A phase 1, first-in-human safety and immunogenicity study of a Lassa fever vaccine, ChAdOx1 LassaJ, in healthy volunteers aged 18 – 55 years in the UK. (ViTaL01)

Research summary

This is a first-in-human phase 1 trial to assess the safety,tolerability,and immunogenicity of two doses of ChAdOx1 LassaJ in healthy volunteers aged 18-55 years. There will be an initial lead-in cohort (cohort 1) of 6 participants,followed by a participant-observer blinded cohort of 25 participants cohort (cohort 2). Participants in cohort 2 will be randomly assigned to subgroups,one of which will receive 2 doses of the ChAdOx1 LassaJ vaccine 12 weeks apart (20 participants) and the other group will receive 2 doses of a saline placebo vaccination 12 weeks apart (5 participants) . Volunteers will be recruited and vaccinated at the designated study site. Participants will be considered enrolled into the trial at the point of their first vaccination. Primary Objective To assess the safety and tolerability of ChAdOx1 LassaJ in healthy volunteers aged 18-55 years. Secondary Objectives To assess the immunogenicity of ChAdOx1 LassaJ in healthy volunteers aged 18-55 years.

Principal Investigator

Prof Maheshi Ramasamy

Contact us

Email: raquel.lomas@ndm.ox.ac.uk

IRAS number

1011278