Phase III, placebo-controlled, randomized, double-blind trial of tableted, therapeutic TB vaccine (V7) containing heat-killed M. vaccae administered daily for one month.
J Clin Tuberc Other Mycobact Dis
; 18: 100141, 2020 Feb.
Article
em En
| MEDLINE
| ID: mdl-31890902
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 21 ratio V7 (Nâ¯=â¯100), placebo (Nâ¯=â¯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% (Pâ¯=â¯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 (Pâ¯=â¯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).
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1
Coleções:
01-internacional
Base de dados:
MEDLINE
Tipo de estudo:
Clinical_trials
/
Observational_studies
/
Prognostic_studies
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Risk_factors_studies
Idioma:
En
Revista:
J Clin Tuberc Other Mycobact Dis
Ano de publicação:
2020
Tipo de documento:
Article
País de afiliação:
Mongólia