swine H1N1 vaccine trial

• Research type

  Research Study

• Full title

  Safety and immunogenicity of cell-culture non-adjuvanted and MF59-adjuvanted influenza A/H1N1 vaccines in healthy adults

• IRAS ID

  25040

• Sponsor organisation

  University Hospitals of Leicester NHS Trust

• Eudract number

  2009-012962-29

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  During April 2009 a new flunza virus called H1N1 was identified in Mexico and then the United States. The novel H1N1 virus comes from swine flunza but has adapted to humans and is able to transmit between people. It is likely that a pandemic declaration from WHO will be announced if the virus continues to spread. Vaccine development and testing is an urgent priority. Experience from birfluvaccines (H5N1) tells us that novel flunza vaccines require 2 doses to work and preferentially should be 'adjuvanted' (contain a compound that stimulates the immune system). It is important to know what the lowest doses of H1N1 vaccine needed would be, so that the available vaccines produced initially can be shared out to as many people as possible as an essential element of pandemic planning is to obtain sufficient supplies of the vaccine against the new strain and to immunise as many people as possible. As part of the preparation for a future flunza H1N1 pandemic, urgent work needs to be done to establish the likely dose and dosing schedule of an flunza candidate vaccineWe will test 2 types of vaccine (one with MF59 adjuvant and one without) in a range of doses (standard dose and half-dose) to see which vaccines produce acceptable antibody responses needed for protection

• REC name

  East Midlands - Leicester Central Research Ethics Committee

• REC reference

  09/H0406/78

• Date of REC Opinion

  25 Jun 2009

• REC opinion

  Further Information Favourable Opinion