H03_02TP Phase 1 Clinical Study with Shigella sonnei vaccine 1790GAHB

• Research type

  Research Study

• Full title

  A Phase 1, randomized, placebo controlled, single center, dose escalation study to evaluate the safety and immunogenicity of 3 vaccinations with Shigella sonnei vaccine (1790GAHB) administered either by intradermal, intranasal or intramuscular route in healthy adults.

• IRAS ID

  140522

• Contact name

  David Lewis

• Contact email

  d.lewis@imperial.ac.uk

• Sponsor organisation

  Novartis Vaccines Institute for Global Health (NVGH)

• Eudract number

  2013-003374-27

• ISRCTN Number

  n/a

• Research summary

  This first in human dose escalation trial aims to evaluate the safety and immunogenicity of a vaccine against shigellosis. Currently there is no vaccine available.

  After participants have been screened, and determined eligible for the study, they will be invited to the first vaccination visit. The vaccine will be administered by three different routes: intramuscularly, intradermally, and intranasally.For the intradermal and intranasal routes, the vaccine will be administered at different dosages. Each participant will attend for 3 vaccinations of Shigella sonnei vaccine via their allocated route. They will also attend two safety visits, and one follow up visit. The total trial duration for each subject will be approximately nine months.

• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  13/LO/1633

• Date of REC Opinion

  16 Dec 2013

• REC opinion

  Further Information Favourable Opinion