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Blood, 15 March 2007, Vol. 109, No. 6, pp. 2322-2326.
Prepublished online as a Blood First Edition Paper on November 7, 2006; DOI 10.1182/blood-2006-06-032284.


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CLINICAL TRIALS AND OBSERVATIONS

Brief Report

Pneumococcal conjugate vaccine provides early protective antibody responses in children after related and unrelated allogeneic hematopoietic stem cell transplantation

Roland Meisel1,2, Lisa Kuypers1, Uta Dirksen1,2, Ralf Schubert3, Bernd Gruhn4, Gabriele Strauss5, Karin Beutel6, Andreas H. Groll7, Ulrich Duffner8, Renate Blütters-Sawatzki9, Wolfgang Holter10, Tobias Feuchtinger11, Hans-Peter Grüttner12, Horst Schroten13, Stefan Zielen3, Christian Ohmann2, Hans-Jürgen Laws1, Dagmar Dilloo1, for the Impfung von Kindern nach allogener Stammzelltransplantation (IKAST) Study Group

1 Clinic for Pediatric Oncology, Hematology and Immunology, University Children's Hospital, Heinrich Heine-University, Düsseldorf, Germany; 2 Coordination Centre for Clinical Trials, University Clinic of Düsseldorf, Düsseldorf, Germany; 3 Department of Pediatric Pneumology/Allergology, University Children's Hospital, J.W. Goethe-University, Frankfurt, Germany; 4 University Children's Hospital, Friedrich Schiller-University, Jena, Germany; 5 Department of Pediatrics, Charité, Campus Virchow Klinikum, Berlin, Germany; 6 Department of Pediatric Hematology and Oncology, University Children's Hospital, Hamburg, Germany; 7 Infectious Disease Research Program, Department of Pediatric Hematology and Oncology, University Children's Hospital, Münster, Germany; 8 Division of Pediatric Hematology and Oncology, Department of Pediatrics and Adolescent Medicine, University Hospital of Freiburg, Germany; 9 Department of Pediatric Hematology and Oncology, University Children's Hospital, Justus Liebig-University, Giessen, Germany; 10 University Children's Hospital, Friedrich Alexander-University Erlangen-Nürnberg, Erlangen, Germany; 11 Department of Pediatric Hematology and Oncology, University Children's Hospital, Tübingen, Germany; 12 Department of Pediatric Hematology and Oncology, University Children's Hospital, J. W. Goethe-University, Frankfurt, Germany; 13 Pediatric Infectious Diseases, Department of General Pediatrics, University Children's Hospital, Heinrich Heine-University, Düsseldorf, Germany

Following allogeneic hematopoietic stem cell transplantation (alloHSCT), children are at risk of life-threatening pneumococcal infections. Whereas vaccination with polysaccharide vaccines fails to elicit protective immunity in most alloHSC transplant recipients, pneumococcal conjugate vaccines may effectively prevent invasive disease by eliciting T-cell–dependent antibody responses. Here, we report safety and immunogenicity in 53 children immunized with a regimen of 3 consecutive doses of a heptavalent pneumococcal conjugate vaccine (7vPCV) in monthly intervals starting 6 to 9 months after alloHSCT. Immunization was well tolerated with no vaccine-related serious adverse events. Serologic response rates evaluable in 43 patients ranged from 41.9% to 86.0% and 58.1% to 93.0% after 2 and 3 vaccinations, respectively, with 55.8% and 74.4% of patients achieving protective antibody levels to all 7 vaccine serotypes. Our study provides the first evidence that vaccination with 7vPCV is safe and elicits protective antipneumococcal antibody responses in pediatric recipients of related or unrelated donor alloHSC transplants within the first year following transplantation. This trial was registered at www.clinicaltrials.gov as NCT00169728 [ClinicalTrials.gov] .


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