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http://repo.knmu.edu.ua/handle/123456789/27884
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DC Field | Value | Language |
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dc.contributor.author | Bourinbaiar, Aldar | - |
dc.contributor.author | Batbold, Uyanga | - |
dc.contributor.author | Efremenko, Yuri | - |
dc.contributor.author | Sanjagdorj, Munkhburam | - |
dc.contributor.author | Butov, Dmytro | - |
dc.contributor.author | Damdinpurev, Narantsetseg | - |
dc.contributor.author | Grinishina, Elena | - |
dc.contributor.author | Mijiddorj, Otgonbayar | - |
dc.contributor.author | Kovolev, Mikola | - |
dc.contributor.author | Baasanjav, Khaliunaa | - |
dc.contributor.author | Butova, Tetiana | - |
dc.contributor.author | Prihoda, Natalia | - |
dc.contributor.author | Batbold, Ochirbat | - |
dc.contributor.author | Yurchenko, Larisa | - |
dc.date.accessioned | 2020-12-08T09:39:09Z | - |
dc.date.available | 2020-12-08T09:39:09Z | - |
dc.date.issued | 2020-02-21 | - |
dc.identifier.citation | Phase III, placebo-controlled, randomized, double-blind trial of tableted, therapeutic TB vaccine (V7) containing heat-killed M. vaccaeadministered daily for one month / A. S.Bourinbaiar, U. Batbold, Yu. Efremenko, M. Sanjagdorj, D. Butov, N. Damdinpurev, E. Grinishina, O. Mijiddorj, M. Kovolev, K. Baasanjav, T. Butova, N. Prihoda, O. Batbold, L. Yurchenko, A. Tseveendorj, O. Arzhanova, E. Chunt, H. Stepanenko, N. Sokolenko, N. Makeeva, M. Tarakanovskaya, V. Borisova, A. Reid, P. Nyasulu, S. A. Prabowo, V. Jirathitikal, A. I. Bain, C. Stanford, J. Stanford // Journal of Clinical Tuberculosis and Other Mycobacterial Diseases. – 2020. – Vol. 18 – P. 1–8. | en_US |
dc.identifier.uri | https://repo.knmu.edu.ua/handle/123456789/27884 | - |
dc.description.abstract | Objective: Immunotherapy of tuberculosis (TB) to shorten treatment duration represents an unmet medical need. Orally delivered, tableted TB vaccine (V7) containing heat-killed Mycobacterium vaccae (NCTC 11659) has been demonstrated in prior clinical studies to be safe and fast-acting immune adjunct. Methods: The outcome of Phase III trial of V7 containing 10 μg of hydrolyzed M. vaccae was evaluated in 152 patients randomized at 2:1 ratio: V7 (N=100), placebo (N=52). Both arms received conventional 1st or 2nd line TB drugs co-administered with daily pill of V7 or placebo. Results: After one month mycobacterial clearance was observed in 68% (P < 0.0001) and 23.1% (P=0.04) of patients on V7 and placebo. Stratified conversion rates in V7 recipients with drug-sensitive and multidrugresistant TB were 86.7% and 55.6% vs 27.2% and 15% in placebo. Patients on V7 gained on average 2.4 kg (P < 0.0001) vs 0.3 kg (P=0.18) in placebo. Improvements in hemoglobin levels, erythrocyte sedimentation rate and leukocyte counts were significantly better than in controls. Liver function tests revealed that V7 can prevent chemotherapy-induced hepatic damage. Conclusion: Oral M. vaccae is safe, can overcome TB-associated weight loss and inflammation, reduce hepatotoxicity of TB drugs, improve sputum conversion three-fold OR 3.15; 95%CI (2.3,4.6), and cut treatment length by at least six-fold. Longer follow-up studies might be needed to further substantiate our findings (Clinicaltrials.gov: NCT01977768). | en_US |
dc.language.iso | en | en_US |
dc.publisher | Elsevier | en_US |
dc.subject | MDR | en_US |
dc.subject | XDR | en_US |
dc.subject | immunotherapy | en_US |
dc.subject | therapeutic vaccine | en_US |
dc.subject | mycobacterium vaccae | en_US |
dc.title | Phase III, placebo-controlled, randomized, double-blind trial of tableted, therapeutic TB vaccine (V7) containing heat-killed M. vaccae administered daily for one month | en_US |
dc.type | Article | en_US |
Appears in Collections: | Наукові праці. Кафедра фтизіатрії та пульмонології |
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1-s2.0-S2405579419300841-main.pdf | 559,11 kB | Adobe PDF | View/Open |
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