Drug Database
TU

tuberculosis vaccine (Mw) (Immuvac / Cadi05 / Sepsivac)

✓ Approved

Cadila Pharmaceuticals Ltd. · Cell-based Therapies · Cell-based Therapies

What is tuberculosis vaccine (Mw)?

tuberculosis vaccine (Mw) is a cell-based therapies developed by Cadila Pharmaceuticals Ltd.. It is approved for therapeutic indications via injectable (others) or intradermal injection.

Drug Profile

Brand NamesImmuvac, Cadi05, Sepsivac
CompanyCadila Pharmaceuticals Ltd.
Drug ClassCell-based Therapies, Vaccine
RouteInjectable (Others), Intradermal Injection
StatusApproved
Sources: ClinicalTrials.gov, Cadila Pharmaceuticals Ltd.

Therapeutic Indications

tuberculosis vaccine (Mw) is developed for 10 unique indications across 2 therapeutic areas.

Therapeutic AreaConditionPhase
Infections and infestationsLeprosy✓ Approved
Neoplasms benign, malignant and unspecified (incl cysts and polyps)Non-small cell lung cancer stage IV✓ Approved
Infections and infestationsSepsis✓ Approved
Neoplasms benign, malignant and unspecified (incl cysts and polyps)Non-small cell lung cancer metastatic✓ Approved
Infections and infestationsSystemic infection✓ Approved

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Related Research Articles

PubMedAAPS PharmSciTech2026-09-19

Comprehensive Stability Assessment of Squalene in a Nanoemulsion Adjuvant and the SpiN-Tec Vaccine: HPLC Quantification, Stress Testing, and Stability Studies.

Gomes Isabela Pereira IP, Rivelli Graziella Gomes GG, Bagno Flávia Fonseca FF, Hojo-Souza Natália Satchiko NS et al.

Squalene-based nanoemulsions are widely used as adjuvants in vaccine formulations, but their stability can be affected by environmental factors such as pH, oxidative stress, temperature, and light. We have produced a squalene nanoemulsion (CTVad1) to support the clinical development of new vaccines. This study aimed to develop and validate an HPLC method for squalene quantification in SpiN-Tec, a recombinant protein vaccine against COVID-19. We also aimed to evaluate the stability of the CTVad1 adjuvant and SpiN-Tec under controlled storage conditions. A reversed-phase HPLC method was developed and validated, and comprehensive forced degradation studies were performed on the raw material and SpiN-Tec under acidic, basic, oxidative, thermal, and photolytic conditions to demonstrate the stability-indicating capability of the method. Physicochemical, morphological, and biological characteristics were assessed, and stability studies of both the vaccine and the CTVad1 adjuvant were performed under accelerated and long-term conditions. The HPLC method was selective, precise, accurate, linear, and robust. Squalene raw material degraded under all tested conditions, whereas formulation in nano-sized globules improved its stability, with degradation observed only under hydrogen peroxide and light exposure. CTVad1 remained stable over time, exhibiting only minor, non-critical changes within the specification limits in both accelerated and long-term stability studies, regardless of the glass packaging used (clear or amber). In addition, the SpiN-Tec vaccine maintained its physicochemical and biological integrity under all tested conditions, with all evaluated parameters remaining within the established specification ranges. Our findings demonstrate that proper formulation, packaging, and storage conditions can preserve squalene stability in nanoemulsion-based vaccines, ensuring the quality, safety, and efficacy of the SpiN-Tec vaccine and its adjuvant throughout shelf life.

PMID 42760453
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PubMedOcular immunology and inflammation2026-09-19

Bilateral Maculopathy in an Infant Following Measles, Mumps, Rubella, and Varicella-Zoster (MMRV) Vaccination.

Ben-Avi Ravid R, Amer Radgonde R

To report on the long-term clinical outcome of a healthy infant who presented with posterior uveitis following the administration of the combined measles, mumps, rubella, and varicella (MMRV) vaccine. Descriptive case report. A 13-month-old infant presented with bilateral visual loss two weeks after receiving the MMRV vaccine. Ophthalmic examination revealed bilateral retinitis and retinal vasculitis with exudative retinal detachment. Extensive infectious work-up was conducted including serologic exams and PCR testing of blood, aqueous humor, cerebrospinal fluid and urine. Serological tests for measles yielded positive IgM and IgG titers. PCR testing for measles in the aqueous humor and urine was negative. Neurologic assessment and neuroimaging were unremarkable, excluding central nervous system involvement. Empiric systemic antiviral and corticosteroid therapy was initiated. Gradual resolution of posterior uveitis ensued, culminating in bilateral macular scars. Over a six-year follow-up period, the patient demonstrated stable ocular findings with no evidence of recurrent inflammation or systemic autoimmune disease. Final visual acuity was 6/9 in each eye. This case represents a rare occurrence of non-necrotizing retinitis following MMRV vaccination. To our knowledge, this is the first report describing the sequential OCT characteristics of presumed measles vaccine-associated retinitis. The prolonged follow-up period supports the absence of an alternative etiology and provides valuable insight into the long-term course and visual prognosis of vaccine-associated retinopathy.

