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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 de julio de 2026 actualizado por: 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.

Descripción general del estudio

Tipo de estudio

Intervencionista

Inscripción (Estimado)

196

Fase

  • Fase 1

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

      • Bloemfontein, Sudáfrica, 9301
        • Reclutamiento
        • GSK Investigational Site
        • Contacto:
        • Contacto:
        • Investigador principal:
          • Edrich Krantz

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto

Acepta Voluntarios Saludables

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Prevención
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación Secuencial
  • Enmascaramiento: Triple

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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.
Experimental: 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.
Experimental: 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.
Experimental: 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.
Comparador de placebos: 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
Otros nombres:
  • TYPHIBEV
Participants receive Placebo (saline solution) as control.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of participants with solicited administration site events
Periodo de tiempo: 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
Periodo de tiempo: From Day 61 to Day 67
From Day 61 to Day 67
Number of participants with solicited administration site events
Periodo de tiempo: From Day 181 to Day 187
From Day 181 to Day 187
Number of participants with solicited systemic events
Periodo de tiempo: 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
Periodo de tiempo: From Day 61 to Day 67
From Day 61 to Day 67
Number of participants with solicited systemic events
Periodo de tiempo: From Day 181 to Day 187
From Day 181 to Day 187
Number of participants with unsolicited events
Periodo de tiempo: 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
Periodo de tiempo: From Day 61 to Day 91
From Day 61 to Day 91
Number of participants with unsolicited events
Periodo de tiempo: From Day 181 to Day 211
From Day 181 to Day 211
Number of participants with serious adverse events (SAEs)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: At Day 188
At Day 188

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of participants with serious adverse events (SAEs)
Periodo de tiempo: 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
Periodo de tiempo: From Day 211 to Day 361
From Day 211 to Day 361
Geometric mean concentration (GMC) of anti-serotype specific immunoglobulin G (IgG) antibody
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: At Day 31, Day 91 and Day 211
At Day 31, Day 91 and Day 211
Adjusted GMC of anti-serotype specific IgG
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

24 de junio de 2026

Finalización primaria (Estimado)

14 de noviembre de 2027

Finalización del estudio (Estimado)

14 de noviembre de 2027

Fechas de registro del estudio

Enviado por primera vez

17 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

17 de junio de 2026

Publicado por primera vez (Actual)

23 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

28 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

26 de julio de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

Descripción del plan 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

Marco de tiempo para compartir 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.

Criterios de acceso compartido de 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.

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • SAVIA
  • CIF
  • RSC

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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