Phase 4
N=182
Immunogenicity of Hepatitis B Vaccination in HIV-infected Adults
Hepatitis B Vaccine
Bottom Line
View on ClinicalTrials.gov: NCT03316807 ↗Enrolled (actual)
182
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcome: Primary: Number and Percentage of Participants With Anti-HBs Seroconversion at Month 7 — 75; 69 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- 60 µg dose hepatitis B vaccine (Biological); 20 µg dose hepatitis B vaccine (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Suping Wang
- Primary completion
- Jul 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number and Percentage of Participants With Anti-HBs Seroconversion at Month 7 |
75; 69 | — |
| SECONDARY Anti-HBs Concentration at Month 7 |
623.3; 469.4 | — |
| SECONDARY Number and Percentage of Participants With Anti-HBs Seroconversion at Month 12 |
55; 50 | — |
| SECONDARY Anti-HBs Concentration at Month 12 |
290.4; 264.4 | — |
| SECONDARY Occurrence of Adverse Events After Vaccination |
1; 1; 2; 1 | — |
| SECONDARY Occurrence of Adverse Events After Vaccination |
1; 1; 2; 1 | — |
| SECONDARY Serious Adverse Events (SAE) Occurred During 42 Month |
0; 0 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03316807). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.