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Immunogenicity of PCV-7 Vaccine in VLBW Infants (PCV-7)

20 maart 2019 bijgewerkt door: NICHD Neonatal Research Network

Observational Study of the Immunogenicity of Heptavalent Pneumococcal Conjugate Vaccine in Very-low-birth-weight Infants

Premature infants are at a high risk for pneumonia. The PCV-7 vaccine effectively prevents the invasive disease from Streptococcus pneumoniae in full-term infants, but was not thoroughly studied in premature infants. This study evaluated the effectiveness and safety of the vaccine given in routine practice to very low birth weight infants, looking at blood antibody levels 4-6 weeks after the final vaccine dose, and adverse events, survival, infections, and neurodevelopmental outcomes at 18-22 months corrected age.

Studie Overzicht

Toestand

Voltooid

Conditie

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Werkelijk)

368

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

Verenigde Staten
- Alabama
  - Birmingham, Alabama, Verenigde Staten, 35233
    - University of Alabama at Birmingham
- California
  - Palo Alto, California, Verenigde Staten, 94304
    - Stanford University
- Florida
  - Miami, Florida, Verenigde Staten, 33136
    - University of Miami
- Georgia
  - Atlanta, Georgia, Verenigde Staten, 30303
    - Emory University
- Michigan
  - Detroit, Michigan, Verenigde Staten, 48201
    - Wayne State University
- New York
  - Rochester, New York, Verenigde Staten, 14642
    - University of Rochester
- North Carolina
  - Charlotte, North Carolina, Verenigde Staten, 27157
    - Wake Forest University
  - Durham, North Carolina, Verenigde Staten, 27710
    - Duke University
  - Durham, North Carolina, Verenigde Staten, 27705
    - RTI International
- Texas
  - Dallas, Texas, Verenigde Staten, 75235
    - University of Texas Southwestern Medical Center at Dallas

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

Niet ouder dan 3 maanden (Kind)

Accepteert gezonde vrijwilligers

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

Infants <1,500g birth weight who receive the 3-dose primary series of PCV-7 immunization by 3 months and complete it by 8 months postnatal age

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat	Tijdsspanne
Serotype 6B pneumococcal capsular polysaccharide antibody >=0.15 μg/ml Tijdsspanne: 4-6 weeks following the third dose of PCV-7	4-6 weeks following the third dose of PCV-7

Secundaire uitkomstmaten

Uitkomstmaat	Tijdsspanne
Pneumococcal capsular polysaccharide antibody >=0.15 μg/ml for the other six vaccine serotypes Tijdsspanne: 4-6 weeks following the third dose of PCV-7	4-6 weeks following the third dose of PCV-7
Pneumococcal capsular polysaccharide antibodies >=1.0 μg/ml for all seven vaccine serotypes Tijdsspanne: 4-6 weeks following the third dose of PCV-7	4-6 weeks following the third dose of PCV-7
Geometric mean titers of pneumococcal capsular polysaccharide antibody to the seven vaccine serotypes Tijdsspanne: 4-6 weeks following the third dose of PCV-7	4-6 weeks following the third dose of PCV-7
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 Tijdsspanne: 4-6 weeks following the third dose of PCV-7	4-6 weeks following the third dose of PCV-7
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 Tijdsspanne: 4-6 weeks following the third dose of PCV-7	4-6 weeks following the third dose of PCV-7
Effect of possible mediating variables on the achievement of levels of serotype 6B pneumococcal capsular polysaccharide antibody >=0.15 μg/ml Tijdsspanne: 4-6 weeks following the third dose of PCV-7	4-6 weeks following the third dose of PCV-7
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 Tijdsspanne: 18-22 months corrected age	18-22 months corrected age
Levels of antibody >=0.15 μg/ml and >=1.0 μg/ml to Hib polyribosylribitol Tijdsspanne: 4-6 weeks following the third dose of PCV-7	4-6 weeks following the third dose of PCV-7
Avidity of antibody to Hib-PRP among infants in the lowest quartile of antibody response,regardless of postnatal or gestational age Tijdsspanne: 4-6 weeks following the third dose of PCV-7	4-6 weeks following the third dose of PCV-7

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

NICHD Neonatal Research Network

Medewerkers

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

National Center for Research Resources (NCRR)

Onderzoekers

Hoofdonderzoeker: Shahnaz Duara, MD, University of Miami
Hoofdonderzoeker: Carl T. D'Angio, MD, University of Rochester

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Nuttige links

NICHD Neonatal Research Network

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 juli 2004

Primaire voltooiing (Werkelijk)

1 juli 2007

Studie voltooiing (Werkelijk)

1 maart 2009

Studieregistratiedata

Eerst ingediend

9 september 2005

Eerst ingediend dat voldeed aan de QC-criteria

5 januari 2006

Eerst geplaatst (Schatting)

9 januari 2006

Updates van studierecords

Laatste update geplaatst (Werkelijk)

22 maart 2019

Laatste update ingediend die voldeed aan QC-criteria

20 maart 2019

Laatst geverifieerd

1 maart 2019

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

NICHD-NRN-0031
M01RR000633 (Subsidie/contract van de Amerikaanse NIH)
UL1RR024982 (Subsidie/contract van de Amerikaanse NIH)
U10HD021385 (Subsidie/contract van de Amerikaanse NIH)
U10HD027851 (Subsidie/contract van de Amerikaanse NIH)
U10HD027880 (Subsidie/contract van de Amerikaanse NIH)
U10HD034216 (Subsidie/contract van de Amerikaanse NIH)
U10HD040492 (Subsidie/contract van de Amerikaanse NIH)
U10HD040689 (Subsidie/contract van de Amerikaanse NIH)
UL1RR025744 (Subsidie/contract van de Amerikaanse NIH)
M01RR000070 (Subsidie/contract van de Amerikaanse NIH)
U10HD021397 (Subsidie/contract van de Amerikaanse NIH)
U10HD040498 (Subsidie/contract van de Amerikaanse NIH)
U10HD040521 (Subsidie/contract van de Amerikaanse NIH)
M01RR000032 (Subsidie/contract van de Amerikaanse NIH)
M01RR000039 (Subsidie/contract van de Amerikaanse NIH)
M01RR000044 (Subsidie/contract van de Amerikaanse NIH)
M01RR007122 (Subsidie/contract van de Amerikaanse NIH)
M01RR016587 (Subsidie/contract van de Amerikaanse NIH)
UL1RR025777 (Subsidie/contract van de Amerikaanse NIH)
UL1RR025008 (Subsidie/contract van de Amerikaanse NIH)
M01RR000030 (Subsidie/contract van de Amerikaanse NIH)
U01HD036790 (Subsidie/contract van de Amerikaanse NIH)
UL1RR024160 (Subsidie/contract van de Amerikaanse NIH)
UL1RR024128 (Subsidie/contract van de Amerikaanse NIH)

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