MedTrace Logo

Combination Hepatitis A and B Vaccine to Induce Immunity in Non-responders

NCT01126853 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2020-06-01

No results posted yet for this study

Summary

Hepatitis B is a vaccine preventable infection which can be transmitted through occupational exposure. Approximately 15% of patients will not respond to an initial series of vaccination. Of those re-vaccinated approximately fifty percent will respond. On the basis of poor response to a third series, repeat vaccination is not recommended and non-responders are considered vulnerable to infection. Cardell studied the use of double dose combination hepatitis A and B vaccine (Twinrix) in non responders who had received four or more doses previously and found a high response rate suggesting this vaccine and dose could be effective. The investigators study seeks to duplicate the findings of Cardell, using a more strict definition of non-responder (6 or more previous doses).

Conditions

Interventions

BIOLOGICAL

Twinrix

Up to three intramuscular doses of 1cc of Twinrix (combined hepatitis A/B vaccine) at 0, 1, and 6 months post-enrollment

Sponsors & Collaborators

  • University of Toronto

    collaborator OTHER

  • Mount Sinai Hospital, Canada

    lead OTHER

Principal Investigators

  • Todd C Lee, MD · Mount Sinai Hospital, University of Toronto

  • Allison J McGeer, MD MSc · Mount Sinai Hospital, University of Toronto

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2011-06-30
Completion
2011-07-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01126853 on ClinicalTrials.gov