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An Immunogenicity and Safety Study of Tetanus, Diphtheria and Acellular Pertussis Vaccine Booster (Tdap Booster)

Primary Purpose

Tetanus, Diphtheria, Pertussis

Status
Unknown status
Phase
Phase 4
Locations
Sweden
Study Type
Interventional
Intervention
Td5ap
Td1aP
Sponsored by
Swedish Institute for Infectious Disease Control
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Tetanus focused on measuring immunogenicity, safety, tetanus, diphtheria, acellular, pertussis, vaccine, booster, adverse event, adverse reaction, DT1aP, DT5ap, FHA, fimbriae, pertactin, SMI, Smittskyddsinstitutet, Immune response and safety profile to a Tdap booster

Eligibility Criteria

14 Years - 15 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • healthy subject
  • 14-15 years old
  • eligible for their school-leaving booster for DTP
  • received a complete primary vaccination with a 5-component acellular pertussis vaccine (DT5aP-IPV-Hib) at 3, 5 and 12 months of age and vaccinated with a 5-component acellular pertussis vaccine (Td5aP-IPV or Td5aP + IPV) as a booster at 5½ years of age
  • informed consent form signed by the subject and parent(s)/legal representative
  • subject understand and comply with the study procedures (i.e. able to read and write Swedish)
  • female must provide an agreement that they are either sexually continent or practice adequate contraceptive methods (intra-uterine contraceptive device (IUCD), hormonal contraceptives, condoms or other adequate barrier contraception).

Exclusion Criteria:

  • acute febrile illness or axillary temperature ≥38.0°C at the time of vaccination
  • receipt of immunoglobulin within the previous 3 months, immunosuppression (e g evidence of impaired cell mediated immunity, receipt of immunosuppressant drugs within the previous 3 months or receipt of systemic corticosteroids given daily or on alternate days at ≥20 mg/day prednisone equivalent during >14 days within the past 30 days)
  • receipt of a non-study vaccine in the past 30 days
  • evolving encephalopathy not attributable to another identifiable cause within 7 days of administration of a previous dose of any vaccine
  • booster vaccination with tetanus, low dose diphtheria and acellular pertussis vaccine since the booster vaccination at 5½ years of age
  • previous clinical or bacteriological diagnosis of diphtheria, tetanus or pertussis
  • hypersensitivity to any component of any of the study vaccines
  • current participation in any other clinical trial or participation in any clinical trial in the previous month
  • inability to adhere to the protocol, including plans to move from the area
  • severe chronic disease
  • family history of congenital or hereditary immunodeficiency
  • any sever thrombocytopenia or any other coagulation disorder that would contraindicate intramuscular injection
  • any medical condition, which in the opinion of the investigator, might interfere with the evaluation of the study objectives.

Sites / Locations

  • Swedish Institute for Infectious Disease Control

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Td5ap

Td1aP

Arm Description

Group 1 receiving Td5ap as a single intramuscular injection.

Group 2 receiving Td1aP as a single intramuscular injection

Outcomes

Primary Outcome Measures

to describe in each arm the immune response to diptheria toxin, tetanus toxoid, pertussis toxin, FHA, fimbriae 2/3 and pertactin four weeks after immunization with Td1aP and Td5ap

Secondary Outcome Measures

safety of a fith dose of DTP vaccines
pre-booster antibody levels
pre-booster and post-booster IgG and IgA levels
pre-booster and post-booster T cell immune responses
pre-booster and post-booster B cell immune responses

Full Information

First Posted
March 26, 2009
Last Updated
June 4, 2010
Sponsor
Swedish Institute for Infectious Disease Control
Collaborators
MCM Vaccines B.V., Statens Serum Institut
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1. Study Identification

