Phase I and II randomised trials of the safety and immunogenicity of a prototype adjuvanted inactivated split-virus influenza A (H5N1) vaccine in healthy adults
Terry M Nolan, Peter C Richmond, Maryanne V Skeljo, Georgina Pearce, Gunter Hartel, Neil T Formica, Katja Hoschler, Jillian Bennet, David Ryan, Kelly Papanaoum, Russell L Basser, Maria C Zambon
VACCINE | ELSEVIER SCI LTD | Published : 2008
OBJECTIVE: The primary objective was to evaluate the safety and immunogenicity of a prototype inactivated, split-virus H5N1 (avian influenza A) vaccine. A secondary objective was to assess the cross-reactivity of immune responses to two variant clade 2 H5N1 strains. METHODS: In two randomised, dose comparison, parallel assignment, multicentre trials conducted in Australia, healthy adult volunteers received two doses of 7.5 microg or 15 microg H5 haemagglutinin (HA) vaccine+/-AlPO4 adjuvant (phase I trial; N=400) or two doses of 30 microg or 45 microg H5 HA with AlPO4 adjuvant (phase II trial; N=400). Revaccination with a booster dose was offered 6 months after dose 2 (phase I trial only). Ma..View full abstract
The data reported here were presented, in part, at the VIII International Symposium on Respiratory Viral Infections, Hawaii, March 16-19, 2006; the 3rd WHO Meeting oil Evaluation of Pandemic Influenza Vaccines in Clinical Trials, WHO/HQ, Geneva, February 15-16, 2007 and the Options for the Control of Influenza VI Conference, Toronto Canada, June 17-23, 2007. The authors would like to extend their thanks to the participants, investigators and personnel at each study site. Specifically, the authors would like to thank staff from the Vaccine and Immunisation Research Group (Murdoch Childrens Research Institute, University of Melbourne) including L. Thorn, K. Alexander, J. McVernon, M. Kefford, K. O'Grady, J. Ryrie and J. Sonego, staff from the Vaccine Trials Group (Institute for Child Health Research, Uniof Western Australia) including S. Nadall, S. Bilic, J. Adams and K. Prosser and D. Lakhman, M. Rico Garcia and K. McCurrie from the Virus Reference Laboratory, The Health Protection Agency: Colindale, UK for their assistance in this study. This study was sponsored by CSL Limited (Parkville, VIC, Australia). The authors acknowledge the independent medical writing assistance provided by ProScribe Medical Communications (www.proscribe.com.au), funded from an unrestricted financial grant from CSL Limited. ProScribe's services complied with international guidelines for Good Publication Practice.