Phase III, placebo-controlled, randomized, double-blind trial of tableted, therapeutic TB vaccine (V7) containing heat-killed M. vaccae administered daily for one month

• Published in: Journal of clinical tuberculosis and other mycobacterial diseases 2020-02, Vol.18, p.100141, Article 100141
• Main Authors: Bourinbaiar, Aldar S., Batbold, Uyanga, Efremenko, Yuri, Sanjagdorj, Munkhburam, Butov, Dmytro, Damdinpurev, Narantsetseg, Grinishina, Elena, Mijiddorj, Otgonbayar, Kovolev, Mikola, Baasanjav, Khaliunaa, Butova, Tetyana, Prihoda, Natalia, Batbold, Ochirbat, Yurchenko, Larisa, Tseveendorj, Ariungerel, Arzhanova, Olga, Chunt, Erkhemtsetseg, Stepanenko, Hanna, Sokolenko, Nina, Makeeva, Natalia, Tarakanovskaya, Marina, Borisova, Vika, Reid, Alan, Kalashnikov, Valeryi, Nyasulu, Peter, Prabowo, Satria A., Jirathitikal, Vichai, Bain, Allen I., Stanford, Cynthia, Stanford, John
• Format: Article
• Language: English
• Subjects: Immunotherapy; MDR; Mycobacterium vaccae; Therapeutic vaccine; XDR
• ISSN: 2405-5794; 2405-5794
• DOI: 10.1016/j.jctube.2019.100141

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. 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. After one month mycobacterial clearance was observed in 68% (P