Immunogenicity of Hepatitis B Vaccination in HIV-infected Adults

Suping Wang

Status and phase: Completed; Phase 4

Conditions: Hepatitis B Vaccine

Treatments: Biological: 60 µg dose hepatitis B vaccine; Biological: 20 µg dose hepatitis B vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT03316807

2012ZX10002001003004004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 182 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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182 participants in 2 patient groups

60 µg dose hepatitis B vaccine

Experimental group

Description:

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

Treatment:

Biological: 60 µg dose hepatitis B vaccine

20 µg dose hepatitis B vaccine

Experimental group

Description:

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

Treatment:

Biological: 20 µg dose hepatitis B vaccine