Phase 4
Completed N=480
Immunogenicity of Hepatitis B Vaccination Among Drug Users
Hepatitis B Vaccination
Source: ClinicalTrials.gov NCT02959775 ↗
Enrolled (actual)
480
Serious AEs
0.0%
Results posted
Feb 2022
Primary outcomePrimary: Number and Rate of Participants With Anti-HBs Seroconversion at Month 7 — 142; 138; 0 Participants
◆ Published Evidence
Emerging
10citations · ~1 / year
Immunogenicity and safety of high-dose hepatitis B vaccine among drug users: A randomized, open-labeled, blank-controlled trial.
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
Linked Publications
-
Immunogenicity and safety of high-dose hepatitis B vaccine among drug users: A randomized, open-labeled, blank-controlled trial.
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 Serious Adverse Events (SAE) Occurred During Month 12 |
0; 0 | — |
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) and the linked publication. 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. Informational only — not medical advice.