The vaccine administered in this study is used to prevent pertussis caused by the bacterium Bordetella pertussis
Conditions
Interventions
Trade Name: Boostrix
Product Name: Boostrix
Product Code: Boostrix
Pharmaceutical Form: Suspension for injection
Sponsors
National Institute for Public Health and the Environment (RIVM, the Netherlands)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, participants must meet all of the following criteria: • Good general health; • 25-29 years of age; • Vaccinated with DTwP-IPV (RIVM) at 3, 4, 5, and 11 months of age; • Received all other regular vaccines according to the Dutch NIP; • Provision of written informed consent; • Adherent to protocol and available during the study period. 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 100 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Any of the following criteria will exclude a participant from this study: • Antibiotic use within 14 days of enrollment; • Present evidence of serious disease(s) demanding immunosuppressive medical treatment, like corticosteroids, that might interfere with the results of the study within the last 3 months; • Known or suspected allergy to any of the vaccine components (by medical history); • Occurrence of serious adverse event after primary DTwP-IPV vaccination or other vaccination (by medical history); • Known or suspected immune deficiency; • History of any neurologic disorder, including epilepsy; • Previous administration of serum products (including immunoglobulins) within 6 months before vaccination and blood/ saliva sampling; • Vaccination with any other pertussis vaccine than those described in the inclusion criteria; • No DT or DT-IPV vaccination at least 5 years before enrollment; • Vaccination within a month before enrollment; • Pregnant at start of study (when vaccination is administered);
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main purpose of this study is to investigate the longitudinal effects of an aP booster vaccination in adults, on long-term humoral (T0-T5)and cellular (T0-T4) memory immunity against B. pertussis. By measuring antibody levels against the various pertussis proteins (, antibody kinetics in serum (T0-T5) and saliva (T0-T4) can be determined.;Secondary Objective: See E.5.2 Secondary end points;Primary end point(s): The main purpose of this study is to investigate the longitudinal effects of an aP booster vaccination in adults, on long-term humoral (T0-T5) and cellular memory (T0-T4) immunity against B. pertussis. By measuring antibody levels against the various pertussis proteins, antibody kinetics in serum (T0-T5) and saliva (T0-T4) can be determined.;Timepoint(s) of evaluation of this end point: T0: First visit (Informed consent, blood sample, saliva sample and vaccination) T1: Second visit, 14 days after T0 (blood sample and saliva sample) T2: Third visit, 28 days after T0 (blood sample and saliva sample) T3: Fourth visit, 1 year after T0 (blood sample and saliva sample) T4: Fifth visit, 2 years after T0 (blood sample and saliva sample) T5: Sixth visit, 6 years after T0 (blood sample) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • To determine pertussis specific IgG-subclasses and –avidity in serum (T0-T4); • To determine pertussis specific IgG-antibodies in saliva (T0-T4); • To measure serum specific IgG-antibodies (T0-T5), and memory B- and T-cell responses (T0-T4) against the other components (Diphtheria and Tetanus) of the booster vaccine; • To measure pertussis specific IgA antibodies in serum and saliva (T0-T4). ;Timepoint(s) of evaluation of this end point: T0: First visit (Informed consent, blood sample, saliva sample and vaccination) T1: Second visit, 14 days after T0 (blood sample and saliva sample) T2: Third visit, 28 days after T0 (blood sample and saliva sample) T3: Fourth visit, 1 year after T0 (blood sample and saliva sample) T4: Fifth visit, 2 years after T0 (blood sample and saliva sample) T5: Sixth visit, 6 years after T0 (blood sample) | — |
Countries
Netherlands
Contacts
Public ContactPauline Versteegen
National Institute for Public Health and the Environment (RIVM, the Netherlands)
Outcome results
None listed