Phase 4
N=352
Immunogenicity of Hepatitis B Vaccination in Hemodialysis Patients
Hepatitis B Vaccine
Bottom Line
View on ClinicalTrials.gov: NCT02963714 ↗Enrolled (actual)
352
Serious AEs
0.0%
Results posted
Feb 2022
Primary outcome: Primary: Anti-HBs Seroconversion Rate at Month 7 — 118; 132 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- 60 µg dose hepatitis B vaccine (Biological); 20 µg dose hepatitis B vaccine (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Suping Wang
- Primary completion
- Jul 2015
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 Occurrence of Adverse Events After Vaccination |
7; 8 | — |
| SECONDARY Anti-HBs Seroconversion Rate at Month 18 |
77; 96 | — |
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.
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). 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.