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Schedules for pneumococcal vaccination of preterm infants: an RCT

Schedules for pneumococcal vaccination of preterm infants: an RCT
Schedules for pneumococcal vaccination of preterm infants: an RCT
BACKGROUND AND OBJECTIVE: Premature infants have a higher risk of invasive pneumococcal disease and are more likely to have lower vaccine responses compared with term infants. Increasingly, immunization schedules are including a reduced, 2-dose, pneumococcal conjugate vaccine priming schedule. Our goal was to assess the immunogenicity of 3 commonly used 13-valent pneumococcal conjugate vaccine (PCV13) priming schedules in premature infants and their response to a 12-month booster dose. METHODS: Premature infants (<35 weeks’ gestation) were randomized to receive PCV13 at 2 and 4 months (reduced schedule); 2, 3, and 4 months (accelerated schedule); or 2, 4, and 6 months (extended schedule). All infants received a 12-month PCV13 booster. Serotype-specific pneumococcal immunoglobulin G (IgG) for PCV13 serotypes was measured by using enzyme-linked immunosorbent assay 1 month after the primary and booster vaccinations. RESULTS: A total of 210 infants (median birth gestation, 29+6 weeks; range, 23+2–34+6 weeks) were included. After the primary vaccination, 75% (95% confidence interval [CI], 62–85), 88% (95% CI, 76–95), and 97% (95% CI, 87–99) of participants had protective antibody concentrations for at least one-half the PCV13 serotypes for the reduced, accelerated, and extended schedules, respectively. After the booster vaccination, participants receiving the extended schedule had significantly lower (P < .05) geometric mean concentrations compared with reduced (for 9 of 13 serotypes) and accelerated (for 4 of 13 serotypes) schedules, but nearly all participations, regardless of schedule or serotype, had seroprotective IgG concentrations. CONCLUSIONS: A reduced priming schedule of PCV13 resulted in higher post-booster IgG concentrations but lower post-primary concentrations. The optimum vaccine schedule for preterm infants will therefore depend on when they are most at risk for invasive pneumococcal disease.
0031-4005
1-13
Kent, Alison
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Ladhani, Shamez
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Andrews, Nick
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Scorrer, Tim
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Pollard, Andrew
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Clarke, Paul
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Hughes, Stephen
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Heal, Carrie
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Menson, Esse
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Chang, John
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Satodia, Prakash
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Collinson, Andrew
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Faust, Saul
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Kent, Alison
80be00a5-48bc-4139-85b4-ec863b6d3f02
Ladhani, Shamez
b359e7e2-44f2-4b97-8a2c-54333217cab3
Andrews, Nick
7d63cec1-f343-4e37-83b3-8f80e4022ed4
Scorrer, Tim
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Pollard, Andrew
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Clarke, Paul
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Hughes, Stephen
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Heal, Carrie
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Menson, Esse
316577d2-4c28-43e8-8dba-9f1da95fb41f
Chang, John
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Satodia, Prakash
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Collinson, Andrew
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Faust, Saul
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Kent, Alison, Ladhani, Shamez, Andrews, Nick, Scorrer, Tim, Pollard, Andrew, Clarke, Paul, Hughes, Stephen, Heal, Carrie, Menson, Esse, Chang, John, Satodia, Prakash, Collinson, Andrew and Faust, Saul (2016) Schedules for pneumococcal vaccination of preterm infants: an RCT. Pediatrics, 138 (3), 1-13, [e20153945]. (doi:10.1542/peds.2015-3945).

Record type: Article

Abstract

BACKGROUND AND OBJECTIVE: Premature infants have a higher risk of invasive pneumococcal disease and are more likely to have lower vaccine responses compared with term infants. Increasingly, immunization schedules are including a reduced, 2-dose, pneumococcal conjugate vaccine priming schedule. Our goal was to assess the immunogenicity of 3 commonly used 13-valent pneumococcal conjugate vaccine (PCV13) priming schedules in premature infants and their response to a 12-month booster dose. METHODS: Premature infants (<35 weeks’ gestation) were randomized to receive PCV13 at 2 and 4 months (reduced schedule); 2, 3, and 4 months (accelerated schedule); or 2, 4, and 6 months (extended schedule). All infants received a 12-month PCV13 booster. Serotype-specific pneumococcal immunoglobulin G (IgG) for PCV13 serotypes was measured by using enzyme-linked immunosorbent assay 1 month after the primary and booster vaccinations. RESULTS: A total of 210 infants (median birth gestation, 29+6 weeks; range, 23+2–34+6 weeks) were included. After the primary vaccination, 75% (95% confidence interval [CI], 62–85), 88% (95% CI, 76–95), and 97% (95% CI, 87–99) of participants had protective antibody concentrations for at least one-half the PCV13 serotypes for the reduced, accelerated, and extended schedules, respectively. After the booster vaccination, participants receiving the extended schedule had significantly lower (P < .05) geometric mean concentrations compared with reduced (for 9 of 13 serotypes) and accelerated (for 4 of 13 serotypes) schedules, but nearly all participations, regardless of schedule or serotype, had seroprotective IgG concentrations. CONCLUSIONS: A reduced priming schedule of PCV13 resulted in higher post-booster IgG concentrations but lower post-primary concentrations. The optimum vaccine schedule for preterm infants will therefore depend on when they are most at risk for invasive pneumococcal disease.

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Accepted/In Press date: 27 May 2016
e-pub ahead of print date: 8 August 2016
Published date: September 2016
Organisations: Faculty of Medicine

Identifiers

Local EPrints ID: 396173
URI: http://eprints.soton.ac.uk/id/eprint/396173
ISSN: 0031-4005
PURE UUID: 1cefabbc-88ac-454d-8a40-dcac5d79d76e
ORCID for Saul Faust: ORCID iD orcid.org/0000-0003-3410-7642

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Date deposited: 13 Jun 2016 08:20
Last modified: 18 Feb 2021 17:07

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Contributors

Author: Alison Kent
Author: Shamez Ladhani
Author: Nick Andrews
Author: Tim Scorrer
Author: Andrew Pollard
Author: Paul Clarke
Author: Stephen Hughes
Author: Carrie Heal
Author: Esse Menson
Author: John Chang
Author: Prakash Satodia
Author: Andrew Collinson
Author: Saul Faust ORCID iD

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