Immune Responses in Adults to Revaccination With ADACEL® 10 Years After a Previous Dose

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Immune Responses in Adults to Revaccination With Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (ADACEL®) 10 Years After a Previous Dose

Conditions
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Pertussis, Tetanus, Diphtheria

Intervention / Treatment
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* Biological: Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis (ADACEL®)
* Biological: Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis (ADACEL®)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1: Previous Tdap or Tdap-IPV Recipients<br>Participants received Tdap or Tdap-Inactivated Poliomyelitis Vaccine (IPV) in a previous study (TD9707 or TD9805) | Biological: Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis (ADACEL®)<br>* 0.5 ml, IM<br>* Other names: ADACEL®;|
| Active Comparator: Group 2: Tdap vaccine-naïve<br>Participants are age-balanced Tdap vaccine-naïve and will receive Tdap vaccine in the study at least 10 years after a previous tetanus, diphtheria and/or pertussis dose. | Biological: Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis (ADACEL®)<br>* 0.5 mL, IM<br>* Other names: Adacel®;|
| No Intervention: Group 3<br>Past participants in Study TD9707 and TD9805 did not qualify for Tdap re-administration in this study or were unwilling to receive a second dose of Tdap. They were not included in the analysis for the study | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Seroprotection Against Tetanus and Diphtheria Before and After Revaccination With ADACEL® 10 Years After a Previous Dose | Diphtheria concentrations were determined by neutralization assay; tetanus concentrations were determined by enzyme-linked immunosorbent assay (ELISA). Seroprotection was defined as anti-tetanus or anti-diphtheria concentrations ≥ 0.1 IU/mL. | Day 0 (pre-vaccination) and 30 post-vaccination | 
| Anti-Pertussis Geometric Mean Concentrations Post-vaccination With ADACEL® 10 Years After a Previous Dose | Post-vaccination geometric mean concentrations (GMCs) for pertussis toxoid (PT), filamentous hemagglutinin (FHA), pertactin (PRN), and fimbriae types 2 and 3 (FIM), were determined by enzyme-linked immunosorbent assay (ELISA). | Day 30 post-vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pertussis, Tetanus, Diphtheria, Acellular pertussis, ADACEL®,, Tdap vaccine