Un estudio de fase 2 para evaluar JCXH-105, una vacuna contra el herpes zóster basada en SrRNA
Un estudio de fase 2, aleatorizado, triple ciego y controlado de forma activa para evaluar la seguridad y la inmunogenicidad de una vacuna en investigación contra el herpes zóster (HZ), JCXH-105, en sujetos sanos ≥ 50 años de edad
The goal of this clinical trial is to assess the safety and immunogenicity of an srRNA-based vaccine, JCXH-105, in the prevention of Herpes Zoster (Shingles).
Subjects will be randomized to receive either JCXH-105 or Shingrix.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This Phase 2 study plans to enroll a total of 460 subjects.
This will be an active-controlled study in healthy male and/or female subjects 50 years of age or older. Subjects will be randomized 1:1 to receive either JCXH-105 or Shingrix. The study vaccine will be administered in two doses approximately 2 months apart. The subject will receive a single intramuscular (IM) injection of JCXH-105 or Shingrix on Day 1 (Dose 1) and again on Day 61 ± 7 days (Dose 2). For each subject, Dose 1 and Dose 2 are the same study vaccine based on randomization on Day 1. A total of 460 subjects will be enrolled into this trial and vaccinated with either JCXH-105 (n=230) or Shingrix (n=230).
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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Arizona
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Tucson, Arizona, Estados Unidos, 85704
- Noble Clinical Research
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California
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Long Beach, California, Estados Unidos, 90805
- Long Beach Research Institute
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Illinois
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Chicago, Illinois, Estados Unidos, 60652
- DM Clinical Research - Chicago
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Nebraska
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Omaha, Nebraska, Estados Unidos, 68114
- Quality Clinical Research
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New Jersey
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Jersey City, New Jersey, Estados Unidos, 07306
- DM Clinical Research - New Jersey
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South Carolina
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Charleston, South Carolina, Estados Unidos, 29407
- Delricht Research
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Texas
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Prosper, Texas, Estados Unidos, 75078
- Delricht Research
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Sugar Land, Texas, Estados Unidos, 77478
- DM Clinical Research - Sugarland
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Key Inclusion Criteria:
- Sex: Male or female; female subjects may be of childbearing potential, of nonchildbearing potential, or postmenopausal.
- Age: ≥ 50 years of age at screening.
- Status: Healthy subjects.
- Subjects must agree to not be vaccinated with any HZ vaccine while participating in this study.
- Subjects must agree to not be vaccinated with any RNA-based vaccines (e.g., Spikevax, Comirnaty, etc.) 30 days before Dose 1 through 30 days after Dose 2 (a 4-month period).
Key Exclusion Criteria:
- Subjects with a history of HZ within the past 10 years or current diagnosis of HZ.
- Previous vaccination against HZ.
- Subjects with any respiratory illness deemed clinically relevant by the Investigator within the past month OR hospitalization >24 hours for any reason within the past month prior to the first vaccine administration (JCXH-105 or Shingrix).
- Subjects who are acutely ill or febrile with body temperature ≥ 38.0º Celsius/100.4º Fahrenheit 72 hours prior to or at the Screening visit or on Day 1 pre-dose. Subjects meeting this criterion may be rescheduled within an allowable window with approval from the Sponsor.
- Subjects with history or current diagnosis of congenital or acquired immunodeficiency/immunocompromising/immunosuppressive conditions, asplenia, or recurrent severe infections. Certain immune-mediated conditions (e.g., Hashimoto thyroiditis) that are well controlled and stable are allowed.
- Subjects with history of myocarditis or pericarditis, or with AEs (including anaphylaxis and severe hypersensitivity) after mRNA vaccination that are in nature and severity beyond the common expected AEs and necessitating medical intervention.
- Subjects who received any non-live vaccine within 14 days prior to Day 1 (first dose of JCXH-105 or Shingrix).
- Subjects who received within 28 days prior to Day 1 (first dose of JCXH-105 or Shingrix): (1) Any live vaccine, (2) Immunomodulators or immune-suppressive medication, (3) Granulocyte or granulocyte-macrophage colony-stimulating factor, (4) Three or more consecutive days of systemic corticosteroids. Note: subjects on stable-dose steroid replacement (for chronic disease such as iatrogenic deficiency) of prednisone ≤10 mg/day or equivalent are allowed and (5) Other investigational agents or devices.
- Subjects receiving systemic antiviral therapy.
- Subjects with a positive screening test for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies, anti-human HIV-1 and 2 antibodies, or syphilis.
