Immunogenicity and Persistence of Hepatitis B Vaccination in HIV-Infected Patients

Sponsor

Shanxi Medical University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT03962803

Collaborator

Centers for Disease Control and Prevention, China (Other)

300

Enrollment

Location

Arms

53.9

Anticipated Duration (Months)

5.6

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Hepatitis B Vaccine	Biological: 20 µg recombinant hepatitis B vaccine at months 0, 1, and 6 Biological: 20 µg recombinant hepatitis B vaccine at months 0, 1, 2, and 6 Biological: 60 µg recombinant hepatitis B vaccine at months 0, 1, 2, and 6	Phase 4

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

A Prospective Study on the Immunogenicity and Persistence of Hepatitis B Vaccine in HIV-Infected Patients

Anticipated Study Start Date :

Jun 5, 2019

Anticipated Primary Completion Date :

Feb 1, 2020

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 20 µg at months 0, 1, and 6 20 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6	Biological: 20 µg recombinant hepatitis B vaccine at months 0, 1, and 6 three-dose, 20 µg per dose
Experimental: 20 µg at months 0, 1, 2,and 6 20 µg recombinant hepatitis B vaccine with four injections at months 0, 1, 2, and 6	Biological: 20 µg recombinant hepatitis B vaccine at months 0, 1, 2, and 6 four-dose, 20 µg per dose
Experimental: 60 µg at months 0, 1, 2,and 6 60 µg recombinant hepatitis B vaccine with four injections at months 0, 1, 2, and 6	Biological: 60 µg recombinant hepatitis B vaccine at months 0, 1, 2, and 6 four-dose, 60 µg per dose

Arm

Intervention/Treatment

Experimental: 20 µg at months 0, 1, and 6

20 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6

Biological: 20 µg recombinant hepatitis B vaccine at months 0, 1, and 6

three-dose, 20 µg per dose

Experimental: 20 µg at months 0, 1, 2,and 6

20 µg recombinant hepatitis B vaccine with four injections at months 0, 1, 2, and 6

Biological: 20 µg recombinant hepatitis B vaccine at months 0, 1, 2, and 6

four-dose, 20 µg per dose

Experimental: 60 µg at months 0, 1, 2,and 6

60 µg recombinant hepatitis B vaccine with four injections at months 0, 1, 2, and 6

Biological: 60 µg recombinant hepatitis B vaccine at months 0, 1, 2, and 6

four-dose, 60 µg per dose

Outcome Measures

Primary Outcome Measures

Anti-HBs Seroconversion Rate at Month 7 [Month 7]
Anti-HBs Seroconversion Rate at month 7 as measured by CMIA

Secondary Outcome Measures

Anti-HBs concentration at month 7 [Month 7]
Anti-HBs concentration at month 7 as measured by CMIA
Occurrence of Adverse Events After Vaccination [Within 7 days after the vaccination]
Occurrence of adverse reactions within 7 days after vaccination with the hepatitis
Anti-HBs Seroconversion Rate at month 12 [Month 12]
Anti-HBs Seroconversion Rate at month 12 as measured by CMIA
Anti-HBs concentration at month 12 [Month 12]
Anti-HBs concentration at month 12 as measured by CMIA
Anti-HBs Seroconversion Rate at month 18 [Month 18]
Anti-HBs Seroconversion Rate at month 18 as measured by CMIA
Anti-HBs concentration at month 18 [Month 18]
Anti-HBs concentration at month 18 as measured by CMIA
Anti-HBs Seroconversion Rate at month 30 [Month 30]
Anti-HBs Seroconversion Rate at month 30 as measured by CMIA
Anti-HBs concentration at month 30 [Month 30]
Anti-HBs concentration at month 30 as measured by CMIA
Anti-HBs Seroconversion Rate at month 42 [Month 42]
Anti-HBs Seroconversion Rate at month 42 as measured by CMIA
Anti-HBs concentration at month 42 [Month 42]
Anti-HBs concentration at month 42 as measured by CMIA

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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