vaccin against diphtheria, tetanus and pertussis. MedDRA version: 18.0 Level: LLT Classification code 10046859 Term: Vaccination System Organ Class: 100000004865
Conditions
Interventions
Trade Name: Boostrix
Product Name: Boostrix
Pharmaceutical Form: Suspension for injection in pre-filled syringe
INN or Proposed INN: Boostrix suspensie voor injectie in voorgevulde spuit
Other descrip
Sponsors
Ghent University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy male or female subjects aged 18-45 years (inclusive). 2. Male: Female ratio – 1:1. 3. 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. 4. 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. 5. Has a body Mass Index =18.0 and =30.0 6. Is able to read and understand the Informed Consent Form (ICF), and understand study procedures. 7. The subject has signed the ICF. 8. The subject is available for follow-up for the duration of the study. 9. The subject agrees to abstain from donating blood during their participation in the study, or longer if necessary. 10. 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. 11. The subject has venous access sufficient to allow blood sampling as per the protocol. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 240 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating at any point during the study from screening to final follow up. 2. Hypersensitivity to any component of the vaccine or subjects having shown signs of hypersensitivity after previous administration of diphtheria, tetanus, or pertussis vaccines. 3. 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). 4. Use of any immune suppressing or immunomodulating drugs within 6 months of Visit 1. 5. 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. 6. 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. 7. Currently performing extreme physical activities (as evaluated by the investigator) and not willing to adapt this use during the study period. 8. 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. 9. Presence of an acute severe febrile illness at time of immunisation. 10. History of alcohol, narcotic, benzodiazepine, rilatine, or other substance abuse or dependence within the 12 months preceding Visit 1. 11. 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. 12. Any condition that, in the investigator’s opinion, compromises the subject’s ability to meet protocol requirements or to complete the study. 13. Receipt of blood products or immunoglobulins, or blood donation within 3 months prior to visit 1. 14. Unable to read and speak Dutch or English to a fluency level adequate for the full comprehension of procedures required in participation and consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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. The dataset will broadly characterise: 1. Physiological responses at various time points after immunisation 2. Metabolic, innate and adaptive immune responses 3. Genetic testing of subjects when deemed necessary (genetic testing analysis may be SNIP analysis or full genome analysis). 4. Correlations in changes in innate and adaptive immune activation and metabolism with adverse events, haematology and biochemistry panels, genotype and physiological assessments. All samples will be biobanked for the duration of the BIOVACSAFE programme so that we can selectively analyse different samples and different time points depending on the results generated, principally from the gene expression analysis of whole blood.;Secondary Objective: none;Primary end point(s): 1. Frequency of local and systemic vaccine-related clinical events 2. Change from pre-immunisation baseline values in temperature from time of immunisation 3. Change from pre-immunisation baseline values in haematology (blood counts and ESR), biochemistry (liver, renal and bone panels) parameters 4. Change from pre-immunisation baseline values in global gene expression measured on whole blood samples 5. Change from pre-immunisation baseline values and fold increase in serum titres of antibodies against vaccine antigens (TT, DT, FHA, PT, PTN) in serum samples 6. Change from pre-immunisation values of adaptive cellular immune response will be evaluated in all subjects via enumeration of antigen-specific CD4+ T cells expressing activation markers and/or cytokines following in vitro stimulation and analysis by flow cytometry. 7. Change from pre-immunisation baseline values in metabolic gene expression and pathway activation measured on whole blood samples 8. Change from pre-immunisation baseline values in concentr | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): none;Timepoint(s) of evaluation of this end point: not applicable | — |
Countries
Belgium
Contacts
Public ContactBimetra Clinics
Ghent University Hospital
Outcome results
None listed