- Subjects with a positive screening test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Investigational Product
Participants randomized to this arm will be given the investigational product (JCXH-105). |
IM injection |
|
Comparador activo: Active Control
Participants randomized to this arm will be given the FDA approved Shingrix. |
IM injection |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
SAE Frequency
Periodo de tiempo: Day 1 - Day 241 (Week 34)
|
Frequency of SAEs characterized by type, severity, duration, and relationship to the vaccine recorded from Day 1 post-vaccine administration through follow-up completion. |
Day 1 - Day 241 (Week 34)
|
|
Solicited local reaction frequency
Periodo de tiempo: Day 1 - Day 7 (After Dose 1), Day 1 - Day 7 (After Dose 2)
|
Occurrence of solicited local injection site reactions characterize by frequency, severity, and duration within 7 days after each vaccine administration. |
Day 1 - Day 7 (After Dose 1), Day 1 - Day 7 (After Dose 2)
|
|
Solicited systemic reaction frequency
Periodo de tiempo: Day 1 - Day 7 (After Dose 1), Day 1 - Day 7 (After Dose 2)
|
Occurrence of solicited systemic reactions characterize by frequency, severity, and duration within 7 days after each vaccine administration. |
Day 1 - Day 7 (After Dose 1), Day 1 - Day 7 (After Dose 2)
|
|
AE Frequency
Periodo de tiempo: Day 1 - Day 241 (Week 34)
|
Adverse events (AEs) including unsolicited AEs and any AEs leading to discontinuation of study vaccine or withdrawal from the study, characterized by frequency, severity, duration, and relationship to the vaccine from Day 1 post-vaccine administration through follow-up completion. |
Day 1 - Day 241 (Week 34)
|
|
AESIs Frequency
Periodo de tiempo: Day 1 - Day 241 (Week 34)
|
AESIs characterized by frequency, severity, duration, and relationship to the vaccine from Day 1 post-vaccine administration through follow-up completion. |
Day 1 - Day 241 (Week 34)
|
|
Medically Attended AE Frequency
Periodo de tiempo: Day 1 - Day 241 (Week 34)
|
Medically attended AEs (MAAEs) characterized by frequency, severity, duration, and relationship to the vaccine from Day 1 post-vaccine administration through follow-up completion. |
Day 1 - Day 241 (Week 34)
|
|
Immune-Mediated Adverse Events of Special Interest Frequency
Periodo de tiempo: Day 1 - Day 241 (Week 34)
|
Immune-mediated adverse events of special interest (imAESIs) characterized by frequency, severity, duration, and relationship to the vaccine (JCXH-105 or Shingrix) recorded from Day 1 post-vaccine administration through follow-up completion. |
Day 1 - Day 241 (Week 34)
|
|
gE-Specific CD4+ T cell Response Rate
Periodo de tiempo: Day 1 - Day 89 (Week 13)
|
Response Rate is defined at the percentage of subjects with ≥ 2 folds increase of gE-specific CD4+ T cells expressing 2 or more markers of activation (IFN-γ, IL-2, TNFα, and CD40L) in PBMCs analyzed with flow cytometry with ICS on Day 89 as compared to baseline (Day 1 pre-dose). |
Day 1 - Day 89 (Week 13)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Cellular immunogenicity of JCXH-105
Periodo de tiempo: Day 1 - Day 241 (Week 34)
|
Frequency of glycoprotein E (gE)-specific CD4+ T cells expressing 2 or more markers of activation (IFN-γ, IL-2, TNF-α, and CD40L) in PBMCs analyzed by flow cytometry with ICS on Day 29, Day 89, and Day 241 as compared to baseline (Day 1 pre-dose). |
Day 1 - Day 241 (Week 34)
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Cellular Immunogenicity of JCXH-105
Periodo de tiempo: Day 1 - Day 241 (Week 34)
|
Frequency of gE-specific CD8+ T cells expressing 2 or more markers of activation (IFN-γ, IL-2, TNF-α, and CD40L) in PBMCs analyzed by flow cytometry on Day 29, Day 89, and Day 241 as compared to baseline (Day 1 pre-dose). |
Day 1 - Day 241 (Week 34)
|
|
Humoral immunogenicity of JCXH-105
Periodo de tiempo: Day 1 - Day 241 (Week 34)
|
Changes in serum of anti-gE-specific antibody geometric mean titers (GMTs) analyzed with enzyme-linked immunosorbent assay (ELISA) on Day 29, Day 89, and Day 241 as compared to baseline (D1 pre-dose). |
Day 1 - Day 241 (Week 34)
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- JCXH-105-021
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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