A multi-criteria decision making approach to identify a vaccine formulation

J Biopharm Stat. 2016;26(2):352-64. doi: 10.1080/10543406.2015.1008517. Epub 2015 Jan 23.

Abstract

This article illustrates the use of a multi-criteria decision making approach, based on desirability functions, to identify an appropriate adjuvant composition for an influenza vaccine to be used in elderly. The proposed adjuvant system contained two main elements: monophosphoryl lipid and α-tocopherol with squalene in an oil/water emulsion. The objective was to elicit a stronger immune response while maintaining an acceptable reactogenicity and safety profile. The study design, the statistical models, the choice of the desirability functions, the computation of the overall desirability index, and the assessment of the robustness of the ranking are all detailed in this manuscript.

Keywords: Desirability index; formulation; multi-criteria decision-making approach; optimization; vaccine.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adjuvants, Immunologic / administration & dosage
  • Adjuvants, Immunologic / adverse effects
  • Adjuvants, Immunologic / chemistry*
  • Aged
  • Clinical Trials, Phase II as Topic* / methods
  • Clinical Trials, Phase II as Topic* / statistics & numerical data
  • Decision Making*
  • Dose-Response Relationship, Drug
  • Drug Compounding / statistics & numerical data
  • Endpoint Determination
  • Humans
  • Influenza Vaccines / administration & dosage
  • Influenza Vaccines / adverse effects
  • Influenza Vaccines / chemistry*
  • Influenza Vaccines / immunology*
  • Influenza, Human / immunology
  • Influenza, Human / prevention & control
  • Models, Statistical*
  • Research Design / statistics & numerical data

Substances

  • Adjuvants, Immunologic
  • Influenza Vaccines