Evaluation of the Safety and Immune Response to an Investigational Dengue Type 1 Vaccine
31 de diciembre de 2012 actualizado por: National Institute of Allergy and Infectious Diseases (NIAID)
A Phase I Evaluation of the Safety and Immunogenicity of the rDEN1∆30 Dengue Serotype 1 Vaccine Given at a Single Dose of 101 PFU in Healthy Flavivirus-naïve Adult Subjects
Dengue viruses can cause dengue fever and other serious health conditions, primarily affecting people living in tropical regions of the world.
There are four types of dengue virus, and infection with one does not offer protection against the others.
This study will test whether a vaccine developed to prevent infection with dengue virus type 1 (DEN1) causes a response in people's immune system and is safe.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
The dengue virus causes approximately 50 million cases of dengue fever and 1.5 million cases of the more severe diseases dengue hemorrhagic fever (DHS) and dengue shock syndrome (DSS) every year. There are four subtypes of the virus, and infection with one offers no protection from infection by the others. In fact, most cases of DHS and DSS occur in people infected by more than one subtype. In areas of the world where multiple subtypes of dengue are common, vaccines must be developed against each of the subtypes of dengue virus. This study will examine the safety and immune response of an investigational vaccine for preventing infection with DEN1.
Participation in this study will last about 6 weeks. Participants will be randomly assigned to be injected with either the investigational study vaccine or a placebo. Participants will have a five in six chance of receiving the vaccine. The first study visit will take place on the vaccination day, on which participants will undergo a physical examination, blood draw, and pregnancy test, and then receive the vaccine. Participants will be given a thermometer and temperature card, and be told to record their temperature three times per day for 16 days after vaccination. Participants will come to follow-up visits every other day for the 16 days after vaccination, and then 3, 4, and 6 weeks after vaccination (Days 21, 28, and 42). Assessments completed during these visits will include a questionnaire about how the participant is feeling, pregnancy test, review of temperature cards, blood draw, and physical exam. Blood drawn will be analyzed to check participants' health, determine the amount of vaccine and antibodies in the blood, test markers in white blood cells and genes, and look for proteins that are important for fighting dengue infection.
Tipo de estudio
Intervencionista
Inscripción (Actual)
18
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
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Vermont
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Burlington, Vermont, Estados Unidos, 05401
- Fletcher Allen Health Care (FAHC) General Clinical Research Center (GCRC)
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Burlington, Vermont, Estados Unidos, 05401
- University of Vermont Vaccine Testing Center
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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
18 años a 50 años (Adulto)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- In good general health as determined by physical examination, laboratory screening, and review of medical history
- Available for the duration of the study, including approximately 6 weeks post-vaccination
- Female participants of childbearing potential must be willing to use effective contraception for the duration of the trial
Exclusion Criteria:
- Currently breast-feeding or pregnant
- Exhibits evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease by history, physical examination, and/or laboratory studies
- Presence of a behavioral, cognitive, or psychiatric disease that affects the ability of the participant to understand and cooperate with the requirements of the study protocol
- Has screening laboratory values of Grade 1 or above for absolute neutrophil count (ANC), ALT, and serum creatinine, as defined in this protocol
- Presence of any condition that would jeopardize the safety or rights of the participant or would render the participant unable to comply with the protocol
- Significant alcohol or drug abuse in the past 12 months which has caused medical, occupational, or family problems, as indicated by participant history
- History of a severe allergic reaction or anaphylaxis
- Severe asthma (emergency room visit or hospitalization within the last 6 months)
- Presence of HIV infection, determined by screening and confirmatory assays
- Presence of hepatitis C virus (HCV) infection, determined by screening and confirmatory assays
- Presence of hepatitis B virus (HBV) infection, determined by hepatitis B surface antigen (HBsAg) screening
- Presence of any known immunodeficiency syndrome
- Uses anticoagulant medications
- Has used corticosteroids (excluding topical or nasal) or immunosuppressive drugs within 42 days prior to or following vaccination. An immunosuppressive dose of corticosteroids is defined as greater than or equal to 10 mg prednisone equivalent per day for greater than or equal to 14 days.
- Has received a live vaccine within 28 days or a killed vaccine within 14 days prior to vaccination or anticipated receipt of any vaccine during the 42 days following vaccination
- Has no spleen
- Received blood products within the past 6 months, including transfusions or immunoglobulin or anticipated receipt of any blood products or immunoglobulin during the 42 days following vaccination
- History or serologic evidence of previous dengue virus infection or other flavivirus infection (e.g., yellow fever virus, St. Louis encephalitis, West Nile virus)
- Has received a flavivirus vaccine (licensed or experimental)
- Anticipates receipt of any investigational agent in the 42 days before or after vaccination
- Participant has definite plans to travel to a dengue endemic area during the study
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: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: DEN1 Vaccine
Participants will receive a single dose of investigational vaccine for dengue virus subtype 1.
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Subcutaneous injection in upper arm of vaccine at dose of 10 plaque-forming units (PFU)
Otros nombres:
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Comparador de placebos: Placebo
Participants will receive a single dose of placebo vaccine.
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Subcutaneous injection of placebo
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Frequency of vaccine-related adverse events (AEs), as classified by both severity and seriousness, through active and passive surveillance
Periodo de tiempo: Measured throughout study
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Measured throughout study
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Immunogenicity to dengue virus subtype one (DEN1), as assessed by neutralizing antibody titers
Periodo de tiempo: Measured 4 and 6 weeks after vaccination
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Measured 4 and 6 weeks after vaccination
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Frequency, quantity, and duration of viremia following vaccination
Periodo de tiempo: Measured every other day after vaccination for 16 days, and on Days 21, 28, and 42
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Measured every other day after vaccination for 16 days, and on Days 21, 28, and 42
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Number of vaccinees infected with DEN1, defined as recovery of vaccine virus from the blood or serum of a participant and/or by seroconversion to DEN1
Periodo de tiempo: Measured at study completion
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Measured at study completion
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Comparison of the infectivity rates, safety, and immunogenicity of a single dose of DEN1 vaccine to those rates of previous clinical trials
Periodo de tiempo: Measured at study completion
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Measured at study completion
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Investigadores
- Investigador principal: Anna Durbin, MD, CIR, Johns Hopkins University
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.
Publicaciones Generales
- Blaney JE Jr, Durbin AP, Murphy BR, Whitehead SS. Development of a live attenuated dengue virus vaccine using reverse genetics. Viral Immunol. 2006 Spring;19(1):10-32. doi: 10.1089/vim.2006.19.10.
- Whitehead SS, Falgout B, Hanley KA, Blaney JE Jr, Markoff L, Murphy BR. A live, attenuated dengue virus type 1 vaccine candidate with a 30-nucleotide deletion in the 3' untranslated region is highly attenuated and immunogenic in monkeys. J Virol. 2003 Jan;77(2):1653-7. doi: 10.1128/jvi.77.2.1653-1657.2003.
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 abril de 2010
Finalización primaria (Actual)
1 de mayo de 2010
Finalización del estudio (Actual)
1 de junio de 2010
Fechas de registro del estudio
Enviado por primera vez
8 de marzo de 2010
Primero enviado que cumplió con los criterios de control de calidad
8 de marzo de 2010
Publicado por primera vez (Estimar)
10 de marzo de 2010
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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CIR 253
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
producto fabricado y exportado desde los EE. UU.
No
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