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Category: Work Related

Bench to Clinic Roadmap

From The Global HIV Vaccine Enterprise

Taking new vaccines into a phase I study requires comprehensive knowledge of a large number of issues in various areas and an understanding of how they impact one another, of which only a handful of investigators, funders and community representatives can fully fathom. Recognition of the various components required and the complexity of moving a product from bench to clinic in a first-in-man study is critical in helping to avoid delay and/or derailment of the process.

This project aims to generate a web-based toolkit to give researchers an overview of steps required to take HIV vaccine candidates from concept into Phase I clinical trial. The roadmap will describe the key steps, relevant expertise and an estimate of the time and costs required at each step, based on past experience.  Areas where country-specific nuances may exist will be highlighted.

Objectives

  • Generate an interactive web tool (Roadmap) to guide researchers through the steps necessary to take an HIV vaccine candidate from concept into a phase I clinical trial.
  • Engage approximately 50 experts from relevant fields to refine the roadmap.
  • Make the roadmap available to the public through presentations at conferences and webinars, the creation of a webpage and other materials.

Format: This is a virtual convening, facilitated by webinars, teleconferences and email distribution lists.

Date: The project is expected to be completed by May 2013.

Organizing Committee

  • Dr. Roger Tatoud, Imperial College, London, UK
  • Dr. Eddy Sayeed, International AIDS Vaccine Initiative, USA
  • Dr. Yegor Voronin, Global HIV Vaccine Enterprise, USA

Background

The results of RV144 are encouraging and suggest that a combination of different vaccine candidates is critical to trigger a successful immune response (1,2,3).  At the same time, manufacturing and combining different products is a challenging enterprise with many complex ramifications that few understand fully or are prepared to undertake.  Discussions among clinicians and scientists often revolve around designing new trials and taking more products into clinical trials. However, the question of how to make these products and the feasibility of combining products of different origins into a clinical trial is rarely discussed, especially within the broader context of funding, expertise required and timing.  Existing roadmaps, such as the Clinical Trial toolkit designed by NIHR, provide a general overview of the clinical trial regulations and best practices, but do not provide the sufficient details on the steps necessary to manufacture and prepare a product to be tested in the trial. Recognizing and understanding key steps required to manufacture a product will help researchers without prior experience, to plan and to embark upon a Phase I trial.

References 

1. Rerks-Ngarm et al.,Vaccination with ALVAC and AIDSVAX to Prevent HIV-1 Infection in Thailand. N Engl J Med. 2009;361:1–12
2. Montefiori DC et al. Magnitude and breadth of the neutralizing antibody response in the RV144 and Vax003 HIV-1 vaccine efficacy trials. J Infect Dis. 2012 Aug 1;206(3):431-41.
3. Karasavvas N, et al. The Thai Phase III HIV Type 1 Vaccine Trial (RV144) Regimen Induces Antibodies That Target Conserved Regions Within the V2 Loop of gp120. AIDS Res Hum Retroviruses. 2012 Nov;28(11):1444-57

Take Part and Tell Us What You Think

We plan to solicit input from a large number of experts in the field. If you would like to contribute, please visit the Enterprise Website.

The SYFA Website

SYFA (Save Your Future Association) was founded in 2001 by Farmer Tantoh Nforba and is located in Nkambe, North West Province of Cameroon.

SYFA works with local farmers, youths and children on environmental protection, organic agriculture and home gardening and currently coordinates the activities of 10 environmental groups at local schools, churches and the prison

The project was to create a new website for SYFA that would provide a better window into the work of Farmer Tantoh

Farmer Tantoh training the students

Farmer Tantoh training students from the agricultural school in Nkambe the importance of botanical gardens in rural communities

Since its inauguration, SYFA has helped to prove numerous compounds (houses) in the Binju neighbourhood of Nkambe, as well as designing many gardens at churches, schools and administrative buildings.

“Farmer” Tantoh is from Nkambe, Cameroon. He studied at the Regional College of Agriculture, in Bambili, Cameroon, where his field of study was Agriculture and Rural Development. He specialized in spring water catchments’ protection using sustainable agro-forestry practices.

Tantoh has worked with local youths and low-income farmers, introducing lawn creation and flower gardening and also organic farming techniques adaptable to the tropics thereby protecting the local environment.

Achievement: The SYFA website is up and running since mid-June 2007.

The Reactome

The Reactome project is a collaboration between Cold Spring Harbor Laboratory, The European Bioinformatics Institute, and The Gene Ontology Consortium to develop a curated resource of core pathways and reactions in human biology.

Project Summary: curation of the IRS/PKB cascade of events (6 months).

Role: Supervision and contribution to the work.

The information in the Reactome database is authored by biological researchers with expertise in their fields, maintained by the Reactome editorial staff, and cross-referenced with PubMed, GO, and the sequence databases at NCBI, Ensembl and UniProt. In addition to curated human events, inferred orthologous events in 21 non-human species including mouse, rat, chicken, fugu fish, worms, fly, yeast and E.coli are also available.

This work involved:

  • researching the literature
  • summarising the published knowledge in a synthetic format
  • training and directing the work of a student

The results of this project is now available online to the scientific community.