Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

Safety of and Immune Response to Recombinant Live Attenuated Parainfluenza Type 3 Virus Vaccine in Healthy Infants and Children

31 de diciembre de 2012 actualizado por: National Institute of Allergy and Infectious Diseases (NIAID)

Phase I Study to Determine the Safety, Infectivity, and Tolerability of 2 Doses of Live Attenuated Recombinant Cold-Passaged (cp) 45 Human Parainfluenza Type 3 Virus Vaccine, rHPIV3cp45, Lot PIV3#102A, Delivered as Nose Drops to HPIV3-Seronegative Infants and Children 6 to 36 Months of Age, at a 6 Month Interval

Human parainfluenza viruses (HPIVs) are a major health concern in infants and young children under 5 years of age, causing serious respiratory tract disease. The primary purpose of this study is to test the safety of and immune response to a new HPIV vaccine in healthy infants and children.

Descripción general del estudio

Descripción detallada

HPIV type 3 (HPIV3) ranks second only to respiratory syncytial virus as the most important cause of bronchiolitis and pneumonia in infants less than 6 months of age. HPIV3 can cause severe disease in the first 2 years of life and is responsible for 11% of hospitalizations for respiratory diseases in children. This study will evaluate the safety and immunogenicity of a live recombinant attenuated intranasal HPIV3 vaccine, rHPIV3cp45.

This study will last for approximately 28 weeks. Infants and children 6 months to 36 months of age will be randomly assigned to one of two groups. Group 1 participants will receive 2 immunizations of rHPIV3cp45. Group 2 participants will receive 2 doses of rHPIV3cp45 placebo. Immunizations will be given as nose drops and administered at study entry and approximately 22 to 27 weeks after study entry.

On the day of immunization, a physical exam and blood collection will occur. Participants will be observed for 15 minutes after immunization for any immediate adverse effects. Parents or guardians will be given a thermometer to take with them and will be instructed on how to take their child's temperature. They will be given the study schedule and will need to provide contact phone numbers so study personnel can contact them by phone during the days after immunization. Parents and guardians will be contacted by telephone daily from Day 1 to Day 18 after each immunization.

Parents or guardians will need to record their child's temperature daily for at least 17 days immediately following immunization. During this 17-day period, study visits will occur on Days 3, 6, and 12 after each dose of vaccine or placebo. Participants will undergo a nasal wash for a viral culture at all study visits. There will be additional follow-up visits occurring sometime between 49 and 63 days after the first dose and 28 to 35 days after the second dose; blood collection will occur at the follow-up visits. Additional visits may be required on selected days during the month after immunization. Infants who experience illness or side effects may be asked to return to the clinic for examination.

Tipo de estudio

Intervencionista

Inscripción (Actual)

12

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.

Ubicaciones de estudio

    • Maryland
      • Baltimore, Maryland, Estados Unidos, 21205
        • Center for Immunization Research (CIR), Johns Hopkins School of Public Health
    • Washington
      • Seattle, Washington, Estados Unidos, 98105
        • Seattle Children's Hospital

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

6 meses a 3 años (Niño)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Good general health
  • HPIV3-uninfected
  • Has received age-appropriate inactivated or subunit routine immunizations at least 2 weeks prior to study entry
  • Has received age-appropriate live routine immunizations at least 4 weeks prior to study entry and at least 2 weeks for rotavirus and inactivated vaccines
  • Available for the duration of the trial
  • Parent or guardian reachable by telephone for post-immunization contact
  • Parent or guardian willing to provide informed consent

Exclusion Criteria:

  • Known or suspected impairment of immunologic functions. Infants who are HIV-infected, who are bone marrow or solid organ transplant recipients, or who have received immunosuppressive therapy, including systemic corticosteroids within 30 days prior to study entry. Infants who are using topical steroids, topical antibiotic ointments and topical antifungal agents are not excluded.
  • Major congenital malformations, including congenital cleft palate, cytogenetic abnormalities, or serious chronic disorders
  • Previously received HPIV3 vaccine
  • Previous serious vaccine-associated adverse event or anaphylactic reaction
  • Known hypersensitivity to any vaccine component
  • Lung or heart disease, including reactive airway disease. Infants with clinically insignificant cardiac abnormalities are not excluded. Infants or children who wheezed once or received bronchodilator therapy once in the first year of life but who have not had any additional wheezing episodes or bronchodilator therapy for at least 12 months are not excluded.
  • Born prematurely before the 37th week of pregnancy if participant is currently less than 12 months of age
  • Member of a household containing immunocompromised individuals, pregnant caregivers, or infants less than 6 months of age
  • Attends day care with infants less than 6 months of age
  • Parent or guardian unable or unwilling to suspend daycare for 14 days following each immunization. More information on this criterion can be found in the protocol.
  • Enrolled in another investigational drug or vaccine study from 30 days prior to study entry until the final follow-up blood draw

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 paralela
  • Enmascaramiento: Triple

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 1
Participants will receive one dose of vaccine virus at study entry and between Weeks 22 and 27
10^5 TCID50 nasal drops
Comparador de placebos: 2
Participants will receive one dose of vaccine virus placebo at study entry and between Weeks 22 and 27
1X-L15 nasal drops

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
Frecuencia de eventos de reactogenicidad relacionados con la vacuna y otros eventos adversos
Periodo de tiempo: A lo largo del estudio
A lo largo del estudio
Amount of serum antibody induced by vaccine in each recipient
Periodo de tiempo: Throughout study
Throughout study

Medidas de resultado secundarias

Medida de resultado
Periodo de tiempo
Estabilidad fenotípica del virus vacunal excretado
Periodo de tiempo: A lo largo del estudio
A lo largo del estudio
Amount of vaccine virus shed by each recipient
Periodo de tiempo: Throughout study
Throughout study
Immunogenicity of a second dose of vaccine and the protection of the first dose against re-infection with the second dose
Periodo de tiempo: From Weeks 22 to 28
From Weeks 22 to 28
Number of vaccinated infants infected with rHPIV3cp45
Periodo de tiempo: Throughout study
Throughout study
Number of vaccinated participants infected with a second dose of rHPIV3cp45
Periodo de tiempo: From Weeks 22 to 28
From Weeks 22 to 28

Colaboradores e Investigadores

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

Investigadores

  • Silla de estudio: Ruth A. Karron, MD, Center for Immunization Research, Johns Hopkins University School of Public Health

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

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

1 de noviembre de 2009

Finalización primaria (Actual)

1 de diciembre de 2011

Finalización del estudio (Actual)

1 de diciembre de 2011

Fechas de registro del estudio

Enviado por primera vez

25 de noviembre de 2009

Primero enviado que cumplió con los criterios de control de calidad

25 de noviembre de 2009

Publicado por primera vez (Estimar)

30 de noviembre de 2009

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

3 de enero de 2013

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

31 de diciembre de 2012

Última verificación

1 de diciembre de 2012

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • CIR 255

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. .

Ensayos clínicos sobre Enfermedades virales

Ensayos clínicos sobre rHPIV3cp45

3
Suscribir