Будь ласка, використовуйте цей ідентифікатор, щоб цитувати або посилатися на цей матеріал:
http://repo.knmu.edu.ua/handle/123456789/27884
Назва: | Phase III, placebo-controlled, randomized, double-blind trial of tableted, therapeutic TB vaccine (V7) containing heat-killed M. vaccae administered daily for one month |
Автори: | Bourinbaiar, Aldar Batbold, Uyanga Efremenko, Yuri Sanjagdorj, Munkhburam Butov, Dmytro Damdinpurev, Narantsetseg Grinishina, Elena Mijiddorj, Otgonbayar Kovolev, Mikola Baasanjav, Khaliunaa Butova, Tetiana Prihoda, Natalia Batbold, Ochirbat Yurchenko, Larisa |
Теми: | MDR XDR immunotherapy therapeutic vaccine mycobacterium vaccae |
Дата публікації: | 21-лют-2020 |
Видавництво: | Elsevier |
Бібліографічний опис: | 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. |
Короткий огляд (реферат): | 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). |
URI (Уніфікований ідентифікатор ресурсу): | https://repo.knmu.edu.ua/handle/123456789/27884 |
Розташовується у зібраннях: | Наукові праці. Кафедра фтизіатрії та пульмонології |
Файли цього матеріалу:
Файл | Опис | Розмір | Формат | |
---|---|---|---|---|
1-s2.0-S2405579419300841-main.pdf | 559,11 kB | Adobe PDF | Переглянути/відкрити |
Усі матеріали в архіві електронних ресурсів захищені авторським правом, всі права збережені.