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New treatment option for Shigellosis
Official title Shigella Sonnei 53G Human Infection Study in Kenyan Adults
ClinicalTrials.gov ID: NCT05959616
What this study is testing
What is Shigella sonnei 53G?
Shigella sonnei 53G is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for shigellosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45. Healthy volunteers may be eligible.
You may be able to join if
- Healthy adults between 18 and 45 years of age (inclusive) Kilifi County residents
- Able and willing (in the Investigator's opinion) to comply with all study requirements.
- Provide informed consent.
- Demonstrate comprehension of the protocol procedures and knowledge of study by passing a test of understanding (pass grade 100%).
- Use of effective method of contraception for the entire duration of study (prior to study start and up to study completion) (women only). Female...
You likely can't join if
- Presence of a significant medical condition (e.g., psychiatric conditions, alcohol or illicit drug abuse/dependency, or gastrointestinal disease...
- Known immunosuppressive illness for example those with cancer, on immunosuppressive therapy, HIV etc.
- Positive serology results for HIV, HBsAg, or HCV antibodies.
- Evidence of inflammatory arthritis on exam and/or HLA-B27 positive.
- Family history of inflammatory arthritis.
- Clinically significant abnormalities in screening lab haematology or serum chemistry, as determined by PI or PI in consultation with the research...
See the full eligibility criteria
- Healthy adults between 18 and 45 years of age (inclusive) Kilifi County residents
- Able and willing (in the Investigator's opinion) to comply with all study requirements.
- Provide informed consent.
- Demonstrate comprehension of the protocol procedures and knowledge of study by passing a test of understanding (pass grade 100%).
- Use of effective method of contraception for the entire duration of study (prior to study start and up to study completion) (women only). Female volunteers will be asked to provide their family planning records to...
- Willingness to participate for an inpatient stay lasting approximately 12 days or longer and an outpatient follow-up lasting about 12 months from challenge.
- Available for all planned follow-up visits.
- Presence of a significant medical condition (e.g., psychiatric conditions, alcohol or illicit drug abuse/dependency, or gastrointestinal disease, such as peptic ulcer, symptoms or evidence of active gastritis or...
- Known immunosuppressive illness for example those with cancer, on immunosuppressive therapy, HIV etc.
- Positive serology results for HIV, HBsAg, or HCV antibodies.
- Evidence of inflammatory arthritis on exam and/or HLA-B27 positive.
- Family history of inflammatory arthritis.
- Clinically significant abnormalities in screening lab haematology or serum chemistry, as determined by PI or PI in consultation with the research monitor and Sponsor.
- Known allergies to fluoroquinolones, β-lactams or trimethoprim-sulfamethoxazole (any of the three are exclusionary).
- Fewer than 3 stools per week or more than 3 stools per day as the usual frequency.
- History of diarrhoea in the 2 weeks prior to planned inpatient phase.
- Use of antibiotics during the 7 days before receiving the challenge inoculum dosing.
- Use of prescription and/or OTC medications that contain imodium, acetaminophen, aspirin, ibuprofen, and/or other non-steroidal anti-inflammatory drugs, during the 48 hours prior to investigational product administration.
- Confirmed PCR positive for SARS-COV-2 three days before challenge i.e., Day -3.
- Use of any medication known to affect the immune function within 30 days preceding receipt of the challenge inoculum or planned use during the active study period.
- Serologic evidence of prior S. sonnei infection as determined by ELISA.
- A chronic disease for which doses of prescription medications are not stable for at least the past 3 months.
- Have known immunocompromised household contacts for example those with cancer, on immunosuppressive therapy, HIV etc.
- A clinically significant abnormality on physical examination, including a systolic blood pressure \>140 mm Hg or diastolic blood pressure \>90 mm Hg, or a resting pulse \>100 beats/min or \<55 beats/min (\<50 beats/min...
- Pregnant, nursing, or planning to become pregnant within 29 days of receipt of the study product.
- In the 4 weeks following challenge, volunteer will be living with or having daily contact with elderly persons aged 70 years or more, diapered individuals, persons with disabilities, children \<2 years old, a woman...
- Work in a health care setting, day care center, or as a food handler in the 4 weeks following the challenge with S. sonnei.
- Use of any investigational drug or any investigational vaccine within 60 days preceding challenge, or planned use during the 6 months after receipt of the study agent.
- Have received a licensed, live vaccine within 28 days or a licensed inactivated vaccine within 14 days of receiving the challenge inoculum.
- Inability to comply with inpatient rules and regulations.
- Has any other condition that, in the opinion of the Investigator, would jeopardize the safety or rights of a volunteer (e.g., infection with another detected pathogen) or would render the volunteer unable to comply with...
- Received blood or blood products within the past six months.
The study team makes the final eligibility decision.
Where it's taking place
- Kilifi, Kenya
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 45 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kilifi, Kenya. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.