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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
immunology and microbiology
Safety, reactogenicity and immunogenicity of a booster dose of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in Malian children
Human Vaccines and Immunotherapeutics, Volume 9, No. 2, Year 2013
Notification
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Description
Background: Primary vaccination with the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) was previously shown to be immunogenic and well tolerated in Malian children. Data on booster vaccination with a fourth consecutive dose of PHiD-CV are available for Europe, Asia and Latin America but are lacking for Africa. The present study evaluated further the safety, reactogenicity and immunogenicity of a fourth consecutive (booster) dose of PHiD-CV. Results: Low incidences of AEs with grade 3 intensity (2.1% of subjects) were observed. There were no reports of large swelling reactions and serious adverse events. One month post-booster vaccination, for each vaccine pneumococcal serotype, at least 97.8% of subjects had antibody concentrations ≥ 0.2 μg/ml, and at least 97.1% of subjects had opsonophagocytic activity ≥ 8. From pre-to post-booster, a 12.3-fold increase in anti-protein D geometric mean concentration was observed. Methods: This phase III, open-label study was conducted in Ouelessebougou, c Mali, between November 2009 and June 2010. The study population consisted of Malian children previously primed (3 doses) with PHiD-CV in study NCT00678301 receiving a fourth consecutive (booster) dose of PHiD-CV in the second year of life. The incidences of adverse events (AEs) with grade 3 intensity (primary objective) or of any intensity (secondary objective), and the immunogenicity (secondary objective) of the PHiD-CV booster dose were assessed. Conclusion: A booster dose of PHiD-CV was well tolerated when administered to Malian children in the second year of life and was highly immunogenic for all 10 vaccine pneumococcal serotypes and NTHi protein D. (ClinicalTrials.gov identifier: NCT00985465). © 2012 Landes Bioscience.
Authors & Co-Authors
Dicko, Alassane A.
Mali, Bamako
University of Bamako
Santara, Gaoussou
Mali, Bamako
University of Bamako
Mahamar, Almahamoudou
Mali, Bamako
University of Bamako
Sidibé, Youssoufa
Mali, Bamako
University of Bamako
Barry, Amadou
Mali, Bamako
University of Bamako
Dicko, Yahia T.
Mali, Bamako
University of Bamako
Diallo, Aminata
Mali, Bamako
Centre Hospitalo-universitaire Gabriel Touré
Dolo, Amagana I.
Mali, Bamako
University of Bamako
Doumbo, Ogobara K.
Mali, Bamako
University of Bamako
Shafi, Fakrudeen
India, Mumbai
Glaxosmithkline Pharmaceuticals Ltd.
François, Nancy A.
Belgium, Wavre
Glaxosmithkline Pharmaceuticals Sa/nv
Strezova, Ana
Belgium, Wavre
Glaxosmithkline Pharmaceuticals Sa/nv
Borys, Dorota
Belgium, Wavre
Glaxosmithkline Pharmaceuticals Sa/nv
Schuerman, Lode M.
Belgium, Wavre
Glaxosmithkline Pharmaceuticals Sa/nv
Statistics
Citations: 14
Authors: 14
Affiliations: 4
Identifiers
Doi:
10.4161/hv.22692
ISSN:
21645515
e-ISSN:
2164554X
Research Areas
Maternal And Child Health
Study Design
Cross Sectional Study
Study Locations
Mali