Phase 4
N=196
Immunogenicity of Hepatitis B Vaccination in Methadone Maintenance Treatment Patients
Hepatitis B Vaccine
Bottom Line
View on ClinicalTrials.gov: NCT02991599 ↗Enrolled (actual)
196
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcome: Primary: Number and Rate of Participants With Anti-HBs Seroconversion at Month 7 — 59; 62 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
- Shanxi Medical University
- Primary completion
- Jul 2015
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 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 | — |
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.
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). 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.