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van CCT (UK)

van CCT (UK)

Effects of maternal pertussis vaccination on infant immune response

- candidate number15871
- NTR NumberNTR4314
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR13-dec-2013
- Secondary IDsNL45652.000.13 2013-003090-98
- Public TitleEffects of maternal pertussis vaccination on infant immune response
- Scientific TitleMaternal pertussis (Tdap) vaccination and its effects on the immune response of the new-born up to 12 months of age.
- ACRONYMMIKI, Maternale Immunisatie Kinkhoest
- hypothesis
- Healt Condition(s) or Problem(s) studiedVaccination, Whooping cough
- Inclusion criteria• Pregnant women 18-40 years of age
• Women with a low risk of pregnancy complications as assessed by a midwife/obstetrician/gynaecologist with a normal 20 weeks ultrasound of the fetus
• Women who are willing to adhere to the protocol and perform all planned visits and sample collections for themselves and their newborn child
• Parents have to be willing to have their infant vaccinated with the hexavalent (DaKTP-Hib-Hep) vaccine at 3, 5 and 11 months of age according to the described procedures
• Presence of a signed informed consent
- Exclusion criteriaExclusion criteria for (pregnant) woman:
- History of having received a pertussis vaccination in the past 5 years
- History of having received a TD containing vaccine in the past 2 years
- Known or suspected serious underlying condition that can interfere with the results of the study such as but not limited to cancer, autoimmune disease, immunodeficiency, seizure disorder or significant psychiatric illness
- Receipt of any high-dose (>= 20 mg of prednisone daily or equivalent) daily corticosteroids (inhaled steroids are acceptable) within 2 weeks of study entry
- Receipt of other immune modulating medication, for instance biologicals
- Receipt of blood products or immunoglobulin, within three months of study entry (Rhesus negative women who Print ABR-formulier voor dossier NL45652.000.13 Page 6 of 15 4-9-2013
D5b. In het Nederlands
D6. Bij welke categorie proefpersonen wordt het onderzoek uitgevoerd (meerdere antwoorden mogelijk)
D8. Waarom wordt het onderzoek niet met meerderjarige/wilsbekwame proefpersonen uitgevoerd?
D10. Verkeren (sommige) proefpersonen in een afhankelijkheidssituatie ten opzichte van de onderzoeker of degene die de deelnemers werft? (lees de toelichting voor voorbeelden wanneer er sprake kan zijn van een afhankelijkheidssituatie)
D11. Waaruit bestaat de vergoeding voor de proefpersonen? receive antirhesus (D)- immunoglobuline will not be excluded from the trial)
- Presence of bleeding disorder
- Having experienced a previous severe adverse reaction to any vaccine
- Receipt of any vaccine(s) within 2 weeks of study vaccine (except influenza vaccine which may be given concomitantly)
- History of febrile illness (>38.0 C orally) within the past 72 hours (immunization may be deferred)
Exclusion criteria for partners or other primary caregivers:
- Having experienced a previous severe adverse reaction to any vaccine
- History of febrile illness (>38.0 C orally) within the past 72 hours (immunization may be deferred)
Exclusion criteria for new-borns of participating mothers:
- Serious underlying medical condition that can interfere with the results of the study
- Premature infants born before 37 weeks gestational age
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2014
- planned closingdate1-jun-2016
- Target number of participants384
- InterventionsPregnant woman in group 1 will receives a single dose of Boostrix vaccine between week 30 and 32 of pregnancy and pregnant woman in group 2 will receive a single dose of Boostrix vaccine postpartum. All partners or other caregivers will receive a single dose of Boostrix within 48 hours after birth.
- Primary outcomeConfirm superiority of IgG antibody levels against pertussis toxin (Ptx), present in the acellular vaccines, in infants at the age of 3 months of mothers having received a pertussis vaccine during pregnancy versus infants of mothers who have been vaccinated postpartum.
- Secondary outcomeDetermine the effect of the presence of maternal antibodies in the infant on the infant's immune response to active immunization with pertussis vaccine - Compare serum IgA levels against pertussis antigens of infants of both groups at the age of 2, 3, 6, 11 and 12 months - Determine the rate of maternal antibody decline in infants between birth and at 2 and 3 months of age before the first infant pertussis vaccination - Determine levels of pertussis IgG antibodies transferred from the mother to the neonate relative to the interval from immunization to delivery, if possible depending on the variation in interval; - Determine whether maternal immunization during pregnancy interferes with active antibody production following routine DTaP-IPV-Hib-Hep and PCV10 vaccination in infants at 3, 6, 11 and 12 months of age - Assess cellular immune response (Plasma B cells and memory B cells) immediately before and 7-9 days after the booster dose at 11-months of age - Safety evaluation after Boostrix vaccination during pregnancy - Assess pertussis IgG antibody levels in mothers of both groups, pre-vaccination, at delivery (=pre-vaccination for control group) and at 6, and 12 months post-delivery;
- TimepointsIgG antibody levels against pertussis toxin (Ptx) at 3 months after birth
- Trial web siteNA
- statusplanned
- Sponsor/Initiator National Institute for Public Health and the Environment (RIVM)
- Funding
(Source(s) of Monetary or Material Support)
Ministry of Health, Welfare and Sports
- PublicationsN/A
- Brief summary Pertussis, “Whooping cough” caused by the Bordetella pertussis bacterium, is a highly contagious potentially life-threatening respiratory illness especially in infants less than 6 months of age. Recently there has been a considerable increase in pertussis activity with a sharp increase in incidence rate in infants < 2months of age who are too young to be protected through routine vaccination but with the highest risk of complications and death. A possible alternative way to protect these very young infants is by indirect protection, either through a cocooning strategy, i.e. vaccinating primary caregivers of new-borns, or by passive transfer of maternal antibodies induced by maternal vaccination. The purpose of this trial is to evaluate the possibility to provide initial immunological protection of newborn babies against pertussis infection by passively acquired maternal IgGs after vaccination of pregnant women. Pregnant woman will receive a single dose of a combination vaccine including reduced dose acellular pertussis, tetanus toxoid and reduced dose diphtheria toxoid (Tdap) between week 30 and 32 of pregnancy. The control group will consist of pregnant women who will be vaccinated with the same Tdap vaccine postpartum. All infants, born of pregnant women of both groups, will then be vaccinated with the routine vaccines of the national immunisation program (NIP) DtaP-IPV-Hib-Hep and PCV10 at the age of 3, 5 and 11 months instead of the standard schedule of 2, 3, 4, and 11 months. Experience in other countries and our own research has shown that vaccinations at age 3 and 5 months, followed by a booster dose will result in equal clinical effectiveness in protection against Hib, pneumococcus, diphtheria, tetanus and polio compared with a schedule which starts at 2 months of age. Infants will probably, up to 3 months of age, be protected through the presence of maternal pertussis antibodies (group 1) or by reducing the risk that new-borns will be infected by their parents by vaccinating their mother and partner or other primary caregivers (cocooning strategy, group 2). In this way the total number of vaccines each child gets can be reduced.
- Main changes (audit trail)
- RECORD13-dec-2013 - 2-feb-2014

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