Immunogenicity of Hepatitis B Vaccination in HIV-infected Adults

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

182 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2018-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hepatitis B Vaccine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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60 µg dose hepatitis B vaccine

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

Group Type EXPERIMENTAL

60 µg dose hepatitis B vaccine

Intervention Type BIOLOGICAL

three-dose, 60 µg per dose

20 µg dose hepatitis B vaccine

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

Group Type EXPERIMENTAL

20 µg dose hepatitis B vaccine

Intervention Type BIOLOGICAL

three-dose, 20 µg per dose

Interventions

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60 µg dose hepatitis B vaccine

three-dose, 60 µg per dose

Intervention Type BIOLOGICAL

20 µg dose hepatitis B vaccine

three-dose, 20 µg per dose

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No