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World-first swine-flu vaccine trial reveals one dose provides 'strong immune response'
September 04, 2009Pilot 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 7.5μg 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.
University of Leicester
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 7.5μg 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.
University of Leicester
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Triple-Combo Drug Shows Promise Against Antiviral-Resistant Swine Flu, UAB Researcher Says
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Will genomics help prevent the next pandemic?
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Important new novel 2009 H1N1 flu advisory for cardiopulmonary transplantation
Each year 3-5 million people have severe cases and 250-500,000 die from complications of seasonal influenza world-wide. This year, the novel 2009 H1N1 (nH1N1) influenza, previously called swine flu, has reached pandemic status.
Major swine flu outbreak at US Air Force Academy, unique opportunity to study virus behavior
With the 2009 influenza season upon us, characterization of the epidemiology and duration of shedding for the nH1N1 virus is critical. Investigators from the U.S. Air Force Academy and the U.S. Air Force School of Aerospace Medicine Epidemiology Consult Service capitalized on a unique opportunity to gain valuable insights about the natural behavior of the nH1N1 virus, including shedding patterns, during a recent large-scale swine flu outbreak at the U.S. Air Force Academy (USAFA).
Earlier flu viruses provided some immunity to current H1N1 influenza, study shows
University of California, Davis, researchers studying the 2009 H1N1 influenza virus, formerly referred to as "swine flu," have identified a group of immunologically important sites on the virus that are also present in seasonal flu viruses that have been circulating for years.
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