- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02145377
PXVX0200 (CVD103-HgR) vs Shanchol in Mali
A Phase 2 Randomized, Double-Blinded Study to Compare in Malian Adults the Immunogenicity, Clinical Acceptability and Excretion Pattern Following the Ingestion of a Single Dose of PXVX0200 (CVD 103-HgR) Live Oral Cholera Vaccine Containing Either 108 Colony Forming Units [Cfu] or 109 Cfu Using Shanchol™ Killed Whole Cell Oral Cholera Vaccine as an Immunological Comparator
To compare the ability of a single dose of PXVX0200 at two different dose levels, to placebo to elicit a significant antibody response 14 days after vaccination, compared to baseline.
To compare the ability of a single dose of PXVX0200 to a comparator vaccine Shanchol, a two dose administration, to elicit antibody response by 14 days after vaccination.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Currently there are two licensed inactivated vibrio oral vaccines (Dukoral® [Crucell; Leiden, The Netherlands] and Shanchol™ [Shantha Biotechnics; Hyderabad, India]) that are pre-qualified by the World Health Organization (WHO) for procurement by United Nations (UN) agencies. Each of these vaccines requires a two-dose regimen which is difficult to implement in the face of explosive outbreaks of cholera in unsettled situations in developing countries. For this reason there is great interest in identifying a cholera vaccine that can provide rapid onset of protection following the ingestion of just a single oral dose.
This Phase 2 randomized, observer-blinded and subject-blinded clinical trial to be conducted in Bamako, Mali will assess the immunogenicity of the 10^8 cfu versus the 10^9 cfu formulation of PaxVax-manufactured CVD 103-HgR.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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Bamako, Malí
- Centre pour le Développement des Vaccins, Mali (CVD-Mali)
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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:
- Able to understand the study and give consent (either written or through a process that involves audio tapes explaining all aspects of the study and the consent form in local languages [Bambara and French] followed by making a mark and signature by a literate witness)
- Healthy men or women, age 18 to 45 years (inclusive) without significant medical history
- Women of child-bearing potential must have negative urine pregnancy test at baseline, prior to vaccination. They must also be willing to use adequate birth control for the duration of the 28-day study and have additional pregnancy tests if indicated. Effective methods of birth control for this study include abstinence, intrauterine device (IUD), oral or depot contraceptive, or barrier plus spermicide
- Willingness to remain in the study area until at least 42 days after receipt of the first vaccine dose
Exclusion Criteria:
- Health care workers who have direct contact with patients who are immune deficient, HIV-positive, or have an unstable medical condition
- Clinically significant history of immunodeficiency, cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease, neurologic illness, psychiatric disorder requiring hospitalization, current drug or alcohol abuse
- History of an abnormal stool pattern or regular use of laxatives
- Previously received a licensed or investigational cholera vaccine
- History of cholera illness
Plan de estudios
¿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: PXVX0200 10E8 then placebo
PXVX0200 10E8 on day 0; Placebo on day 14
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Oral dose of PXVX0200 10E8
Oral dose of sodium bicarbonate buffer
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Experimental: Placebo, then PXVX0200 10E8
Placebo on day 0; PXVX0200 10E8 on day 14
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Oral dose of PXVX0200 10E8
Oral dose of sodium bicarbonate buffer
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Experimental: PXVX0200 10E9 then Placebo
PXVX0200 10E9 on day 0; Placebo on day 14
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Oral dose of sodium bicarbonate buffer
Oral dose of PXVX0200 10E9
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Experimental: Placebo then PXVX0200 10E9
Placebo on day 0; PXVX0200 10E9 on day 14
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Oral dose of sodium bicarbonate buffer
Oral dose of PXVX0200 10E9
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Comparador activo: Shanchol
Two doses of Shanchol, on day 0 and day 14
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Licensed comparator
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
To elicit a significant rise in serum Inaba vibriocidal antibody after a single vaccination
Periodo de tiempo: 14 days
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A comparison of the ability of a single ≥2 x10E9 cfu oral dose versus a single ≥2 x10E8 cfu oral dose of PXVX0200 (CVD 103-HgR) versus placebo to elicit a significant (> 4-fold) rise in serum Inaba vibriocidal antibody 14 days after vaccination, compared to baseline
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14 days
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
To measure antibody response for a 10E8 dose and 10E9 dose of PXVX0200 oral vaccine
Periodo de tiempo: 14 days
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To compare the ability of a single ≥2 x108 cfu dose of PXVX0200 (CVD 103-HgR) or ≥2 x109 oral dose of PXVX0200 (CVD 103-HgR) versus Shanchol™ to elicit serum Inaba vibriocidal antibody mean fold rise (compared to baseline titer) and GMT
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14 days
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To plot the kinetics of the serum Inaba Vibriocidal antibody response
Periodo de tiempo: Baseline and post-vaccination time point.
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To plot the kinetics of the serum Inaba vibriocidal antibody response after ingestion of a single oral dose of PXVX0200 (CVD 103-HgR) containing ≥2 x10E8 cfu or ≥2 x10E9 cfu versus Shanchol™.
(With GMT on the Y axis and time points on the X axis, the GMTs at baseline and at each post-vaccination time point will be connected as a line graph).
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Baseline and post-vaccination time point.
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Assess fecal shedding of PXVX0200
Periodo de tiempo: Day 1-3, day 7 and day 14
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Shedding of CVD 103-HgR in stool as determined by stool culture (whole specimen or rectal swab)
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Day 1-3, day 7 and day 14
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Compare rate of diarrhea
Periodo de tiempo: 7 days
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To compare the rate of diarrhea (≥ 4 loose stools within 24 hours) following administration of each vaccine regimen versus placebo over 7 days of follow-up
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7 days
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Plot seroconversion
Periodo de tiempo: Day 7, 14, 21, 28, 35 and 42
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To plot the seroconversion (≥ 4-fold increase over baseline), mean fold rise (comparing baseline titer with post-vaccination titer), and kinetics of serum IgG cholera antitoxin antibody following the ingestion of a single oral dose of PXVX0200 (CVD 103-HgR) containing ≥2 x10E8 cfu or ≥2 x10E9 cfu versus Shanchol™.
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Day 7, 14, 21, 28, 35 and 42
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Assess reactogenicity
Periodo de tiempo: For seven days after each dose of PXVX0200
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Assess tiredness, vomiting, loss of appetite, abdominal pain and headache
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For seven days after each dose of PXVX0200
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Samba O Sow, MD, MS, Centre pour le Developpement des Vaccins - Mali
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- HP-00059690
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