- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02154061
Systems Biology of Flu Vaccine in Healthy Adults With and Without the Use of Antibiotics (VAX-002)
Systems Biology of Inactivated Influenza Vaccine (IIV) in Healthy Adults With or Without Use of Broad Spectrum Antibiotics
The purpose of the study is to better understand how the use of antibiotics changes micro-organisms in the intestines. The change to micro-organisms in the intestines may change the body's vaccine immune response and alter the effectiveness of the IIV (seasonal flu) vaccine.
In particular, the investigators will be looking at certain markers in blood after vaccination with IIV (seasonal flu vaccine) with or without the use of antibiotics before vaccination.
There will be two randomized groups. Group A will start taking antibiotic by mouth 3 days prior to vaccination and continue taking antibiotics the day of vaccination and one day after vaccination for a total of 5 days. Group B will only receive the IIV (seasonal flu vaccine) and will not take any antibiotics.
The investigators hope to enroll 50 subjects at Emory.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Georgia
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Atlanta, Georgia, Estados Unidos, 30030
- Emory Vaccine Center
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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:
- Healthy individuals aged 18-40 years.
- Able to understand and give informed consent.
- Women of child-bearing potential (not surgically sterile via tubal ligation, bilateral oophorectomy or hysterectomy or who are not postmenopausal for ≥1 year) must agree to practice adequate contraception that may include, but is not limited to, abstinence, monogamous relationship with vasectomized partner, barrier methods such as condoms, diaphragms, spermicides, intrauterine devices, and licensed hormonal methods for 30 days before and 30 days after TIV vaccination
Exclusion Criteria:
- You received blood product within 3 months of enrolling in the study or a live attenuated vaccine within 4 weeks or inactivated vaccines within 2 weeks.
- You received the 2014-2015 flu vaccine or had a confirmed case of influenza during 2014-2015.
- You received any antibiotics 6 months prior to enrolling in the study or expect to take antibiotics one month after vaccination.
- You received probiotics or prebiotics 3 months prior before enrolling in the study or expect to take one month after vaccination.
- You received proton pump inhibitors, H2 blocker receptors, or antacids 3 months regularly before enrolling in the study or one month after
- You had an allergic response or sensitivity to past vaccinations.
- You have health conditions that weaken your body's ability to fight infections or you are taking drugs like steroids that weaken your body's ability to fight infections.(Some nasal and topical steroids are allowed.).
- You have a chronic medical problem including (but not limited to) insulin dependent diabetes, severe heart disease including arrhythmias, severe lung disease, auto immune diseases and or grade 4 uncontrolled hypertension.
- Chronic neurological conditions such as seizure disorder, Parkinson disease, myasthenia gravis, neuropathy, or histories of encephalopathy, meningitis or ototoxicity.
- Any history of gastrointestinal disease, kidney or liver diseases.
- Alcohol or drug abuse or psychiatric conditions that in the opinion of the investigator would compromise your participation in this trial.
- Pregnant or are breast feeding.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: IIV Flu Vaccine with Antibiotics
This arm will receive antibiotics prior and after IIV administration.
|
This is an FDA approved and tested Inactivated Flu Vaccine.
Otros nombres:
This is a standard antibiotic
Otros nombres:
This is a standard antibiotic.
This is a standard antibiotic.
Otros nombres:
|
|
Comparador activo: IIV Flu Vaccine
This arm will not take antibiotics in conjunction with IIV.
|
This is an FDA approved and tested Inactivated Flu Vaccine.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Number of Participants With Four Fold Rise in HAI Titers or HAI 1:40 and Above in Each Group at D30
Periodo de tiempo: At day 30
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Number of participants with four fold rise in HAI titers or HAI 1:40 and above in each group at D30 will be recorded based on immunologic testing of blood samples
|
At day 30
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
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
- Infecciones por virus de ARN
- Enfermedades virales
- Infecciones
- Infecciones del Tracto Respiratorio
- Enfermedades de las vías respiratorias
- Infecciones por Orthomyxoviridae
- Influenza Humana
- Mecanismos moleculares de acción farmacológica
- Agentes antiinfecciosos
- Inhibidores de enzimas
- Agentes antibacterianos
- Inhibidores de la síntesis de proteínas
- Agentes antiprotozoarios
- Agentes antiparasitarios
- Vancomicina
- Metronidazol
- Neomicina
Otros números de identificación del estudio
- IRB00074239
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