Unique Protocol Identification Number
NCT00870350
Brief Title
An Immunogenicity and Safety Study of Tetanus, Diphtheria and Acellular Pertussis Vaccine Booster
Acronym
Tdap Booster
Official Title
An Immunogenicity and Safety Study of Combined Adsorbed Tetanus, Low Dose Diphtheria and Acellular Pertussis Vaccine (Td5ap and Td1aP) Given as a School-leaving Booster to 14-15-year-old Children Primed With a Five Component Acellular Pertussis Vaccine at 3, 5 and 12 Months of Age, and a Booster Dose at 5½ Years of Age
Study Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Unknown status
Study Start Date
April 2009 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
June 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Swedish Institute for Infectious Disease Control
Collaborators
MCM Vaccines B.V., Statens Serum Institut

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Open-label, randomized, multi-centre study in which 400 subjects, divided into two groups, will receive Td5ap or Td1aP as a single injection. We will then describe the immune response and safety profile of the combined vaccine booster.
Detailed Description
The vaccines in the study are COVAXIS (Td5ap), Sanofi Pasteur Canada, and diTekiBooster (Td1aP), Statens Serum Institut, Denmark. The primary objective of the study is to describe the immune response to diphtheria toxin, tetanus toxoid, pertussis toxin, filamentous haemagglutinin (FHA), fimbriae 2/3 and pertactin four weeks after immunization with Td1aP and Td5ap. The secondary objectives include: describing the safety of a fith dose of DTP vaccines in 14-15 year-old children by observing systemic and local adverse reactions describing pre-booster antibody levels describing pre-booster and post-booster IgG and IgA levels in saliva describing in a subpopulation the pre-booster and post-booster T cell immune responses as determined by the production of cytokines describing in a subpopulation the pre-booster and post-booster B cell immune responses as determined by the number of effector and memory B-cells The sample size is 400 subjects (200 in group 1 and 200 in group 2). It will be an open-label, randomized, multi-centre study in which group 1 will receive Td5ap as a single injection and group 2 will receive Td1aP as a single injection. DTP antibodies will be measured before and 28 days (+ 14 days) after Td5ap and Td1aP vaccination. The proportion of children with positive IgG antibody response will be measured in each study arm. Sera will be tested blindly by established ELISA methods and saliva samples will be analyzed by exploratory assays. In a subpopulation cellmediated immunity will be analyzed. The safety evaluation criteria will be the percentage of subjects with adverse events describing injection-site adverse reactions, systemic adverse events, daily temperatures and serious adverse events.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tetanus, Diphtheria, Pertussis
Keywords
immunogenicity, safety, tetanus, diphtheria, acellular, pertussis, vaccine, booster, adverse event, adverse reaction, DT1aP, DT5ap, FHA, fimbriae, pertactin, SMI, Smittskyddsinstitutet, Immune response and safety profile to a Tdap booster

