Combination Hepatitis A and B Vaccine to Induce Immunity in Non-responders
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|ClinicalTrials.gov Identifier: NCT01126853|
Recruitment Status : Unknown
Verified May 2010 by Mount Sinai Hospital, Canada.
Recruitment status was: Recruiting
First Posted : May 20, 2010
Last Update Posted : May 20, 2010
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis B||Biological: Twinrix||Phase 4|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||April 2010|
|Estimated Primary Completion Date :||June 2011|
|Estimated Study Completion Date :||July 2011|
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
- Protective immunity to Hepatitis B [ Time Frame: up to 7 months (average) ]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) ]The number and description of adverse events.
- Rate of Recruitment [ Time Frame: 1 year ]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) ]The number of patients who develop antibodies against hepatitis B surface antibody at titres of 1-10 IU/ml.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01126853
|Contact: Todd C Lee, MD||4165864800 ext email@example.com|
|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|