Persistence of Protection by Shingrix

Persistence of Protection Conferred by Shingrix Against Herpes Zoster

Patrocinadores

Patrocinador principal: University of Colorado, Denver

Colaborador: National Institute of Allergy and Infectious Diseases (NIAID)

Fuente University of Colorado, Denver
Resumen breve

The study plans to learn more about how the shingles vaccine, Shingrix (SRX), successfully prevents shingles in older people. Two vaccines are currently approved by the Food and Drug Administration (FDA) to prevent shingles. Zostavax is a live virus vaccine which has been available since 2006 and prevents shingles about 50% of the time, though it is less effective the older a person is when they receive it. Shingrix, which was approved by the FDA in 2017, is not a live virus, but has an additive in the vaccine to boost immune response. It is about 97% effective at preventing shingles regardless of a person's age and so far has been effective for at least 4 years after vaccination. Because Zostavax has live virus in it, giving a "challenge" dose of Zostavax - vOka varicella zoster virus - to people who have received both vaccines (Zostavax or Shingrix) in the past, will allow researchers to learn more about how the body works to prevent shingles and how any shingles vaccination helps protect against shingles.

Estado general Recruiting
Fecha de inicio July 28, 2020
Fecha de Terminación March 2022
Fecha de finalización primaria March 2022
Fase Phase 1
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Magnitude of Varicella-Zoster Virus (VZV) DNAemia Until VZV DNA is undetectable in the blood, measured up to Day 7
Inscripción 140
Condición
Intervención

Tipo de intervención: Biological

Nombre de intervención: Zostavax

Descripción: Intradermal injection of Zostavax

Tipo de intervención: Biological

Nombre de intervención: Shingrix

Descripción: Given to subjects in Arm 4 who've never had a herpes zoster vaccine

Etiqueta de grupo de brazo: No previous ZVL

Elegibilidad

Criterios:

Inclusion Criteria:

- Age 55-89

- General good health

- Women of non-childbearing potential must be postmenopausal or have undergone hysterectomy or bilateral oophorectomy

- ARM 1 ONLY: Documented evidence of immunization with ZVL or SRX at least 5 years previously

- ARM 2 ONLY; Documented evidence of immunization with ZVL 6-12 months prior to enrollment

- ARM 3 ONLY: Have never received any shingles vaccination

Exclusion Criteria:

- Prior history of herpes zoster (HZ)

- Blood products received in the 3 months prior to study enrollment or planned for the subsequent week for Arm 1; Arm 2 requires same exclusion; Arm 3 extends the exclusion to the week after the vOka challenge, which is 6 months after completing SRX administration.

- Significant immune suppressive illness or therapy

- Concomitant vaccine received within 2 (inactive) or 4 (live) weeks prior to the study or during the first week of the study.

- Women of childbearing potential.

- Pregnancy or breastfeeding.

- Participation in a concurrent clinical study in which the subject will be exposed to and investigational product during the period starting 7 days before the first dose of study vaccine through the completion of the study.

Género: All

Edad mínima: 55 Years

Edad máxima: 89 Years

Voluntarios Saludables: Accepts Healthy Volunteers

Oficial general
Apellido Papel Afiliación
Adriana Weinberg, MD Principal Investigator University of Colorado, Denver
Contacto general

Apellido: Nancy Lang, BSN

Teléfono: 303/724-2454

Email: [email protected]

Ubicación
Instalaciones: Estado: Contacto: Copia de seguridad de contactos: Clinical Trials Center at University of Colorado Anschutz Medical Center Nancy Lang, BSN 303-724-2454 [email protected]
Ubicacion Paises

United States

Fecha de verificación

July 2020

Fiesta responsable

Tipo: Sponsor

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Número de brazos 4
Grupo de brazo

Etiqueta: ZVL >5 years previously

Tipo: Active Comparator

Descripción: Participants have received Zostavax (ZVL) at least 5 years previously. Will be administered intradermal vOka varicella zoster virus (ZVL) in non-dominant deltoid. A skin biopsy will be performed at the injection site on 20 subjects.

Etiqueta: ZVL 6-12 months previously

Tipo: Active Comparator

Descripción: Participants who received ZVL 6-12 months previously will be administered an intradermal dose of vOka varicella zoster virus (ZVL) in non-dominant deltoid.

Etiqueta: No previous ZVL

Tipo: Active Comparator

Descripción: Participants who've never received a shingles vaccine will be given the 2 standard doses of RZV. Six months later they will be given the intradermal dose of vOka varicella zoster virus (ZVL) in the non-dominant deltoid.

Etiqueta: SRX >5 years previously

Tipo: Active Comparator

Descripción: Participants have received Shingrix at least 5 years previously. Will be administered intradermal vOka varicella zoster virus (ZVL) in non-dominant deltoid. A skin biopsy will be performed at the injection site on 20 subjects.

Datos del paciente No
Información de diseño del estudio

Asignación: Non-Randomized

Modelo de intervención: Parallel Assignment

Propósito primario: Basic Science

Enmascaramiento: None (Open Label)

Fuente: ClinicalTrials.gov