Prevention of Infections With Bordetella PertussisPhase 4NCT02555540
Placebo Controlled Study to Generate Data Characterising Safety Parameters and Immune Responses
A Phase 4 study testing Boostrix in people with Prevention of Infections With Bordetella Pertussis, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
The purpose of this protocol is to generate a set of data that will be analysed by integrated systems biology approach, for validation in subsequent clinical trials or in animal models. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Prevention of Infections With Bordetella Pertussis
- What is being tested?
- Boostrix
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteBelgium
- Study dates
- 24 Aug 2015to 15 Dec 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female subjects aged 18-45 years (inclusive).
- Male: Female ratio - 1:1.
- Half of the subjects (n=120) will have received a previous Dt(pa) dose less than 5 years before, the other half (n=120) will have received a previous Dt(pa) dose 5 or more years before participating at this study.
- The subject is, in the opinion of the investigator healthy based on medical history and clinical exam, with no active disease process that could interfere with the study endpoints.
- Has a body Mass Index ≥18.0 and ≤30.0
- Is able to read and understand the Informed Consent Form (ICF), and understand study procedures.
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- The subject has signed the ICF.
- The subject is available for follow-up for the duration of the study.
- The subject agrees to abstain from donating blood during their participation in the study, or longer if necessary.
- If the subject is a heterosexually active female, she is willing to use an effective method of contraception with partner (oral contraceptive pill; intrauterine device; injectable or implanted contraceptive; condoms incorporating spermicide if using these; physiological or anatomical sterility) from 30 days prior to, and 3 months after, vaccination. Willing to undergo urine pregnancy tests prior to vaccination at screening.
- The subject has venous access sufficient to allow blood sampling as per the protocol.
Who cannot join
- Pregnant or lactating at any point during the study from screening to final follow up.
- Hypersensitivity to any component of the vaccine or subjects having shown signs of hypersensitivity after previous administration of diphtheria, tetanus, or pertussis vaccines.
- Presence of primary or acquired immunodeficiency states with a total lymphocyte count less than 1,200 per mm3 or presenting other evidence of lack of cellular immune competence e.g. leukaemias, lymphomas, blood dyscrasias, or patients receiving immunosuppressive therapy (including regular use of oral or parenteral corticosteroids).
- Use of any immune suppressing or immunomodulating drugs within 6 months of Visit 1.
- Regular and prolonged use of non-steroidal anti-inflammatory drugs (oral or parenteral route) within 6 months of Visit 1 considered by the study physician as likely to interfere with immune responses.
- Current intake of excessive amounts of alcohol and/or caffeine (as evaluated by the investigator) and not willing to adapt this use during the study period.
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- Currently performing extreme physical activities (as evaluated by the investigator) and not willing to adapt this use during the study period.
- Receipt of a vaccine within 30 days prior to visit 1, or requirement to receive a vaccine within the 28 days following study vaccination, vaccination with a tetanus, diphtheria, pertussis combined vaccine within the last 6 months before the first study visit.
- Presence of an acute severe febrile illness at time of immunisation.
- History of alcohol, narcotic, benzodiazepine, rilatine, or other substance abuse or dependence within the 12 months preceding Visit 1.
- Currently participating in another clinical study with an investigational or non-investigational drug or device, or has participated in a clinical trial within the 3 months preceding Visit 1.
- Any condition that, in the investigator's opinion, compromises the subject's ability to meet protocol requirements or to complete the study.
- Receipt of blood products or immunoglobulins, or blood donation within 3 months prior to visit 1.
- Unable to read and speak Dutch or English to a fluency level adequate for the full comprehension of procedures required in participation and consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Study to Generate a Set of Data Characterising Clinical Events, Physiological Responses, and Innate and Adaptive Immune Responses Following a Single IM Immunisation With Boostrix® or Placebo in Healthy Adults
The purpose of this protocol is to generate a set of data that will be analysed by integrated systems biology approach, for validation in subsequent clinical trials or in animal models.
240 healthy participants (18-45y) will be enrolled, 200 will be administered a dose of Boostrix on Day 0, 20 will receive a placebo on Day 0.
Read the detailed description
This study is part of the BIOVACSAFE project, a 5-year project funded by the Innovative Medicine Initiative, which will undertake a series of correlated clinical studies that will apply and develop technologies to generate clinical data on inflammation with licensed vaccines as benchmarks, and identify biomarkers to predict acceptable reactogenicity, for correlation with standardized clinical readouts and inflammatory markers assessed in natural infections.
