Memory response against Bordetella pertussis in adults: immunological effects of an acellular pertussis booster vaccinatio

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 106

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

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);

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>• To assess pertussis specific IgG antibody levels in serum prior to<br /><br>vaccination (T0) and 14 days (T1), 28 days (T2), 1 year (T3), 2 years (T4) and<br /><br>6 years (T5) after vaccination to determine the kinetics of pertussis specific<br /><br>antibody levels after an aP booster vaccination in adults 25-29 years of age;<br /><br>• To assess memory B- and T-cell responses against the various B. pertussis<br /><br>proteins at all time points to determine the effects of an aP booster<br /><br>vaccination in adults 25-29 years of age (prior to vaccination, 14 days, 28<br /><br>days, 1 year and, 2 years after vaccination.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• To determine pertussis specific IgG-subclasses and -avidity in serum (T0-T4);<br /><br>• To determine pertussis specific IgG-antibodies in saliva (T0-T4);<br /><br>• To measure serum specific IgG-antibodies (T0-T5), and memory B- and T-cell<br /><br>responses (T0-T4) against the other components (Diphtheria and Tetanus) of the<br /><br>booster vaccine;<br /><br>• To measure pertussis specific IgA antibodies in serum and saliva (T0-T4).</p><br>