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World-first swine-flu vaccine trial reveals one dose provides 'strong immune response'

07.09.2009
Pilot Leicester study suggests one dose of vaccine may be sufficient
Results from the first swine-flu vaccine trials taking place in Leicester reveal a strong immune response after just one dose.

The pilot study, run by the University of Leicester and Leicester Hospitals, was trialled with 100 healthy volunteers, aged between 18 and 50.

Dr Iain Stephenson, who led the trial at the Leicester Royal Infirmary, said: "The clinical trial of Novartis MF59-adjuvanted cell-based A (H1N1) vaccine indicates that the "swine flu" vaccine elicits a strong immune response and is well-tolerated.

"Results showed that the serum antibody responses were highest among subjects who received two doses of vaccine, however a single vaccine dose also induced responses associated with protection against influenza.

"The findings showed that it is possible to induce protective antibody against A(H1N1) infection within two weeks of administration of a single low-dose adjuvanted vaccine."

Non-adjuvanted formulations were not evaluated in this part of the study and will be evaluated shortly

The trial evaluated the tolerability and immunogenicity of the vaccine, and tested different schedules of vaccination, in terms of time between vaccinations. The vaccine schedule was one or two doses of 7.5ìg MF-59 adjuvanted surface-antigen A/California/2009 vaccine derived from cell-culture.

Dr. Stephenson, of the Department of Infection, Immunity and Inflammation at the University of Leicester is a clinical senior lecturer at the University, and a consultant in infectious diseases at the University Hospitals of Leicester NHS Trust. He said: "The aim of the trial was to find out how many doses and what type of vaccine is needed to give protection. These initial results should help to plan vaccination campaigns in the autumn, including doses and timings. We concluded that the MF59-adjuvanted A(H1N1) vaccine of low antigen content was well tolerated and generated antibody responses associated with protection against influenza, even after a single dose."

"The results suggest that one vaccine dose may be sufficient to protect against the A(H1N1) swine flu, rather than two. Larger trials are already underway around the world. Timings on when the vaccine will be available to governments will depend on the results of these clinical trials, and approvals by regulatory authorities''

The research found the vaccine is well tolerated with pain at the injection site the most frequent adverse event.

Additional pivotal trials with both cell culture and traditional egg based vaccines under way around the world that will include more than 6000 adults and children.

Previous research had indicated that two doses of the vaccine would be needed against swine flu. You can access earlier stories here:

http://www2.le.ac.uk/ebulletin/news/press-releases/2000-2009/2009/08/nparticle.2009-08-11.3248230936

You can view the press release from Novartis here: http://www.novartis.com/newsroom/media-releases/en/2009/1339223.shtml

NOTES TO NEWSDESK:

Due to ongoing NHS commitments and research trials Dr Iain Stephenson is not available for interview.

Please cite University of Leicester and Leicester Royal Infirmary in any report

University of Leicester - Times Higher Education University of the Year 2008/09

Press Office Contact:
Ather Mirza
Press Office
Division of Marketing and Communications
University of Leicester
University Road
Leicester
LE1 7RH
tel: 0116 252 3335
email: pressoffice@le.ac.uk
ABOUT THE UNIVERSITY OF LEICESTER
A member of the 1994 Group of universities that share a commitment to research excellence, high quality teaching and an outstanding student experience.
Named University of the Year by Times Higher (2008) Shortlisted (2006, 2005) and by the Sunday Times (2007)
Ranked top with Cambridge for student satisfaction amongst full time students taught at mainstream universities in England
Ranked as a Top 20 university by the Sunday Times, Guardian,Times and UK Complete University Guide, published in The Independent
Ranked in world's top 200 universities by Shanghai Jiao Tong International Index, 2005-08 and the Times Higher Education-QS World University Rankings
Ranked top 10 in England for research impact by The Guardian
Students' Union of the Year award 2005, short listed 2006 and 2007
Founded in 1921, the University of Leicester has more than 20,000 students from 136 countries. Teaching in 18 subject areas has been graded Excellent by the Quality Assurance Agency- including 14 successive scores - a consistent run of success matched by just one other UK University. Leicester is world renowned for the invention of DNA Fingerprinting by Professor Sir Alec Jeffreys and houses Europe's biggest academic Space Research Centre. The latest Research Assessment Exercise adjudged Leicester to have world leading research in every subject panel and identified Museum Studies (at 65%) as having the highest proportion of world leading researchers compared with any other subject area at any university in the UK. Leicester also emerged as having one of the highest proportions of staff who are research active in the UK, with approximately 93% of staff submitted for the exercise. The University's research grant income places it among the top 20 UK research universities. The University employs over 3,000 people, has an annual turnover of over £200m, covers an estate of 94 hectares and is engaged in a £300m investment programme- among the biggest of any UK university.

Ather Mirza | EurekAlert!
Further information:
http://www.le.ac.uk

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