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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06992141




Registration number
NCT06992141
Ethics application status
Date submitted
19/05/2025
Date registered
28/05/2025
Date last updated
4/06/2025

Titles & IDs
Public title
A Strep Throat Controlled Human Infection Trial in Healthy Adults
Scientific title
CHIVAS- M1 (Controlled Human Infection for Vaccination Against Streptococcus Pyogenes M1UK): Expanding the Scope of Experimental Human Streptococcus Pyogenes Pharyngitis
Secondary ID [1] 0 0
CHIVAS-M1
Universal Trial Number (UTN)
Trial acronym
CHIVAS-M1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Streptococcus Pyogenes Pharyngitis 0 0
Streptococcus Infection 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Sexually transmitted infections
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Streptococcus pyogenes M1UK strain MCRI0102

Experimental: Human challenge participants - Participants will be allocated a dose of M1 S. pyogenes sequentially by date of challenge based on the attack rate in the preceding participants. Up to 4 dose levels will be tested commencing at 1-5 x10\^5 CFU/mL, increasing by 1 log to a maximum dose of 1-5 x 10\^7 CFU/mL, or decreasing by 1 log to a minimum dose of 1-5 x 10\^4 CFU/mL.


Treatment: Other: Streptococcus pyogenes M1UK strain MCRI0102
Human challenge with S. pyogenes M1UK strain MCRI0102
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The proportion of participants at each dose level of M1 S. pyogenes who reach the study pharyngitis endpoint
Timepoint [1] 0 0
Up to 5 days after the challenge dose of M1 S. pyogenes is administered

Eligibility
Key inclusion criteria
1. Males or females, aged 18 - 40 years (inclusive) on the day of informed consent.
2. Medically healthy, which can be determined by medical history, physical examination, BMI, transthoracic echocardiogram, non-clinically significant laboratory profiles, vital signs, and 12-lead ECG at screening, as deemed necessary by the research physician or investigator.
3. Systolic blood pressure (SBP) of 90 mmHg - 140 mmHg and diastolic blood pressure (DBP) of 60 mmHg - 90 mmHg. Vital signs can be repeated up to two times.
4. Resting heart rate (HR) of 55-100 bpm (confirmed by one repeat at screening).
5. Females must be non-pregnant, non-lactating, or postmenopausal for at least 1 year (as confirmed by follicle-stimulating hormone [FSH]), or surgically sterile for at least 6 months prior to dosing.

Females of childbearing potential will be required to use an effective form of contraception from the time of signing informed consent until the second planned outpatient visit approximately 1 month following the inpatient challenge admission.
6. Males must not have a pregnant partner and must agree to use condoms as a method of contraception from the time of signing informed consent until the second planned outpatient visit approximately 1 month following the inpatient challenge admission.
7. Must be willing and able to read, understand, and sign the participant information and consent form. Willing to comply with all study requirements, including the inpatient period and outpatient visits for the duration of the study (approx. 3 months).
8. Willing to abstain from the use of mouthwash from the day of screening until the first outpatient visit at one week post discharge.
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. History of any clinically important cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, and renal, or other major disease, as determined by the Investigator.
2. Significant history of hospitalisation for illness within the six months prior to enrolment into study, or major surgery within the 12 months prior to enrolment into study, as assessed by research physician or investigator.
3. History of tonsillectomy, adenoidectomy or splenectomy.
4. Known or suspected autoimmune disease or impairment/alteration of immune function resulting from:

