Abstract
The proteoliposomes and cochleates are used as adjuvants for vaccines since they are potent immune stimulators. However, the hyper stimulation of the immune system provoked by adjuvants can cause immune-toxicological side effects. The present study was carried out to evaluate the toxic and immuno-toxicological effects of new adjuvants for anti-meningococci vaccines based on neo-proteoliposomes (nPL) and neo-cochleates (nCh), in Balb/c mice that were administered doses of 15 �g each, over periods of 14 days through intramuscular route and three inoculations with the same doses through intranasal route, every 7 days. The Scanning and Transmission Electron Microscopy showed that the nPL and nCh had nanometric dimensions and their normal peculiar forms. The experimental formulations did not provoke general toxic effects in the tested animals, which tended to the progressive normal growing of this species, that did not statistically differ from the control ones. The studies of pathologic anatomy in inoculation organs and sites did not reveal modifications that can indicate toxicity and there was no sign of hepatic damage. The structural observations found in the spleen and lymphatic nodes showed the physiological development of the immune response, which was normal in all cases showing the restitution of the stimulation signs. The relative weight values of the spleen were within the standard range. These results showed that the nPL and nCh elaborated as adjuvants for vaccines did not show any evident induction of general toxic or particular immune-toxicologicl effects.
Highlights
All the authors have equal contribution at this original articleREV.CHIM.(Bucharest)♦70♦No 4 ♦2019 their own adjuvant properties. The interaction between the NP and the human immune system can lead to an immunomodulation that can be beneficial or not, according to its therapeutic objective [16]
Vaccines are one of the most successful medical invention of the last century
The vaccines with accurate molecular structures of the new generation are presented as proteoliposomes (PL) and cochleates (Ch), whose particle structures allow them to function as drug delivery carriers and adjuvants, enhancing or modulating immune responses to antigens, with a high level of purity
Summary
REV.CHIM.(Bucharest)♦70♦No 4 ♦2019 their own adjuvant properties. The interaction between the NP and the human immune system can lead to an immunomodulation that can be beneficial or not, according to its therapeutic objective [16]. The hyper-stimulation potential of vaccines can unleash adverse immuno-toxicological effects [17]. The stimulation of the immune response has to be carefully measured, since a hyper-activation can produce cytotoxic and autoimmune responses, among others, which could be more destructive than expected. The toxicology studies of the vaccine formulations based on NP are few, and so far, there aren’t official regulatory guides with these purposes. Considering all the previous statements and the fact that we wanted to explore the anti-meningococcal vaccines from another point of view (immunotoxicological) than the issues already approached in our previous paper [6], in the present study have been evaluated immuno-toxicological parameters of the new adjuvant formulations with PL and Ch nanoparticles (that have been designed with immune-modulator properties). The experiments were made using the Balb/c mouse model
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