immune responses in adults to revaccination with adacel® 10 years after a previous dose

Conditions: Pertussis; Tetanus; Diphtheria

Summary: the purpose of this study is to collect additional immunogenicity and safety data on re-dosing with tdap vaccine (adacel®) in a continuing effort to address the public health need to establish broader population immunity against pertussis, as well as diphtheria and tetanus. primary objective: * to assess immune response to tdap vaccine (adacel®) one month after booster vaccination.

this is an open-label, multicenter study to describe the immunological response and safety of repeat administration of an adolescent/adult-formulation tetanus-diphtheria-acellular pertussis tdap vaccine (adacel®), 10 years following initial administration of tdap vaccine.

Eligibility criteria:
inclusion criteria : * received tdap or tdap-ipv vaccine in study td9707 or td9805. * never previously received tdap vaccine and has not received any tetanus-, diphtheria , or pertussis-containing vaccine in the past 10 years. * participated in td9707 or td9805 but does not meet inclusion/ exclusion criteria or willing to undergo phlebotomy but not willing to receive tdap (adacel®) vaccine. * signed institutional review board (irb)-approved informed consent form * able to attend all scheduled visits and to comply with all trial procedures * for a woman, a negative urine pregnancy test and the use of effective method(s) of contraception, or the inability to become pregnant exclusion criteria : * any condition listed as a contraindication in the adacel® canadian product monograph * any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the evaluation of the vaccine * chronic illness, at a stage that could interfere with trial conduct or completion, in the opinion of the investigator * known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic (injected or oral) corticosteroid therapy. individuals on a tapering dose schedule of oral steroids lasting less than 7 days may be included in the trial as long as they have not received more than 1 course within the last 2 weeks prior to enrollment * febrile illness (temperature ≥ 37.5°c \[99.5°f\]) at the time of inclusion * history of documented diphtheria, pertussis, or tetanus disease since participation in studies td9707 or td9805. or history of documented diphtheria, pertussis, or tetanus disease in the last 10 years. * known or suspected receipt of a diphtheria-, pertussis-, or tetanus-containing vaccine since participation in study td9707 or td9805. for group 2, known or suspected receipt of a diphtheria-, pertussis-, or tetanus-containing vaccine in the last 10 years. * receipt of any vaccine, other than influenza vaccine, in the 28-day period prior to visit 1 or scheduled to receive any vaccine, other than influenza vaccine, in the period between visit 1 and visit 2. for influenza vaccine only, defer if received in the 14 days prior to enrollment or scheduled to receive prior to visit 2. * receipt of blood or blood-derived products in the past 3 months * suspected or known hypersensitivity to any of the vaccine components, or a life-threatening reaction after previous administration of the vaccine or a vaccine containing the same substances * unable to attend the scheduled visits or to comply with the study procedures * in females of childbearing potential, known pregnancy or positive serum/urine pregnancy test * breast-feeding woman * participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding enrollment. planned participation in another clinical trial during the present trial period * current alcohol or recreational drug use that may interfere with the subject's ability to comply with trial procedures * thrombocytopenia, bleeding disorder, anticoagulation therapy contraindicating intramuscular (im) vaccination * subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent. * other events which in the judgment of the investigator would preclude vaccination at the time of visit 1 for group 3 * history of documented diphtheria, pertussis, or tetanus disease since participation in study td9707 or td9805 * known or suspected receipt of a diphtheria-, pertussis-, or tetanus-containing vaccine since participation in study td9707 or td9805.

Keywords: pertussis tetanus diphtheria acellular pertussis adacel®, tdap vaccine