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Proposal 1277

Title of the Proposed Research

Immunotherapy trial simulators: Using mathematical, computational and statistical techniques to simulate trial design for new products in the treatment, vaccination and immunoprophylaxis of disease.

Lead Researcher

Roy Anderson

Affiliation

Imperial College
London

Funding Source

The research project is fully supported by Crucell Vaccine Institute (CVI), the Netherlands. They are now known as the Janssen Prevention Centre.

Potential Conflicts of Interest

Independent Non-Executive Director for GSK

Data Sharing Agreement Date

18 May 2016

Lay Summary

Background of the Project

Influenza A infection has a huge impact on human health; the WHO estimates that annual epidemics result in around 3-5 million cases of severe illness, and 250-500,000 deaths. The Influenza virus mutates frequently, meaning drugs and vaccines have a limited lifespan and development of new treatment and vaccines is necessary. Mathematical models can aid our understanding of disease progression and can therefore help in the design of drugs, vaccines and immunotherapies. In addition, simulating clinical trials can help predict outcomes of novel therapy and make the trials more productive for researchers and less intrusive for patients. Sophisticated computational models of the immune response to Influenza can predict various things such as; when to administer treatment, what samples need to be collected, what needs to be measured and how many people must be tested to prove an effect.

Aim and Objectives

The aim of our research project is to design a clinical trial simulator, to examine new vaccines and immunotherapy approaches against Influenza A infection. We will develop deterministic and stochastic mathematical models of the time course of Influenza within the human host and the associated immune response. The aim is to keep these models as simple and tractable as possible and only to include the essential features that characterise the immune response to influenza. To reliably identify these features we will need access to high-quality human data. Once the essential features have been identified we will introduce potential immunomodulatory treatments into the model to predict their effects.

Integral to the development of these model simulators will be the construction of databases for Influenza A. The goal is to collect the best cohort studies from around the world to be able to include reliable data on both the progression and incidence of Influenza A. The compilation of these databases themselves is a valuable exercise, rarely attempted in clinical studies

Study Data Provided

Study ROCHE-WV15670: A double-blind, randomized, placebo-controlled study of oral Ro 64-0796 (GS4104) in the treatment of influenza infection
Study ROCHE-WV15671: A double-blind, randomized, placebo controlled study of GS4104 (Ro 64-0796) in the treatment of influenza infection
Study ROCHE-WV15730: A double blind,randomised, placebo controlled study of Ro 64-0796 (also known as GS4104) in the treatment of influenza infection
Study ROCHE-WV15707 : A double-blind, stratified, randomized, placebo controlled study of Ro 64-0796 (GS4104) in the treatment of influenza infection in elderly adults
Study ROCHE-WV15819: A double-blind, randomized, stratified, placebo controlled study of Ro 64-0796 (also known as GS4104) in the treatment of influenza infection in elderly patients
Study ROCHE-WV16277: A double-blind, randomized, stratified, placebo-controlled study of oseltamivir in the treatment of influenza infection in patients
Study ROCHE-WV16193: A randomized, open-label, parallel group study of oseltamivir used for management of influenza in households.
Study ROCHE-NV25118: A Multicenter Study of the Safety of Oseltamivir Administered Intravenously for the Treatment of Influenza in Patients Aged Greater than or Equal to 13 Years.
Study ROCHE-WV15758: A double-blind, randomized, stratified, placebo-controlled study of Ro 64-0796 (also known as GS4104) in children with influenza.
Study ROCHE-PV15615: Safety, tolerability and activity of oral Ro 64-0796 (GS4104) for prophylaxis against experimental inoculation with human influenza virus
Study ROCHE-PV15616: Safety, Tolerability and Activity of oral GS 4104 (Ro 64-0796) in Treatment of Subjects experimentally Inoculated with Human Influenza Virus

Statistical Analysis Plan

Publication Citation

The publication citation will be added after the research is published.

Summary Results

Results summary or link will be posted when available.