ISSN: 2161-1068
Mycobacterial Diseases
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Therapeutic Vaccination of Treatment-Failed TB Patients on ?Palliative? Support Consisting of Isoniazid and Rifampicin

Arjanova OV1, Butov DA2, Prihoda ND1, Zaitzeva SI2, Yurchenko LV1, Sokolenko NI1, Stepanenko AL2, Butova TS2, Jirathitikal V3, Bourinbaiar AS4 and Kutsyna GA5*
1Lisichansk Regional Tuberculosis Dispensary, Lisichansk, Ukraine
2Department of Phtysiatry and Pulmonology, Kharkov National Medical University; Kharkov, Ukraine
3Immunitor Thailand Co., LLC, Bangpakong Industrial Park, Chachoengsao, Thailand
4Immunitor USA Inc., College Park, MD 20740, USA
5Luhansk State Medical University, Luhansk, Ukraine
Corresponding Author : Kutsyna GA
Luhansk State Medical University, Luhansk, Ukraine
E-mail: kutsynagalyna@yahoo.com
Received December 15, 2011; Accepted January 30, 2012; Published February 02, 2012
Citation: Arjanova OV, Butov DA, Prihoda ND, Zaitzeva SI, Yurchenko LV, et al. (2012) Therapeutic Vaccination of Treatment-Failed TB Patients on “Palliative” Support Consisting of Isoniazid and Rifampicin. Mycobact Diseases S1:001. doi:10.4172/2161-1068.S1-001
Copyright: © 2012 Arjanova OV, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

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Abstract

Open label phase 2b retrospectively controlled trial was conducted in 72 treatment-failed TB patients on socalled palliative support consisting of isoniazid (H) and rifampicin (R) with or without adjunct immunotherapy. The intervention group (N=36) received once-daily pill of V-5 Immunitor (V5) and comparison control (N=36) received HR only. The subjects in V5 and control groups had miliary: cavitary: MDR-TB: DR-TB: TB/HIV at 10: 26: 5: 4: 1 and 14: 22: 6: 6: 2 ratios, respectively. After 3 months 69.4% of V5-treated patients experienced negative sputum smear conversion (P<0.0001) vs. 16.7% (P=0.02) in comparison group who were treated for 3.5 months on average. 9 out of 10 V5 recipients with drug-resistant TB and TB/HIV became sputum negative, whereas none of 14 patients with same diagnosis converted (P<0.0001; OR 1732; 100-30008 at 95% CI). TB-associated inflammation was downregulated by V5 as shown by normalization of leukocytosis 7.9 vs. 6.2 x109/L (P=0.005) and decreased erythrocyte sedimentation rate 22.7 vs. 13.3 mm/h (P<0.0001), whereas among HR recipients changes were smaller, i.e., 7.2 vs. 7.5 x109/L (P=0.49) and 26.4 vs. 22.5 mm/h (P<0.0001). The body °C temperature was reduced from 37.4 ± 0.5 to 37.1 ± 0.3 (P=0.001) and from 37.7 ± 0.5 to 37.2 ± 0.5 (P=0.0002) in V5 and control respectively. In V5 arm average body weight accrual 2.2 ± 1.7 kg (P<0.0001) was higher than 0.08 ± 1.1 kg in control. No adverse effects or reactivation of disease were seen at any time. V5 is safe and in combination with simple two-drug regimen was highly effective as an immune adjunct for management of treatment-failed and/or drug-resistant TB.

Arjanova OV1, Butov DA2, Prihoda ND1, Zaitzeva SI2, Yurchenko LV1, Sokolenko NI1, Stepanenko AL2, Butova TS2, Jirathitikal V3, Bourinbaiar AS4 and Kutsyna GA5*
1Lisichansk Regional Tuberculosis Dispensary, Lisichansk, Ukraine
2Department of Phtysiatry and Pulmonology, Kharkov National Medical University; Kharkov, Ukraine
3Immunitor Thailand Co., LLC, Bangpakong Industrial Park, Chachoengsao, Thailand
4Immunitor USA Inc., College Park, MD 20740, USA
5Luhansk State Medical University, Luhansk, Ukraine
Corresponding Author : Kutsyna GA
Luhansk State Medical University, Luhansk, Ukraine
E-mail: kutsynagalyna@yahoo.com
Received December 15, 2011; Accepted January 30, 2012; Published February 02, 2012
Citation: Arjanova OV, Butov DA, Prihoda ND, Zaitzeva SI, Yurchenko LV, et al. (2012) Therapeutic Vaccination of Treatment-Failed TB Patients on “Palliative” Support Consisting of Isoniazid and Rifampicin. Mycobact Diseases S1:001. doi:10.4172/2161-1068.S1-001
Copyright: © 2012 Arjanova OV, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
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