The purpose of this protocol is to generate data to undergo integrated systems biology analysis to validate biomarkers identified in the exploratory studies conducted previously or to identify new biomarkers of responses to immunisation
The data set will include data characterising:
- Physiological responses at various time points after immunisation by measuring:
- Local and systemic vaccine-related clinical events.
- Haematology (blood counts and ESR) and biochemistry parameters.
- Innate and adaptive immune responses including:
- Innate immune activation detected by global gene expression in whole blood
- Adaptive humoral immunity determined by the quantification antibodies directed against Tetanus toxoid (TT), Diphteria toxoid (DT), Pertussis toxin (PT), Fimbrial haemagglutinin (FHA) and Pertactin (PTN).
- Adaptive immune activation detected by gene pathway activation in whole blood
- Metabolic responses as detected by metabolic gene expression and pathway activation in whole blood
- Innate and adaptive immune activation detected by measuring the concentration of selected soluble mediators in serum including: chemokines and cytokines and acute phase proteins
- As an exploratory endpoint, the adaptive cellular immune response will be evaluated via counting vaccine antigen-specific Cluster of Differentiation 4 (CD4)+ T cells expressing activation markers and/or cytokines following in vitro stimulation and analysis by flow cytometry (and or CyTOF).
- Genetic testing of subjects when deemed necessary (genetic testing analysis may be SNP (single nucleotide polymorphism) analysis or full genome analysis).
- Correlations in changes in innate immune activation and metabolism with adverse events, haematology and biochemistry panels, genotype and physiological assessments
The investigators will biobank all samples for the duration of the BIOVACSAFE programme so that they can selectively analyse different samples and different time points depending on the results generated, principally from the gene expression analysis of whole blood.
- Being tested
- Boostrix, Placebo (Saline)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BoostrixBiological
Randomised assignment
Placebo (Saline)Biological
Randomised assignment
| Study group | Role | What they receive |
|---|---|---|
| Boostrix, Male, >/= 5 years, D2 visit | Active comparator | 25 male subjects who have received their last dT(Pa) vaccine at least 5 years ago, and who have the Visit 2 on 'Day 2'.
5 out-patient visits: Day 0 (blood sampling, vaccination), Day 1 (blood sampling), Day 2 (blood sampling), Day 7 (blood sampling), Day 28 (blood sampling) Receives: Biological: Boostrix |
| Boostrix, Male, >/= 5 years, D3 visit | Active comparator | 25 male subjects who have received their last dT(Pa) vaccine at least 5 years ago, and who have the Visit 2 on 'Day 3'.
5 out-patient visits: Day 0 (blood sampling, vaccination), Day 1 (blood sampling), Day 3 (blood sampling), Day 7 (blood sampling), Day 28 (blood sampling) Receives: Biological: Boostrix |
| Boostrix, Female, >/= 5 years, D2 visit | Active comparator | 25 female subjects who have received their last dT(Pa) vaccine at least 5 years ago, and who have the Visit 2 on 'Day 2'.
5 out-patient visits: Day 0 (blood sampling, vaccination), Day 1 (blood sampling), Day 2 (blood sampling), Day 7 (blood sampling), Day 28 (blood sampling) Receives: Biological: Boostrix |
| Boostrix, Female, >/= 5 years, D3 visit | Active comparator | 25 female subjects who have received their last dT(Pa) vaccine at least 5 years ago, and who have the Visit 2 on 'Day 3'.
5 out-patient visits: Day 0 (blood sampling, vaccination), Day 1 (blood sampling), Day 3 (blood sampling), Day 7 (blood sampling), Day 28 (blood sampling) Receives: Biological: Boostrix |
| Placebo, Male, >/= 5 years, D2 visit | Placebo comparator | 5 male subjects who have received their last dT(Pa) vaccine at least 5 years ago, and who have the Visit 2 on 'Day 2'.
5 out-patient visits: Day 0 (blood sampling, vaccination), Day 1 (blood sampling), Day 2 (blood sampling), Day 7 (blood sampling), Day 28 (blood sampling) Receives: Biological: Placebo (Saline) |
| Placebo, Male, >/= 5 years, D3 visit | Placebo comparator | 5 male subjects who have received their last dT(Pa) vaccine at least 5 years ago, and who have the Visit 2 on 'Day 3'.
