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.
- 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.
- Dr. Roger Tatoud, Imperial College, London, UK
- Dr. Eddy Sayeed, International AIDS Vaccine Initiative, USA
- Dr. Yegor Voronin, Global HIV Vaccine Enterprise, USA
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.
References1. 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.