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Study the immune responses after pertussis vaccination in adults


- candidate number17217
- NTR NumberNTR4494
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR7-apr-2014
- Secondary IDsNL47382.094.13 IIV-275
- Public TitleStudy the immune responses after pertussis vaccination in adults
- Scientific TitleMemory response against Bordetella pertussis in adults: immunological effects of an acellular pertussis booster vaccination
- ACRONYMVIKING-studie
- hypothesisThe 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. In addition, if the decay of vaccine induced antibody levels is limited for a long period in women, these antibodies could help protect an infant when specific pertussis antibodies are transported across the placenta during pregnancy.
- Healt Condition(s) or Problem(s) studiedWhooping cough, Bordetella pertussis, Vaccination, Humoral immunity, Cellular immunity
- Inclusion 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• 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)
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 21-apr-2014
- planned closingdate30-mei-2016
- Target number of participants100
- InterventionsSingle vaccination with Tdap at first study visit. 5 blood- and saliva-sample collections. before vaccination, two weeks, four weeks, one year and two years after vaccination.
- Primary outcome• To assess pertussis specific IgG antibody levels in serum at T0 (prior to vaccination), 14 days (T1), 28 days (T2), 1 year (T3) and 2 (T4) years 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 vaccine proteins at all time points to determine the effects of an aP booster vaccination in adults 25-29 years of age.
- Secondary outcome• To determine pertussis specific IgG-subclasses and –avidity in serum;
• To determine pertussis specific IgG-antibodies in saliva;
• To measure serum specific IgG-antibodies, and memory B- and T-cell responses against the other components (Diphtheria and Tetanus) of the booster vaccine;
• To measure pertussis specific IgA antibodies in serum and saliva.
- TimepointsT0 (prior to vaccination), 14 days (T1), 28 days (T2), 1 year (T3) and 2 (T4) years after vaccination
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES Saskia Lee, van der
- CONTACT for SCIENTIFIC QUERIES Saskia Lee, van der
- Sponsor/Initiator Rijksinstituut voor Volksgezondheid en Milieu (RIVM)
- Funding
(Source(s) of Monetary or Material Support)
Rijksinstituut voor Volksgezondheid en Milieu (RIVM)
- PublicationsN/A
- Brief summaryPertussis, 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 longterm 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.
- Main changes (audit trail)
- RECORD7-apr-2014 - 27-apr-2014


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