5 out-patient visits: Day 0 (blood sampling, vaccination), Day 1 (blood sampling), Day 3 (blood sampling), Day 7 (blood sampling), Day 28 (blood sampling) Receives: Biological: Placebo (Saline) |
| Placebo, Female, >/= 5 years, D2 visit | Placebo comparator | 5 female subjects who have received their last dT(Pa) vaccine at least 5 years ago, and who have the Visit 2 on 'Day 2'.
5 out-patient visits: Day 0 (blood sampling, vaccination), Day 1 (blood sampling), Day 2 (blood sampling), Day 7 (blood sampling), Day 28 (blood sampling) Receives: Biological: Placebo (Saline) |
| Placebo, Female, >/= 5 years, D3 visit | Placebo comparator | 5 female subjects who have received their last dT(Pa) vaccine at least 5 years ago, and who have the Visit 2 on 'Day 3'.
5 out-patient visits: Day 0 (blood sampling, vaccination), Day 1 (blood sampling), Day 3 (blood sampling), Day 7 (blood sampling), Day 28 (blood sampling) Receives: Biological: Placebo (Saline) |
| Boostrix, Male, <5 years, D2 visit | Active comparator | 25 male subjects who have received their last dT(Pa) vaccine between 5 years and 6 months ago, and who have the Visit 2 on 'Day 2'.
5 out-patient visits: Day 0 (blood sampling, vaccination), Day 1 (blood sampling), Day 2 (blood sampling), Day 7 (blood sampling), Day 28 (blood sampling) Receives: Biological: Boostrix |
| Boostrix, Male, <5 years, D3 visit | Active comparator | 25 male subjects who have received their last dT(Pa) vaccine between 5 years and 6 months ago, and who have the Visit 2 on 'Day 3'.
5 out-patient visits: Day 0 (blood sampling, vaccination), Day 1 (blood sampling), Day 3 (blood sampling), Day 7 (blood sampling), Day 28 (blood sampling) Receives: Biological: Boostrix |
| Boostrix, Female, <5 years, D2 visit | Active comparator | 25 female subjects who have received their last dT(Pa) vaccine between 5 years and 6 months ago, and who have the Visit 2 on 'Day 2'.
5 out-patient visits: Day 0 (blood sampling, vaccination), Day 1 (blood sampling), Day 2 (blood sampling), Day 7 (blood sampling), Day 28 (blood sampling) Receives: Biological: Boostrix |
| Boostrix, Female, <5 years, D3 visit | Active comparator | 25 female subjects who have received their last dT(Pa) vaccine between 5 years and 6 months ago, and who have the Visit 2 on 'Day 3'.
5 out-patient visits: Day 0 (blood sampling, vaccination), Day 1 (blood sampling), Day 3 (blood sampling), Day 7 (blood sampling), Day 28 (blood sampling) Receives: Biological: Boostrix |
| Placebo, Male, <5 years, D2 visit | Placebo comparator | 5 male subjects who have received their last dT(Pa) vaccine between 5 years and 6 months ago, and who have the Visit 2 on 'Day 2'.
5 out-patient visits: Day 0 (blood sampling, vaccination), Day 1 (blood sampling), Day 2 (blood sampling), Day 7 (blood sampling), Day 28 (blood sampling) Receives: Biological: Placebo (Saline) |
| Placebo, Male, <5 years, D3 visit | Placebo comparator | 5 male subjects who have received their last dT(Pa) vaccine between 5 years and 6 months ago, and who have the Visit 2 on 'Day 3'.
5 out-patient visits: Day 0 (blood sampling, vaccination), Day 1 (blood sampling), Day 3 (blood sampling), Day 7 (blood sampling), Day 28 (blood sampling) Receives: Biological: Placebo (Saline) |
| Placebo, Female, <5 years, D2 visit | Placebo comparator | 5 female subjects who have received their last dT(Pa) vaccine between 5 years and 6 months ago, and who have the Visit 2 on 'Day 2'.
5 out-patient visits: Day 0 (blood sampling, vaccination), Day 1 (blood sampling), Day 2 (blood sampling), Day 7 (blood sampling), Day 28 (blood sampling) Receives: Biological: Placebo (Saline) |
| Placebo, Female, <5 years, D3 visit | Placebo comparator | 5 female subjects who have received their last dT(Pa) vaccine between 5 years and 6 months ago, and who have the Visit 2 on 'Day 3'.
