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Workshop on the immunological basis of vaccine efficacy

Vaccine and Infectious Disease InstituteDecember 14, 2009

Ira M. Longini, Jr.Center for Statistical and Quantitative Infectious Diseases

(CSQUID)Vaccine and Infectious Disease Institute

Fred Hutchinson Cancer Research Center and

The University of WashingtonSeattle Washington

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The State of Vaccinology

• We need immune markers for vaccine protect against infection, disease and transmission.

• We need to predict vaccine efficacy and effectiveness as well as indirect effectiveness from immunogenicity data.

• Up until now, estimation of VE has been an empirical science based on phase III vaccine trials

3Guiding PrinciplesUp Until Now

• We only care if vaccines work• We don’t care how they work• Problems with this

– Need phase III trials for licensure• Sometimes immunological bridging works

– So far, we have failed to develop truly effective vaccines for complex infections and mutagenic agents, e.g.,

• Malaria• TB• HIV• Flu

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Solution

• Identify and quantify correlates of protection and surrogates of efficacy– Humoral (antibody) level– Cell mediated immunity

• Need within host models of the immune response coupled with transmission models

• Need phase III human trials where both immunological and clinical data available on same subjects

• Animal models

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Today’s Workshop

• Session I– Statistical Basics

• Session II - III– Immune memory and dynamics of the

immune response

• Session IV– T – cell based vaccines

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Tuesday Morning

• Informal discussion of workshop concepts

• 10 am - noon

• M5-C815 Arnold Building

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The End