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Salmonella InfectionsPhase 1NCT07663032

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

A Phase 1 study testing Pan-Salmonella-with-Alum (Low dose) vaccine, Pan-Salmonella-with-Alum (Full dose) vaccine and Pan-Salmonella-without-Alum (Low dose) vaccine in people with Salmonella Infections, run by GlaxoSmithKline at 1 site in South Africa.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Salmonella Infections
What is being tested?
Pan-Salmonella-with-Alum (Low dose) vaccine, Pan-Salmonella-with-Alum (Full dose) vaccine and Pan-Salmonella-without-Alum (Low dose) vaccine
Type of treatment
Vaccines
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
196 participants
Where
1 siteSouth Africa
Study dates
24 Jun 2026to 14 Nov 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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*.
  • Hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies, and human immunodeficiency virus (HIV) antibodies will also be tested at Screening.
  • 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.
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  • Participants of childbearing potential may be enrolled in the study if the participant:
  • Has practiced adequate contraception (as indicated in Section 10.5) for at least 30 days prior to study intervention administration, and
  • Has a negative pregnancy test within 24 hours prior to the study intervention administration, and
  • Has agreed to continue adequate contraception during the entire treatment period and for 8 weeks after completion of the study intervention administration series.
  • Negative HLA-B27 testing.
  • Body mass index of 18>= to <=30 kg/m2 at Screening.
  • Living in the study area and plan to remain in the study area for the study duration.

Who cannot join

  • Medical Conditions:
  • 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.
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  • 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.
  • Acute or chronic illness which may be severe enough to preclude participation.
  • Any other clinical condition that, in the opinion of the Investigator, might pose additional risk to the participant due to participation in the study.
  • Prior/Concomitant Therapy:
  • History of receiving any typhoid vaccine (Ty21a, Vi capsular polysaccharide, or TCV) in the participant's life.
  • History of receiving any investigational iNTS, S. Paratyphi A, or GMMA vaccines in the participant's life.
  • Use of any investigational or non-registered product (drug, vaccine, or medical device) other than the study interventions during the period beginning 30 days (Days -30 to 1) before the first dose of study interventions, or their planned use during the study period.
  • Use of herbs and traditional treatments is not considered an exclusion criterion.
  • A vaccine not foreseen by the study protocol administered during the period starting at 14 days before the first dose and ending 30 days after the last dose of study interventions administration, with the exception of flu vaccines or Coronavirus disease 2019 vaccine.
  • Administration of long-acting immune-modifying drugs (e.g., infliximab) at any time during the study period.
  • Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 3 months before the administration of the first dose of study interventions or planned administration during the study period.
  • Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting 3 months prior to the first study intervention dose(s). For corticosteroids, this will be prednisone equivalent >=20 mg/day for adult participants. Inhaled and topical steroids are allowed.
  • Prior/Concurrent Clinical Study Experience:
  • Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention (vaccine and drug).
  • Other Exclusions:
  • Pregnant or lactating female.
  • Female planning to become pregnant or planning to discontinue contraceptive precautions.
  • History of/current chronic alcohol consumption and/or drug abuse. This will be decided at the discretion of the Investigator.
  • Any study personnel or their immediate dependents, family, or household members.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

US GSK Clinical Trials Call Center contact

877-379-3718

GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center contact

+44 (0) 20 89904466

GSKClinicalSupportHD@gsk.com

South Africa1 site, 1 recruiting
  • GSK Investigational Site

    Bloemfontein, 9301

    US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com

    EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com

    Recruiting

Other trials in South Africa

About this study

Official title: A Phase 1, Randomized, Controlled, Observer-blind Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of the GVGH Quadrivalent Pan-Salmonella Vaccine With and Without Alum in Healthy Adults 18 to 45 Years of Age in Africa

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.

Being tested
Pan-Salmonella-with-Alum (Low dose) vaccine, Pan-Salmonella-with-Alum (Full dose) vaccine, Pan-Salmonella-without-Alum (Low dose) vaccine, Pan-Salmonella-without-Alum (Full dose) vaccine, Typhoid Vi conjugate vaccine
Keywords
GVGH Quadrivalent Pan-Salmonella vaccine, Salmonella (S.) Typhi, S. Paratyphi A, S. Typhimurium (STm), S. Enteritidis (SEn), Immunogenicity, Reactogenicity, Safety
Medical subject headings
Salmonella Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pan-Salmonella-with-Alum (Low dose) vaccineBiological

    Participants receive low dose of the Pan-Salmonella-with-Alum.

  • Pan-Salmonella-with-Alum (Full dose) vaccineBiological

    Participants receive full dose of the Pan-Salmonella-with-Alum.

  • Pan-Salmonella-without-Alum (Low dose) vaccineBiological

    Participants receive low dose of the Pan-Salmonella-without-Alum.

  • Pan-Salmonella-without-Alum (Full dose) vaccineBiological

    Participants receive full dose of the Pan-Salmonella-without-Alum.

  • Typhoid Vi conjugate vaccineBiological

    Also called TYPHIBEV

    Participants receive Typhoid Vi conjugate vaccine as control

  • PlaceboOther

    Participants receive Placebo (saline solution) as control.

