Combination Hepatitis A and B Vaccine to Induce Immunity in Non-responders
Recruitment status was Recruiting
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).
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||A Pilot Study Evaluating the Combination Hepatitis A and B Vaccine (Twinrix®) in Healthy Healthcare Workers Who Meet the CDC Definition for Non-responders.|
- Protective immunity to Hepatitis B [ Time Frame: up to 7 months (average) ] [ Designated as safety issue: No ]The number of patients who develop protective antibody titres (>10 mIU/ml) during the immunization period. This will be followed 1 month after each dose received.
- Adverse Events [ Time Frame: up to 7 months (average) ] [ Designated as safety issue: Yes ]The number and description of adverse events.
- Rate of Recruitment [ Time Frame: 1 year ] [ Designated as safety issue: No ]Proportion of subjects who are eligible who agree to participate and who complete the trial. This will be used as a marker of whether a larger trial would be feasible.
- Partial immunity to Hepatitis B [ Time Frame: up to 7 months (average) ] [ Designated as safety issue: No ]The number of patients who develop antibodies against hepatitis B surface antibody at titres of 1-10 IU/ml.
|Study Start Date:||April 2010|
|Estimated Study Completion Date:||July 2011|
|Estimated Primary Completion Date:||June 2011 (Final data collection date for primary outcome measure)|
Receipt of up to 3 series of double dose combination hepatitis A/B vaccine (Twinrix)
Up to three intramuscular doses of 1cc of Twinrix (combined hepatitis A/B vaccine) at 0, 1, and 6 months post-enrollment
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01126853
|Contact: Todd C Lee, MD||4165864800 ext firstname.lastname@example.org|
|Mount Sinai Hospital||Recruiting|
|Toronto, Ontario, Canada, M5G 1K5|
|Principal Investigator: Todd C Lee, MD|
|Principal Investigator: Allison J McGeer, MD MSc|
|Principal Investigator:||Todd C Lee, MD||Mount Sinai Hospital, University of Toronto|
|Principal Investigator:||Allison J McGeer, MD MSc||Mount Sinai Hospital, University of Toronto|