A Study to Evaluate the Safety, Reactogenicity, and Immune Response of the GSK Vaccines Institute… (NCT07663032) | Clinical Trial Compass
RecruitingPhase 1
A Study to Evaluate the Safety, Reactogenicity, and Immune Response of the GSK Vaccines Institute for Global Health (GVGH) Quadrivalent Pan-Salmonella Vaccine With and Without Alum in Healthy Young Adults
South Africa196 participantsStarted 2026-06-24
Plain-language summary
The current clinical study will evaluate the GVGH Quadrivalent Pan-Salmonella vaccine for the first time in healthy adults in Africa. The purpose of the current Phase 1 study is to evaluate the safety, reactogenicity, and the immune response induced by the Pan-Salmonella vaccine.
Who can participate
Age range
18 Years – 45 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 (e.g., completion of the Diary cards, return for follow-up visits).
. Written 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\*.
. A male or female between and including 18 to 45 years of age at the time of the first study intervention administration, and no older than 45 years of age at second dose 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 menopause.
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.
1Since this is a Phase 1 trial focused almost entirely on safety and side effects, what does that mean for how much is already known about whether this vaccine actually protects against Salmonella infection — and is that a concern for me?
2The trial is measuring injection-site reactions, systemic events like fever or fatigue, and blood test changes in kidney, liver, and blood cell levels — based on my personal health history, are any of those monitoring points something I should be especially cautious about?
3The vaccine is being tested with and without an alum adjuvant, which is an ingredient meant to boost immune response — is there anything about my health background that would make one version potentially more or less suitable for me to discuss with the research team?
4This trial is recruiting healthy young adults, so how would my doctor define whether I fit that profile, and are there any conditions I have or medications I take that might conflict with participation?
5Given that this is an early-phase safety study and not yet measuring real-world protection against Salmonella, are there other established vaccines or preventive measures my doctor would recommend I consider alongside or instead of enrolling in this trial?
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
Number of participants with solicited administration site events
Timeframe: From Day 1 to Day 7
2
Number of participants with solicited administration site events
Timeframe: From Day 61 to Day 67
3
Number of participants with solicited administration site events
Timeframe: From Day 181 to Day 187
4
Number of participants with solicited systemic events
Timeframe: From Day 1 to Day 7
5
Number of participants with solicited systemic events
Timeframe: From Day 61 to Day 67
6
Number of participants with solicited systemic events
. Participants of childbearing potential may be enrolled in the study if the participant:
. Negative HLA-B27 testing.
. Body mass index of 18\>= to \<=30 kg/m2 at Screening.
Exclusion criteria
. Known exposure to S. Typhi, S. Paratyphi A, and non-typhoidal Salmonella confirmed by blood culture during the period starting 3 years prior to first study intervention administration as confirmed using medical history.
. History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention.
. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
. Acute or chronic clinically significant pulmonary, cardiovascular, hepatic, or renal functional abnormality, as determined by physical examination or laboratory screening tests.
. Recurrent history or uncontrolled neurological disorders or seizures.
. Any clinically significant hematological and/or biochemical laboratory abnormality.
. Clinical conditions representing a contraindication to intramuscular (IM) injections and/or blood draws.
. Any behavioral or cognitive impairment or psychiatric disease that in the opinion of the Investigator, may interfere with the participant's ability to participate in the study.
Number of participants with unsolicited events
Timeframe: From Day 61 to Day 91
9
Number of participants with unsolicited events
Timeframe: From Day 181 to Day 211
10
Number of participants with serious adverse events (SAEs)
Timeframe: From Day 1 to Day 211
11
Number of participants with adverse events (AEs) or SAEs leading to withdrawal from the study or discontinuation of study intervention
Timeframe: From Day 1 to Day 211
12
Number of participants with changes from baseline or changes from normal values for hematological, renal, and hepatic panels test results
Timeframe: At Day 8
13
Number of participants with changes from baseline or changes from normal values for hematological, renal, and hepatic panels test results
Timeframe: At Day 68
14
Number of participants with changes from baseline or changes from normal values for hematological, renal, and hepatic panels test results