Comparative Immunogenicity and Efficacy of 13-Valent and 7-Valent Pneumococcal Conjugate Vaccines in Reducing Nasopharyngeal Colonization: A Randomized Double-Blind Trial
Open Access
- 26 June 2013
- journal article
- research article
- Published by Oxford University Press (OUP) in Clinical Infectious Diseases
- Vol. 57 (7), 952-962
- https://doi.org/10.1093/cid/cit428
Abstract
Background. The 13-valent pneumococcal conjugate vaccine (PCV13) was licensed to replace the 7-valent pneumococcal conjugate vaccine (PCV7) based on serological noninferiority criteria. To date no randomized PCV13 pediatric trial has included clinical endpoints. Methods. This randomized double-blind trial compared the impact of PCV13 versus PCV7 on nasopharyngeal (NP) colonization and immunogenicity. Healthy infants were randomized (1:1) to receive PCV7 or PCV13 at ages 2, 4, 6, and 12 months; NP swabs were collected at 2, 4, 6, 7, 12, 13, 18, and 24 months, and blood was drawn at 7 and 13 months. Rates of NP acquisition and prevalence, and serotype-specific immunoglobulin G (IgG) concentrations were assessed. Results. The per protocol analysis population included 881 PCV13 and 873 PCV7 recipients. PCV13 significantly reduced NP acquisition of the additional PCV13 serotypes 1, 6A, 7F, and 19A; the cross-reacting serotype 6C; and the common PCV7 serotype 19F. For serotype 3, and the other PCV7 serotypes, there were no significant differences between the vaccine groups. There were too few serotype 5 events to draw inference. The impact on prevalence at predefined time points was similar to that observed with NP acquisition. PCV13 elicited significantly higher IgG responses for PCV13 additional serotypes and serotype 19F, and similar or lower responses for 6/7 PCV7 serotypes. Conclusions. PCV13 resulted in lower acquisition and prevalence of NP colonization than PCV7 did for 4 additional PCV13 serotypes, and serotypes 6C and 19F. It was comparable with PCV7 for all other common serotypes. These findings predict vaccine effectiveness through both direct and indirect protection. Clinical Trials Registration. NCT00508742.Keywords
This publication has 19 references indexed in Scilit:
- The fundamental link between pneumococcal carriage and diseaseExpert Review of Vaccines, 2012
- Serotype replacement in disease after pneumococcal vaccinationThe Lancet, 2011
- Systematic Evaluation of Serotypes Causing Invasive Pneumococcal Disease among Children Under Five: The Pneumococcal Global Serotype ProjectPLoS Medicine, 2010
- Increasing Importance of Multidrug-Resistant Serotype 6A Streptococcus pneumoniae Clones in Acute Otitis Media in Southern IsraelThe Pediatric Infectious Disease Journal, 2010
- Estimation of vaccine efficacy against acquisition of pneumococcal carriageVaccine, 2009
- Emergence ofStreptococcus pneumoniaeSerotypes 19A, 6C, and 22F and Serogroup 15 in Cleveland, Ohio, in Relation to Introduction of the Protein‐Conjugated Pneumococcal VaccineClinical Infectious Diseases, 2008
- Discovery of a New Capsular Serotype (6C) within Serogroup 6 ofStreptococcus pneumoniaeJournal of Clinical Microbiology, 2007
- Serum Serotype‐Specific Pneumococcal Anticapsular Immunoglobulin G Concentrations after Immunization with a 9‐Valent Conjugate Pneumococcal Vaccine Correlate with Nasopharyngeal Acquisition of PneumococcusThe Journal of Infectious Diseases, 2005
- Assignment of Weight-Based Antibody Units for 13 Serotypes to a Human Antipneumococcal Standard Reference Serum, Lot 89-S(F)Clinical and Vaccine Immunology, 2004
- 3. The Quellung Reaction: A Neglected Microbiologic TechniquePublished by University of Pennsylvania Press ,1985