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

Tetanus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00712959
• Other study ID #: TD526
• Status: Completed
• Phase: Phase 4
• First received: July 7, 2008
• Last updated: April 1, 2014
• Start date: June 2008
• Est. completion date: December 2009

Study information

• Verified date: April 2014
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 769
• Est. completion date: December 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diphtheria
• Pertussis
• Tetanus
• Whooping Cough

Intervention

Biological:
• Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis (ADACEL®)
0.5 ml, IM
• Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis (ADACEL®)
0.5 mL, IM

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Halperin SA, Scheifele D, De Serres G, Noya F, Meekison W, Zickler P, Larrivée 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, a — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Other	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	No
Other	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	No
Other	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	No
Other	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	No
Primary	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	No
Primary	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	No

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