CompletedPhase 2

A Study to Investigate the Safety and Immunogenicity of the SF2a-TT15 Synthetic Carbohydrate-based Conjugate Vaccine Against Shigella Flexneri 2a

Kenya248 participantsStarted 2020-10-06

Plain-language summary

A study among adults, children and infants in Kenya to determine if a new type of glycoconjugate vaccine incorporating a synthetic carbohydrate component is safe and induces immunity against Shigella.

Who can participate

Age range

8 Months – 50 Years

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

. Healthy men and women between 18 and 50 (inclusive) years of age.
. Subjects who provide written informed consent or thumb print in the presence of a witness to participate in the study
. Women willing to use at least 1 reliable method of contraception during the study period, or are surgically sterilized, and agree to undergo repeated pregnancy tests (before each vaccination) and men willing to use an effective method of contraception (e.g. condom).
. Healthy boys and girls between 2 and 5 years of age for the children group (cohort 2)
. Healthy boys and girls 9 mo-old (+/- 1 month) for the infant group (cohort 3)
. Parents or legally acceptable representatives, as appropriate, who are willing and able to provide signed/thumb printed informed consent for children and infants.
. Infant and children should have a normal nutritional Z score (-2 or greater) according to the mother and child health handbook of the republic of Kenya - Ministry of Health before entering the trial.
. Signed/thumb written informed consent, in accordance with local practice, provided by adult volunteers (participants 18 years of age and older), parent(s) or legal representative(s) for children and infants participants as applicable, who, in the opinion of the Investigator, can and will comply with the requirements of the protocol.

Exclusion criteria

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

Number, proportion,severity and relatedness of adverse events (AEs) to measure the safety and tolerability of SF2a-TT15 vaccine (2 μg OS and 10 μg OS) in each cohort.

Timeframe: 15 months

Analyses of the serum anti-S. flexneri 2a lipopolysaccharide (LPS) IgG antibody response in the infant target population to assess the immunogenicity of the vaccine.

Timeframe: 15 months

Trial details

NCT IDNCT04602975

SponsorInstitut Pasteur

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-04-12

View on ClinicalTrials.gov More Healthy trials

Who can participate

Age range

8 Months – 50 Years

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

. Healthy men and women between 18 and 50 (inclusive) years of age.
. Subjects who provide written informed consent or thumb print in the presence of a witness to participate in the study
. Women willing to use at least 1 reliable method of contraception during the study period, or are surgically sterilized, and agree to undergo repeated pregnancy tests (before each vaccination) and men willing to use an effective method of contraception (e.g. condom).
. Healthy boys and girls between 2 and 5 years of age for the children group (cohort 2)
. Healthy boys and girls 9 mo-old (+/- 1 month) for the infant group (cohort 3)
. Parents or legally acceptable representatives, as appropriate, who are willing and able to provide signed/thumb printed informed consent for children and infants.
. Infant and children should have a normal nutritional Z score (-2 or greater) according to the mother and child health handbook of the republic of Kenya - Ministry of Health before entering the trial.
. Signed/thumb written informed consent, in accordance with local practice, provided by adult volunteers (participants 18 years of age and older), parent(s) or legal representative(s) for children and infants participants as applicable, who, in the opinion of the Investigator, can and will comply with the requirements of the protocol.

Exclusion criteria

What they're measuring

Number, proportion,severity and relatedness of adverse events (AEs) to measure the safety and tolerability of SF2a-TT15 vaccine (2 μg OS and 10 μg OS) in each cohort.

Timeframe: 15 months

Analyses of the serum anti-S. flexneri 2a lipopolysaccharide (LPS) IgG antibody response in the infant target population to assess the immunogenicity of the vaccine.

Timeframe: 15 months