Phase 4
Completed N=196
Immunogenicity of Hepatitis B Vaccination in Methadone Maintenance Treatment Patients
Hepatitis B Vaccine
Source: ClinicalTrials.gov NCT02991599 ↗
Enrolled (actual)
196
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcomePrimary: Number and Rate of Participants With Anti-HBs Seroconversion at Month 7 — 59; 62 Participants
◆ Published Evidence
Emerging
10citations · ~1 / year
Immunogenicity and safety of a high-dose hepatitis B vaccine among patients receiving methadone maintenance treatment: A randomized, double-blinded, parallel-controlled trial.
Summary
This is a randomized, controlled trial. The study will evaluate the immunogenicity, immune persistence, and safety of 20 µg and 60 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6 in methadone maintenance treatment patients.
Linked Publications
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Immunogenicity and safety of a high-dose hepatitis B vaccine among patients receiving methadone maintenance treatment: A randomized, double-blinded, parallel-controlled trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number and Rate of Participants With Anti-HBs Seroconversion at Month 7 |
59; 62 | — |
| SECONDARY Anti-HBs Concentration at Month 7 |
630.4; 742.9 | — |
| SECONDARY Anti-HBs Concentration at Month 12 |
125.9; 182.2 | — |
| SECONDARY Number and Rate of Participants With Anti-HBs Seroconversion at Month 12 |
41; 43 | — |
| SECONDARY Occurrence of Adverse Events After Vaccination |
2; 3 | — |
| SECONDARY Anti-HBs Concentration at Month 18 |
382.2; 490.5 | — |
| SECONDARY Number and Rate of Participants With Anti-HBs Seroconversion at Month 18 |
29; 29 | — |
| SECONDARY Anti-HBs Concentration at Month 30 |
239.9; 306.4 | — |
| SECONDARY Number and Rate of Participants With Anti-HBs Seroconversion at Month 30 |
20; 25 | — |
| SECONDARY Anti-HBs Concentration at Month 42 |
88.6; 97.7 | — |
| SECONDARY Number and Rate of Participants With Anti-HBs Seroconversion at Month 42 |
14; 20 | — |
Eligibility Criteria
Inclusion Criteria
- Aged between 18 and 70 years at the enrolment
- 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
- Intolerance or allergy to any component of the vaccine
- Any vaccination during the month preceding enrollment
- Ongoing opportunistic infection
- Liver disease
- Hematological disorder
- Cancer
- Unexplained fever the week before enrollment
Data sourced from ClinicalTrials.gov (NCT02991599) 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.