Protocol for the Production of a Vaccine Against Argentinian Hemorrhagic Fever

Abstract

Argentinian hemorrhagic Fever (AHF) is a febrile, acute disease caused by Junín virus (JUNV), a member of the Arenaviridae. Different approaches to obtain an effective antigen to prevent AHF using complete live or inactivated virus, as well as molecular constructs, have reached diverse development stages. This chapter refers to JUNV live attenuated vaccine strain Candid #1, currently used in Argentina to prevent AHF. A general standardized protocol used at Instituto Nacional de Enfermedades Virales Humanas (Pergamino, Pcia. Buenos Aires, Argentina) to manufacture the tissue culture derived Candid #1 vaccine is described. Intermediate stages like viral seeds and cell culture bank management, bulk vaccine manufacture, and finished product processing are also separately presented in terms of Production and Quality Control/Quality Assurance requirements, under the Adminitracion Nacional de Medicamentos, Alimentos y Tecnología Medica (ANMAT), the Argentine national regulatory authority.

Recent developments on Junin virus, a causative agent for Argentine haemorrhagic fever

“…Instituto Nacional de Enfermedades Virales Human (INEVH) in Pergamino was considered the best place for the production of vaccine boosters. The people working at the Salk Institute in Pennsylvania were trained in Goods manufacturing practices and quality control practices 66 . The vaccine produced in Argentina was tested on 946 human volunteers between 2005 and 2006.…”

“…The people working at the Salk Institute in Pennsylvania were trained in Goods manufacturing practices and quality control practices. 66 The vaccine produced in Argentina was tested on 946 human volunteers between 2005 and 2006. Results showed that Candid#1 produced in Argentina was equally effective as Candid#1 produced in the U.S.…”