ID: 739
Titel: ETVAX bridging study
Provsamlingsansvarig: Dan Curiac
Start insamling: -
Slut insamling: -
Beskrivning: This clinical vaccine trial is part of a larger project aimed at developing a drinkable vaccine against diarrhoea caused by enterotoxigenic Escherichia coli (ETEC) bacteria. In this trial, healthy adults will drink two doses of either a previously tested formulation of the ETEC vaccine (n=140 subjects) or a new formulation (n=140 subjects), which is more practical to use than the previous formulation. The primary endpoint of the study is to show that the new vaccine formulation gives rise to immune responses that are non-inferior to those induced by the previously tested formulation (n=280). This is investigated through a comparison of vaccine-specific serum antibody responses in study participants who have been vaccinated with respective vaccine formulations. The study also includes exploratory studies in 40 research participants for the purpose of investigating whether long-lived vaccine-specific memory cells are formed after vaccination and whether they can be detected using newly established assays. 
From all 280 subjects serum samples are collected before administration of the first dose and one week after the second dose. In the exploratory study, serum and heparin blood samples are also collected 5 days after the second dose (n=40) and 30 and 90 days after the second dose (n=20).
Samples are collected at the Center for clinical trials at Sahlgrenska Hospital. Serum is frozen for later analysis of serum antibodies at the Dept. of Microbiology and Immunology (DMI) at the University of Gothenburg. Heparin blood is used for isolation of peripheral mononuclear cells (PBMCs) at DMI. Fresh and frozen serum, PBMCs and cell culture supernatants from PBMCs samples are analyzed for T- and B-cell responses at DMI and Clinical Immunology at the Sahlgrenska Hospital.

PROVTYP;PROVGIVARE
Serum;280
Blod heparin;40