A trial to asses co-administration of MVA-NP+M1 and TIV

• Research type

  Research Study

• Full title

  A phase I study to determine the safety and immunogenicity of co-administration of the candidate influenza vaccine MVA-NP+M1 and seasonal influenza vaccine

• IRAS ID

  85137

• Eudract number

  2011-002509-31

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  This study is designed to test the safety and efficacy (effectiveness) of a combination of two vaccines for flunza. One of these vaccines will be the normal seasonal flunza vaccine. The second will be a novel viral vectored vaccine called MVA-NP. The rationale for combining these two vaccines is that they work differently, by stimulating different immune responses. We hope that by combining the two vaccines, stronger and broader immune responses are produced.The MVA-NP vaccine has been evaluated in two previous clinical trialsflu01 anflu02). In total, 66 volunteers have received this vaccine. There have been no vaccine related serious adverse events. The reactogenicity of MVA-NP has been shown to increase with dose, however at the dose to be used in this study, the majority of adverse events are mild.We will recruit 24 volunteers in this study. They will all be adults over the age of 50. Volunteers will be randomly allocated to one of two groups. Volunteers in group 1 will receive the seasonl flunza vaccine, followed by a dose of MVA-NP. Volunteers in group 2 will receive the seasonal flunza vaccine followed by a placebo injection (saline). Volunteers will be blinded so that they do not know which group they have been allocated to.Vaccinations will be administered into the thigh as the deltoid muscle is not normally large enough to accept two intramuscular injection.Volunteers will then be followed up. Two days after vaccination they will receive a telephone call from one of the clinical team. They will then attend three follow up visits (at week 1, week 3 and week 26). At each visit, volunteers will have blood tests taken and will be questioned about any adverse events they may have experienced. In addition, volunteers will have nasal washes performed on two occasions.

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  11/SC/0299

• Date of REC Opinion

  25 Aug 2011

• REC opinion

  Further Information Favourable Opinion