Cervicovaginal Immune Responses to 3 Deltoid or Thigh Intramuscular (IM) TicoVac
Status:
Completed
Trial end date:
2014-10-01
Target enrollment:
Participant gender:
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 antiviral antibody on mucosal surfaces may enhance the protection against
a number of important infections. Preclinical studies have anatomically targeted vaccine
antigens to sites where genital tract immunity is induced. This response is likely due to the
ability of regional lymph Preclinical studies have anatomically targeted vaccine antigens to
sites where genital tract immunity is induced. 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. 20 subjects will be randomised to each of2
groups immunised in right deltoid or 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 cervicovaginal 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.
The study is funded by ADITEC, which is a collaborative research programme that aims to
accelerate the development of novel and powerful immunisation technologies for the next
generation of human vaccines.