5 out-patient visits: Day 0 (blood sampling, vaccination), Day 1 (blood sampling), Day 3 (blood sampling), Day 7 (blood sampling), Day 28 (blood sampling) Receives: Biological: Placebo (Saline) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of local vaccine-related clinical events
Participants will report these events on a diary, measuring local events or scoring them from 0 (absent) to 3 (severe)
Measured: At all timepoints from vaccination up to 28 days after vaccination
Frequency of systemic vaccine-related clinical events.
Participants will report these events on a diary, scoring them from 0 (absent) to 3 (severe)
Measured: At all timepoints from vaccination up to 28 days after vaccination
Physiological assessments: Change from pre-immunisation baseline values in body temperature.
Measured: Up to 7 days after vaccination
Change from pre-immunisation baseline values in 'Erythrocyte Sedimentation Rate' (ESR)
Measured: At all timepoints from vaccination up to 28 days after vaccination
Change from pre-immunisation baseline values in creatinin
Measured: At all timepoints from vaccination up to 28 days after vaccination
Change from pre-immunisation baseline values in C Reactive Protein (CRP)
Measured: At all timepoints from vaccination up to 28 days after vaccination
Change from pre-immunisation baseline values in aspartate transaminase (AST)/ alanine transaminase (ALT)
Measured: At all timepoints from vaccination up to 28 days after vaccination
Change from pre-immunisation baseline values in albumin
Measured: At all timepoints from vaccination up to 28 days after vaccination
Change from pre-immunisation baseline values in estimated glomerular filtration rate (eGFR)
Measured: At all timepoints from vaccination up to 28 days after vaccination
Change from pre-immunisation baseline values in gamma glutamyl transpeptidase (GGT)
Measured: At all timepoints from vaccination up to 28 days after vaccination
Change from pre-immunisation baseline values in total protein
Measured: At all timepoints from vaccination up to 28 days after vaccination
Change from pre-immunisation baseline values in prothrombin/fibrinogen
Measured: At all timepoints from vaccination up to 28 days after vaccination
Change from pre-immunisation baseline values in global gene expression measured on whole blood samples.
Measured: At selected timepoints from vaccination up to 28 days after vaccination
Change from pre-immunisation baseline values in metabolic gene expression measured on whole blood samples.
Measured: At selected timepoints from vaccination up to 28 days after vaccination
Change from pre-immunisation baseline values in serum levels of antibodies to vaccine antigens (anti-T, anti-D, anti-PT, anti-FHA and anti-PRN) in serum samples.
Measured: At selected timepoints from vaccination up to 28 days after vaccination
Change from pre-immunisation values of adaptive cellular immune response via enumeration of TT-, DT-, PT-, FHA- and PTN-specific CD3/CD4+ or CD3/CD8+ T cells expressing activation markers/cytokines following IV stimulation and analysis by flow cytometry.
Measured: At 7 days after vaccination
Change from pre-immunisation baseline values in concentration of selected cytokines and acute phase proteins in serum samples
Measured: At selected timepoints from vaccination up to 28 days after vaccination
Change from pre-immunisation baseline values in pathway activation measured on whole blood samples.
Measured: At selected timepoints from vaccination up to 28 days after vaccination
Change from pre-immunisation baseline values in haemoglobin
Measured: At all timepoints from vaccination up to 28 days after vaccination
Change from pre-immunisation baseline values in red blood cell count
Measured: At all timepoints from vaccination up to 28 days after vaccination
Change from pre-immunisation baseline values in haematocrit
Measured: At all timepoints from vaccination up to 28 days after vaccination
Change from pre-immunisation baseline values in white blood cell count
Measured: At all timepoints from vaccination up to 28 days after vaccination
Change from pre-immunisation baseline values in platelet count
Measured: At all timepoints from vaccination up to 28 days after vaccination
Change from pre-immunisation baseline values in white blood cells
Measured: At all timepoints from vaccination up to 28 days after vaccination
Change from pre-immunisation baseline values in 'mean corpuscular volume'
Measured: At all timepoints from vaccination up to 28 days after vaccination
