Document Detail


A new approach to estimate vaccine efficacy based on immunogenicity data applied to influenza vaccines administered by the intradermal or intramuscular routes.
MedLine Citation:
PMID:  20930559     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Despite their pivotal role in the assessment of influenza vaccines, limited attempts have been made to use haemagglutination inhibition (HI) titers for predicting vaccine efficacy against laboratory-confirmed influenza. We present here the second step of a two-step approach allowing performing such predictions and use it to compare a new trivalent inactivated influenza vaccine administered by the intradermal (ID) route (INTANZA® /IDFlu®) with the vaccine administered by the classical intramuscular (IM) route.
METHODS: The first step corresponding to the estimation of the level of protection against laboratory-confirmed influenza that can be linked to each HI titer, referred to as the HI protection curve, was achieved by using a meta-analytical approach based on published information. Vaccine efficacy and differences in vaccine efficacy are predicted in a second step using this HI protection curve alongside the results of two randomized clinical trials providing comparative information on the immunogenicity of trivalent inactivated influenza vaccines administered ID or IM in 3503 & 1645 elderly participants, respectively.
RESULTS: Pooling all available immunogenicity data, the predicted vaccine efficacy was 63.3% [CI: 58.1; 68.7] for ID route and 54.4% [CI: 49.4; 59.2] for IM route. The corresponding relative increase in efficacy that is of 16.5% [CI: 12.7; 20.1]. Predicted vaccine efficacies decreased with age for both vaccines, but the decrease was less marked by ID route: the relative increase in efficacy for subjects aged 70 years and above is of 18.0% [CI:12;24].
CONCLUSION: The analysis performed confirmed that the superior immune response provided by the vaccine using the ID route should translate into a higher vaccine efficacy against laboratory-confirmed influenza.
Authors:
Laurent Coudeville; Philippe Andre; Fabrice Bailleux; Françoise Weber; Stanley Plotkin
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Publication Detail:
Type:  Journal Article     Date:  2010-10-01
Journal Detail:
Title:  Human vaccines     Volume:  6     ISSN:  1554-8619     ISO Abbreviation:  Hum Vaccin     Publication Date:  2010 Oct 
Date Detail:
Created Date:  2011-03-04     Completed Date:  2011-06-14     Revised Date:  2013-07-03    
Medline Journal Info:
Nlm Unique ID:  101265291     Medline TA:  Hum Vaccin     Country:  United States    
Other Details:
Languages:  eng     Pagination:  841-8     Citation Subset:  IM    
Affiliation:
Sanofi Pasteur, Lyon, France. laurent.coudeville@sanofipasteur.com
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MeSH Terms
Descriptor/Qualifier:
Aged
Aged, 80 and over
Antibodies, Viral / blood*
Clinical Laboratory Techniques / methods*
Dose-Response Relationship, Immunologic
Female
Hemagglutination Inhibition Tests
Humans
Influenza Vaccines / administration & dosage,  immunology*
Influenza, Human / prevention & control*
Injections, Intradermal
Injections, Intramuscular
Male
Middle Aged
Randomized Controlled Trials as Topic
Vaccines, Inactivated / administration & dosage,  immunology
Chemical
Reg. No./Substance:
0/Antibodies, Viral; 0/Influenza Vaccines; 0/Vaccines, Inactivated
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