The main purpose of this study is to investigate the longitudinal effects of an aP booster vaccination in adults, on long-term humoral and cellular memory immunity against B. pertussis. By measuring antibody levels against the various pertussis…
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Source
Brief title
Condition
- Bacterial infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
• 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 outcome
• 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).
Background summary
Pertussis, or whooping cough, is caused by the bacterium Bordetella pertussis
and is an acute and serious respiratory infection, in particular for young and
unvaccinated children. Since the introduction of whole-cell pertussis (wP)
vaccines in 1953 in the Netherlands, the incidence of pertussis in childhood
reduced rapidly. However, despite high vaccination coverage (95%), pertussis is
re-emerging in the Netherlands since 1996. This phenomenon is also observed in
most other western countries with high vaccination coverage. The most recent
epidemic in 2012 in the Netherlands highlighted the vulnerability of infants
for a pertussis infection since three infants died. Vaccine derived protection
against pertussis is not yet established in the first months of life. The
pertussis incidence in adults increases as well. Prolonged cough episodes is
one of the symptoms adults suffer from.
The main purpose of this study is to investigate the longitudinal effects of an
aP booster vaccination in adults, on long-term humoral and cellular memory
immunity against B. pertussis. By measuring antibody levels against the various
pertussis proteins, antibody kinetics in serum and saliva can be determined.
These insights are necessary to understand the possible effects of an adult aP
booster vaccination on long-term immunity against pertussis. If the decay of
vaccine induced antibody levels is limited for a long period, these antibodies
could help protect an infant when antibodies cross the placenta during
pregnancy.
Study objective
The main purpose of this study is to investigate the longitudinal effects of an
aP booster vaccination in adults, on long-term humoral and cellular memory
immunity against B. pertussis. By measuring antibody levels against the various
pertussis proteins, antibody kinetics in serum and saliva can be determined.
Study design
Longitudinal intervention study
Intervention
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 samples will be drawn before,
at two and four weeks and one and two years after vaccination.
Study burden and risks
Participants will benefit from participating in this study by receiving an
additional Tdap vaccination. From the public health perspective, participation
in this study will contribute to insight in pertussis immunity. Vaccination,
venapunctures and fingerpricks are unpleasant at the moment of injection,
however, they are low risk invasive procedures. Boostrix® is a registered
vaccine in the Netherlands. Adverse reactions to the vaccine may occur but they
are expected to be mainly local and transient. Severe allergic reactions to one
of the vaccine components are unlikely to occur. Tdap booster vaccination in
adults is a common procedure in several countries already. As a compensation
for the vaccination, venapunctures, the fingerprick, and the saliva drawings,
all participants will receive a total of ¤37,50 in vouchers.
Antonie van Leeuwenhoeklaan 9
Bilthoven 3721 MA
NL
Antonie van Leeuwenhoeklaan 9
Bilthoven 3721 MA
NL
Listed location countries
Age
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);
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2013-005355-32-NL |
| CCMO | NL47382.094.13 |
| OMON | NL-OMON28859 |