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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

26 lipca 2026 zaktualizowane przez: GlaxoSmithKline

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.

Przegląd badań

Typ studiów

Interwencyjne

Zapisy (Szacowany)

196

Faza

  • Faza 1

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły

Akceptuje zdrowych ochotników

Tak

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Zapobieganie
  • Przydział: Randomizowane
  • Model interwencyjny: Zadanie sekwencyjne
  • Maskowanie: Potroić

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Pan-Salmonella with Alum (Low dose) Group
Participants will receive the low dose level of the candidate Pan-Salmonella-with-aluminium-hydroxide (Alum) vaccine at Days 1, 61 and 181.
Participants receive low dose of the Pan-Salmonella-with-Alum.
Eksperymentalny: Pan-Salmonella with Alum (Full dose) Group
Participants will receive the full dose level of the candidate Pan-Salmonella-with-Alum vaccine at Days 1, 61 and 181.
Participants receive full dose of the Pan-Salmonella-with-Alum.
Eksperymentalny: Pan-Salmonella without Alum (Low dose) Group
Participants will receive the low dose level of the candidate Pan-Salmonella-without-Alum vaccine at Days 1, 61 and 181.
Participants receive low dose of the Pan-Salmonella-without-Alum.
Eksperymentalny: Pan-Salmonella without Alum (Full dose) Group
Participants will receive the full dose level of the candidate Pan-Salmonella-without-Alum vaccine at Days 1, 61 and 181.
Participants receive full dose of the Pan-Salmonella-without-Alum.
Komparator placebo: Control Group
Participants will receive placebo at Days 1 and 181, and Typhoid Vi conjugate vaccine at Day 61.
Participants receive Typhoid Vi conjugate vaccine as control
Inne nazwy:
  • TYPHIBEV
Participants receive Placebo (saline solution) as control.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Number of participants with solicited administration site events
Ramy czasowe: From Day 1 to Day 7
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
Ramy czasowe: From Day 61 to Day 67
From Day 61 to Day 67
Number of participants with solicited administration site events
Ramy czasowe: From Day 181 to Day 187
From Day 181 to Day 187
Number of participants with solicited systemic events
Ramy czasowe: From Day 1 to Day 7
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
Ramy czasowe: From Day 61 to Day 67
From Day 61 to Day 67
Number of participants with solicited systemic events
Ramy czasowe: From Day 181 to Day 187
From Day 181 to Day 187
Number of participants with unsolicited events
Ramy czasowe: From Day 1 to Day 30
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
Ramy czasowe: From Day 61 to Day 91
From Day 61 to Day 91
Number of participants with unsolicited events
Ramy czasowe: From Day 181 to Day 211
From Day 181 to Day 211
Number of participants with serious adverse events (SAEs)
Ramy czasowe: From Day 1 to Day 211
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
Ramy czasowe: From Day 1 to Day 211
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
Ramy czasowe: At Day 8
At Day 8
Number of participants with changes from baseline or changes from normal values for hematological, renal, and hepatic panels test results
Ramy czasowe: At Day 68
At Day 68
Number of participants with changes from baseline or changes from normal values for hematological, renal, and hepatic panels test results
Ramy czasowe: At Day 188
At Day 188

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Number of participants with serious adverse events (SAEs)
Ramy czasowe: From Day 211 to Day 361
From Day 211 to Day 361
Number of participants with AEs/SAEs leading to withdrawal from the study or discontinuation of study intervention
Ramy czasowe: From Day 211 to Day 361
From Day 211 to Day 361
Geometric mean concentration (GMC) of anti-serotype specific immunoglobulin G (IgG) antibody
Ramy czasowe: Pre-intervention at Day 1, Day 61 and Day 181
The GMC will be determined using Enzyme-linked immunosorbent assay (ELISA).
Pre-intervention at Day 1, Day 61 and Day 181
Adjusted GMC of anti-serotype specific IgG antibody
Ramy czasowe: Pre-intervention at Day 1, Day 61 and Day 181
Pre-intervention at Day 1, Day 61 and Day 181
GMC of anti-serotype specific IgG antibody
Ramy czasowe: At Day 31, Day 91 and Day 211
At Day 31, Day 91 and Day 211
Adjusted GMC of anti-serotype specific IgG
Ramy czasowe: At Day 31, Day 91 and Day 211
At Day 31, Day 91 and Day 211
Number of participants with anti-serotype specific IgG antibody concentration fold increase
Ramy czasowe: At Day 31, Day 91 and Day 211 compared with baseline (Day 1)
At least a 4-fold rise will be evaluated.
At Day 31, Day 91 and Day 211 compared with baseline (Day 1)
Number of participants with Anti-Vi Ag IgG antibody concentrations
Ramy czasowe: Pre-dose at Day 1, Day 61 and Day 181
The concentration considered will be equivalent to ≥4.3 microgram per milliliter (μg/mL).
Pre-dose at Day 1, Day 61 and Day 181
Number of participants with Anti-Vi Ag IgG antibody concentrations
Ramy czasowe: At Day 31, Day 91 and Day 211
The concentration considered will be equivalent to ≥4.3 μg/mL
At Day 31, Day 91 and Day 211
Number of participants with Anti-Vi Ag IgG antibody concentrations
Ramy czasowe: Pre-dose at Day 1, Day 61 and Day 181
The concentration considered will be ≥2.0 μg/mL
Pre-dose at Day 1, Day 61 and Day 181
Number of participants with Anti-Vi Ag IgG antibody concentrations
Ramy czasowe: At Day 31, Day 91 and Day 211
The concentration considered will be ≥2.0 μg/mL.
At Day 31, Day 91 and Day 211

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

24 czerwca 2026

Zakończenie podstawowe (Szacowany)

14 listopada 2027

Ukończenie studiów (Szacowany)

14 listopada 2027

Daty rejestracji na studia

Pierwszy przesłany

17 czerwca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

17 czerwca 2026

Pierwszy wysłany (Rzeczywisty)

23 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

28 lipca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

26 lipca 2026

Ostatnia weryfikacja

1 lipca 2026

Więcej informacji

Terminy związane z tym badaniem

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu IPD

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

Ramy czasowe udostępniania IPD

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.

Kryteria dostępu do udostępniania IPD

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.

Typ informacji pomocniczych dotyczących udostępniania IPD

  • PROTOKÓŁ BADANIA
  • SOK ROŚLINNY
  • ICF
  • CSR

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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