Clinical trial NCT03962881: Research on Optimal Immunization Strategy of Hepatitis B Vaccine in Chronic Kidney Disease Population
Official title: Research on Optimal Immunization Strategy of Hepatitis B Vaccine in Chronic Kidney Disease Population
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hepatitis B Vaccine
Keywords: Hepatitis B Vaccine
Randomized Controlled Trial
Chronic Kidney Disease Population
Immunogenicity
Long-term Immune Response
Lead sponsor: Shanxi Medical University
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention, China
First posted: 2019-05-24
Enrollment: 300
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: At present, chronic kidney disease population are vaccinated with hepatitis B vaccine according to the standard three-dose schedule immunization program, and the effect of preventing HBV infection is not ideal.

This is a randomized, controlled trial. The study will evaluate the immunogenicity and persistence of 20 µg and 60 µg recombinant hepatitis B vaccine with three or four injections at months 0, 1, and 6 or 0, 1, 2, and 6 in chronic kidney disease population.

Detailed description: Participants are randomized in a ratio of 1:1:1 into 20 µg recombinant hepatitis B vaccine group at months 0, 1, and 6 or 20µg recombinant hepatitis B vaccine group at months 0, 1, 2, and 6 or 60µg recombinant hepatitis B vaccine group at months 0, 1, 2, and 6. HBsAg and anti-HBs will be tested during the study period. Adverse reactions will be recorded after vaccination.

Eligibility criteria: Inclusion Criteria:

* Aged between 18 and 70 years at the enrolment
* Serologically negative for hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (anti-HBs) and hepatitis B core antibody (anti-HBc) at enrollment
* Sign informed consent, willing to participate in this study

Exclusion Criteria:

* Being pregnant
* Intolerance or allergy to any component of the vaccine
* Any vaccination during the month preceding enrollment
* Patients with severe acute or chronic diseases (such as liver disease, blood disease, cancer), acute onset of chronic diseases and fever
* Patients with Hepatitis B virus associated glomerulone nephritis or HBV DNA Positive

Primary outcomes:
measure: Anti-HBs Seroconversion Rate at Month 7
timeFrame: Month 7
Secondary outcomes:
measure: Anti-HBs concentration at month 7
timeFrame: Month 7
measure: Occurrence of Adverse Events After Vaccination
timeFrame: Within 7 days after the vaccination
measure: Anti-HBs Seroconversion Rate at Month 12
timeFrame: Month 12
measure: Anti-HBs Concentration at Month 12
timeFrame: Month 12
measure: Anti-HBs Seroconversion Rate at Month 18
timeFrame: Month 18
measure: Anti-HBs Concentration at Month 18
timeFrame: Month 18
measure: Anti-HBs Seroconversion Rate at Month 30
timeFrame: Month 30
measure: Anti-HBs Concentration at Month 30
timeFrame: Month 30
measure: Anti-HBs Seroconversion Rate at Month 42
timeFrame: Month 42
measure: Anti-HBs Concentration at Month 42
timeFrame: Month 42
Other outcomes:
Locations:
city: Linfen
country: China
facility: The Central Hospital of Linfen
city: Linfen
country: China
facility: The People's Hospital of Linfen
Study officials:
affiliation: Shanxi Medical University
name: Yongliang Feng, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Han Y, Cao N, Lu X, Yao T, Shi J, Wu Y, Dong S, Shao Z, Wang J, Liu H, Guo H, Chai G, Liu L, Wang F, Feng Y, Liang X, Wang S. Duration of immunogenicity of high-dose and prolonged-schedule hepatitis B vaccine among patients with chronic kidney disease: A one year follow-up study in China. Expert Rev Vaccines. 2022 Nov;21(11):1675-1682. doi: 10.1080/14760584.2022.2112951. Epub 2022 Aug 18.
citation: Feng Y, Yao T, Han Y, Shi J, Dong S, Wu Y, Shao Z, Liu H, Guo H, Chai G, Liu L, Wang F, Wang J, Liang X, Wang S. Immunogenicity and safety of a high-dose and prolonged-schedule hepatitis B vaccine among chronic kidney disease patients: a randomized, parallel-controlled trial. Expert Rev Vaccines. 2021 Jun;20(6):743-751. doi: 10.1080/14760584.2021.1915777. Epub 2021 May 31.