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Development of cellular immune response after infant pneumococcal conjugate vaccinations.


- candidate number4535
- NTR NumberNTR1538
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR17-nov-2008
- Secondary IDsNVI-248 
- Public TitleDevelopment of cellular immune response after infant pneumococcal conjugate vaccinations.
- Scientific TitleDevelopment of cellular immune response after infant pneumococcal conjugate vaccinations.
- ACRONYMN/A
- hypothesisPrevenar« is thought to induce immediate protection through stimulation of antibody production by polysaccharide specific plasma B cells, sustained protection is conferred by a memory B cell pool which induces an accelerated increase in antibody titres during secondary immune responses seen after re-infection or boosting.
- Healt Condition(s) or Problem(s) studiedImmune system, Memory B cells, Prevenar vaccination
- Inclusion criteria1. The children have to be of normal health (same health criteria apply as used in well-baby clinics when a child receives a vaccination, e.g. also children with small increases in temperature or cold are seen as children with normal health)
2. They have to be willing and able to allow their child to participate in the trial according to the described procedures
3. Presence of a signed informed consent (the parents/legally representatives have given written informed consent after receiving oral and written information)
4. The children have received or will receive the Prevenar« vaccinations according to the 3+1 schedule of the Dutch NIP
- Exclusion criteria1. Previous vaccinations with Prevenar« using a schedule that differs from the Dutch 3+1 schedule
2. Previous vaccinations with other pneumoccocal vaccines
3. Presence of a serious disease that requires medical care that can interfere with the results of the study
4. Known or expected allergy/hypersensitivity against one of the vaccine ingredients (anamnestic, be alert if the child has had medical complaints after previous Prevenar« vaccinations)
5. Known or suspected immunological disorder
6. Previously administration of plasma products (including immunoglobulin), within three months of study enrolment
7. Bleeding disorders
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-dec-2008
- planned closingdate1-jul-2009
- Target number of participants100
- Interventions4 groups of children, in all groups the children will have 1 blood collection. The children in group 4 (n=25) receive a challenge vaccination of Prevenar« at 24 months of age.
- Primary outcome- Cellular immunogenicity (plasmacells and memory B-cells frequencies)
- Secondary outcome- Geometric mean titres (GMT)
- Avidity
- Opsonophagocytoses
- Timepoints- inclusion: 6 months
- evaluation: 3 months
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESIr. D.E. Kleijne
- CONTACT for SCIENTIFIC QUERIESDr. G.P.J.M. Dobbelsteen, van den
- Sponsor/Initiator Nederlands Vaccin Instituut (NVI)
- Funding
(Source(s) of Monetary or Material Support)
Nederlands Vaccin Instituut (NVI)
- PublicationsN/A
- Brief summaryPrevenar«, a seven-valent pneumococcal conjugate vaccine has been registered for use in a so-called 3+1 vaccination schedule consisting of a three dose primary series followed by a booster vaccination. It has been introduced in the Dutch National Immunization Program in April 2006 for vaccination at 2, 3, 4 and 11 months of age.
Prevenar vaccination provides immediate protection against pneumoccocal related diseases through the induction of functional antibodies, which however only have a short half-life indicating the need for a memory response. Both the induction and maintenance of functional serum antibody titres have a cellular basis which is still poorly understood.
In general, antigens trigger na´ve B-cells to expand and differentiate into two types of affinity matured B-cells: antibody secreting plasma B cells and memory B-cells. Since plasma cells are unlikely to persist for more than 6-8 weeks (Gourley TS et al, 2004) maintenance of steady state antibody levels over periods of years requires a continuous low level of differentiation of memory B cells into plasma cells. Factors such as recurrent antigen exposure for example through carriage might be involved in this process. Prevenar is thought to induce immediate protection through stimulation of antibody production by polysaccharide specific plasma B cells, sustained protection is conferred by a memory B cell pool which induces an accelerated increase in antibody titres during secondary immune responses seen after re-infection or boosting. An improved understanding of the immunobiology of the B-cell response to conjugate vaccines, such as Prevenar, is essential to develop immunization strategies that provide sustained protection.
- Main changes (audit trail)
- RECORD17-nov-2008 - 5-jun-2010


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