PreprintBrief ReportVersion 1This version is not peer-reviewed
Generalised Modules for Membrane Antigens (GMMA) Do Not Elicit Concerning Local Reactogenicity after Intramuscular Injection in Absence of Aluminum Salt Adjuvant
Version 1
: Received: 9 August 2024 / Approved: 9 August 2024 / Online: 12 August 2024 (08:09:24 CEST)
How to cite:
Cecchi, R.; Maccari, S.; Alfini, R.; Di Benedetto, R.; Gallorini, S.; Cartocci, E.; Marchi, S.; Romagnoli, G.; Bartolini, E.; Micoli, F.; Piccioli, D. Generalised Modules for Membrane Antigens (GMMA) Do Not Elicit Concerning Local Reactogenicity after Intramuscular Injection in Absence of Aluminum Salt Adjuvant. Preprints2024, 2024080730. https://doi.org/10.20944/preprints202408.0730.v1
Cecchi, R.; Maccari, S.; Alfini, R.; Di Benedetto, R.; Gallorini, S.; Cartocci, E.; Marchi, S.; Romagnoli, G.; Bartolini, E.; Micoli, F.; Piccioli, D. Generalised Modules for Membrane Antigens (GMMA) Do Not Elicit Concerning Local Reactogenicity after Intramuscular Injection in Absence of Aluminum Salt Adjuvant. Preprints 2024, 2024080730. https://doi.org/10.20944/preprints202408.0730.v1
Cecchi, R.; Maccari, S.; Alfini, R.; Di Benedetto, R.; Gallorini, S.; Cartocci, E.; Marchi, S.; Romagnoli, G.; Bartolini, E.; Micoli, F.; Piccioli, D. Generalised Modules for Membrane Antigens (GMMA) Do Not Elicit Concerning Local Reactogenicity after Intramuscular Injection in Absence of Aluminum Salt Adjuvant. Preprints2024, 2024080730. https://doi.org/10.20944/preprints202408.0730.v1
APA Style
Cecchi, R., Maccari, S., Alfini, R., Di Benedetto, R., Gallorini, S., Cartocci, E., Marchi, S., Romagnoli, G., Bartolini, E., Micoli, F., & Piccioli, D. (2024). Generalised Modules for Membrane Antigens (GMMA) Do Not Elicit Concerning Local Reactogenicity after Intramuscular Injection in Absence of Aluminum Salt Adjuvant. Preprints. https://doi.org/10.20944/preprints202408.0730.v1
Chicago/Turabian Style
Cecchi, R., Francesca Micoli and Diego Piccioli. 2024 "Generalised Modules for Membrane Antigens (GMMA) Do Not Elicit Concerning Local Reactogenicity after Intramuscular Injection in Absence of Aluminum Salt Adjuvant" Preprints. https://doi.org/10.20944/preprints202408.0730.v1
Abstract
Generalised Modules for Membrane Antigens (GMMA) are outer membrane vesicles derived from Gram-negative bacteria that can be used to design affordable subunit vaccines. GMMA are highly immunogenic and capable to induce an optimal antigen-specific humoral immune response both in animals and humans. Despite their potent immunogenicity, GMMA are usually formulated with aluminum salts (Alum) to reduce their potential systemic reactogenicity. GMMA, in fact, contain agonists of Toll-Like Receptor 4 (TLR4) and TLR2 that possess pro-inflammatory activity. The adsorption of GMMA onto Alum is believed to reduce their systemic exposure. However, it has been found that GMMA formulated without Alum did not induce concerning signs of systemic reactogenicity in the rabbit model. Here we asked whether GMMA promote local reactogenicity. We immunized mice intramuscularly with GMMA alone or formulated with Alum and we analyzed the injection site during 7 days after treatment. We found that GMMA alone promoted only mild inflammation within the muscle, whereas Alum induced severe muscle inflammation, as expected. Thus, in the mouse model, GMMA demonstrated to possess mild reactogenic potential locally, while Alum is confirmed a major driver of local reactogenicity. Our results further support the idea to investigate the reactogenicity of GMMA formulated without Alum in clinical studies.
Biology and Life Sciences, Immunology and Microbiology
Copyright:
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
