Un ensayo para evaluar la tolerabilidad e inmunogenicidad de V540D en adultos sanos (V540D-004)
Un ensayo de fase 1, aleatorizado, doble ciego, controlado por un comparador y de aumento de dosis para evaluar la tolerabilidad y la inmunogenicidad de V540D en adultos sanos.
Researchers are looking for new ways to prevent cancers related to human papillomavirus (HPV). HPV is a common virus that can cause an infection. There are many different types of HPV. Most people's immune system can fight HPV infection and it goes away without treatment. For some people, HPV infections can last longer and may cause cancer years later.
A standard vaccine to prevent HPV-related cancers is GARDASIL®9 (G9). G9 protects against 9 types of HPV but it does not protect against other types of HPV. The study vaccine (called V540D) is designed to protect against the same HPV types that G9 protects against plus other HPV types. The main goal of this study is to learn about the safety of V540D in healthy adults and if people tolerate it.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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Florida
-
Hollywood, Florida, Estados Unidos, 33024
- Research Centers of America ( Hollywood ) ( Site 0001)
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Georgia
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Savannah, Georgia, Estados Unidos, 31406
- Velocity Clinical Research, Savannah ( Site 0005)
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Missouri
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Kansas City, Missouri, Estados Unidos, 64114
- Alliance for Multispecialty Research, LLC ( Site 0003)
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Tennessee
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Knoxville, Tennessee, Estados Unidos, 37920
- Alliance for Multispecialty Research, LLC ( Site 0004)
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
The key inclusion criteria include but are not limited to the following:
- Is in good health based on medical history, physical examination, vital sign (VS) measurements and electrocardiograms (ECGs) performed before randomization
Exclusion Criteria:
The key exclusion criteria include but are not limited to the following:
- Has a history of abnormal Pap smears, HPV- related external genital lesions (eg, condyloma acuminate, vulval intraepithelial neoplasia (VIN), or prostatic intraepithelial neoplasia (PIN)) or external genital cancer (eg, penile cancer), HPV-related vaginal or anal lesions (eg, condyloma acuminata or vaginal intraepithelial neoplasia (VaIN)) or vaginal or anal cancer
- Has a history of cancer (malignancy)
- Has received any HPV vaccine or is expected to receive any HPV vaccine during the study, outside the protocol
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación Secuencial
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: V540D
Participants will receive vaccinations with V540D. |
Experimental vaccine and adjuvant administered via intramuscular (IM) injection |
|
Comparador activo: GARDASIL®9
Participants will receive vaccinations with GARDASIL®9. |
Suspension administered via IM injection
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Number of Participants Who Experience a Solicited Injection-Site Adverse Event (AE)
Periodo de tiempo: Up to approximately 6 months
|
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. |
Up to approximately 6 months
|
|
Number of Participants Who Experience a Solicited Systemic AE
Periodo de tiempo: Up to approximately 6 months
|
Solicited systemic AEs include headache, fatigue, nausea, dizziness, muscle aches, joint pain. |
Up to approximately 6 months
|
|
Number of Participants Who Experience Immediate Reactions Occurring Within 30 Minutes After Any Vaccination
Periodo de tiempo: Up to approximately 6 months
|
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. |
Up to approximately 6 months
|
|
Number of Participants Who Experience Unsolicited AEs
Periodo de tiempo: Up to approximately 7 months
|
An unsolicited AE is an event that is not predefined as a solicited AE or is predefined as a solicited AE but reported at any time outside the solicited time period. |
Up to approximately 7 months
|
|
Number of Participants Who Experience a Serious Adverse Event (SAE)
Periodo de tiempo: Up to approximately 18 months
|
SAEs include AEs that result in any of the following outcomes: death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. |
Up to approximately 18 months
|
|
Number of Participants Who Experience a Medically-Attended AE (MAAE)
Periodo de tiempo: Up to approximately 18 months
|
AEs in which medical attention is received during an unscheduled, non-routine outpatient visit, such as an emergency department visit, office visit, or an urgent care visit with any medical personnel for any reason. Routine visits are not considered MAAEs. Examples of routine visits include physical examination, wellness visits, or vaccinations. |
Up to approximately 18 months
|
|
Number of Participants Who Experience an Event of Clinical Interest (ECI)
Periodo de tiempo: Up to approximately 18 months
|
ECIs are defined as an overdose of Sponsor's product, drug-induced liver injury events, or potential immune-mediated diseases (pIMDs). |
Up to approximately 18 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Total Immunoglobulin G (IgG) Geometric Mean Ratios (GMRs) for anti-HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58
Periodo de tiempo: Up to approximately 7 months
|
GMR of titers for participants vaccinated with V540D versus those who received GARDASIL®9 alone will be calculated. |
Up to approximately 7 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Medical Director, Merck Sharp & Dohme LLC
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- V540D-004
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
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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