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Td5ap
Arm Type
Active Comparator
Arm Description
Group 1 receiving Td5ap as a single intramuscular injection.
Arm Title
Td1aP
Arm Type
Active Comparator
Arm Description
Group 2 receiving Td1aP as a single intramuscular injection
Intervention Type
Biological
Intervention Name(s)
Td5ap
Other Intervention Name(s)
COVAXiS
Intervention Description
Intramuscular injection of 0.5 mL Td5ap (COVAXiS) on day 1.
Intervention Type
Biological
Intervention Name(s)
Td1aP
Other Intervention Name(s)
diTekiBooster
Intervention Description
Intramuscular injection of 0.5 mL Td1aP (diTekiBooster) on day 1.
Primary Outcome Measure Information:
Title
to describe in each arm the immune response to diptheria toxin, tetanus toxoid, pertussis toxin, FHA, fimbriae 2/3 and pertactin four weeks after immunization with Td1aP and Td5ap
Time Frame
42 days
Secondary Outcome Measure Information:
Title
safety of a fith dose of DTP vaccines
Time Frame
42 days
Title
pre-booster antibody levels
Time Frame
42 days
Title
pre-booster and post-booster IgG and IgA levels
Time Frame
42 days
Title
pre-booster and post-booster T cell immune responses
Time Frame
42 days
Title
pre-booster and post-booster B cell immune responses
Time Frame
42 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: healthy subject 14-15 years old eligible for their school-leaving booster for DTP received a complete primary vaccination with a 5-component acellular pertussis vaccine (DT5aP-IPV-Hib) at 3, 5 and 12 months of age and vaccinated with a 5-component acellular pertussis vaccine (Td5aP-IPV or Td5aP + IPV) as a booster at 5½ years of age informed consent form signed by the subject and parent(s)/legal representative subject understand and comply with the study procedures (i.e. able to read and write Swedish) female must provide an agreement that they are either sexually continent or practice adequate contraceptive methods (intra-uterine contraceptive device (IUCD), hormonal contraceptives, condoms or other adequate barrier contraception). Exclusion Criteria: acute febrile illness or axillary temperature ≥38.0°C at the time of vaccination receipt of immunoglobulin within the previous 3 months, immunosuppression (e g evidence of impaired cell mediated immunity, receipt of immunosuppressant drugs within the previous 3 months or receipt of systemic corticosteroids given daily or on alternate days at ≥20 mg/day prednisone equivalent during >14 days within the past 30 days) receipt of a non-study vaccine in the past 30 days evolving encephalopathy not attributable to another identifiable cause within 7 days of administration of a previous dose of any vaccine booster vaccination with tetanus, low dose diphtheria and acellular pertussis vaccine since the booster vaccination at 5½ years of age previous clinical or bacteriological diagnosis of diphtheria, tetanus or pertussis hypersensitivity to any component of any of the study vaccines current participation in any other clinical trial or participation in any clinical trial in the previous month inability to adhere to the protocol, including plans to move from the area severe chronic disease family history of congenital or hereditary immunodeficiency any sever thrombocytopenia or any other coagulation disorder that would contraindicate intramuscular injection any medical condition, which in the opinion of the investigator, might interfere with the evaluation of the study objectives.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leif Gothefors, Prof. em.
Organizational Affiliation
Swedish Institute for Infectious Disease Control
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eva Netterlid
Organizational Affiliation
Swedish Institute for Infectious Disease Control
Official's Role
Study Director
Facility Information:
Facility Name
Swedish Institute for Infectious Disease Control
City
Lund
ZIP/Postal Code
221 85
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
31945015
Citation
Lin A, Apostolovic D, Jahnmatz M, Liang F, Ols S, Tecleab T, Wu C, van Hage M, Solovay K, Rubin K, Locht C, Thorstensson R, Thalen M, Lore K. Live attenuated pertussis vaccine BPZE1 induces a broad antibody response in humans. J Clin Invest. 2020 May 1;130(5):2332-2346. doi: 10.1172/JCI135020.
Results Reference
derived
PubMed Identifier
26057135
Citation
Carlsson RM, Gustafsson L, Hallander HO, Ljungman M, Olin P, Gothefors L, Nilsson L, Netterlid E. Two consecutive randomized controlled pertussis booster trials in children initially vaccinated in infancy with an acellular vaccine: The first with a five-component Tdap vaccine to 5-year olds and the second with five- or monocomponent Tdap vaccines at age 14-15 years. Vaccine. 2015 Jul 17;33(31):3717-25. doi: 10.1016/j.vaccine.2015.05.079. Epub 2015 Jun 7.
Results Reference
derived
PubMed Identifier
25008903
Citation
Jahnmatz M, Ljungman M, Netterlid E, Jenmalm MC, Nilsson L, Thorstensson R. Pertussis-specific memory B-cell and humoral IgG responses in adolescents after a fifth consecutive dose of acellular pertussis vaccine. Clin Vaccine Immunol. 2014 Sep;21(9):1301-8. doi: 10.1128/CVI.00280-14. Epub 2014 Jul 9.
Results Reference
derived

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An Immunogenicity and Safety Study of Tetanus, Diphtheria and Acellular Pertussis Vaccine Booster

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