A Phase 1 Clinical Study to Evaluate the Safety and Immunogenicity of a Novel GMMA Vaccine Against Invasive Non-Typhoidal Salmonella in healthy Kenyan adults.

niversity of Oxford0 sites120 target enrollmentOctober 3, 2023

Overview

No summary available.

Registry

who.int

Start Date

October 3, 2023

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

•Written or witnessed/thumb printed informed consent obtained from the participant.
•Aged between 18 – 45 years
•In good health as determined by study clinician by: Medical history, Physical examination and heamatology and biochemistry laboratory assessments and Clinical judgement of the investigators
•Participants satisfying all screening requirements.
•Participants seronegative for HIV, hepatitis B, and hepatitis C.
•Females willing to use effective contraception and should be on contraception for at least one month prior to receiving the first vaccine and for the duration of the study.
•Able to attend the scheduled visits and to comply with all study procedures

•History of significant organ/system disease that could interfere with the trial conduct or completion in the clinical judgement of the investigators.
•Have any known or suspected impairment or alteration of immune function
•Study significant abnormalities on screening that are either unlikely to resolve or do not resolve on repeat testing
•Known exposure to non typhoidal Salmonella during lifetime of the subject participant as documented by patient records (e.g., history of microbiologically\-confirmed NTS infection)
•History of any reaction or hypersensitivity likely to be exacerbated by any component of the study.
•Receipt of a live vaccine within 4 weeks prior to vaccination or a killed vaccine within 7 days prior to vaccination
•Prior receipt of a typhoid vaccine or the Shigella GMMA vaccine.
•Plan to receive any vaccine other than the study vaccine within 4 weeks after vaccination. COVID19 vaccines are an exception.
•Scheduled procedures requiring general anaesthesia during the study
•Participant who is terminally ill