CompletedPhase 1/2

A Study to Evaluate Safety, Reactogenicity, and Immune Response of GVGH iNTS-TCV Vaccine Against Invasive Nontyphoidal Salmonella and Typhoid Fever

Belgium, Malawi155 participantsStarted 2022-09-13

Plain-language summary

The purpose of this study is to assess the safety, reactogenicity, and immune response induced by the GlaxoSmithKline Biologicals SA (GSK) Vaccines Institute for Global Health (GVGH) invasive nontyphoidal Salmonella-typhoid conjugate (iNTS-TCV) candidate vaccine to be administered for the first time in humans. The study intervention will be evaluated in European adults in Stage 1 (a 2-step staggered design) followed by African adults in Stage 2.

Who can participate

Age range

18 Years – 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 * Participants, 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 participant prior to performance of any study-specific procedure. * Healthy participants as established by medical history, clinical examination, and laboratory assessment. * Participant satisfying screening requirements. * A male or female between and including 18 and 50 years of age at the time of the first study intervention administration. * Female participants of nonchildbearing potential may be enrolled in the study. Nonchildbearing potential is defined as pre-menarche, current bilateral tubal ligation or occlusion, hysterectomy, bilateral ovariectomy, or post-menopause. * Female participants of childbearing potential may be enrolled in the trial if the participant: * Has practiced adequate contraception for 1 month prior to study intervention administration, and * Has a negative pregnancy test on the day of study intervention administration, and * Has agreed to continue adequate contraception during the entire treatment period and for 1 month after completion of the study intervention administration series. * Blood sample for simultaneous follicle-stimulating hormone (FSH) and estradiol levels may be collected at the discretion of the Investigator to confirm non-reproductive potential according to local laboratory reference range. * Genetic testing for HLA-B27 will…

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

Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration

Timeframe: Within 7 days post vaccination (day of administration and 6 subsequent days post-first vaccination on Day 1)

Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration

Timeframe: Within 7 days post vaccination (day of administration and 6 subsequent days post-second vaccination on Day 57)

Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration

Timeframe: Within 7 days post vaccination (day of administration and 6 subsequent days post-third vaccination on Day 169)

Stage 1: Number of Participants With Any Solicited Systemic Events After the First Study Intervention Administration

Timeframe: Within 7 days post vaccination (day of administration and 6 subsequent days post-first vaccination on Day 1)

Stage 1: Number of Participants With Any Solicited Systemic Events After the Second Study Intervention Administration

Timeframe: Within 7 days post vaccination (day of administration and 6 subsequent days post-second vaccination on Day 57)

Trial details

NCT IDNCT05480800

SponsorGlaxoSmithKline

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-09-02

Results submitted2025-09-01

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