Last updated: 06/17/2026 13:00:11
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
GSK study ID
300281
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Not yet recruiting
Not yet recruiting
Trial overview
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
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Sequential Assignment
Masking:
Triple (Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Number of participants with solicited administration site events
Timeframe: From Day 1 to Day 7
Number of participants with solicited administration site events
Timeframe: From Day 61 to Day 67
Number of participants with solicited administration site events
Timeframe: From Day 181 to Day 187
Number of participants with solicited systemic events
Timeframe: From Day 1 to Day 7
Number of participants with solicited systemic events
Timeframe: From Day 61 to Day 67
Number of participants with solicited systemic events
Timeframe: From Day 181 to Day 187
Number of participants with unsolicited events
Timeframe: From Day 1 to Day 30
Number of participants with unsolicited events
Timeframe: From Day 61 to Day 91
Number of participants with unsolicited events
Timeframe: From Day 181 to Day 211
Number of participants with serious adverse events (SAEs)
Timeframe: 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
Timeframe: 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
Timeframe: At Day 8
Number of participants with changes from baseline or changes from normal values for hematological, renal, and hepatic panels test results
Timeframe: At Day 68
Number of participants with changes from baseline or changes from normal values for hematological, renal, and hepatic panels test results
Timeframe: At Day 188
Secondary outcomes:
Number of participants with serious adverse events (SAEs)
Timeframe: From Day 211 to Day 361
Number of participants with AEs/SAEs leading to withdrawal from the study or discontinuation of study intervention
Timeframe: From Day 211 to Day 361
Geometric mean concentration (GMC) of anti-serotype specific immunoglobulin G (IgG) antibody
Timeframe: Pre-intervention at Day 1, Day 61 and Day 181
Adjusted GMC of anti-serotype specific IgG antibody
Timeframe: Pre-intervention at Day 1, Day 61 and Day 181
GMC of anti-serotype specific IgG antibody
Timeframe: At Day 31, Day 91 and Day 211
Adjusted GMC of anti-serotype specific IgG
Timeframe: At Day 31, Day 91 and Day 211
Number of participants with anti-serotype specific IgG antibody concentration fold increase
Timeframe: At Day 31, Day 91 and Day 211 compared with baseline (Day 1)
Number of participants with Anti-Vi Ag IgG antibody concentrations
Timeframe: Pre-dose at Day 1, Day 61 and Day 181
Number of participants with Anti-Vi Ag IgG antibody concentrations
Timeframe: At Day 31, Day 91 and Day 211
Number of participants with Anti-Vi Ag IgG antibody concentrations
Timeframe: Pre-dose at Day 1, Day 61 and Day 181
Number of participants with Anti-Vi Ag IgG antibody concentrations
Timeframe: At Day 31, Day 91 and Day 211
Interventions:
Biological/vaccine: Pan-Salmonella-with-Alum (Low dose) vaccine
Biological/vaccine: Pan-Salmonella-with-Alum (Full dose) vaccine
Biological/vaccine: Pan-Salmonella-without-Alum (Low dose) vaccine
Biological/vaccine: Pan-Salmonella-without-Alum (Full dose) vaccine
Biological/vaccine: Typhoid Vi conjugate vaccine
Other: Placebo
Enrollment:
196
Observational study model:
Not applicable
Primary completion date:
2027-14-11
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Salmonella Infections
Product
Not applicable
Collaborators
Not applicable
Study date(s)
June 2026 to November 2027
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 45 Years
Accepts healthy volunteers
Yes
- 1. 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).
- 2. Written informed consent obtained from the participant prior to performance of any study specific procedure.
- Medical Conditions:
- 1. 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.
Inclusion and exclusion criteria
Inclusion criteria:
- 1. 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). 2. Written informed consent obtained from the participant prior to performance of any study specific procedure. 3. 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. 4. 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. 5. 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. 6. 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. 7. Negative HLA-B27 testing. 8. Body mass index of 18>= to <=30 kg/m2 at Screening. 9. Living in the study area and plan to remain in the study area for the study duration.
Exclusion criteria:
- Medical Conditions: 1. 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. 2. History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention. 3. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). 4. Acute or chronic clinically significant pulmonary, cardiovascular, hepatic, or renal functional abnormality, as determined by physical examination or laboratory screening tests. 5. Recurrent history or uncontrolled neurological disorders or seizures. 6. Any clinically significant hematological and/or biochemical laboratory abnormality. 7. Clinical conditions representing a contraindication to intramuscular (IM) injections and/or blood draws. 8. 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. 9. Acute or chronic illness which may be severe enough to preclude participation. 10. 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: 11. History of receiving any typhoid vaccine (Ty21a, Vi capsular polysaccharide, or TCV) in the participant’s life. 12. History of receiving any investigational iNTS, S. Paratyphi A, or GMMA vaccines in the participant’s life. 13. 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. 14. 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. 15. Administration of long-acting immune-modifying drugs (e.g., infliximab) at any time during the study period. 16. 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. 17. 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: 18. 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: 19. Pregnant or lactating female. 20. Female planning to become pregnant or planning to discontinue contraceptive precautions. 21. History of/current chronic alcohol consumption and/or drug abuse. This will be decided at the discretion of the Investigator. 22. Any study personnel or their immediate dependents, family, or household members.
Trial location(s)
No location data available.
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Not yet recruiting
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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