Cervico-vaginal immune responses to 3 deltoid or thigh IM TicoVac

• Research type

  Research Study

• Full title

  Phase 4 clinical trial of cervico-vaginal immune responses following three right deltoid or right lateral thigh intramuscular immunisations with TicoVac (Tick Borne Encephalitis Virus [TBEV]) vaccine in adult female participants

• IRAS ID

  105593

• Contact name

  David Lewis

• Sponsor organisation

  University of Surrey

• Eudract number

  2012-002027-15

• ISRCTN Number

  xx

• Research summary

  Many viral infections of global importance, including HIV, are transmitted across the mucosal surface of the genital tract. As immunity against these infections is likely to be primarily mediated by antibodies in mucosal secretions, developing techniques to increase the levels and persistence of anti-viral antibody on mucosal surfaces may enhance the protection against a number of important infections. Pre-clinical studies have anatomically targeted vaccine antigens to sites where genital tract immunity is induced. For example, in macaques injecting antigens near to the inguinal nodes which drain the cervix/vagina enhanced mucosal protection against subsequent vaginal virus challenge. This response is likely due to the ability of regional lymph nodes to ??pattern? the cell surface markers of responding vaccine-specific lymphocytes with homing markers. In contrast, injecting a distant muscle (such as in the arm) which shares no anatomical relationship with the vagina, may not pattern cells with homing markers for the genital tract. Direct injection of inguinal lymph nodes is impractical in humans but intramuscular injection into the thigh will target antigens to the deep inguinal lymph nodes shared in common with the cervix/vagina. This study will be a Phase IV randomised, single-centre, open-label, laboratory assessment-blinded exploratory trial to assess mucosal immunogenicity following three targeted intramuscular immunisations with TicoVac vaccine. Twenty subjects will be randomised to each of two groups immunised in: 1) right deltoid or 2) right anterolateral thigh. Following an initial screening visit subjects will be immunised at 0, 1 and 6 months. There will be follow up visits 5 days after each immunisation and a final visit at 7 months. Blood samples and cervico-vaginal secretions will be taken prior to each immunisation for immunological measures. In addition, blood samples will be taken at each immunisation and follow up visit for measurement of peripheral blood mononuclear cells.

• REC name

  London - Brent Research Ethics Committee

• REC reference

  12/LO/0996

• Date of REC Opinion

  27 Jun 2012

• REC opinion

  Favourable Opinion