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

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

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.

Study Overview

• Status: Completed
• Conditions: Pertussis; Tetanus; Diphtheria
• Intervention / Treatment: Biological: Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis (ADACEL®); Biological: Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis (ADACEL®)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 769
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Coquitlam, British Columbia, Canada, V3C 4J2
    • Surrey, British Columbia, Canada, V3R 8P8
    • Vancouver, British Columbia, Canada, V6H 3V4
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3K 6R8
  • Quebec
    • Pierrefonds, Quebec, Canada, H9H 4Y6
    • Québec City, Quebec, Canada, G1E 7G9
    • Sherbrooke, Quebec, Canada, J1H 4J6

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1: Previous Tdap or Tdap-IPV Recipients; 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®); 0.5 ml, IM; Other Names: ADACEL®; Tdap; Biological: Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis (ADACEL®); 0.5 mL, IM; Other Names: Adacel®; Tdap
Active Comparator: Group 2: Tdap vaccine-naïve; 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®); 0.5 ml, IM; Other Names: ADACEL®; Tdap; Biological: Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis (ADACEL®); 0.5 mL, IM; Other Names: Adacel®; Tdap
No Intervention: Group 3; 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?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving Booster Response of Anti-Tetanus and Anti-Diptheria Following Revaccination With ADACEL® 10 Years After a Previous Dose	Anti-diphtheria or anti-tetanus booster responses were defined as: Pre-vaccination antibody concentrations of < 0.1 IU/mL and a post-vaccination levels ≥ 0.4 IU/mL; or a pre-vaccination antibody concentrations of ≥ 0.1 IU/mL to < 2 IU/mL and a 4-fold rise; or pre-vaccination antibody concentrations of ≥ 2.0 IU/mL and a 2-fold response.	Day 30 post-vaccination
Percentage of Participants Achieving Booster Response for Each Anti-Pertussis Antibody Following Revaccination With ADACEL® 10 Years After a Previous Dose	Booster response for each anti-pertussis antibody was defined as a post-vaccination antibody concentration: ≥ 4 x the Lower limit of quantitation (LLOQ), if the pre-vaccination concentration was < LLOQ; or; ≥ 4 x the pre-vaccination antibody concentration, if the pre-vaccination concentration was ≥ LLOQ but < 4 x LLOQ; or; ≥ 2 x the pre-vaccination antibody concentration, if the pre-vaccination concentration was ≥ 4 x LLOQ.	Day 30 post-vaccination
Geometric Mean Concentrations Against Pertussis Antigens Before and Post-vaccination With ADACEL® 10 Years After a Previous Dose	Post-vaccination geometric mean concentrations (GMCs) against pertussis toxoid (PT), filamentous hemagglutinin (FHA), pertactin (PRN), and fimbriae types 2 and 3 (FIM), were determined by enzyme-linked immunosorbent assay (ELISA).	Day 0 (pre-vaccination) and Day 30 post-vaccination
Geometric Mean Concentrations Against Tetanus and Diphtheria Antigens Before and Post-vaccination With ADACEL® 10 Years After a Previous Dose	Post-vaccination geometric mean concentrations (GMCs) for Diphtheria was determined by neutralization assay; GMCs for tetanus was determined by enzyme-linked immunosorbent assay (ELISA).	Day 0 (pre-vaccination) and Day 30 post-vaccination
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-vaccination With ADACEL® 10 Years After a Previous Dose	Solicited Injection Site Reactions: Pain, Erythema, and swelling. Solicited Systemic Reactions: Fever (temperature), Headache, Malaise, and Myalgia. Grade 3 - Pain: Incapacitating, : Incapacitating, unable to perform usual activities, may have/or required medical care or absenteeism; Erythema and Swelling: ≥5 cm; Fever: > 39.0°C, Headache, Malaise, and Myalgia Prevents daily activities.	Day 0 up to Day 7 post-vaccination

Collaborators and Investigators

• Sponsor: Sanofi Pasteur, a Sanofi Company

Publications and helpful links

General Publications

• Halperin SA, Scheifele D, De Serres G, Noya F, Meekison W, Zickler P, Larrivee L, Langley JM, McNeil SA, Dobson S, Jordanov E, Thakur M, Decker MD, Johnson DR. Immune responses in adults to revaccination with a tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine 10 years after a previous dose. Vaccine. 2012 Jan 20;30(5):974-82. doi: 10.1016/j.vaccine.2011.11.035. Epub 2011 Nov 21.

Helpful Links

• Related Info
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Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Actual): September 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: July 7, 2008
• First Submitted That Met QC Criteria: July 9, 2008
• First Posted (Estimate): July 10, 2008

Study Record Updates

• Last Update Posted (Estimate): April 30, 2014
• Last Update Submitted That Met QC Criteria: April 1, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: Pertussis; Diphtheria; Tetanus; Acellular pertussis; Tdap vaccine; ADACEL®,
• Additional Relevant MeSH Terms: Metabolic Diseases; Nervous System Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Neurologic Manifestations; Bordetella Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Neuromuscular Manifestations; Actinomycetales Infections; Clostridium Infections; Hypocalcemia; Calcium Metabolism Disorders; Corynebacterium Infections; Whooping Cough; Tetanus; Diphtheria; Tetany
• Other Study ID Numbers: TD526