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A003 Protocol - A Phase 1, randomized, blinded, dose-escalation study of rAAV1-PG9DP recombinant AAV vector coding for PG9 antibody in healthy male adults

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posted on 18.03.2019 by Frances H. Priddy, David J. M. Lewis, Huub C. Gelderblom, Hanaa A. Hassanin, Claire Streatfield, Celia LaBranche, Jonathan Hare, Josephine H. Cox, Len Dally, Daryl Bendel, David Montefiori, Eddy Sayeed, Jim Ackland, Jill Gilmour, Bruce C. Schnepp, Fraser Wright, Philip Johnson

Clinical Trial protocol for a Phase 1, randomized, blinded, dose-escalation study of rAAV1-PG9DP recombinant AAV vector coding for PG9 antibody in healthy male adults

Funding

We gratefully acknowledge the Surrey Clinical Research Centre study team and study volunteers for their dedication, Alex Horton (Royal Surrey County Hospital, Guildford, UK) who performed the muscle biopsies, Michael Pensiero and Dale Hu (Division of AIDS, US National Institutes of Health, Bethesda, MD, USA), the Safety Review Board members Jerome Kim (International Vaccine Institute, Seoul, Korea), Eric Sandström (Karolinska Institute, Stockholm, Sweden), Kevin Flanigan (Nationwide Children's Hospital and The Ohio State University, Columbus, OH, USA), Sheena McCormack (MRC Clinical Trials Unit, London, UK), Andrew Pollard (University of Oxford, Oxford, UK), and Alexander Lyon (Royal Brompton Hospital, London, UK), Monogram Biosciences (San Francisco, CA, USA), which conducted the pseudovirion panel neutralisation assay, Neogenomics (Houston, TX, USA), which detected vector DNA in blood and muscle, the International AIDS Vaccine Initiative (IAVI) adeno-associated virus project team for trial oversight, and the Human Immunology Laboratory, Imperial College London for developing the immunology assays and sample testing. IAVI's work is made possible by generous support from many donors, including the Bill & Melinda Gates Foundation, the Ministry of Foreign Affairs of Denmark, Irish Aid, the Ministry of Finance of Japan in partnership with The World Bank, the Ministry of Foreign Affairs of the Netherlands, the Norwegian Agency for Development Cooperation, the United Kingdom Department for International Development, and the US Agency for International Development (USAID). The full list of IAVI donors is available online. This study was made possible by the generous support of the American people through USAID, the Bill & Melinda Gates Foundation, and the US National Institutes of Health (R01 AI106509–01 and 272201400042C-0–0-1). The contents of this Article are the responsibility of IAVI and do not necessarily reflect the views of USAID or the US Government.

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