- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00273325
Immunogenicity of PCV-7 Vaccine in VLBW Infants (PCV-7)
Observational Study of the Immunogenicity of Heptavalent Pneumococcal Conjugate Vaccine in Very-low-birth-weight Infants
Aperçu de l'étude
Statut
Description détaillée
Streptococcus pneumoniae causes an estimated 10-25% of all pneumonias in the United States, and is responsible for an estimated 40,000 deaths per year. Invasive pneumococcal disease has a peak incidence of 235/100,000 among children aged 6-11 months. Pneumococcal meningitis carries a higher risk of death (15%) or neurodevelopmental impairment (12-28%) than Hib or Neisseria meningitides.
Premature infants are at a higher risk for invasive disease with Streptococcus pneumoniae. The heptavalent pneumococcal-CRM197 conjugate vaccine (PCV-7) effectively prevents invasive pneumococcal disease in full-term infants, but was been incompletely studied in premature infants. The American Academy of Pediatrics (AAP) recommends that "prematurely born infants, including infants of low birth weight, should be immunized at the usual chronological age in most cases", but cautions that "some studies suggest a reduced immune response in very low-birth-weight infants (<1500 g)."
This observational study assessed the effectiveness of the PCV-7 vaccine to generate a sufficient immune response in a safe manner when given to very low birth weight (VLBW) infants in routine pediatric practice. We hypothesized that among VLBW infants, the frequency of estimated minimum protective antibody titers to PCV-7 (>=0.15 μg/mL) would decrease with decreasing birth weight.
Infants 501-1500g birth weight and <32 0/7 weeks gestational age were enrolled from nine NICHD Neonatal Research Network centers from 2004 to 2006. Enrollment was stratified by weight group to yield approximately 20 infants per 100g increments from 501-1500g birth weight whose primary PCV-7 series was initiated before 3 months and completed by 8 months after birth. The infants' primary providers gave PCV-7 vaccination at 2, 4, and 6 months after birth. Infants had a single 2-ml blood sample drawn 4-6 weeks following the third dose of PCV-7. Antibodies for each of the seven vaccine serotypes included in PCV-7 were measured by enzyme-linked immunosorbent assay. Children were followed until 18-22 months corrected age to assess survival, infection, and neurodevelopmental outcomes.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Alabama
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Birmingham, Alabama, États-Unis, 35233
- University of Alabama at Birmingham
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California
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Palo Alto, California, États-Unis, 94304
- Stanford University
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Florida
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Miami, Florida, États-Unis, 33136
- University of Miami
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Georgia
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Atlanta, Georgia, États-Unis, 30303
- Emory University
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Michigan
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Detroit, Michigan, États-Unis, 48201
- Wayne State University
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New York
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Rochester, New York, États-Unis, 14642
- University of Rochester
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North Carolina
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Charlotte, North Carolina, États-Unis, 27157
- Wake Forest University
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Durham, North Carolina, États-Unis, 27710
- Duke University
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Durham, North Carolina, États-Unis, 27705
- RTI International
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Texas
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Dallas, Texas, États-Unis, 75235
- University of Texas Southwestern Medical Center at Dallas
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion criteria
- Gestational age <32 0/7 weeks
- Included in Neonatal Research Network Generic Database
- Family has a telephone at home
- Anticipated availability for blood draw 4-6 weeks following 3rd vaccine dose
- Consent obtained before first dose of PCV-7 is given
Exclusion criteria
- Known immunodeficiency
- HIV exposure
- Parental non-consent
- Primary care pediatrician not willing to participate
- Enrollment in a conflicting trial
- Infant has not received first dose of PCV-7 vaccine by 3 months of age
Plan d'étude
