Shigella Sonnei 53G Human Infection Study in Kenyan Adults

Summary

Diarrhoea caused by Shigella (shigellosis) is of major public health importance. However, there are no licensed Shigella vaccines in routine use, with several candidates still in various stages of clinical development. Shigella human infection studies (HIS) have played a key role in vaccine development. These models also allow for the evaluation of immunity and other non-immunological parameters that are important to understand resistance and/or susceptibility to disease. This is particularly useful in individuals from endemic areas with varying levels of prior exposure and immunity to Shigella. Thus, establishing a Shigella HIS would enable the testing of interventions such as vaccines in a population that would most benefit from a subsequent vaccine and has potential to accelerate vaccine development. Here, the goal is to successfully establish a Shigella sonnei human infection model in Kenyan adults. This will be achieved by conducting dose-finding and dose verification Shigella studies that safely and reproducibly induce ≥60% attack rates. In this study, investigators aim to use Shigella HIS in healthy adults to develop a model as a platform to test vaccines, to study immune responses identifying potential correlates of infection, and non-immunological factors mediating and influencing susceptibility to disease. To achieve this, the study will be carried out in two phases over a period of 12-14 months. Phase A will enroll (N=up to 40 volunteers) and Phase B will enroll an additional (N=30 volunteers). To be eligible to receive a dose of 53G, volunteers must pass the screening visit. Investigators will vary the dose of bacteria in individuals enrolled for challenge to identify the dose needed to cause ≥60% shigellosis (attack rate) (Phase A) followed by testing and demonstrate the reproducibility of the model (Phase B). Thus, the main outcomes of the study will be: (1) optimisation of bacterial dose for infection success (≥60% attack rate); and (2) safety.

Conditions

• Shigellosis

Interventions

BIOLOGICAL

Shigella sonnei 53G

Lyophilized S. sonnei 53G strain (Lot 1794)

DRUG

Ciprofloxacin 500 mg

Ciprofloxacin (500 mg orally twice daily for three days),

Sponsors & Collaborators

• KEMRI-Wellcome Trust Collaborative Research Program

  collaborator OTHER

• KEMRI United States Army Medical Research Directorate-Kenya

  collaborator UNKNOWN

• Walter Reed Army Institute of Research (WRAIR)

  collaborator FED

• Naval Medical Research Center

  collaborator FED

• PATH

  collaborator OTHER

• Johns Hopkins University

  collaborator OTHER

• University of Oxford

  lead OTHER

Study Design

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-01-21

Primary Completion

2026-04-30

Completion

2027-08-30

Countries

• Kenya

Study Locations