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Completed

NCT Number: NCT02963714

Immunogenicity of Hepatitis B Vaccination in Hemodialysis Patients

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.

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Key information

Conditions

Hepatitis B Vaccine Blood-Borne Infections Communicable Diseases DNA Virus Infections Digestive System Diseases Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis, Viral, Human Infections Liver Diseases Virus Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

60 µg dose hepatitis B vaccine

Biological

three-dose, 60 µg per dose

20 µg dose hepatitis B vaccine

Biological

three-dose, 20 µg per dose

Primary outcomes

  1. Anti-HBs Seroconversion Rate at Month 7

    Time frame: Month 7

Secondary outcomes

  1. Anti-HBs Seroconversion Rate at Month 42

    Time frame: Month 42

  2. Anti-HBs Seroconversion Rate at Month 36

    Time frame: Month 36

  3. Anti-HBs Seroconversion Rate at Month 30

    Time frame: Month 30

  4. Anti-HBs Seroconversion Rate at Month 24

    Time frame: Month 24

  5. Anti-HBs Concentration at Month 7

    Time frame: Month 7

    Anti-HBs concentration at month 7 as measured by CMIA

  6. Anti-HBs Concentration at Month 12

    Time frame: Month 12

    Anti-HBs concentration at month 12 as measured by CMIA

  7. Anti-HBs Seroconversion Rate at Month 12

    Time frame: Month 12

  8. 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

  9. 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

  10. Anti-HBs Seroconversion Rate at Month 18

    Time frame: Month 18

Other outcomes

  1. High-level Response Rate at Month 7

    Time frame: Month 7

  2. High-level Response Rate at Month 12

    Time frame: Month 12

  3. High-level Response Rate at Month 18

    Time frame: Month 18

  4. High-level Response Rate at Month 30

    Time frame: Month 30

  5. High-level Response Rate at Month 36

    Time frame: Month 36

  6. High-level Response Rate at Month 42

    Time frame: Month 42

  7. High-level Response Rate at Month 24

    Time frame: Month 24

Sponsors and collaborators

Lead sponsor

Suping Wang

Other

Collaborators

  • Centers for Disease Control and Prevention, China

Registry information

Official study title

Immunogenicity and Persistence of Intramuscular High Dose Recombinant Hepatitis B Vaccine in Hemodialysis Patients in China: a Multicenter Randomized Controlled Trial

Important dates

Study start
2014
Primary completion
2015
Study completion
2018
First posted
Nov 15, 2016
Registry last updated
Feb 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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