The parasite Plasmodium vivax is the most frequent cause of malaria outside of sub-Saharan Africa, but efforts to develop viable vaccines against P. vivax so far have been inadequate. We recently developed pathogen-mimicking polymeric vaccine nanoparticles composed of the FDA-approved biodegradable polymer poly(lactide-co-glycolide) acid (PLGA) "enveloped" by a lipid membrane. In this study, we...

The Gram negative bacterium, Vibrio cholerae (Vc) causes cholera, an enteric disease that has killed untold numbers of humans. In the 19 th century, whole-cell (W-C) cholera vaccines were tested in humans. Field trials (1960s70s) of injected, killed W-C (kW-C) Vc showed cholera-specific immune responses (antibodies, Abs) could be induced with a single dose in certain cohorts, but more durable i...

Plague is one of the world's most lethal human diseases caused by Yersinia pestis, a Gram-negative bacterium. Despite overwhelming studies for many years worldwide, there is no safe and effective vaccine against this fatal disease. Inhalation of Y. pestis bacilli causes pneumonic plague, a fast growing and deadly dangerous disease. F1/LcrV-based vaccines failed to provide adequate protection in...

This document provides guidance to national regulatory authorities (NRAs) and vaccine manufacturers on the production and quality control of candidate live attenuated dengue virus vaccines by outlining the international regulatory expectations for product characterization. It should be read in conjunction with the WHO guidelines on nonclinical evaluation of vaccines (1), and the WHO guidelines ...

Over the years, many of our efforts have focused on the development of PRRS vaccines that we hoped would be just as effective as those used to help prevent several other economically important viral diseases of swine (eg, swine fever, pseudorabies, parvovirus-induced reproductive failure, and swine influenza), but unfortunately, this has not been the case. While attenuated-live-virus PRRS vacci...