Change from pre-immunisation baseline values in 'mean corpuscular heamoglobin'
Measured: At all timepoints from vaccination up to 28 days after vaccination
Change from pre-immunisation baseline values in 'mean corpuscular heamoglobin concentration'
Measured: At all timepoints from vaccination up to 28 days after vaccination
Change from pre-immunisation baseline values in Cell Mediated Immunity status in response to in vitro antigen stimulation
Measured: At all timepoints from vaccination up to 28 days after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2015 (estimated)
- Study start24 Aug 2015
- Primary completion15 Dec 2015
- Study completion15 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prevention of Infections With Bordetella PertussisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- University of Surrey, Novartis Vaccines, Max Planck Institute for Infection Biology, deCODE genetics, GlaxoSmithKline, Sanofi Pasteur, a Sanofi Company, Innovative Medicines Initiative
- Responsible party
- Sponsor
- Investigators
- Geert Leroux-Roels, Prof., MD, Principal investigator, Center for Vaccinology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02555540
- Sponsor's protocol ID
- BioVacSafe - Boostrix
- Status last verified
- Dec 2022
- First submitted
- 24 Aug 2015
- Last updated
- 20 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Generate a Set of Data Characterising Clinical Events, Physiological Responses, and Innate and Adaptive Immune Responses Following a Single IM Immunisation With Boostrix® or Placebo in Healthy Adults
- ClinicalTrials.gov ID
- NCT02555540
- Acronym / sponsor ID
- BioVacSafe - Boostrix
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- University of Surrey, Novartis Vaccines, Max Planck Institute for Infection Biology, deCODE genetics, GlaxoSmithKline, Sanofi Pasteur, a Sanofi Company, Innovative Medicines Initiative
- Study start
- 24 Aug 2015 (actual)
- Primary completion
- 15 Dec 2015 (actual)
- Study completion
- 15 Dec 2016 (actual)
- First posted
- 21 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this protocol is to generate a set of data that will be analysed by integrated systems biology approach, for validation in subsequent clinical trials or in animal models.
240 healthy participants (18-45y) will be enrolled, 200 will be administered a dose of Boostrix on Day 0, 20 will receive a placebo on Day 0.
Detailed description
This study is part of the BIOVACSAFE project, a 5-year project funded by the Innovative Medicine Initiative, which will undertake a series of correlated clinical studies that will apply and develop technologies to generate clinical data on inflammation with licensed vaccines as benchmarks, and identify biomarkers to predict acceptable reactogenicity, for correlation with standardized clinical readouts and inflammatory markers assessed in natural infections.
The purpose of this protocol is to generate data to undergo integrated systems biology analysis to validate biomarkers identified in the exploratory studies conducted previously or to identify new biomarkers of responses to immunisation
The data set will include data characterising:
- Physiological responses at various time points after immunisation by measuring:
- Local and systemic vaccine-related clinical events.
- Haematology (blood counts and ESR) and biochemistry parameters.
- Innate and adaptive immune responses including:
- Innate immune activation detected by global gene expression in whole blood
- Adaptive humoral immunity determined by the quantification antibodies directed against Tetanus toxoid (TT), Diphteria toxoid (DT), Pertussis toxin (PT), Fimbrial haemagglutinin (FHA) and Pertactin (PTN).
- Adaptive immune activation detected by gene pathway activation in whole blood
- Metabolic responses as detected by metabolic gene expression and pathway activation in whole blood
- Innate and adaptive immune activation detected by measuring the concentration of selected soluble mediators in serum including: chemokines and cytokines and acute phase proteins
- As an exploratory endpoint, the adaptive cellular immune response will be evaluated via counting vaccine antigen-specific Cluster of Differentiation 4 (CD4)+ T cells expressing activation markers and/or cytokines following in vitro stimulation and analysis by flow cytometry (and or CyTOF).
- Genetic testing of subjects when deemed necessary (genetic testing analysis may be SNP (single nucleotide polymorphism) analysis or full genome analysis).
