World-first swine-flu vaccine trial reveals one dose provides
'strong immune response'
5 September 2009
Results from the first swine-flu vaccine trials taking place in
Leicester, UK 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
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
“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 7.5μg
MF-59 adjuvanted surface-antigen A/California/2009 vaccine derived from
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.
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