Evaluating Vaccine Responses in Healthy Infants Receiving Their Routine Primary Immunisation According to the Accelerated United Kingdom Schedule at 2, 3 and 4 Months (P13UK)
20 mars 2019 mis à jour par: Prof. Elizabeth Miller
A Prospective Study to Evaluate the Immune Response of UK Infants Receiving the 13-valent Pneumococcal Conjugate Vaccine as Part of Their Routine Primary Immunisation Schedule at 2 and 4 Months
Streptococcus pneumoniae is a major cause of serious bacterial infections, particularly among young children.
Over 30 different types of the pneumococcus germ can cause invasive disease, but 7 types (namely serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) are responsible for around 75% of cases in young children.
A pneumococcal conjugate vaccine against these 7 serotypes (PCV7; Prevenar ®, Wyeth Vaccines) was introduced into the UK national immunisation programme in September 2006 and has resulted in a rapid reduction in pneumococcal disease caused by the 7 serotypes among both vaccinated children and older unvaccinated children and adults through herd immunity.
By 2009, over half of all invasive pneumococcal cases in young children were caused by six other pneumococcal serotypes (1, 3, 5, 6A, 7F and 19A) that are included in a newly licensed 13 valent pneumococcal vaccine (PCV13; Prevenar 13®, Wyeth Vaccines).
In April 2010, PCV13 replaced PCV7 in the UK immunisation programme with the aim of further reducing cases of invasive pneumococcal disease.
The antibody responses induced by the 7 serotypes in both PCV13 and PCV7 have been shown to be comparable, but the protection offered by the additional 6 serotypes in PCV13 merits further study.
Also, it is possible that the use of PCV13 instead of PCV7 may interfere with immune responses to other vaccines, such as Haemophilus influenzae serotype b (Hib), which are given to infants at the same time as PCV13.
The proposed study will aim to collect one blood sample from infants after they receive their routine vaccinations at 2, 3 and 4 months in order to their measure immune responses to routine vaccines.
The investigators hope that their results will help us better understand the added protection offered by the 13valent pneumococcal vaccine and ensure that children are adequately protected by the other vaccines they receive.
Aperçu de l'étude
Statut
Complété
Les conditions
Description détaillée
This study will aim to prospectively recruit infants in the first 6 months of life who are either due to receive or in the process of receiving their routine infant immunisation and request one blood sample one month after completing their primary immunisation schedule, which will be at around 5 months of age, if they fulfil the inclusion criteria for the study.
NUMBER OF SUBJECTS AND DURATION OF STUDY
A total of 200 infants will be recruited in two centres - Hertfordshire and Gloucestershire.
Type d'étude
Observationnel
Inscription (Réel)
93
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Hertfordshire And Gloucstershire, Royaume-Uni
- Multiple GP surgeries
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
Pas plus vieux que 6 mois (Enfant)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
Healthy infants who have received their primary immunisation schedule at appropriate intervals
La description
Inclusion Criteria:
Male or female infants born at term (at least 37 weeks gestation) aged <6 months:
- With written informed consent obtained from the parent or legal guardian of the infant to participate in the study and to allow the infant's General Practitioner (GP) to be informed of participation in the study and be contacted, if required, for confirmation of the vaccination history
Who have received all their primary immunisations in the 1st 6 months of life, including:
- 3 doses of Pediacel®
- 2 doses of Prevenar13®, with the 1st dose given at 6-12 weeks of age and the 2nd dose at 8-12 weeks after the 1st dose
- 2 doses of any MenC vaccine
- Do not fulfil any of the Exclusion Criteria
Exclusion Criteria:
Participant may not be included in the study if any of the following apply:
- History of invasive Haemophilus influenzae serotype b (Hib), pneumococcal or meningococcal disease
- Confirmed or suspected immunosuppressive or immunodeficient condition (including HIV)
- Bleeding disorders and/or prolonged bleeding time
- Major congenital defects or chronic disease
- Premature birth (<37 weeks gestation at birth)
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
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1. To determine the proportion of infants with pneumococcal serotype-specific IgG antibody concentrations ≥0.35 μg/ml for the 13 serotypes included in Prevenar13 at one month after completion of primary immunisation
Délai: 24 months
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24 months
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
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1. To determine the geometric mean concentrations (GMCs) of pneumococcal serotype-specific IgG antibody concentrations for each of the 13 serotypes in Prevenar13 one month after primary immunisation
Délai: 24 months
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24 months
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2. To determine, using a functional opsonophagocytic assay (OPA), the proportion of infants with geometric mean titres (GMT) ≥1:8 for the 13 serotypes in Prevenar13 one month after primary immunisation
Délai: 24 months
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24 months
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3. To determine serum bactericidal assay (SBA) titres with 95%CI for MenC and the proportion of infants achieving SBA titres ≥8 or ≥128 one month after primary immunisation
Délai: 24 months
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24 months
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4. To determine Hib GMC with 95%CI and proportions of infants with Hib antibody concentrations ≥0.15 μg/ml or ≥1.0 μg/ml one month after primary immunisation
Délai: 24 months
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24 months
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chaise d'étude: Elizabeth Coates, PhD, Public Health England
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- Andrews NJ, Waight PA, Burbidge P, Pearce E, Roalfe L, Zancolli M, Slack M, Ladhani SN, Miller E, Goldblatt D. Serotype-specific effectiveness and correlates of protection for the 13-valent pneumococcal conjugate vaccine: a postlicensure indirect cohort study. Lancet Infect Dis. 2014 Sep;14(9):839-46. doi: 10.1016/S1473-3099(14)70822-9. Epub 2014 Jul 17.
- Ladhani SN, Andrews NJ, Waight P, Hallis B, Matheson M, England A, Findlow H, Bai X, Borrow R, Burbidge P, Pearce E, Goldblatt D, Miller E. Interchangeability of meningococcal group C conjugate vaccines with different carrier proteins in the United Kingdom infant immunisation schedule. Vaccine. 2015 Jan 29;33(5):648-55. doi: 10.1016/j.vaccine.2014.12.018. Epub 2014 Dec 12.
Liens utiles
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 novembre 2010
Achèvement primaire (Réel)
1 mai 2012
Achèvement de l'étude (Réel)
1 juin 2013
Dates d'inscription aux études
Première soumission
26 août 2011
Première soumission répondant aux critères de contrôle qualité
29 août 2011
Première publication (Estimation)
30 août 2011
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
22 mars 2019
Dernière mise à jour soumise répondant aux critères de contrôle qualité
20 mars 2019
Dernière vérification
1 août 2018
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Infections
- Infections des voies respiratoires
- Maladies des voies respiratoires
- Pneumonie
- Maladies pulmonaires
- Infections bactériennes
- Infections bactériennes et mycoses
- Infections streptococciques
- Infections bactériennes à Gram positif
- Pneumonie bactérienne
- Infections pneumococciques
- Pneumonie, pneumocoque
Autres numéros d'identification d'étude
- P13UK
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