A phase I study to assess two new influenza vaccine candidates

• Research type

  Research Study

• Full title

  A phase I study to determine the safety and immunogenicity of vaccination regimens employing the candidate influenza vaccines MVA-NP+M1 and ChAdOx1 NP+M1

• IRAS ID

  120495

• Contact name

  Adrian Hill

• Eudract number

  2012-004626-25

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  This will be a randomised observational phase 1 study in 48 healthy volunteers aged 18-50. The study is assessing safety and immunogenicity of viral vectored vaccines ChAdOx1 NP and MVA NP in heterologous prime-boost regimens. A Crossover design will allow comparison of the two vaccines. Volunteers will be divided into 4 groups (n=12 in each group). Groups will be recruited simultaneously to control formseasonal changes in influenza. This is because at certain times of year there is likely to be a higher naturally acquired T cell response to influenza than at other times due to circulating influenza virus in the community. The vaccines have both been used safely in humans before. A recent dose Escalation study has demonstrated that a ChAdOx1 NP dose of 2.5 x 10ûøvp is safe and immunogenic. Previous studies in Oxford have demonstrated that the optimal dose of MVA NP is 1.5 x 108pfu, balancing immunogenicity and reactogenicity. Both vaccines are administered intramuscularly.48 volunteers will be recruited and will be randomised in blocks of 6 to receive either ChAdOx1 NP or MVA NP prime at day 0. 24 individuals will be boosted 8 weeks later, and the remaining 24 volunteers will be boosted 52 weeks later, with the other vaccine.vaccines will be administered at the Centre for Clinical Vaccinology and Tropical Medicine (CCVTM) in Oxford. Volunteers will all be followed up to week 78, with clinic visits and blood tests at various time points to assess the safety and immunogenicity of the vaccines.

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  13/SC/0004

• Date of REC Opinion

  18 Feb 2013

• REC opinion

  Further Information Favourable Opinion