- Correlations in changes in innate immune activation and metabolism with adverse events, haematology and biochemistry panels, genotype and physiological assessments
The investigators will biobank all samples for the duration of the BIOVACSAFE programme so that they can selectively analyse different samples and different time points depending on the results generated, principally from the gene expression analysis of whole blood.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 16
| Arm | Type | Receives |
|---|---|---|
| Boostrix, Male, >/= 5 years, D2 visit | Active comparator | Biological: Boostrix25 male subjects who have received their last dT(Pa) vaccine at least 5 years ago, and who have the Visit 2 on 'Day 2'. 5 out-patient visits: Day 0 (blood sampling, vaccination), Day 1 (blood sampling), Day 2 (blood sampling), Day 7 (blood sampling), Day 28 (blood sampling) |
| Boostrix, Male, >/= 5 years, D3 visit | Active comparator | Biological: Boostrix25 male subjects who have received their last dT(Pa) vaccine at least 5 years ago, and who have the Visit 2 on 'Day 3'. 5 out-patient visits: Day 0 (blood sampling, vaccination), Day 1 (blood sampling), Day 3 (blood sampling), Day 7 (blood sampling), Day 28 (blood sampling) |
| Boostrix, Female, >/= 5 years, D2 visit | Active comparator | Biological: Boostrix25 female subjects who have received their last dT(Pa) vaccine at least 5 years ago, and who have the Visit 2 on 'Day 2'. 5 out-patient visits: Day 0 (blood sampling, vaccination), Day 1 (blood sampling), Day 2 (blood sampling), Day 7 (blood sampling), Day 28 (blood sampling) |
| Boostrix, Female, >/= 5 years, D3 visit | Active comparator | Biological: Boostrix25 female subjects who have received their last dT(Pa) vaccine at least 5 years ago, and who have the Visit 2 on 'Day 3'. 5 out-patient visits: Day 0 (blood sampling, vaccination), Day 1 (blood sampling), Day 3 (blood sampling), Day 7 (blood sampling), Day 28 (blood sampling) |
| Placebo, Male, >/= 5 years, D2 visit | Placebo comparator | Biological: Placebo (Saline)5 male subjects who have received their last dT(Pa) vaccine at least 5 years ago, and who have the Visit 2 on 'Day 2'. 5 out-patient visits: Day 0 (blood sampling, vaccination), Day 1 (blood sampling), Day 2 (blood sampling), Day 7 (blood sampling), Day 28 (blood sampling) |
| Placebo, Male, >/= 5 years, D3 visit | Placebo comparator | Biological: Placebo (Saline)5 male subjects who have received their last dT(Pa) vaccine at least 5 years ago, and who have the Visit 2 on 'Day 3'. 5 out-patient visits: Day 0 (blood sampling, vaccination), Day 1 (blood sampling), Day 3 (blood sampling), Day 7 (blood sampling), Day 28 (blood sampling) |
| Placebo, Female, >/= 5 years, D2 visit | Placebo comparator | Biological: Placebo (Saline)5 female subjects who have received their last dT(Pa) vaccine at least 5 years ago, and who have the Visit 2 on 'Day 2'. 5 out-patient visits: Day 0 (blood sampling, vaccination), Day 1 (blood sampling), Day 2 (blood sampling), Day 7 (blood sampling), Day 28 (blood sampling) |
| Placebo, Female, >/= 5 years, D3 visit | Placebo comparator | Biological: Placebo (Saline)5 female subjects who have received their last dT(Pa) vaccine at least 5 years ago, and who have the Visit 2 on 'Day 3'. 5 out-patient visits: Day 0 (blood sampling, vaccination), Day 1 (blood sampling), Day 3 (blood sampling), Day 7 (blood sampling), Day 28 (blood sampling) |
| Boostrix, Male, <5 years, D2 visit | Active comparator | Biological: Boostrix25 male subjects who have received their last dT(Pa) vaccine between 5 years and 6 months ago, and who have the Visit 2 on 'Day 2'. 5 out-patient visits: Day 0 (blood sampling, vaccination), Day 1 (blood sampling), Day 2 (blood sampling), Day 7 (blood sampling), Day 28 (blood sampling) |
| Boostrix, Male, <5 years, D3 visit | Active comparator | Biological: Boostrix25 male subjects who have received their last dT(Pa) vaccine between 5 years and 6 months ago, and who have the Visit 2 on 'Day 3'. 5 out-patient visits: Day 0 (blood sampling, vaccination), Day 1 (blood sampling), Day 3 (blood sampling), Day 7 (blood sampling), Day 28 (blood sampling) |
| Boostrix, Female, <5 years, D2 visit | Active comparator | Biological: Boostrix25 female subjects who have received their last dT(Pa) vaccine between 5 years and 6 months ago, and who have the Visit 2 on 'Day 2'. 5 out-patient visits: Day 0 (blood sampling, vaccination), Day 1 (blood sampling), Day 2 (blood sampling), Day 7 (blood sampling), Day 28 (blood sampling) |
