Journal article

Phase I trial of RV3-BB rotavirus vaccine: A human neonatal rotavirus vaccine

M Danchin, CD Kirkwood, KJ Lee, RF Bishop, E Watts, FA Justice, V Clifford, D Cowley, JP Buttery, JE Bines

Vaccine | ELSEVIER SCI LTD | Published : 2013

Grants

Awarded by Australian National Health and Medical Research Council


Awarded by Centre for Clinical Research Excellence in Child and Adolescent Immunisation and Fellowship


Awarded by NHMRC CDA fellowship


Funding Acknowledgements

MCRI has received funds from GlaxoMithKline and CSL Biologicals for investigator initiated post-marketing surveillance activities of Julie Bines, Margie Danchin and Jim Buttery. Carl Kirkwood is director of Australian Rotavirus Surveillance Program, which is supported by research grants from vaccine manufacturers CSL and GSK, as well as Department of Health and Aging.We would sincerely like to thank the participants and their families for participating in this study. We would also like acknowledge the contribution of consultants to this study Sue Mitchell, Pene Amor from Mitchell Consulting, Mark Sullivan, Gerhard Rank, Amanda Handley from Medicines Development and Jim Ackland, the managing director at Global BioSolutions. We thank the Vaccine and Immunisation Research Group (VIRGo) at Murdoch Childrens Research Institute for access to their immunisation database for recruitment and for assistance in home visits for participants. We would like to acknowledge the significant contribution of Prof Graeme Barnes and Emma Watts, the RV3 Program manager and would like to thank Diane Strong, research assistant, Dr Carl Kuschel, neonatologist at the Royal Womens' Hospital for assistance with recruitment of the infants and Nada Bogdanovic-Sakran for her work in the Enteric Virus Group, MCRI. We would like to thank the Maternal and Child Health Centre Nurses and Antenatal Clinic staff for allowing us access to their families for recruitment. We are grateful to the Data Safety Monitoring Board, in particular the Chair Karen Kotloff, and including Peter Richmond, Michael Nissen and Andrew Forbes. This study was supported by the Australian National Health and Medical Research Council through a Project Grant (ID491239), funding as part of the Centre for Clinical Research Excellence in Child and Adolescent Immunisation and Fellowship support (MD ID437000). CDK is supported by an NHMRC CDA fellowship (607347). The manufacture of the clinical trial lots used in this trial were part-funded by PATH. This research was also supported by the Victorian Government's Operational Infrastructure Support Program.MCRI has received funds from GlaxoMithKline and CSL Biologicals for investigator initiated post-marketing surveillance activities of Julie Bines, Margie Danchin and Jim Buttery. Carl Kirkwood is director of Australian Rotavirus Surveillance Program, which is supported by research grants from vaccine manufacturers CSL and GSK, as well as Department of Health and Aging.