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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Serotype 6B pneumococcal capsular polysaccharide antibody >=0.15 μg/ml
Délai: 4-6 weeks following the third dose of PCV-7
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4-6 weeks following the third dose of PCV-7
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
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Pneumococcal capsular polysaccharide antibody >=0.15 μg/ml for the other six vaccine serotypes
Délai: 4-6 weeks following the third dose of PCV-7
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4-6 weeks following the third dose of PCV-7
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Pneumococcal capsular polysaccharide antibodies >=1.0 μg/ml for all seven vaccine serotypes
Délai: 4-6 weeks following the third dose of PCV-7
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4-6 weeks following the third dose of PCV-7
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Geometric mean titers of pneumococcal capsular polysaccharide antibody to the seven vaccine serotypes
Délai: 4-6 weeks following the third dose of PCV-7
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4-6 weeks following the third dose of PCV-7
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Pneumococcal capsular polysaccharide antibodies >=0.15 μg/ml and >=1.0 μg/ml, and geometric mean titers of antibody, to the seven vaccine serotypes in children completing the primary series, regardless of postnatal age
Délai: 4-6 weeks following the third dose of PCV-7
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4-6 weeks following the third dose of PCV-7
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Opsonization of 6B pneumococcal capsular polysaccharide plus 1 low immunogenicity, high prevalence serotype (e.g., 23F) among infants in the lowest quartile of antibody response
Délai: 4-6 weeks following the third dose of PCV-7
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4-6 weeks following the third dose of PCV-7
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Effect of possible mediating variables on the achievement of levels of serotype 6B pneumococcal capsular polysaccharide antibody >=0.15 μg/ml
Délai: 4-6 weeks following the third dose of PCV-7
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4-6 weeks following the third dose of PCV-7
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Effect of pneumococcal conjugate immunization status (complete & timely v. complete v. incomplete) on outcome (survival, serious infection, neurodevelopmental outcome) at 18-22 months corrected age in infants <=1000g
Délai: 18-22 months corrected age
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18-22 months corrected age
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Levels of antibody >=0.15 μg/ml and >=1.0 μg/ml to Hib polyribosylribitol
Délai: 4-6 weeks following the third dose of PCV-7
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4-6 weeks following the third dose of PCV-7
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Avidity of antibody to Hib-PRP among infants in the lowest quartile of antibody response,regardless of postnatal or gestational age
Délai: 4-6 weeks following the third dose of PCV-7
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4-6 weeks following the third dose of PCV-7
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Shahnaz Duara, MD, University of Miami
- Chercheur principal: Carl T. D'Angio, MD, University of Rochester
Publications et liens utiles
Publications générales
- D'Angio CT, Heyne RJ, O'Shea TM, Schelonka RL, Shankaran S, Duara S, Goldberg RN, Stoll BJ, Van Meurs KP, Vohr BR, Das A, Li L, Burton RL, Hastings B, Phelps DL, Sanchez PJ, Carlo WA, Stevenson DK, Higgins RD; NICHD Neonatal Research Network. Heptavalent pneumococcal conjugate vaccine immunogenicity in very-low-birth-weight, premature infants. Pediatr Infect Dis J. 2010 Jul;29(7):600-6. doi: 10.1097/INF.0b013e3181d264a6.
- Wynn JL, Li L, Cotten CM, Phelps DL, Shankaran S, Goldberg RN, Carlo WA, Van Meurs K, Das A, Vohr BR, Higgins RD, Stoll BJ, D'Angio CT. Blood stream infection is associated with altered heptavalent pneumococcal conjugate vaccine immune responses in very low birth weight infants. J Perinatol. 2013 Aug;33(8):613-8. doi: 10.1038/jp.2013.5. Epub 2013 Jan 31.
- Ang JY, Lua JL, Asmar BI, Shankaran S, Heyne RJ, Schelonka RL, Das A, Li L, Jackson DM, Higgins RD, D'Angio CT; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Nasopharyngeal carriage of Streptococcus pneumoniae in very low-birth-weight infants after administration of heptavalent pneumococcal conjugate vaccine. Arch Pediatr Adolesc Med. 2010 Dec;164(12):1173-5. doi: 10.1001/archpediatrics.2010.233. No abstract available.
