Clinical trial NCT02963714: Immunogenicity of Hepatitis B Vaccination in Hemodialysis Patients
Official title: Immunogenicity and Persistence of Intramuscular High Dose Recombinant Hepatitis B Vaccine in Hemodialysis Patients in China: a Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis B Vaccine
Keywords: Hepatitis B, Vaccine
Randomized Controlled Trial
Hemodialysis
Immunogenicity
Lead sponsor: Shanxi Medical University
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention, China
First posted: 2016-11-15
Enrollment: 352
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility 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

Primary outcomes:
measure: Anti-HBs Seroconversion Rate at Month 7
timeFrame: Month 7
Secondary outcomes:
measure: Anti-HBs Seroconversion Rate at Month 42
timeFrame: Month 42
measure: Anti-HBs Seroconversion Rate at Month 36
timeFrame: Month 36
measure: Anti-HBs Seroconversion Rate at Month 30
timeFrame: Month 30
measure: Anti-HBs Seroconversion Rate at Month 24
timeFrame: Month 24
measure: Anti-HBs Concentration at Month 7
timeFrame: Month 7
measure: Anti-HBs Concentration at Month 12
timeFrame: Month 12
measure: Anti-HBs Seroconversion Rate at Month 12
timeFrame: Month 12
measure: Occurrence of Adverse Events After Vaccination
timeFrame: Within 7 days after the vaccination
measure: Occurrence of Adverse Events After Vaccination
timeFrame: Within 28 days after the vaccination
measure: Anti-HBs Seroconversion Rate at Month 18
timeFrame: Month 18
Other outcomes:
measure: High-level Response Rate at Month 7
timeFrame: Month 7
measure: High-level Response Rate at Month 12
timeFrame: Month 12
measure: High-level Response Rate at Month 18
timeFrame: Month 18
measure: High-level Response Rate at Month 30
timeFrame: Month 30
measure: High-level Response Rate at Month 36
timeFrame: Month 36
measure: High-level Response Rate at Month 42
timeFrame: Month 42
measure: High-level Response Rate at Month 24
timeFrame: Month 24
Locations:
Study officials:
affiliation: Shanxi Medical University
name: Suping Wang
role: PRINCIPAL_INVESTIGATOR
References:
citation: Feng Y, Shi X, Shi J, Gao L, Liu G, Cheng Y, Pan M, Li C, Wang J, Guo X, Zhang Y, Liang X, Wang S. Immunogenicity, antibody persistence, and safety of the 60 mug hepatitis B vaccine in hemodialysis patients: a multicenter, randomized, double-blind, parallel-controlled trial. Expert Rev Vaccines. 2017 Oct;16(10):1045-1052. doi: 10.1080/14760584.2017.1367667. Epub 2017 Aug 21.