Study groups in NCT07663032
Study groupRoleWhat they receive
Pan-Salmonella with Alum (Low dose) GroupExperimentalParticipants will receive the low dose level of the candidate Pan-Salmonella-with-aluminium-hydroxide (Alum) vaccine at Days 1, 61 and 181.
Receives: Biological: Pan-Salmonella-with-Alum (Low dose) vaccine
Pan-Salmonella with Alum (Full dose) GroupExperimentalParticipants will receive the full dose level of the candidate Pan-Salmonella-with-Alum vaccine at Days 1, 61 and 181.
Receives: Biological: Pan-Salmonella-with-Alum (Full dose) vaccine
Pan-Salmonella without Alum (Low dose) GroupExperimentalParticipants will receive the low dose level of the candidate Pan-Salmonella-without-Alum vaccine at Days 1, 61 and 181.
Receives: Biological: Pan-Salmonella-without-Alum (Low dose) vaccine
Pan-Salmonella without Alum (Full dose) GroupExperimentalParticipants will receive the full dose level of the candidate Pan-Salmonella-without-Alum vaccine at Days 1, 61 and 181.
Receives: Biological: Pan-Salmonella-without-Alum (Full dose) vaccine
Control GroupPlacebo comparatorParticipants will receive placebo at Days 1 and 181, and Typhoid Vi conjugate vaccine at Day 61.
Receives: Biological: Typhoid Vi conjugate vaccine; Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with solicited administration site events

    Assessed solicited administration site events will be pain, redness and swelling.

    Measured: From Day 1 to Day 7

  2. Number of participants with solicited administration site events

    Measured: From Day 61 to Day 67

  3. Number of participants with solicited administration site events

    Measured: From Day 181 to Day 187

  4. Number of participants with solicited systemic events

    Assessed solicited systemic events will be fever, headache, myalgia, arthralgia and fatigue.

    Measured: From Day 1 to Day 7

  5. Number of participants with solicited systemic events

    Measured: From Day 61 to Day 67

  6. Number of participants with solicited systemic events

    Measured: From Day 181 to Day 187

  7. Number of participants with unsolicited events

    An unsolicited adverse event (AE) is an AE that was either not included in the list of solicited AEs, or could. be included in the list of solicited AEs but with an onset outside the specified period of. follow-up for solicited AEs. Unsolicited AEs must have been communicated by participants who have signed informed consent. Unsolicited AEs include serious and non-serious AEs.

    Measured: From Day 1 to Day 30

  8. Number of participants with unsolicited events

    Measured: From Day 61 to Day 91

  9. Number of participants with unsolicited events

    Measured: From Day 181 to Day 211

  10. Number of participants with serious adverse events (SAEs)

    An SAE is defined as any untoward medical occurrence that, at any dose, results in persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening, or results in death.

    Measured: 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

    Measured: 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

    Measured: At Day 8

  13. Number of participants with changes from baseline or changes from normal values for hematological, renal, and hepatic panels test results

    Measured: At Day 68

  14. Number of participants with changes from baseline or changes from normal values for hematological, renal, and hepatic panels test results

    Measured: At Day 188

Secondary outcomes (11)
  1. Number of participants with serious adverse events (SAEs)

    Measured: From Day 211 to Day 361

  2. Number of participants with AEs/SAEs leading to withdrawal from the study or discontinuation of study intervention

    Measured: From Day 211 to Day 361

  3. Geometric mean concentration (GMC) of anti-serotype specific immunoglobulin G (IgG) antibody

    The GMC will be determined using Enzyme-linked immunosorbent assay (ELISA).

    Measured: Pre-intervention at Day 1, Day 61 and Day 181

  4. Adjusted GMC of anti-serotype specific IgG antibody

    Measured: Pre-intervention at Day 1, Day 61 and Day 181

  5. GMC of anti-serotype specific IgG antibody

    Measured: At Day 31, Day 91 and Day 211

  6. Adjusted GMC of anti-serotype specific IgG

    Measured: At Day 31, Day 91 and Day 211

  7. Number of participants with anti-serotype specific IgG antibody concentration fold increase

    At least a 4-fold rise will be evaluated.

    Measured: At Day 31, Day 91 and Day 211 compared with baseline (Day 1)

  8. Number of participants with Anti-Vi Ag IgG antibody concentrations

    The concentration considered will be equivalent to ≥4.3 microgram per milliliter (μg/mL).

    Measured: Pre-dose at Day 1, Day 61 and Day 181

  9. Number of participants with Anti-Vi Ag IgG antibody concentrations

    The concentration considered will be equivalent to ≥4.3 μg/mL

    Measured: At Day 31, Day 91 and Day 211

  10. Number of participants with Anti-Vi Ag IgG antibody concentrations

    The concentration considered will be ≥2.0 μg/mL

    Measured: Pre-dose at Day 1, Day 61 and Day 181

  11. Number of participants with Anti-Vi Ag IgG antibody concentrations

    The concentration considered will be ≥2.0 μg/mL.

    Measured: At Day 31, Day 91 and Day 211

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jun 2026
  2. Study start24 Jun 2026
  3. Primary completion14 Nov 2027 (estimated)
  4. Study completion14 Nov 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Sequential
Masking
Triple blind
Who is masked
Care provider, Investigator, Outcomes assessor
Enrolment
196 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07663032
Sponsor's protocol ID
300281
Status last verified
Jul 2026
First submitted
17 Jun 2026
Last updated
28 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.pdf

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Pan-Salmonella-with-Alum (Low dose) vaccine, Pan-Salmonella-with-Alum (Full dose) vaccine and Pan-Salmonella-without-Alum (Low dose) vaccine in people with Salmonella Infections, run by GlaxoSmithKline at 1 site in South Africa.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact US GSK Clinical Trials Call Center (877-379-3718, GSKClinicalSupportHD@gsk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with solicited administration site events (time frame: From Day 1 to Day 7). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.

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