Immunological and histochemical assessment of an Alzheimer´s vaccine

Purpose and goal

The purpose of this project was to evaluate the vaccine ALZ-101 in a novel species and via a novel route of administration. The overall objective was to evaluate the species as a model organism for the continued preclinical development of the test article. An assessment of systemic toxicological effects was also included. The project delivered results indicating the usefulness of the chosen animal model and that the novel route of administration is acceptable. Furhtermore, the safety profile of the vaccine appears to be good.

Results and expected effects

The animal species chosen for this study responded well to vaccination already after two immunizations. The antibody titers were all comparable to those observed after repeated vaccinations of a transgenic mouse model, thus supporting both the chosen animal as a model and the novel route of administration evaluated in this project. No systemic toxicity was considered to be related to the test article, in accordance with previous vaccinations performed in mice.

Approach and implementation

Most of the activities in this project were subcontracted to a large international CRO. However, the chosen CRO was not able to start the study in time, thus necessitating a switch to another similar type of organization which resulted in a delay of four months. The new CRO was able to deliver the project in accordance with the signed contract.