A Study on the Immune Response and Safety of a Multicomponent Shigella Vaccine in Preventing Shig… (NCT06663436) | Clinical Trial Compass
CompletedPhase 2
A Study on the Immune Response and Safety of a Multicomponent Shigella Vaccine in Preventing Shigellosis in Infants
Kenya200 participantsStarted 2024-11-13
Plain-language summary
This study evaluates the immune response and safety of a multicomponent, 2-dose Shigella vaccine in preventing shigellosis in African infants. The candidate vaccine, altSonflex1-2-3, is currently being evaluated in a Phase 2 age de-escalation (from least vulnerable adult population to most vulnerable paediatric population) clinical study in Kenya, with the aim of identifying a preferred dose, using a 3-dose vaccination schedule in infants from 9 months of age (NCT05073003). This Phase 2 clinical study will evaluate the safety and immunogenicity of an alternative 2-dose vaccination schedule.
Who can participate
Age range
39 Weeks – 43 Weeks
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participants' parent(s)/ Legally acceptable representative (LAR), who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
* Written or witnessed/thumb printed informed consent obtained from the parent(s)/LAR(s) of the participant prior to performance of any study specific procedure.
* Healthy participants as established by medical history, clinical examination, and laboratory assessment.
* Participants satisfying all screening requirements.
* Participants seronegative for hepatitis B, and hepatitis C.
* A male or female 9 months of age at the time of the first study intervention administration.
* Normal nutritional z-score.
* Previously completed routine childhood vaccinations to the best knowledge of the participant's parent(s)/LAR(s).
* Born at a gestation period of \>=37 weeks to the best knowledge of the participant's parent(s)/LAR(s).
* Participants negative for human immunodeficiency virus as confirmed by DNA polymerase chain reaction testing.
* Participants negative for HLA-B27.
Exclusion Criteria:
* Known exposure to Shigella during lifetime of the participant as confirmed during interview with the participant's parent(s)/LAR(s) or documented by participant's records.
* Progressive, unstable, or uncontrolled clinical conditions.
* History (known or suspected) of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention.
* Major congenital defects, as assesse…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Geometric mean titers (GMTs) of anti-serotype-specific Shigella lipopolysaccharides/O-antigen (LPS/OAg) serum Immunoglobulin G (IgG)
Timeframe: Day 1 (before administration of Dose 1)
2
GMTs of anti-serotype-specific Shigella LPS/OAg serum IgG
Timeframe: Day 169 (before administration of Dose 2)
3
GMTs of anti-serotype-specific Shigella LPS/OAg serum IgG
Timeframe: Day 29 (28 days after administration of Dose 1)
4
GMTs of anti-serotype-specific Shigella LPS/OAg serum IgG
Timeframe: Day 197 (28 days after administration of Dose 2)
5
Geometric mean concentrations (GMCs) of anti-serotype-specific Shigella LPS/OAg serum IgG
Timeframe: Day 1 (before administration of Dose 1)
6
GMCs of anti-serotype-specific Shigella LPS/OAg serum IgG
Timeframe: Day 169 (before administration of Dose 2)
7
GMCs of anti-serotype-specific Shigella LPS/OAg serum IgG