- D'Angio CT, Murray TE, Li L, Heyne RJ, O'Shea TM, Schelonka RL, Shankaran S, Duara S, Goldberg RN, Stoll BJ, Stevenson DK, Vohr BR, Phelps DL, Carlo WA, Pichichero ME, Das A, Higgins RD; NICHD Neonatal Research Network. Immunogenicity of Haemophilus influenzae type b protein conjugate vaccines in very low birth weight infants. Pediatr Infect Dis J. 2013 Dec;32(12):1400-2. doi: 10.1097/01.inf.0000437263.04493.7c. No abstract available.
Liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
- Vaccins antipneumococciques
- Immunogénicité
- Prématurité
- Vaccins, Conjugué
- Réponse vaccinale
- Réseau de recherche néonatale du NICHD
- Très faible poids à la naissance (TFPN)
- Poids de naissance extrêmement faible (ELBW)
- Heptavalent pneumococcal conjugate vaccine (PCV-7)
- pneumococcal polysaccharide, type 6B
- Pneumococcal polysaccharide, type 14
- Pneumococcal polysaccharide, type 19F,
- Pneumococcal polysaccharide, 23F
- Pneumococcal polysaccharide, 18C
- Pneumococcal polysaccharide, 4
- Pneumococcal polysaccharide, 9V
Termes MeSH pertinents supplémentaires
- Infections
- Infections des voies respiratoires
- Maladies des voies respiratoires
- Pneumonie
- Maladies pulmonaires
- Poids
- Infections bactériennes
- Infections bactériennes et mycoses
- Infections streptococciques
- Infections bactériennes à Gram positif
- Pneumonie bactérienne
- Infections pneumococciques
- Pneumonie, pneumocoque
- Poids à la naissance
Autres numéros d'identification d'étude
- NICHD-NRN-0031
- M01RR000633 (Subvention/contrat des NIH des États-Unis)
- UL1RR024982 (Subvention/contrat des NIH des États-Unis)
- U10HD021385 (Subvention/contrat des NIH des États-Unis)
- U10HD027851 (Subvention/contrat des NIH des États-Unis)
- U10HD027880 (Subvention/contrat des NIH des États-Unis)
- U10HD034216 (Subvention/contrat des NIH des États-Unis)
- U10HD040492 (Subvention/contrat des NIH des États-Unis)
- U10HD040689 (Subvention/contrat des NIH des États-Unis)
- UL1RR025744 (Subvention/contrat des NIH des États-Unis)
- M01RR000070 (Subvention/contrat des NIH des États-Unis)
- U10HD021397 (Subvention/contrat des NIH des États-Unis)
- U10HD040498 (Subvention/contrat des NIH des États-Unis)
- U10HD040521 (Subvention/contrat des NIH des États-Unis)
- M01RR000032 (Subvention/contrat des NIH des États-Unis)
- M01RR000039 (Subvention/contrat des NIH des États-Unis)
- M01RR000044 (Subvention/contrat des NIH des États-Unis)
- M01RR007122 (Subvention/contrat des NIH des États-Unis)
- M01RR016587 (Subvention/contrat des NIH des États-Unis)
- UL1RR025777 (Subvention/contrat des NIH des États-Unis)
- UL1RR025008 (Subvention/contrat des NIH des États-Unis)
- M01RR000030 (Subvention/contrat des NIH des États-Unis)
- U01HD036790 (Subvention/contrat des NIH des États-Unis)
- UL1RR024160 (Subvention/contrat des NIH des États-Unis)
- UL1RR024128 (Subvention/contrat des NIH des États-Unis)
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur Infections pneumococciques
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Angela BiancoStryker NordicRésiliéCésarienne | Infection du site opératoire | Infection nosocomialeÉtats-Unis
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Cairo UniversityRecrutementInfection postopératoire | Complications de la césarienne | Infection vaginaleEgypte
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Gundersen Lutheran Medical FoundationGundersen Lutheran Health SystemComplétéInfection du site opératoire | Infection superficielle du site opératoire | Infection profonde du site chirurgical | Infection du site chirurgical d'un organe/de l'espaceÉtats-Unis
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Hospices Civils de LyonRecrutement