| Boostrix, Female, <5 years, D3 visit | Active comparator | Biological: Boostrix25 female subjects who have received their last dT(Pa) vaccine between 5 years and 6 months ago, and who have the Visit 2 on 'Day 3'. 5 out-patient visits: Day 0 (blood sampling, vaccination), Day 1 (blood sampling), Day 3 (blood sampling), Day 7 (blood sampling), Day 28 (blood sampling) |
| Placebo, Male, <5 years, D2 visit | Placebo comparator | Biological: Placebo (Saline)5 male subjects who have received their last dT(Pa) vaccine between 5 years and 6 months ago, and who have the Visit 2 on 'Day 2'. 5 out-patient visits: Day 0 (blood sampling, vaccination), Day 1 (blood sampling), Day 2 (blood sampling), Day 7 (blood sampling), Day 28 (blood sampling) |
| Placebo, Male, <5 years, D3 visit | Placebo comparator | Biological: Placebo (Saline)5 male subjects who have received their last dT(Pa) vaccine between 5 years and 6 months ago, and who have the Visit 2 on 'Day 3'. 5 out-patient visits: Day 0 (blood sampling, vaccination), Day 1 (blood sampling), Day 3 (blood sampling), Day 7 (blood sampling), Day 28 (blood sampling) |
| Placebo, Female, <5 years, D2 visit | Placebo comparator | Biological: Placebo (Saline)5 female subjects who have received their last dT(Pa) vaccine between 5 years and 6 months ago, and who have the Visit 2 on 'Day 2'. 5 out-patient visits: Day 0 (blood sampling, vaccination), Day 1 (blood sampling), Day 2 (blood sampling), Day 7 (blood sampling), Day 28 (blood sampling) |
| Placebo, Female, <5 years, D3 visit | Placebo comparator | Biological: Placebo (Saline)5 female subjects who have received their last dT(Pa) vaccine between 5 years and 6 months ago, and who have the Visit 2 on 'Day 3'. 5 out-patient visits: Day 0 (blood sampling, vaccination), Day 1 (blood sampling), Day 3 (blood sampling), Day 7 (blood sampling), Day 28 (blood sampling) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Healthy male or female subjects aged 18-45 years (inclusive).
- Male: Female ratio - 1:1.
- Half of the subjects (n=120) will have received a previous Dt(pa) dose less than 5 years before, the other half (n=120) will have received a previous Dt(pa) dose 5 or more years before participating at this study.
- The subject is, in the opinion of the investigator healthy based on medical history and clinical exam, with no active disease process that could interfere with the study endpoints.
- Has a body Mass Index ≥18.0 and ≤30.0
Key exclusion criteria (14 listed)
- Pregnant or lactating at any point during the study from screening to final follow up.
- Hypersensitivity to any component of the vaccine or subjects having shown signs of hypersensitivity after previous administration of diphtheria, tetanus, or pertussis vaccines.
- Presence of primary or acquired immunodeficiency states with a total lymphocyte count less than 1,200 per mm3 or presenting other evidence of lack of cellular immune competence e.g. leukaemias, lymphomas, blood dyscrasias, or patients receiving immunosuppressive therapy (including regular use of oral or parenteral corticosteroids).
- Use of any immune suppressing or immunomodulating drugs within 6 months of Visit 1.
- Regular and prolonged use of non-steroidal anti-inflammatory drugs (oral or parenteral route) within 6 months of Visit 1 considered by the study physician as likely to interfere with immune responses.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BoostrixRandomised assignment | Biological | Boostrix, Female, <5 years, D2 visit, Boostrix, Female, <5 years, D3 visit, Boostrix, Female, >/= 5 years, D2 visit, Boostrix, Female, >/= 5 years, D3 visit, Boostrix, Male, <5 years, D2 visit, Boostrix, Male, <5 years, D3 visit, Boostrix, Male, >/= 5 years, D2 visit, Boostrix, Male, >/= 5 years, D3 visit |
| Placebo (Saline)Randomised assignment | Biological | Placebo, Female, <5 years, D2 visit, Placebo, Female, <5 years, D3 visit, Placebo, Female, >/= 5 years, D2 visit, Placebo, Female, >/= 5 years, D3 visit, Placebo, Male, <5 years, D2 visit, Placebo, Male, <5 years, D3 visit, Placebo, Male, >/= 5 years, D2 visit, Placebo, Male, >/= 5 years, D3 visit |
Primary outcome
Frequency of local vaccine-related clinical events
Time frame: At all timepoints from vaccination up to 28 days after vaccination
Participants will report these events on a diary, measuring local events or scoring them from 0 (absent) to 3 (severe)
Frequency of systemic vaccine-related clinical events.
