Publication: Phase I trial of a Plasmodium vivax CS derived synthetic peptide vaccine candidate
Loading...
Date
2001
Authors
Journal Title
Journal ISSN
Volume Title
Publisher
Universidad del Valle
Colciencias
Colciencias
Abstract
This project was aimed at conducting a Phase 1 clinical trial to assess the safety, immunogenicity and protective efficacy of synthetic peptides derived from different regions of the P. vívax es protein in human volunteers. The trial was proposed on the bases of previous studies that had allowed us to partially characterize immunologically the protein . We had study the P . vívax CS antigenicity in humans and monkeys and had defined B, Th and eTL epitopes (refs) . Additionally we had conducted studies on the immunogenicity of peptides derived from this protein both in rodents and in non-human primates using bench quality synthetic peptides . Because of the minimal requirement of the vaccine quality for human use , we proposed to produce 3 long synthetic peptides under GLP conditions and to test them in young human naive volunteers . Although this objective was approved , Colciencias recommended that a further pre-clinical trial in monkeys must be performed with the new GLP quality vaccines . This recommendation was accepted by the group and is reported here.
Description
1 documento