Combination Hepatitis A and B Vaccine to Induce Immunity in Non-responders
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01126853|
Recruitment Status : Withdrawn
First Posted : May 20, 2010
Last Update Posted : June 1, 2020
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis B||Biological: Twinrix||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 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
|Mount Sinai Hospital|
|Toronto, Ontario, Canada, M5G 1K5|
|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|