Heptavalent pneumococcal conjugate vaccine immunogenicity in very-low-birth-weight, premature infants
Carl T D'Angio, Roy J Heyne, T Michael O'Shea, Robert L Schelonka, Seetha Shankaran, Shahnaz Duara, Ronald N Goldberg, Barbara J Stoll, Krisa P Van Meurs, Betty R Vohr, Abhik Das, Lei Li, Robert L Burton, Betty Hastings, Dale L Phelps, Pablo J Sanchez, Waldemar A Carlo, David K Stevenson, Rosemary D Higgins, NICHD Neonatal Research Network, Alan Jobe, Michael S Caplan, C Michael Cotten, Ricki F Goldstein, Kathy J Auten, Melody B Lohmeyer, Ira Adams-Chapman, W Kenneth Poole, Elizabeth McClure, Rebecca L Perritt, Steve Emrich, Kristin Zaterka-Baxter, Carolyn Petrie Huitema, Jamie E Newman, Scott E Schaefer, Jeanette O'Donnell Auman, Susan R Hintz, Maria Elena DeAnda, M Bethany Ball, Myriam Peralta-Carcelen, Monica V Collins, Shirley S Cosby, Vivien A Phillips, Moon H Nahm, Charles R Bauer, Ruth Everett-Thomas, Gary J Myers, Cassandra A Horihan, Rosemary L Jensen, Diane L Hust, Charles R Rosenfeld, Walid A Salhab, Janet S Morgan, Jackie F Hickman, Alicia Guzman, Nancy A Miller, Gaynelle Hensley, Robert G Dillard, Nancy J Peters, Debbie C Hiatt, Dia D Roberts, Yvette Johnson, Athina Pappas, Rebecca Bara, Geraldine Muran, Deborah Kennedy, Carl T D'Angio, Roy J Heyne, T Michael O'Shea, Robert L Schelonka, Seetha Shankaran, Shahnaz Duara, Ronald N Goldberg, Barbara J Stoll, Krisa P Van Meurs, Betty R Vohr, Abhik Das, Lei Li, Robert L Burton, Betty Hastings, Dale L Phelps, Pablo J Sanchez, Waldemar A Carlo, David K Stevenson, Rosemary D Higgins, NICHD Neonatal Research Network, Alan Jobe, Michael S Caplan, C Michael Cotten, Ricki F Goldstein, Kathy J Auten, Melody B Lohmeyer, Ira Adams-Chapman, W Kenneth Poole, Elizabeth McClure, Rebecca L Perritt, Steve Emrich, Kristin Zaterka-Baxter, Carolyn Petrie Huitema, Jamie E Newman, Scott E Schaefer, Jeanette O'Donnell Auman, Susan R Hintz, Maria Elena DeAnda, M Bethany Ball, Myriam Peralta-Carcelen, Monica V Collins, Shirley S Cosby, Vivien A Phillips, Moon H Nahm, Charles R Bauer, Ruth Everett-Thomas, Gary J Myers, Cassandra A Horihan, Rosemary L Jensen, Diane L Hust, Charles R Rosenfeld, Walid A Salhab, Janet S Morgan, Jackie F Hickman, Alicia Guzman, Nancy A Miller, Gaynelle Hensley, Robert G Dillard, Nancy J Peters, Debbie C Hiatt, Dia D Roberts, Yvette Johnson, Athina Pappas, Rebecca Bara, Geraldine Muran, Deborah Kennedy
Abstract
Background: The heptavalent pneumococcal CRM197 conjugate vaccine (PCV-7) has been incompletely studied in very-low-birth-weight (< or =1500 g) infants.
Objective: To assess PCV-7 immunogenicity in very-low-birth-weight, premature infants. We hypothesized that the frequency of postvaccine antibody concentrations > or =0.15 microg/mL would vary directly with birth weight.
Methods: This was a multicenter observational study. Infants 401 to 1500 g birth weight and <32 0/7 weeks gestation, stratified by birth weight, were enrolled from 9 National Institute of Child Health and Human Development Neonatal Research Network centers. Infants received PCV-7 at 2, 4, and 6 months after birth and had blood drawn 4 to 6 weeks following the third dose. Antibodies against the 7 vaccine serotypes were measured by enzyme-linked immunosorbent assay.
Results: Of 369 enrolled infants, 244 completed their primary vaccine series by 8 months and had serum obtained. Subjects were 27.8 +/- 2.2 (mean +/- standard deviation) weeks gestation and 1008 +/- 282 g birth weight. Twenty-six percent had bronchopulmonary dysplasia and 16% had received postnatal glucocorticoids. Infants 1001 to 1500 g birth weight were more likely than those 401 to 1000 g to achieve antibody concentrations > or =0.15 microg/mL against the least 2 immunogenic serotypes (6B: 96% vs. 85%, P = 0.003 and 23F: 97% vs. 88%, P = 0.009). In multiple logistic regression analysis, lower birth weight, postnatal glucocorticoid use, lower weight at blood draw, and Caucasian race were each independently associated with antibody concentrations <0.35 microg/mL against serotypes 6B and/or 23F.
Conclusions: When compared with larger premature infants, infants weighing < or =1000 g at birth have similar antibody responses to most, but not all, PCV-7 vaccine serotypes.
Trial registration: ClinicalTrials.gov NCT00273325.
Conflict of interest statement
All authors confirm that they made substantial contributions to the work, were involved in the drafting and/or reviewing of the article, and have approved the version to be published. No author has a relevant financial interest or other conflict of interest as regards this research.
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Source: PubMed