EuroNeut-41: Safety & immunogenicity of immunisations with HIV vaccine

• Research type

  Research Study

• Full title

  Phase 1, randomised, single-centre, observer-blind clinical trial of safety and immunogenicity of nasal-prime and intramuscular boost immunisation with EN41-FPA2 HIV vaccine in healthy female volunteers

• IRAS ID

  64743

• Contact name

  David J M Lewis

• Sponsor organisation

  PX'THERAPEUTICS

• Eudract number

  2010-023693-39

• ISRCTN Number

  n/a

• Research summary

  This First in Human clinical trial aims to evaluate the safety and immunogenicity of an HIV prophylactic vaccine. The population of subjects will be women. HIV infection is growing faster in women than in men and currently women infected represent approximately 50 % of the population infected by the virus.As no treatment exists (only symptomatic treatment) this vaccine would be a new way to prevent the HIV infection.The trial design will be based on three nasal vaccinations and two Intramuscular injection vaccinations, five safety visits and three follow-up visits (total of trial duration: 11 to 12 months). We anticipate that nasal immunisation will prime the body for a good response in the genital tract, which will be boosted by the intramuscular inmmunisations.

• REC name

  London - Brent Research Ethics Committee

• REC reference

  11/LO/1700

• Date of REC Opinion

  16 Nov 2011

• REC opinion

  Favourable Opinion