Please use this identifier to cite or link to this item: http://sgc.anlis.gob.ar/handle/123456789/527
Title: Vacuna contra la fiebre hemorrágica argentina Candid#1 producida en la Argentina: Inmunogenicidad y seguridad
Other Titles: Candid # 1 vaccine against Argentine Hemorrhagic Fever produced in Argentina. Immuno- genicity and safety
Authors: Enria, Delia 
Ambrosio, Ana M. 
Briggiler, Ana M. 
Feuillade, María Rosa 
Crivelli, Eleonora 
Issue Date: 2010
Description: Se realizó un estudio clínico en 946 voluntarios humanos sanos, donde se comparó la vacuna Candid#1 producida en Argentina con la elaborada en EE.UU., que había sido utilizada en estu- dios previos. Como objetivo primario se evaluó la equivalencia en la eficacia utilizando como marcador subrogante a la inmunogenicidad medida por detección de anticuerpos neutralizantes. Como objetivo secundario se evaluó la equivalencia en inocuidad comparando las tasas de reacciones adversas. Ambas vacunas mostraron una tasa equivalente de inmunogenicidad ligeramente superior al 95.5%, que es la eficacia estimada para Candid #1 en estudios previos. No se observaron eventos adversos graves relacionados con la vacuna. Los eventos adversos generales considerados relacionados fueron de escasa significación clínica y de resolución espontánea o con tra- tamiento sintomático; se presentaron en los receptores de ambas vacunas en tasas equivalentes (29.9% para la vacuna fabricada en la Argentina y 35.0% para la fabricada en EE.UU.), e incluyeron: cefalea, decaimiento, mialgias, plaquetopenia leve (< 150 000 plaquetas/mm 3 ), náuseas y/o vómitos, leucopenia leve (< 4 000 blancos/mm 3 ), fie- bre, dolor retroocular, mareos, microhematuria, lumbalgia y exantema. Estos resultados indican que la vacuna Candid #1 elaborada en la Argentina es equivalente a la elaborada en los EE.UU. Este estudio permitió el registro del biológico producido en la Argentina ante la autoridad regulatoria del país (ANMAT).
A clinical study in 946 human volunteers was done to compare Candid #1 vaccine manufactured in Argentina with the vaccine produced in USA that had been previously used. The effi- cacy was evaluated using immunogenicity measured by the detection of neutralizing antibodies as a subrogate marker. Safety was evaluated comparing the rate of adverse events. Both vaccines showed a comparable rate of seroconversion, slighty higher than the efficacy estimated from previous studies (95.5%). There were no se- vere adverse events related to the vaccines. The general events considered related to the vaccines were not clinically relevant and disappeared either spontaneously or with symptomatic treatment. Similar rates of adverse events (29.9% for the Argentine vaccine and 35.0% for the USA vaccine) were found for both vaccines. These included: headache, weakness, myalgias, mild low blood cell (< 4 000/mm 3 ) and platelet (< 150 000/mm 3 ) counts, nausea and/or vomiting, fever, retroocular pain, dizziness, microhematuria, low backache and exantema. These results indicate that the vaccine Candid#1 manufactured in Argentina is equivalent to the manufactured in USA. These results allowed the National Institute of Human Viral Diseases (INEVH) to register the vaccine produced locally under the National Regulatory Authority (ANMAT).
URI: http://sgc.anlis.gob.ar/handle/123456789/527
Rights: info:eu-repo/semantics/openAccess
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