate at month 6 before the third injection [ Time Frame: Month 6 before the third injection ]
    High-level response rate at month 6 before the third injection

  6. Anti-HBs seroconversion rate at month 30 [ Time Frame: Month 30 ]
    Anti-HBs seroconversion rate at month 30

  7. Anti-HBs seroconversion rate at month 42 [ Time Frame: Month 42 ]
    Anti-HBs seroconversion rate at month 42



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Having end-stage renal disease (ESRD) on maintenance hemodialysis
  • Aged between 18 and 70 years at enrollment
  • Serologically negative for hepatitis B surface antigen (HBsAg) and hepatitis B surface antibody (anti-HBs) at enrollment
  • Willing to adhere to the study protocol

Exclusion Criteria:

  • Being pregnant
  • Acute cytolysis in the last three months before enrollment
  • Any vaccination during the month preceding enrollment
  • Intolerance or allergy to any component of the vaccine
  • Ongoing opportunistic infection
  • Hepatitis C virus infection
  • Hematological disorder
  • Cancer
  • Unexplained fever the week before enrollment
  • Immunosuppressive or immunomodulating treatment in the last six months
  • Renal transplantation or upcoming renal transplantation
  • Liver disease
  • Other immunocompromised condition not related to ESRD
  • An expected survival of < 6 months

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): NCT02963714


Sponsors and Collaborators
Suping Wang
Centers for Disease Control and Prevention, China
Investigators
Layout table for investigator information
Principal Investigator: Suping Wang Shanxi Medical University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Suping Wang, Professor, Shanxi Medical University
ClinicalTrials.gov Identifier: NCT02963714     History of Changes
Other Study ID Numbers: 2012ZX10002001003004001
First Posted: November 15, 2016    Key Record Dates
Last Update Posted: November 15, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Suping Wang, Shanxi Medical University:
Hepatitis B, Vaccine
Randomized Controlled Trial
Hemodialysis
Immunogenicity
Additional relevant MeSH terms:
Layout table for MeSH terms
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