The safety and efficacy of BCG encapsulated alginate particle (BEAP) against M.tb H37Rv infection in Macaca mulatta : A pilot study

The safety and efficacy of BCG encapsulated alginate particle (BEAP) against M.tb H37Rv infection in Macaca mulatta : A pilot study

Abstract Due to the limited utility of Bacillus Calmette–Guérin (BCG), the only approved vaccine available for tuberculosis, there is a need to develop a more effective and safe vaccine. We evaluated the safety and efficacy of a dry powder aerosol (DPA) formulation of BCG encapsulated alginate parti...

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Autores principales: Ashwani Kesarwani, Parul Sahu, Kshama Jain, Prakriti Sinha, K. Varsha Mohan, Puja S. Nagpal, Surender Singh, Rana Zaidi, Perumal Nagarajan, Pramod Upadhyay
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Publicado: Nature Portfolio 2021
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spelling oai:doaj.org-article:5a53b440eb214cefafd4123e85eecc972021-12-02T14:06:11ZThe safety and efficacy of BCG encapsulated alginate particle (BEAP) against M.tb H37Rv infection in Macaca mulatta : A pilot study10.1038/s41598-021-82614-52045-2322https://doaj.org/article/5a53b440eb214cefafd4123e85eecc972021-02-01T00:00:00Zhttps://doi.org/10.1038/s41598-021-82614-5https://doaj.org/toc/2045-2322Abstract Due to the limited utility of Bacillus Calmette–Guérin (BCG), the only approved vaccine available for tuberculosis, there is a need to develop a more effective and safe vaccine. We evaluated the safety and efficacy of a dry powder aerosol (DPA) formulation of BCG encapsulated alginate particle (BEAP) and the conventional intradermal BCG immunization in infant rhesus macaques (Macaca mulatta). The infant macaques were immunized intratracheally with DPA of BEAP into the lungs. Animals were monitored for their growth, behaviour, any adverse and allergic response. The protective efficacy of BEAP was estimated by the ex-vivo H37Rv infection method. Post-immunization with BEAP, granulocytes count, weight gain, chest radiography, levels of liver secreted enzymes, cytokines associated with inflammation like TNF and IL-6 established that BEAP is non-toxic and it does not elicit an allergic response. The T cells isolated from BEAP immunized animals’ blood, upon stimulation with M.tb antigen, secreted high levels of IFN-γ, TNF, IL-6 and IL-2. The activated T cells from BEAP group, when co-cultured with M.tb infected macrophages, eliminated largest number of infected macrophages compared to the BCG and control group. This study suggests the safety and efficacy of BEAP in Non-human primate model.Ashwani KesarwaniParul SahuKshama JainPrakriti SinhaK. Varsha MohanPuja S. NagpalSurender SinghRana ZaidiPerumal NagarajanPramod UpadhyayNature PortfolioarticleMedicineRScienceQENScientific Reports, Vol 11, Iss 1, Pp 1-10 (2021)
institution DOAJ
collection DOAJ
language EN
topic Medicine
R
Science
Q
spellingShingle Medicine
R
Science
Q
Ashwani Kesarwani
Parul Sahu
Kshama Jain
Prakriti Sinha
K. Varsha Mohan
Puja S. Nagpal
Surender Singh
Rana Zaidi
Perumal Nagarajan
Pramod Upadhyay
The safety and efficacy of BCG encapsulated alginate particle (BEAP) against M.tb H37Rv infection in Macaca mulatta : A pilot study
description Abstract Due to the limited utility of Bacillus Calmette–Guérin (BCG), the only approved vaccine available for tuberculosis, there is a need to develop a more effective and safe vaccine. We evaluated the safety and efficacy of a dry powder aerosol (DPA) formulation of BCG encapsulated alginate particle (BEAP) and the conventional intradermal BCG immunization in infant rhesus macaques (Macaca mulatta). The infant macaques were immunized intratracheally with DPA of BEAP into the lungs. Animals were monitored for their growth, behaviour, any adverse and allergic response. The protective efficacy of BEAP was estimated by the ex-vivo H37Rv infection method. Post-immunization with BEAP, granulocytes count, weight gain, chest radiography, levels of liver secreted enzymes, cytokines associated with inflammation like TNF and IL-6 established that BEAP is non-toxic and it does not elicit an allergic response. The T cells isolated from BEAP immunized animals’ blood, upon stimulation with M.tb antigen, secreted high levels of IFN-γ, TNF, IL-6 and IL-2. The activated T cells from BEAP group, when co-cultured with M.tb infected macrophages, eliminated largest number of infected macrophages compared to the BCG and control group. This study suggests the safety and efficacy of BEAP in Non-human primate model.
format article
author Ashwani Kesarwani
Parul Sahu
Kshama Jain
Prakriti Sinha
K. Varsha Mohan
Puja S. Nagpal
Surender Singh
Rana Zaidi
Perumal Nagarajan
Pramod Upadhyay
author_facet Ashwani Kesarwani
Parul Sahu
Kshama Jain
Prakriti Sinha
K. Varsha Mohan
Puja S. Nagpal
Surender Singh
Rana Zaidi
Perumal Nagarajan
Pramod Upadhyay
author_sort Ashwani Kesarwani
title The safety and efficacy of BCG encapsulated alginate particle (BEAP) against M.tb H37Rv infection in Macaca mulatta : A pilot study
title_short The safety and efficacy of BCG encapsulated alginate particle (BEAP) against M.tb H37Rv infection in Macaca mulatta : A pilot study
title_full The safety and efficacy of BCG encapsulated alginate particle (BEAP) against M.tb H37Rv infection in Macaca mulatta : A pilot study
title_fullStr The safety and efficacy of BCG encapsulated alginate particle (BEAP) against M.tb H37Rv infection in Macaca mulatta : A pilot study
title_full_unstemmed The safety and efficacy of BCG encapsulated alginate particle (BEAP) against M.tb H37Rv infection in Macaca mulatta : A pilot study
title_sort safety and efficacy of bcg encapsulated alginate particle (beap) against m.tb h37rv infection in macaca mulatta : a pilot study
publisher Nature Portfolio
publishDate 2021
url https://doaj.org/article/5a53b440eb214cefafd4123e85eecc97
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