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Despite decades of investigation in countries on three continents, an efficacious vaccine against Leishmania infections has not been developed. Although some indication of protection was observed in some of the controlled trials conducted with “first-generation” whole, inactivated Leishmania parasite vaccines, convincing evidence of protection was lacking. After reviewing all previously published...
The WHO Initiative for Vaccine Research and Global Malaria Programme convened a joint scientific forum in June 2008 to discuss scientific, regulatory and public health perspectives on the measurement of efficacy in malaria vaccine field efficacy trials. Participants included clinical trialists, statisticians and epidemiologists from both developed and developing countries, vaccine researchers and...
First generation candidate vaccines against leishmaniasis, prepared using inactivated whole parasites as their main ingredient, were considered as promising because of their relative ease of production and low cost. These vaccines have been the subject of many investigations over several decades and are the only leishmaniasis vaccine candidates which have undergone phase 3 clinical trial evaluation...
A new manufacturing process, known as process upgrade varicella vaccine (PUVV) was developed for a refrigerated formulation of varicella vaccine and for an investigational zoster vaccine. Safety and tolerability of a two-dose regimen of high-titered (∼50,000PFU) PUVV were compared to a lower-titer formulation (∼5400PFU) of VARIVAX™; in 1366 healthy subjects ≥13 years old. Only one vaccine-related...
Safety and efficacy of killed (autoclaved) L. major promastigotes, ALM, mixed with BCG against zoonotic cutaneous leishmaniasis was tested in healthy volunteers (n=2453) in a randomized double blind trial vs. BCG as control. Side-effects were similar in both groups but tended to be slightly more frequent and prolonged in the ALM+BCG group. Leishmanin skin test conversion (induration ≥5 mm) was significantly...
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