SciELO - Scientific Electronic Library Online

 
vol.70 issue3Secondary prophylaxis with rFVIIa in hemophilia and inhibitors: Recommendations from an Experts Committee from ArgentinaSleep related eating disorders as a side effect of zolpidem author indexsubject indexarticles search
Home Pagealphabetic serial listing  

Services on Demand

Journal

Article

Indicators

  • Have no cited articlesCited by SciELO

Related links

  • Have no similar articlesSimilars in SciELO

Share


Medicina (Buenos Aires)

Print version ISSN 0025-7680

Abstract

ENRIA, Delia A.  and  GRUPO DE ESTUDIO DE LA VACUNA CONTRA LA FIEBRE HEMORRAGICA ARGENTINA et al. Candid#1 vaccine against Argentine Hemorrhagic Fever produced in Argentina: Immunogenicity and safety. Medicina (B. Aires) [online]. 2010, vol.70, n.3, pp.215-222. ISSN 0025-7680.

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 efficacy 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 severe 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/mm3) and platelet (< 150 000/mm3) 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).

Keywords : Argentine hemorrhagic fever; Junin virus; Arenaviridae; Candid#1 vaccine.

        · abstract in Spanish     · text in Spanish     · Spanish ( pdf )

 

Creative Commons License All the contents of this journal, except where otherwise noted, is licensed under a Creative Commons Attribution License