Dataset Information

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

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 multidrug-resistant 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).

SUBMITTER: Bourinbaiar AS

PROVIDER: S-EPMC6933248 | biostudies-literature | 2020 Feb

REPOSITORIES: biostudies-literature

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

Bourinbaiar Aldar S AS Batbold Uyanga U Efremenko Yuri Y Sanjagdorj Munkhburam M Butov Dmytro D Damdinpurev Narantsetseg N Grinishina Elena E Mijiddorj Otgonbayar O Kovolev Mikola M Baasanjav Khaliunaa K Butova Tetyana T Prihoda Natalia N Batbold Ochirbat O Yurchenko Larisa L Tseveendorj Ariungerel A Arzhanova Olga O Chunt Erkhemtsetseg E Stepanenko Hanna H Sokolenko Nina N Makeeva Natalia N Tarakanovskaya Marina M Borisova Vika V Reid Alan A Kalashnikov Valeryi V Nyasulu Peter P Prabowo Satria A SA Jirathitikal Vichai V Bain Allen I AI Stanford Cynthia C Stanford John J

Journal of clinical tuberculosis and other mycobacterial diseases 20191212

<h4>Objective</h4>Immunotherapy of tuberculosis (TB) to shorten treatment duration represents an unmet medical need. Orally delivered, tableted TB vaccine (V7) containing heat-killed <i>Mycobacterium vaccae</i> (NCTC 11659) has been demonstrated in prior clinical studies to be safe and fast-acting immune adjunct.<h4>Methods</h4>The outcome of Phase III trial of V7 containing 10 µg of hydrolyzed <i>M. vaccae</i> was evaluated in 152 patients randomized at 2:1 ratio: V7 (<i>N</i> = 100), placebo ( ...[more]

PMID: 31890902

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