EDCTP Alumni Network

Call	Career Development Fellowship (CDF)
Programme	EDCTP2
Start Date	2018-10-01
End Date	2022-03-31
Project Code	TMA2017CDF-1860
Status	Active

Title

Strategies to optimize the Stability and Bio-activity of a Clinical Tuberculosis Vaccine (ID93-TBVaccine)

Objectives

The objectives of this study are to: (a) explore the use of two chemical conjugation strategies to attach ID93 to GLA-LSQ (b) formulate thermostable single-vial lyophilised ID93 + GLA-LSQ and lead conjugates from (a). (c) evaluate the field-based stability of the lyophilised non-conjugate and the lyophilised conjugate candidate vaccine from (b) in six health facilities in South–Western, Nigeria.

Host Organisation

Study Design

Ethical approval from the ethics committee of the Institute of Public Health of Obafemi Awolowo University will be obtained for the use of blood samples from 30 healthy volunteers (15 male and 15 females) for the whole blood assay. The subjects will fill and sign an informed consent form permitting the use of their blood in this study. Five millilitres of blood sample will be collected every three months into heparinized blood collection tubes on the day of the assay for 18 months to help in monitoring the vaccine activity. Inclusion criteria will include subjects that do not have any history of infection or have taken any anti-infective drugs in last 2 months and have prior exposure to BCG vaccines or tuberculin skin test (TST) to allow for the study of memory T cell responses. This subject will also be screened for Latent Tuberculosis Infection using interferon-gamma release assays (IGRAs). Pregnant women or lactating mothers and subjects that have been in contacts with TB patients in recent times will be excluded from the study.

Publications