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

NCT07663032 | Recruiting Phase 1 DMC

• 1 other identifier: 300281
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Salmonella Infections

Keywords

GVGH Quadrivalent Pan-Salmonella vaccine; Salmonella (S.) Typhi; S. Paratyphi A; S. Typhimurium (STm); S. Enteritidis (SEn); Immunogenicity; Reactogenicity; Safety

Outcome Measures

Primary Outcomes (14)

• Number of participants with solicited administration site events

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

  From Day 1 to Day 7

• Number of participants with solicited administration site events

  From Day 61 to Day 67

• Number of participants with solicited administration site events

  From Day 181 to Day 187

• Number of participants with solicited systemic events

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

  From Day 1 to Day 7

• Number of participants with solicited systemic events

  From Day 61 to Day 67

• Number of participants with solicited systemic events

  From Day 181 to Day 187

• 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.

  From Day 1 to Day 30

• Number of participants with unsolicited events

  From Day 61 to Day 91

• Number of participants with unsolicited events

  From Day 181 to Day 211

• 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.

  From Day 1 to Day 211

• Number of participants with adverse events (AEs) or SAEs leading to withdrawal from the study or discontinuation of study intervention

  From Day 1 to Day 211

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

  At Day 8

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

  At Day 68

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

  At Day 188

Secondary Outcomes (11)

• Number of participants with serious adverse events (SAEs)

  From Day 211 to Day 361

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

  From Day 211 to Day 361

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

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

• Adjusted GMC of anti-serotype specific IgG antibody

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

• GMC of anti-serotype specific IgG antibody

  At Day 31, Day 91 and Day 211

Study Arms (5)

Pan-Salmonella with Alum (Low dose) Group

EXPERIMENTAL

Participants will receive the low dose level of the candidate Pan-Salmonella-with-aluminium-hydroxide (Alum) vaccine at Days 1, 61 and 181.

Biological: Pan-Salmonella-with-Alum (Low dose) vaccine

Pan-Salmonella with Alum (Full dose) Group

EXPERIMENTAL

Participants will receive the full dose level of the candidate Pan-Salmonella-with-Alum vaccine at Days 1, 61 and 181.

Biological: Pan-Salmonella-with-Alum (Full dose) vaccine

Pan-Salmonella without Alum (Low dose) Group

EXPERIMENTAL

Participants will receive the low dose level of the candidate Pan-Salmonella-without-Alum vaccine at Days 1, 61 and 181.

Biological: Pan-Salmonella-without-Alum (Low dose) vaccine

Pan-Salmonella without Alum (Full dose) Group

EXPERIMENTAL

Participants will receive the full dose level of the candidate Pan-Salmonella-without-Alum vaccine at Days 1, 61 and 181.

Biological: Pan-Salmonella-without-Alum (Full dose) vaccine

Control Group

PLACEBO COMPARATOR

Participants will receive placebo at Days 1 and 181, and Typhoid Vi conjugate vaccine at Day 61.

Biological: Typhoid Vi conjugate vaccine; Other: Placebo

Interventions

Pan-Salmonella-with-Alum (Low dose) vaccine BIOLOGICAL

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

Pan-Salmonella with Alum (Low dose) Group

Pan-Salmonella-with-Alum (Full dose) vaccine BIOLOGICAL

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

Pan-Salmonella with Alum (Full dose) Group

Pan-Salmonella-without-Alum (Low dose) vaccine BIOLOGICAL

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

Pan-Salmonella without Alum (Low dose) Group

Pan-Salmonella-without-Alum (Full dose) vaccine BIOLOGICAL

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

Pan-Salmonella without Alum (Full dose) Group

Typhoid Vi conjugate vaccine BIOLOGICAL

Participants receive Typhoid Vi conjugate vaccine as control

Also known as: TYPHIBEV

Control Group

Placebo OTHER

Participants receive Placebo (saline solution) as control.

Control Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Bloemfontein, 9301, South Africa

RECRUITING

MeSH Terms

Conditions

Salmonella Infections

Interventions

Vaccines

Condition Hierarchy (Ancestors)

Enterobacteriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Biological Products; Complex Mixtures

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2026
• First Posted: June 23, 2026
• Study Start: June 24, 2026
• Primary Completion (Estimated): November 14, 2027
• Study Completion (Estimated): November 14, 2027
• Last Updated: July 28, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.

Locations

ZA (1)