Clinical trial NCT03962803: Immunogenicity and Persistence of Hepatitis B Vaccination in HIV-Infected Patients
Official title: A Prospective Study on the Immunogenicity and Persistence of Hepatitis B Vaccine in HIV-Infected Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hepatitis B Vaccine
Keywords: Hepatitis B Vaccine
Randomized Controlled Trial
HIV-Infected Patients
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, HIV-Infected Patients of Hepatitis B Vaccination in 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 HIV-Infected Patients

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:

* 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
* CD4 cell count ≤ 200 cells/µL
* Patients with severe acute or chronic diseases (such as liver disease, blood disease, cancer), acute onset of chronic diseases and fever
* The use of immunosuppressive agents in patients with nearly three months

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: Taiyuan
country: China
facility: Shanxi Center for Disease Control and Prevention
Study officials:
affiliation: Shanxi Medical University
name: Suping Wang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Feng Y, Chen Z, Xie R, Yao T, Wu Y, Yang F, Yuan C, Nie X, Wang F, Liang X, Wang S. Immunogenicity and safety of 4 intramuscular standard-dose and high-dose hepatitis B vaccine in people living with HIV: a randomized, parallel-controlled trial. Expert Rev Vaccines. 2022 Jun;21(6):861-868. doi: 10.1080/14760584.2022.2056024. Epub 2022 Apr 1.