Time frame: At all timepoints from vaccination up to 28 days after vaccination
Participants will report these events on a diary, scoring them from 0 (absent) to 3 (severe)
Physiological assessments: Change from pre-immunisation baseline values in body temperature.
Time frame: Up to 7 days after vaccination
Change from pre-immunisation baseline values in 'Erythrocyte Sedimentation Rate' (ESR)
Time frame: At all timepoints from vaccination up to 28 days after vaccination
Change from pre-immunisation baseline values in creatinin
Time frame: At all timepoints from vaccination up to 28 days after vaccination
Change from pre-immunisation baseline values in C Reactive Protein (CRP)
Time frame: At all timepoints from vaccination up to 28 days after vaccination
Change from pre-immunisation baseline values in aspartate transaminase (AST)/ alanine transaminase (ALT)
Time frame: At all timepoints from vaccination up to 28 days after vaccination
Change from pre-immunisation baseline values in albumin
Time frame: At all timepoints from vaccination up to 28 days after vaccination
Change from pre-immunisation baseline values in estimated glomerular filtration rate (eGFR)
Time frame: At all timepoints from vaccination up to 28 days after vaccination
Change from pre-immunisation baseline values in gamma glutamyl transpeptidase (GGT)
Time frame: At all timepoints from vaccination up to 28 days after vaccination
Change from pre-immunisation baseline values in total protein
Time frame: At all timepoints from vaccination up to 28 days after vaccination
Change from pre-immunisation baseline values in prothrombin/fibrinogen
Time frame: At all timepoints from vaccination up to 28 days after vaccination
Change from pre-immunisation baseline values in global gene expression measured on whole blood samples.
Time frame: At selected timepoints from vaccination up to 28 days after vaccination
Change from pre-immunisation baseline values in metabolic gene expression measured on whole blood samples.
Time frame: At selected timepoints from vaccination up to 28 days after vaccination
Change from pre-immunisation baseline values in serum levels of antibodies to vaccine antigens (anti-T, anti-D, anti-PT, anti-FHA and anti-PRN) in serum samples.
Time frame: At selected timepoints from vaccination up to 28 days after vaccination
Change from pre-immunisation values of adaptive cellular immune response via enumeration of TT-, DT-, PT-, FHA- and PTN-specific CD3/CD4+ or CD3/CD8+ T cells expressing activation markers/cytokines following IV stimulation and analysis by flow cytometry.
Time frame: At 7 days after vaccination
Change from pre-immunisation baseline values in concentration of selected cytokines and acute phase proteins in serum samples
Time frame: At selected timepoints from vaccination up to 28 days after vaccination
Change from pre-immunisation baseline values in pathway activation measured on whole blood samples.
Time frame: At selected timepoints from vaccination up to 28 days after vaccination
Change from pre-immunisation baseline values in haemoglobin
Time frame: At all timepoints from vaccination up to 28 days after vaccination
Change from pre-immunisation baseline values in red blood cell count
Time frame: At all timepoints from vaccination up to 28 days after vaccination
Change from pre-immunisation baseline values in haematocrit
Time frame: At all timepoints from vaccination up to 28 days after vaccination
Change from pre-immunisation baseline values in white blood cell count
Time frame: At all timepoints from vaccination up to 28 days after vaccination
Change from pre-immunisation baseline values in platelet count
Time frame: At all timepoints from vaccination up to 28 days after vaccination
Change from pre-immunisation baseline values in white blood cells
Time frame: At all timepoints from vaccination up to 28 days after vaccination
Change from pre-immunisation baseline values in 'mean corpuscular volume'
Time frame: At all timepoints from vaccination up to 28 days after vaccination
Change from pre-immunisation baseline values in 'mean corpuscular heamoglobin'
Time frame: At all timepoints from vaccination up to 28 days after vaccination
Change from pre-immunisation baseline values in 'mean corpuscular heamoglobin concentration'
Time frame: At all timepoints from vaccination up to 28 days after vaccination
Change from pre-immunisation baseline values in Cell Mediated Immunity status in response to in vitro antigen stimulation
Time frame: At all timepoints from vaccination up to 28 days after vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2022.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Geert Leroux-Roels, Prof., MD principal investigator
Center for Vaccinology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Boostrix in people with Prevention of Infections With Bordetella Pertussis, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of local vaccine-related clinical events (time frame: At all timepoints from vaccination up to 28 days after vaccination). The study lists 28 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2022.