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Antibody response to primary and booster immunization in infants born to mothers immunized with pertussis-containing vaccines during pregnancy versus unimmunized women: a systematic review and meta-analysis
Proposal
11280
Title of Proposed Research
Antibody response to primary and booster immunization in infants born to mothers immunized with pertussis-containing vaccines during pregnancy versus unimmunized women: a systematic review and meta-analysis
Lead Researcher
Dr. Manish Sadarangani
Affiliation
University of British Columbia, Canada
Funding Source
Potential Conflicts of Interest
Data Sharing Agreement Date
18 June 2020
Lay Summary
Background: Pertussis (or whooping cough) is a highly contagious respiratory illness caused by a type of bacteria called Bordetella pertussis. Despite high vaccination coverage against pertussis among children, there have been recent outbreaks of B. pertussis with accompanying morbidity and mortality. Infants during their first months of life have the highest rates of laboratory confirmed pertussis cases and nearly all fatalities occur in infants younger than three months of age. In an attempt to protect infants too young to be vaccinated and those who have not yet completed their primary immunization series, antenatal immunization against pertussis have been implemented. Immunization during pregnancy has the potential to curtail infectious disease morbidity and mortality of pregnant women and their offspring by reducing the risk of transmission of infectious pathogens and enhancing the transfer of vaccine-specific antibodies from the mother to her newborn. Immunization against pertussis during pregnancy is an increasingly accepted public health preventative strategy and is currently recommended in the United States, UK, Australia and other countries. There is controversy whether high maternally-derived antibody titers induced by antenatal immunization against pertussis can have a suppressive effect on infants' immune responses to their own immunizations. Immunization against pertussis is expected to be implemented in increasing number of countries; thus, the gaps in knowledge must be addressed to inform an evidence-based immunization program.This systematic review and individual participant data meta-analysis aims to fill this knowledge gap. This review will describe infants' active immune response to their own vaccination following their mothers' immunization with pertussis-containing vaccines during pregnancy. The objective of this study is to evaluate whether immunization against pertussis in pregnancy affects infants' immune responses to their own vaccines administered in infancy
Study Data Provided
[{ "PostingID": 19670, "Title": "GSK-117119", "Description": "Immunogenicity and safety study of GSK Biologicals’ Infanrix hexa at 2, 4 and 6 months of age in healthy infants" },{ "PostingID": 20275, "Title": "GSK-116945", "Description": "Immunogenicity and safety study of GSK Biologicals’ dTpa vaccine, Boostrix™ (263855) in pregnant women" },{ "PostingID": 20276, "Title": "GSK-201330", "Description": "Immunogenicity and safety study of GSK Biologicals’ combined diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated polio-virus and Haemophilus influenzae type b vaccine (Infanrix hexa™) (217744) in healthy infants born to mothers vaccinated with Boostrix™ during pregnancy or immediately post-delivery" }]
Statistical Analysis Plan
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