PMID 42760840
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PubMedMedicine2026-09-19

The safety and efficacy of different anti-tuberculosis regimens containing Lzd for RR/MDR/Pre-XDR-TB patients in China.

Tang Xian-Zhen XZ, Ma Yao Y, Tang Shen-Jie SJ, Chen Qing Q et al.

China remains a high-burden country for rifampicin-resistant tuberculosis. The treatment of drug-resistant tuberculosis is expensive, with many adverse drug reactions and greater difficulty to cure. Searching for appropriate treatment regimens is urgent. A retrospective study was conducted on HIV-negative patients aged 18 to 60 years with rifampicin- or multidrug- or pre-extensively drug-resistant tuberculosis (RR/MDR/Pre-XDR-TB) at the Public Health Clinical Center of Chengdu, China from May 1, 2018 to July 31, 2022. Patients were divided into 3 groups: linezolid (Lzd) + bedaquiline (Bdq) containing group (regimen A), Lzd + delamanid (Dlm) containing group (regimen B), and Lzd + other drugs containing group (regimen C, not containing Bdq or Dlm). A total of 142 RR/MDR/Pre-XDR-TB patients were included (63 in regimen A, 34 in regimen B, and 45 in regimen C). At 2 months of treatment, 1 patient was lost to follow-up in regimen A and regimen C, respectively. At 6 months of treatment, 3 patients were lost to follow-up in regimen A and regimen C, respectively, and 2 patients were lost to follow-up in regimen B. The sputum culture conversion rates of RR/MDR/Pre-XDR-TB patients in regimen A, B, and C at the end of 2 and 6 months were (72.6% [45/62] vs 64.7% [22/34] vs 18.2% [8/44]) and (95.0% [57/60] vs 90.6% [29/32] vs 81.0% [34/42]), respectively (P < .05). 88.2% (30/34) of the Dlm group used Lzd-Dlm-clofazimine (Cfz)-cycloserine (Cs) containing regimens. 7.9% (5/63) of patients stopped using Bdq due to corrected QT interval by Fredericia >500 ms. 2.9% (1/34) of patients with corrected QT interval by Fredericia prolongation and an increase of 88 ms from baseline stopped Dlm. No patient experienced any malignant heart disease events. Due to related adverse events of Lzd, 14.1% (20/142) reduced Lzd dosage and 6.3% (9/142) had permanent discontinuation of Lzd. 6-month Lzd + (Bdq or Dlm) containing regimens were associated with favorable early culture conversion and showed good safety among HIV-negative patients aged 18 to 60 years with RR/MDR/Pre-XDR-TB. Lzd-Dlm-Cfz-Cs containing regimens may serve as promising candidate regimens for future research on rifampicin-resistant tuberculosis. Multicenter prospective studies with longer follow-up and definitive treatment outcomes are needed to establish comparative effectiveness or treatment superiority of these regimens.

PMID 42760708
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PubMedMedicine2026-09-19

Development and validation of a blood-based diagnostic model for pulmonary tuberculosis combining GBP5 expression and routine laboratory indicators.

Zhao Miaomiao M, Hu Qiuxiang Q, Wang Qing Q, Cha Xinlang X et al.

WHO reports that only 54% of tuberculosis (TB) patients received rapid diagnostic tests at their initial presentation. Conventional laboratory methods in TB detection have high specificity (>90%) but low sensitivity (<50%). This means a large number of tuberculosis patients are missed. A better diagnostic approach is essential to decrease the TB burden. Studies on multi-indicator blood-based models for rapid TB diagnosis remain limited. We developed a rapid, non-sputum-based model to improve the efficiency of TB diagnosis. This was a retrospective case-control study including 301 patients with active tuberculosis (ATB) and 191 patients with other pulmonary diseases (OPD) who were evaluated at the Department of Pulmonary Medicine of the Affiliated Infectious Diseases Hospital of Soochow University between May 2023 and May 2024. A composite clinical diagnosis served as the gold standard for ATB diagnosis, including either a clinical diagnosis or bacteriological confirmation. The diagnostic outcome of ATB (ATB vs OPD) was defined as the dependent variable, while guanylate-binding protein 5 (GBP5) expression levels and routine laboratory indicators (including blood cell counts and plasma protein measurements) were defined as independent variables. Univariate and multivariate logistic regression analyses were performed to identify key predictors, and an AdaBoost algorithm was used to construct a TB diagnostic model. The performance of the model was compared with traditional laboratory-based TB tests. DeLong's Test was used to evaluate the statistical difference of AUC between AdaBoost and traditional methods. Through univariate and multivariate logistic regression analyses, the GBP5 gene, white blood cell (WBC) count, platelet (PLT) count, and prothrombin time (PT) were selected to construct an ATB diagnosis model using the AdaBoost algorithm. The AdaBoost model achieved an AUC of 0.808 in the training set and 0.805 in the test set, while the AUC of smear microscopy, MTB culture, Xpert MTB/RIF, and IGRA were 0.67, 0.59, 0.63 and 0.75 respectively. Therefore, our model demonstrated better diagnostic performance than conventional methods. This study preliminarily demonstrates that our AdaBoost diagnostic model based on GBP5 gene expression and routine blood indicators could serve as a potential tool for the clinical diagnosis of ATB. However, to be applied to the clinic, large samples are needed to validate the performance of the model.

