Clinical trial NCT01439165: Safety and Immunogenicity in Adults of Revaccination With Adacel® Vaccine 10 Years After a Previous Dose
Official title: Safety and Immunogenicity in Adults of Revaccination With Adacel® Vaccine 10 Years After a Previous Dose
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Tetanus
Diphtheria
Pertussis
Whooping Cough
Keywords: Adacel vaccine
Tetanus
Diphtheria
whooping cough
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2011-09-23
Enrollment: 1330
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to describe the safety and immunogenicity of repeat administration of Adacel vaccine approximately 10 years following initial administration of the vaccine. Antibody levels prior to revaccination will also be used to characterize antibody persistence following initial vaccination 10 years earlier.

Primary Objectives:

* To compare seroprotection rates against tetanus and diphtheria induced by Adacel vaccine to those induced by Td Adsorbed vaccine.
* To compare booster response rates against tetanus and diphtheria induced by Adacel vaccine to those induced by Td Adsorbed vaccine.
* To compare anti-pertussis geometric mean antibody concentrations (GMCs) induced by Adacel vaccine to the GMCs induced by Daptacel® vaccine given to infants.

Secondary Objectives:

* To describe the rates of immediate reactions, solicited reactions, unsolicited adverse events (AEs), and serious adverse events (SAEs) following vaccination with Adacel or Td Adsorbed vaccine.
* To describe booster response rates for pertussis antigens following revaccination with Adacel vaccine.

Detailed description: Healthy adults \< 65 years of age who received Adacel vaccine 10 years previously will be randomized to receive either Adacel or TENIVAC (Td Adsorbed) vaccine. They will be assessed for immunogenicity at baseline and post-vaccination. Safety data will be collected for 6 months following vaccination.

Eligibility criteria: Inclusion criteria:

* Subject is ≥ 18 to \< 65 years of age at the time of vaccination.
* Received Adacel vaccine no less than 9 and no more than 11 years previously.
* Informed consent form has been signed and dated.
* Subject is able to attend all scheduled visits and to comply with all trial procedures.

Exclusion criteria:

* Subject is pregnant, or lactating, or of child bearing potential without using an effective method of contraception or not practicing abstinence for at least 4 weeks prior to vaccination and until at least 4 weeks after vaccination. Females who are pre-menarche or post-menopausal for at least one year, or surgically sterile will not be excluded.
* Any condition that, in the opinion of the Investigator, would pose a health risk to the participant or interfere with the evaluation of the vaccine.
* Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion.
* Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).
* Known or suspected receipt of tetanus toxoid (T), tetanus and diphtheria toxoids (Td), or tetanus and diphtheria toxoids and acellular pertussis (Tdap) vaccine since receipt of the qualifying dose of Adacel vaccine described in Inclusion Criterion #2.
* A personal history of physician-diagnosed or laboratory-confirmed pertussis disease within the last 10 years.
* A previous severe reaction to pertussis, diphtheria or tetanus vaccine including immediate anaphylaxis, encephalopathy within 7 days or seizure within 3 days of receiving the vaccine.
* Receipt of immune globulins, blood or blood-derived products in the past 3 months.
* Suspected or known hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances.
* Receipt of any vaccine within 30 days before receiving study vaccine, or plans to receive another vaccine before the 2nd visit; except that influenza vaccine may have been received between 30 and 15 days (but no less than 15 days) before receiving study vaccine.
* Participation in another interventional clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 30 days preceding the first study vaccination or during the course of the study, at the discretion of the Sponsor.
* Seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C, as reported by the subject.
* Laboratory-confirmed thrombocytopenia, which may be a contraindication for IM vaccination, at the discretion of the Investigator.
* Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion, which may be a contraindication for intramuscular (IM) vaccination, at the discretion of the Investigator.
* Personal history of Guillain-Barré syndrome.
* Moderate or severe acute illness/infection (according to Investigator judgment) or febrile illness (temperature ≥ 38.0°C \[≥ 100.4°F\]) on the day of vaccination. A prospective subject should not be enrolled in the study until the condition has resolved or the febrile event has subsided.
* Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study.
* Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.
* Current alcohol or drug use that, in the opinion of the Investigator, might interfere with the ability to comply with trial procedures.

Primary outcomes:
measure: Percentage of Participants With Diphtheria and Tetanus Seroprotection
timeFrame: 1 month post-booster vaccination
measure: Percentage of Participants With Diphtheria and Tetanus Booster Response
timeFrame: 1 month post-booster vaccination
measure: Geometric Mean Concentrations (GMC) of Anti Pertussis Antibodies
timeFrame: 1 month post-booster vaccination
measure: Percentage of Subjects With Pertussis Antigen Booster Response
timeFrame: 1 month post-booster vaccination
Secondary outcomes:
measure: Percentage of Participants Reporting a Solicited Injection Site or Systemic Reactions
timeFrame: Day 0 up to Day 7 post-vaccination
Other outcomes:
Locations:
city: Huntsville
country: United States
state: Alabama
city: Jonesboro
country: United States
state: Arkansas
city: Little Rock
country: United States
state: Arkansas
city: San Diego
country: United States
state: California
city: Boulder
country: United States
state: Colorado
city: Marietta
country: United States
state: Georgia
city: Woodstock
country: United States
state: Georgia
city: Peoria
country: United States
state: Illinois
city: Mishawaka
country: United States
state: Indiana
city: Louisville
country: United States
state: Kentucky
city: Rockville
country: United States
state: Maryland
city: Woburn
country: United States
state: Massachusetts
city: Columbia
country: United States
state: Missouri
city: Saint Louis
country: United States
state: Missouri
city: Albuquerque
country: United States
state: New Mexico
city: Brooklyn
country: United States
state: New York
city: Ithaca
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Raleigh
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Clairton
country: United States
state: Pennsylvania
city: Hershey
country: United States
state: Pennsylvania
city: Latrobe
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Syracuse
country: United States
state: Utah
city: Virginia Beach
country: United States
state: Virginia
city: Vancouver
country: United States
state: Washington
city: Chippewa Falls
country: United States
state: Wisconsin
city: Marshfield
country: United States
state: Wisconsin
city: Harbour Grace
country: Canada
state: Newfoundland and Labrador
city: St. John
country: Canada
state: Newfoundland and Labrador
Study officials:
affiliation: Sanofi Pasteur Inc.
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Halperin SA, Donovan C, Marshall GS, Pool V, Decker MD, Johnson DR, Greenberg DP; Tdap Booster Investigators. Randomized Controlled Trial of the Safety and Immunogenicity of Revaccination With Tetanus-Diphtheria-Acellular Pertussis Vaccine (Tdap) in Adults 10 Years After a Previous Dose. J Pediatric Infect Dis Soc. 2019 May 11;8(2):105-114. doi: 10.1093/jpids/pix113.
citation: Pool V, Tomovici A, Johnson DR, Greenberg DP, Decker MD. Humoral immunity 10 years after booster immunization with an adolescent and adult formulation combined tetanus, diphtheria, and 5-component acellular pertussis vaccine in the USA. Vaccine. 2018 Apr 19;36(17):2282-2287. doi: 10.1016/j.vaccine.2018.03.029. Epub 2018 Mar 21.