Clinical trial NCT03316807: Immunogenicity of Hepatitis B Vaccination in HIV-infected Adults
Official title: Immunogenicity and Persistence of Intramuscular High Dose Recombinant Hepatitis B Vaccine in HIV-infected Adults in China
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis B Vaccine
Keywords: Hepatitis B, Vaccine
Randomized Controlled Trial
HIV
Immunogenicity
Lead sponsor: Shanxi Medical University
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention, China
First posted: 2017-10-20
Enrollment: 182
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: Uptake, adherence, and completion of vaccination among HIV-infected adults were low, and their immune function and immune response to hepatitis B vaccination were also suboptimal, indicating that the current practice of hepatitis B vaccination can't protect HIV-infected adults from HBV infection. And the persistence of immunity induced by hepatitis B vaccination remains a challenge.

This is a randomized, open-label trial, conducted among HIV-infected adults with drug rehabilitation. This study will compare the immunogenicity, immune persistence, and safety of three intramuscular 20µg and 60µg recombinant hepatitis B vaccines at months 0, 1, and 6 among HIV-infected adults.

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

Eligibility criteria: Inclusion Criteria:

* HIV-infected
* Aged between 18 and 70 years
* 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 before or during the month preceding enrollment
* Any Intolerance or allergy to any component of the vaccine
* Ongoing opportunistic infection
* Hematological disorder
* Cancer
* Unexplained fever the week before enrollment
* Immunosuppressive or immunomodulating treatment in the last six months
* Liver disease

Primary outcomes:
measure: Number and Percentage of Participants With Anti-HBs Seroconversion at Month 7
timeFrame: Month 7
Secondary outcomes:
measure: Anti-HBs Concentration at Month 7
timeFrame: Month 7
measure: Number and Percentage of Participants With Anti-HBs Seroconversion at Month 12
timeFrame: Month 12
measure: Anti-HBs Concentration at Month 12
timeFrame: Month 12
measure: Occurrence of Adverse Events After Vaccination
timeFrame: Within 7 days after the vaccination
measure: Occurrence of Adverse Events After Vaccination
timeFrame: Within 28 days after vaccination
measure: Serious Adverse Events (SAE) Occurred During 42 Month
timeFrame: Month 0-42
Other outcomes:
measure: Number and Percentage of Participants With Anti-HBs High-level Response at Month 7
timeFrame: Month 7
measure: Number and Percentage of Participants With Anti-HBs High-level Response at Month 12
timeFrame: Month 12
measure: Number and Percentage of Participants With Anti-HBs Antibodies at Month 6 Before the Third Injection
timeFrame: Month 6 before the third injection
measure: Anti-HBs Concentration at Month 6 Before the Third Injection
timeFrame: Month 6 before the third injection
measure: Number and Percentage of Participants With Anti-HBs High-level Response at Month 6 Before the Third Injection
timeFrame: Month 6 before the third injection
measure: Number and Percentage of Participants With Anti-HBs Seroconversion at Month 42
timeFrame: Month 42
Locations:
Study officials:
affiliation: Shanxi Medical University
name: Suping Wang
role: PRINCIPAL_INVESTIGATOR
References:
citation: Feng Y, Yao T, Chang Y, Gao L, Shao Z, Dong S, Wu Y, Shi X, Shi J, Feng D, Cheng Y, Pan M, Li C, Wang J, Lan G, Lu H, Wang P, Xiang S, Nong L, Wang F, Liang X, Wang S. Immunogenicity and persistence of high-dose recombinant hepatitis B vaccine in adults infected with human immunodeficiency virus in China: A randomized, double-blind, parallel controlled trial. Vaccine. 2021 Jun 16;39(27):3582-3589. doi: 10.1016/j.vaccine.2021.05.044. Epub 2021 May 26.