Phase 4
Completed N=352
Immunogenicity of Hepatitis B Vaccination in Hemodialysis Patients
Hepatitis B Vaccine
Source: ClinicalTrials.gov NCT02963714 ↗
Enrolled (actual)
352
Serious AEs
0.0%
Results posted
Feb 2022
Primary outcomePrimary: Anti-HBs Seroconversion Rate at Month 7 — 118; 132 Participants
◆ Published Evidence
Established
30citations · ~3 / year
Immunogenicity, antibody persistence, and safety of the 60 μg hepatitis B vaccine in hemodialysis patients: a multicenter, randomized, double-blind, parallel-controlled trial.
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.
Linked Publications
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Immunogenicity, antibody persistence, and safety of the 60 μg hepatitis B vaccine in hemodialysis patients: a multicenter, randomized, double-blind, parallel-controlled trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Anti-HBs Seroconversion Rate at Month 7 |
118; 132 | — |
| SECONDARY Anti-HBs Seroconversion Rate at Month 42 |
33; 40 | — |
| SECONDARY Anti-HBs Seroconversion Rate at Month 36 |
41; 51 | — |
| SECONDARY Anti-HBs Seroconversion Rate at Month 30 |
48; 62 | — |
| SECONDARY Anti-HBs Seroconversion Rate at Month 24 |
54; 78 | — |
| SECONDARY Anti-HBs Concentration at Month 7 |
1488.5; 1916.6 | — |
| SECONDARY Anti-HBs Concentration at Month 12 |
407.8; 476.2 | — |
| SECONDARY Anti-HBs Seroconversion Rate at Month 12 |
109; 114 | — |
| SECONDARY Occurrence of Adverse Events After Vaccination |
7; 8 | — |
| SECONDARY Anti-HBs Seroconversion Rate at Month 18 |
77; 96 | — |
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
Data sourced from ClinicalTrials.gov (NCT02963714) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.