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[Candid#1 vaccine against Argentine hemorrhagic fever produced in Argentina. Immunogenicity and safety].
Medicina (B Aires). 2010; 70(3):215-22.M

Abstract

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, slightly 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/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).

Authors+Show Affiliations

Instituto Nacional de Enfermedades Virales Humanas Dr. J.I. Maiztegui (INEVH), Buenos Aires, Argentina. deliaenria@gmail.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

English Abstract
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

spa

PubMed ID

20529769

Citation

Enria, Delia A., et al. "[Candid#1 Vaccine Against Argentine Hemorrhagic Fever Produced in Argentina. Immunogenicity and Safety]." Medicina, vol. 70, no. 3, 2010, pp. 215-22.
Enria DA, Ambrosio AM, Briggiler AM, et al. [Candid#1 vaccine against Argentine hemorrhagic fever produced in Argentina. Immunogenicity and safety]. Medicina (B Aires). 2010;70(3):215-22.
Enria, D. A., Ambrosio, A. M., Briggiler, A. M., Feuillade, M. R., & Crivelli, E. (2010). [Candid#1 vaccine against Argentine hemorrhagic fever produced in Argentina. Immunogenicity and safety]. Medicina, 70(3), 215-22.
Enria DA, et al. [Candid#1 Vaccine Against Argentine Hemorrhagic Fever Produced in Argentina. Immunogenicity and Safety]. Medicina (B Aires). 2010;70(3):215-22. PubMed PMID: 20529769.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - [Candid#1 vaccine against Argentine hemorrhagic fever produced in Argentina. Immunogenicity and safety]. AU - Enria,Delia A, AU - Ambrosio,Ana M, AU - Briggiler,Ana M, AU - Feuillade,María Rosa, AU - Crivelli,Eleonora, AU - ,, PY - 2010/6/10/entrez PY - 2010/6/10/pubmed PY - 2011/4/5/medline SP - 215 EP - 22 JF - Medicina JO - Medicina (B Aires) VL - 70 IS - 3 N2 - 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, slightly 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/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). SN - 0025-7680 UR - https://www.unboundmedicine.com/medline/citation/20529769/[Candid L2 - http://www.diseaseinfosearch.org/result/3317 DB - PRIME DP - Unbound Medicine ER -