BACKGROUND:Pneumococcal conjugate vaccine (PCV) was introduced in the United Kingdom immunization schedule in September 2006. This study was conducted to establish the immunogenicity of licensed PCV (Prevenar) at a reduced, 2 priming dose schedule (2+1) and to evaluate functional responses in the context of vaccine effectiveness. METHODS: Infants were randomized to receive PCV at 2 and 3 months or 2 and 4 months of age. Boosters were administered at the same time as Haemophilus influenzae type B/meningococcal C conjugate and Measles, Mumps and Rubella or with Measles, Mumps and Rubella alone (www.ClinicalTrials.gov NCT00197808). RESULTS:PCV at 2/3 months of age was poorly immunogenic and recruitment to this arm was terminated. PCV at 2/4 months of age resulted in lower than expected responses to serotypes 6B and 23F. Functional analysis of serotype 6B by OPA revealed that an enzyme-linked immunosorbent assay cutoff of 0.2 microg/mL was a better predictor of OPA positivity than a cut off of 0.35 microg/mL. PCV booster responses were excellent and no interference from concomitant vaccines was noted. CONCLUSIONS: An interval of at least 8 weeks is required when starting PCV vaccination at 2 months of age although not all serotypes are equally immunogenic. Correlates of protection derived from enzyme-linked immunosorbent assay values may not be equally appropriate for all serotypes as illustrated by results for 6B in this study.
RCT Entities:
BACKGROUND:Pneumococcal conjugate vaccine (PCV) was introduced in the United Kingdom immunization schedule in September 2006. This study was conducted to establish the immunogenicity of licensed PCV (Prevenar) at a reduced, 2 priming dose schedule (2+1) and to evaluate functional responses in the context of vaccine effectiveness. METHODS:Infants were randomized to receive PCV at 2 and 3 months or 2 and 4 months of age. Boosters were administered at the same time as Haemophilus influenzae type B/meningococcal C conjugate and Measles, Mumps and Rubella or with Measles, Mumps and Rubella alone (www.ClinicalTrials.gov NCT00197808). RESULTS: PCV at 2/3 months of age was poorly immunogenic and recruitment to this arm was terminated. PCV at 2/4 months of age resulted in lower than expected responses to serotypes 6B and 23F. Functional analysis of serotype 6B by OPA revealed that an enzyme-linked immunosorbent assay cutoff of 0.2 microg/mL was a better predictor of OPA positivity than a cut off of 0.35 microg/mL. PCV booster responses were excellent and no interference from concomitant vaccines was noted. CONCLUSIONS: An interval of at least 8 weeks is required when starting PCV vaccination at 2 months of age although not all serotypes are equally immunogenic. Correlates of protection derived from enzyme-linked immunosorbent assay values may not be equally appropriate for all serotypes as illustrated by results for 6B in this study.
Authors: Paul V Licciardi; Anne Balloch; Fiona M Russell; Robert L Burton; Jisheng Lin; Moon H Nahm; Edward K Mulholland; Mimi L K Tang Journal: J Allergy Clin Immunol Date: 2012-02-02 Impact factor: 10.793
Authors: F M Russell; J R Carapetis; R L Burton; J Lin; P V Licciardi; A Balloch; L Tikoduadua; L Waqatakirewa; Y B Cheung; M L K Tang; M H Nahm; E K Mulholland Journal: Vaccine Date: 2010-10-31 Impact factor: 3.641
Authors: Elizabeth Miller; Nick Andrews; Pauline Waight; Helen Findlow; Lindsey Ashton; Anna England; Elaine Stanford; Mary Matheson; Joanna Southern; Elizabeth Sheasby; David Goldblatt; Ray Borrow Journal: Clin Vaccine Immunol Date: 2010-12-29
Authors: Tolulope A Adebanjo; Tracy Pondo; David Yankey; Holly A Hill; Ryan Gierke; Mirasol Apostol; Meghan Barnes; Susan Petit; Monica Farley; Lee H Harrison; Corinne Holtzman; Joan Baumbach; Nancy Bennett; Suzanne McGuire; Ann Thomas; William Schaffner; Bernard Beall; Cynthia G Whitney; Tamara Pilishvili Journal: Pediatrics Date: 2020-02-13 Impact factor: 7.124
Authors: Shabir A Madhi; Alane Izu; Avye Violari; Mark F Cotton; Ravindre Panchia; Els Dobbels; Poonam Sewraj; Nadia van Niekerk; Patrick Jean-Philippe; Peter V Adrian Journal: Vaccine Date: 2012-12-08 Impact factor: 3.641