Phase 4
N=480
Immunogenicity of Hepatitis B Vaccination Among Drug Users
Hepatitis B Vaccination
Bottom Line
View on ClinicalTrials.gov: NCT02959775 ↗Enrolled (actual)
480
Serious AEs
0.0%
Results posted
Feb 2022
Primary outcome: Primary: Number and Rate of Participants With Anti-HBs Seroconversion at Month 7 — 142; 138; 0 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
- Male
- Sponsor
- Shanxi Medical University
- Primary completion
- May 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number and Rate of Participants With Anti-HBs Seroconversion at Month 7 |
142; 138; 0 | — |
| SECONDARY Anti-HBs Concentration at Month 7 |
909.6; 2022.5; 0.3 | — |
| SECONDARY Anti-HBs Concentration at Month 12 |
470.5; 676.7; 0.3 | — |
| SECONDARY Number and Rate of Participants With Anti-HBs Seroconversion at Month 12 |
119; 122; 0 | — |
| SECONDARY Occurrence of Adverse Events After Vaccination |
2; 2 | — |
| SECONDARY Occurrence of Adverse Events After Vaccination |
2; 2 | — |
| SECONDARY Serious Adverse Events (SAE) Occurred During Month 12 |
0; 0 | — |
Summary
Uptake, adherence, and completion of vaccination among drug users 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 drug users from HBV infection.
This is a randomized, open-label, blank-controlled trial, conducted among drug users with drug rehabilitation. This study will compare the immunogenicity and safety of three intramuscular 20µg and 60µg recombinant hepatitis B vaccines at months 0, 1, and 6 among drug users
Eligibility Criteria
Inclusion Criteria
- Aged between 18 and 70 years at the enrolment
- current illicit drug users before drug rehabilitation
- negative for hepatitis B surface antigen (HBsAg) and hepatitis B surface antibody (anti-HBs) at enrollment
- having spent acute physiological detoxification phase
Exclusion Criteria
- any intolerance or allergy to any component of the vaccine
- ongoing opportunistic infection
- liver disease
- hemopathy
- cancer
- unexplained fever in the last week before the recruiting
Data sourced from ClinicalTrials.gov (NCT02959775). 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.