A Strep Throat Controlled Human Infection Trial in Healthy Adults

Summary

This aim of this study is to further develop a new way to study the bacteria that causes pharyngitis (strep throat). The scientific name for this bacterium is Streptococcus pyogenes and it is commonly known as Strep A. Strep A is a common type of bacteria that can cause various infections. These range from skin infections and strep throat to more serious conditions like rheumatic heart disease. In recent years there has been an increase in severe Strep A infections in most countries. Many of these cases have been reported in the news.

Human challenge models are studies which allow researchers to study organisms that cause infections in humans. In this human challenge model study, healthy participants will be carefully exposed to a specific type of Strep A under controlled conditions to cause sore throat and learn more about how Strep A causes infection. The study team has already developed a safe human challenge model using a strain of Strep A called M75. This study will use a different strain of Strep A, called M1.

The main goal of this study is to check if the procedure is safe for participants and to understand how the participant's body responds to M1 Strep A. The study will explore:

1. How much M1 Strep A is required to cause an infection.
2. How M1 Strep A grows in the body.
3. How the body reacts to M1 Strep A.

The information the investigators will get about M1 Strep A from this study will help plan future research. It may also help in designing better studies to test vaccines against Strep A.

Conditions

• Streptococcus Pyogenes Pharyngitis
• Streptococcus Infection

Interventions

BIOLOGICAL

Streptococcus pyogenes M1UK strain MCRI0102

Human challenge with S. pyogenes M1UK strain MCRI0102

Sponsors & Collaborators

• University of Auckland, New Zealand

  collaborator OTHER

• University of Melbourne

  collaborator OTHER

• University of Wollongong

  collaborator OTHER

• Université Libre de Bruxelles

  collaborator OTHER

• University of California, San Diego

  collaborator OTHER

• Leducq Foundation

  collaborator OTHER

• National Health and Medical Research Council, Australia

  collaborator OTHER

• Monash University

  collaborator OTHER

• Duke University

  collaborator OTHER

• The University of Queensland

  collaborator OTHER

• Doherty Clinical Trials Ltd

  collaborator UNKNOWN

• Murdoch Childrens Research Institute

  lead OTHER

Principal Investigators

• Joshua Osowicki, FRACP PhD · Murdoch Childrens Research Institute

Study Design

Allocation

NA

Purpose

BASIC_SCIENCE

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

40 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-07-24

Primary Completion

2025-10-31

Completion

2026-02-16

Countries

• Australia

Study Locations