1. Congenital or acquired immunodeficiency (including immunoglobulin A [IgA] deficiency)
2. Receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months.
5. History of a severe drug reaction or severe allergic reaction (eg. anaphylaxis, convulsions) or clinically significant allergic disease diagnosed by a physician.
6. Personal or family history of severe S. pyogenes infection (toxic shock syndrome, necrotizing fasciitis, bloodstream infection, pleural empyema, meningitis) or post-infectious sequelae (such as acute rheumatic fever, rheumatic heart disease, post-streptococcal glomerulonephritis).
7. Clinically significant disease or any condition or disease that might affect drug absorption, distribution or excretion, e.g. gastrectomy, diarrhoea.
8. Any vaccination within the last 28 days or use of any antibiotic therapy during the 14 days before challenge.
9. Presence of an acute infectious disease or febrile illness (e.g., sub-lingual temperature = 38.5°C) within the five days prior to inoculation.
10. Significant acute or chronic infection within 14 days prior to inoculation that the research physician or investigator deems may compromise participant safety.
11. Any clinically significant abnormal finding on biochemistry or haematology blood tests, urine analysis, ECG or transthoracic echocardiogram.
12. Positive serologic results for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), and/or hepatitis C virus (HCV) antibodies.
13. Ex-smoker with a >10 pack per year smoking history or a current smoker who is unable to stop smoking for the duration of the study.
14. History or presence of alcohol abuse (defined as regular alcohol consumption of more than 40g per day) or drug habituation, or any prior intravenous usage of an illicit substance.
15. A positive alcohol breath test at screening or admission.
16. A positive urine drug test at screening or admission (e.g., amphetamines, barbiturates, benzodiazepines, cocaine, methylenedioxymethamphetamine [MDMA], methamphetamine, methadone, opiates, phencyclidine [PCP] and tetrahydrocannabinol [THC]) unless there is an explanation acceptable to the Investigator (e.g. the participant has stated in advance that they consumed a prescription or over-the-counter product which contained the detected drug) and the participant has a negative urine drug screen on retest.
17. A positive point of care (POC) test for S. pyogenes on screening or day -1 throat swab.
18. Known hypersensitivity to more than two of the following antibiotics: penicillin, azithromycin, clindamycin, or other beta-lactam antibiotic(s).
19. Known hypersensitivity to soya protein.
20. Have participated in previous S. pyogenes challenge studies (with application of challenge agent).
21. Intolerance of throat swab procedure (exaggerated gag reflex).
22. Systemic corticosteroid in the 14 days prior to admission, or for more than seven consecutive days within the past 3 months, or anticipated use during the study period.
23. Any chronic (more than 1 month) use of inhaled high potency corticosteroids (budesonide 800 µg or fluticasone 750 µg per day).
24. Any intranasal corticosteroid use is not allowed in the 14 days prior to admission, during the inpatient period, and is discouraged prior to the first outpatient visit. Topical corticosteroid use is allowed.
25. Any use of drugs which may suppress the hypothalamic-pituitary-adrenal (HPA) axis such as adrenocorticotrophic hormone (ACTH) within the previous 3 months.
26. Any anti-inflammatory drugs (besides sporadic use of non-steroidal anti-inflammatory drugs), immunomodulators (such as monoclonal antibodies) or anticoagulants in the previous 3 months, or anticipated use of such drugs during the study period.
27. Use of prescription or non-prescription drugs and herbal supplements (such as St John´s Wort) within 14 days or 5 half-lives (whichever is the longer) prior to the inoculation administration. Use of vitamin supplements taken at standard doses is allowed.
28. Participation in a research study that involved blood sampling of more than 450 mL/1 unit of blood, received or donated blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation within 3 months of informed consent.
29. History of severe infections requiring hospitalisation for intravenous antibiotics (within the last 10 years). Exceptions to this would include a short course of intravenous antibiotics for appendicitis, biliary sepsis, diverticulitis and cellulitis or a similar non-severe infection.
30. History of cancer (except adequately treated squamous cell or basal cell carcinoma of the skin and cervical intraepithelial neoplasia).
31. Presence of implants or prosthesis (e.g. artificial joints, pacemakers) deemed significant for infective complications as assessed by research physician or investigator. Participants with cosmetic implants or prosthesis may be included, as per principal investigator's discretion.
32. Participation in another research study within the 30 days prior to enrolment involving an investigational product or other intervention that might affect risk of invasive S. pyogenes infection or compromise the integrity of the study (e.g. significant volumes of blood already taken in previous study).
33. Any significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the results of the study, or the participant's ability to participate in the study.
34. Any employee of the sponsor or research site personnel directly affiliated with this study or their immediate family members defined as a spouse, parent, sibling, or child whether biological or legally adopted.

Study design
Purpose of the study
Other
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 0
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/06/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2027
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Doherty Clinical Trials Ltd - Melbourne
Recruitment postcode(s) [1] 0 0
3002 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Murdoch Childrens Research Institute
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Auckland, New Zealand
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
University of Melbourne
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
University of Wollongong
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Université Libre de Bruxelles
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
University of California, San Diego
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
Leducq Foundation
Address [6] 0 0
Country [6] 0 0
Other collaborator category [7] 0 0
Other
Name [7] 0 0
National Health and Medical Research Council, Australia
Address [7] 0 0
Country [7] 0 0
Other collaborator category [8] 0 0
Other
Name [8] 0 0
Monash University
Address [8] 0 0
Country [8] 0 0
Other collaborator category [9] 0 0
Other
Name [9] 0 0
Duke University
Address [9] 0 0
Country [9] 0 0
Other collaborator category [10] 0 0
Other
Name [10] 0 0
The University of Queensland
Address [10] 0 0
Country [10] 0 0
Other collaborator category [11] 0 0
Other
Name [11] 0 0
Doherty Clinical Trials Ltd
Address [11] 0 0
Country [11] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Joshua Osowicki, FRACP PhD
Address 0 0
Murdoch Childrens Research Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06992141