Combination Hepatitis A and B Vaccine to Induce Immunity in Non-responders
|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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|