Adult vaccination against Bordetella pertussis
Conditions
Interventions
Participants will receive one injection of Tdap (tetanus, reduced diphtheria
and reduced acellular pertussis) (Boostrix® (GSK)) combination vaccine
intramuscular in the upper arm. Blood and saliva s
Sponsors
RIVM
Eligibility
Age
18 Years to 99 Years
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.
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 |
|---|---|
| • To assess pertussis specific IgG antibody levels in serum prior to vaccination (T0) and 14 days (T1), 28 days (T2), 1 year (T3), 2 years (T4) and 6 years (T5) after vaccination to determine the kinetics of pertussis specific antibody levels after an aP booster vaccination in adults 25-29 years of age; • To assess memory B- and T-cell responses against the various B. pertussis proteins at all time points to determine the effects of an aP booster vaccination in adults 25-29 years of age (prior to vaccination, 14 days, 28 days, 1 year and, 2 years after vaccination. | — |
Secondary
| Measure | Time frame |
|---|---|
| • 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). | — |
Countries
Netherlands
Outcome results
None listed