Oliva-Hernández R

Language: Spanish
References: 0
Page: 48-51
PDF size: 214.53 Kb.

Text Extraction

Regarding the article published in the journal Vaccimonitor, volume 28 number 1 of the year 2019, where the results of the toxicological study carried out on the meningococcal vaccine VA-MENGOC-BC^® are presented after 24 and 36 months of storage in 4 to 8°C. I would like to issue a list of considerations on some of the parameters generally evaluated in vaccine toxicology studies, in order to optimize the results that can be achieved. In this sense, we could contribute to a better design of preclinical toxicology studies in order to reach a predictive value closer to what is expected in posterior clinical trials. Similarly, these considerations can be taken into account for the analysis of ethical aspects, animal welfare and determination of the humanitarian endpoint.
Preclinical vaccine toxicology studies have become mandatory since the last decade of the 20th century, where different studies have been proposed and designed to meet these requirements. We can mention, for example, pharmacological safety studies, single dose, local tolerance and repeated dose, amongst others.(1) In each of them there are parameters to be evaluated, such as the clinical observation of the animals, body weight, water and food consumption, and the local and systemic response. However, the information that we could obtain from these parameters from the “proof of concept” studies to the toxicological studies themselves, is not exploited to the maximum.