[Candid#1 vaccine against Argentine hemorrhagic fever produced in Argentina. Immunogenicity and safety].
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).
Enria
Delia A
DA
Instituto Nacional de Enfermedades Virales Humanas Dr. J.I. Maiztegui (INEVH), Buenos Aires, Argentina. deliaenria@gmail.com
Ambrosio
Ana M
AM
Briggiler
Ana M
AM
Feuillade
María Rosa
MR
Crivelli
Eleonora
E
D000293:Adolescent; D000328:Adult; D000368:Aged; D057134:Antibodies, Neutralizing / Q000097:blood; D000914:Antibodies, Viral / Q000097:blood; D001118:Argentina; D004311:Double-Blind Method; D005260:Female; D006478:Hemorrhagic Fever, American / Q000276:immunology / Q000517:prevention & control*; D006801:Humans; D018051:Junin virus / Q000276:immunology*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D014613:Vaccines, Attenuated / Q000009:adverse effects / Q000276:immunology; D014765:Viral Vaccines / Q000009:adverse effects* / Q000276:immunology*; D055815:Young Adult
D057134:Antibodies, Neutralizing; D000914:Antibodies, Viral; D014613:Vaccines, Attenuated; D014765:Viral Vaccines