PMID 42760747
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PubMedBMC infectious diseases2026-09-19

Prevalence and factors associated with tuberculosis recurrence among key vulnerable populations in the Ashanti region, Ghana.

Adangabe Ebenezer E, Idan Jacob Solomon JS, Cheabu Benjamin Spears Ngmekpele BSN, Obiefuna Austin Arinze AA et al.

Tuberculosis (TB) is a leading public health challenge, with limited data on the prevalence of recurrence TB and its associated factors among key vulnerable populations (KVPs) in Ghana. This study aimed to determine the prevalence of TB recurrence and identify factors associated with recurrence among PLHIV, informal miners, prisoners, the rural poor, smokers, and children. A cross-sectional study was conducted in five health districts in the Ashanti Region, Ghana, from September to November, 2024. A total of 436 participants, including PLHIV, informal miners, prisoners, the rural poor, smokers, and children, were recruited through systematic random sampling. Data on socio-demographic, clinical and behavioral factors were collected using a validated structured questionnaire. Descriptive statistics were used to summarize data, and logistic regression to identify factors associated with TB recurrence, adjusting for potential confounders using Stata/SE version 16.1. The overall prevalence of TB recurrence among KVPs was 15.6% (68/436). Recurrence was highest among smokers at 25.0% (95% CI: 14.7-37.9), followed by the rural poor at 23.1% (95% CI: 14.9-33.1), informal miners at 19.1% (95% CI: 11.8-28.6), and prisoners at 14.3% (95% CI: 1.8-42.8). PLHIV had a recurrence prevalence of 12.0% (95% CI: 6.4-20.0), while no recurrence was observed among children (0%). In the multivariable logistic regression, two factors were independently associated with TB recurrence, which included; residing in a single-family home compared to a family compound house (AOR: 2.055; 95% CI: 1.002-4.212), and those with the history of heavy alcohol consumption (AOR = 3.596; 95% CI: 1.283-10.080) Compared with participants who reported never consuming alcohol. All other factors, including age, sex, educational level, marital status, key vulnerable population category, and TB support, were not significantly associated with TB recurrence in the adjusted model. TB recurrence among KVPs in the Ashanti Region is an important public health concern, with the burden disproportionately concentrated among smokers, the rural poor, and informal miners. Individuals residing in single-family homes and those with heavy alcohol consumption had higher odds of TB recurrence. These findings indicate that TB control programmes must address both housing conditions that isolate individuals from family support networks and implement integrated alcohol screening and brief interventions within treatment protocols. Targeted interventions addressing these modifiable factors are essential to reduce TB recurrence and improve treatment outcomes among vulnerable populations in Ghana. Not applicable.

PMID 42760524
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PubMedChemical biology & drug design2026-09-19

Design, Synthesis, Antimycobacterial Evaluation, and In Silico Investigation of Benzisothiazole-Based Hydrazide Derivatives as Potential Anti-Tuberculosis Agents.

Sharma Vivek V, Sharma Arun A, Poria Ruchi R, Kumar Pardeep P

A series of novel benzisothiazole-based hydrazide derivatives was rationally designed, synthesized, and evaluated for their antitubercular activity. Among the synthesized compounds, derivative 8k emerged as the most potent candidate, exhibiting a minimum inhibitory concentration (MIC) of 0.25 μg/mL, along with a high selectivity index (SI) of 42 and confirmed bactericidal activity. To gain preliminary insights into its possible mechanism of action, compound 8k was subjected to molecular docking and 100 ns molecular dynamics simulations, using enoyl-acyl carrier protein reductase (InhA) as the proposed molecular target. The computational studies revealed favorable binding interactions and a relatively stable protein-ligand complex, suggesting InhA as a potential molecular target. However, experimental target-validation studies are required to confirm direct InhA inhibition and establish the proposed mechanism of action. Furthermore, in silico ADMET predictions indicated favorable pharmacokinetic characteristics and drug-likeness properties for the lead compound. Collectively, these findings highlight the potential of benzisothiazole-based hydrazide derivatives as promising scaffolds for the development of new antitubercular agents.

PMID 42760852
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