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DTP-HBV-Hib vaccine (Comvac5)

✓ Approved

Bharat Biotech Ltd. · Vaccine · Vaccine

What is DTP-HBV-Hib vaccine?

DTP-HBV-Hib vaccine is a vaccine developed by Bharat Biotech Ltd.. It is approved for therapeutic indications via injectable (others) or intravenous (iv).

Drug Profile

Brand NamesComvac5
CompanyBharat Biotech Ltd.
Drug ClassVaccine
RouteInjectable (Others), Intravenous (IV)
StatusApproved

Therapeutic Indications

DTP-HBV-Hib vaccine is developed for 4 unique indications across 1 therapeutic area.

Therapeutic AreaConditionPhase
Infections and infestationsDiphtheria✓ Approved
Infections and infestationsHepatitis B✓ Approved
Infections and infestationsPertussis✓ Approved
Infections and infestationsTetanus✓ Approved

Related Research Articles

PubMedVirology journal2026-09-20

Regulatory roles of G-quadruplexes and G-quadruplex-binding proteins across the enhancer and promoter of the HBV genome.

He Lina L, Huang Baoyue B, Ma Haiyang H, Wang Lin L et al.

Hepatitis B virus (HBV) infection poses a global threat to human health due to the limited availability of effective treatment options. Recent studies have shown that the structures of G-quadruplex (G4) are related to the pathogenesis of the virus and potential targets for antiviral therapy. G-quadruplex-binding proteins (G4BPs) play a key role in regulating the G4 landscape and its associated functions by anchoring, stabilizing, or unwinding G4 structures. Researchers have actively pursued the identification of G4 structures within the HBV genome, yet a comprehensive, genome-wide analysis revealing their regulatory role and that of G4BPs has remained largely elusive. Consequently, our understanding of the intricate interactions between HBV G4 and G4BPs remains quite limited. Biophysical and molecular biology approaches were employed to investigate HBV G4, focusing on core promoter and enhancer (CP/EN) activities. Mass spectrometry, DNA pull-down, and surface plasmon resonance (SPR) characterized interactions between G4 and G4BPs. Employing the dual luciferase reporter system and HBV infection model, this study utilized binding assays designed for the G4 mutant, alongside overexpression and knockdown experiments, to delve into the regulatory functions of G4 and G4BPs. We identified two functional G4 elements located at positions 1204 and 1732 within the HBV CP/EN regulatory region. Reporter assays containing the CP/EN sequences showed that disruption of either the 1204 or 1732 G4 structure significantly reduced promoter activity. In the HBV 1.3-mer system, disruption of the 1732 G4 markedly decreased HBsAg, HBeAg and HBcAg expression, whereas total HBV RNA and 3.5 kb RNA levels were not significantly affected. Both G4 elements selectively recruited multiple host proteins in vitro, among which the 1732 displayed stronger binding to HNF4A. Functional assays further demonstrated that HNF4A enhanced CP/EN-driven reporter activity in a G4-dependent manner, and stabilization of G4 structures by BRACO-19 further promoted the interaction between G4 and HNF4A. In addition, CNBP, the most highly enriched G4-binding protein, positively regulated HBV antigen and RNA expression; however, CNBP did not enhance CP/EN promoter activity, indicating a regulatory mechanism independent of CP/EN activation. This study reveals that two G4 structures within the HBV CP/EN regulatory region function as structural platforms for host factor recruitment and play distinct roles in regulating viral gene expression. In particular, the 1732 G4 facilitates HNF4A-dependent activation of CP/EN activity, thereby supporting efficient viral protein production, whereas CNBP promotes HBV expression through a CP/EN-independent mechanism.

PubMedAdvances in virology2026-09-20

Comparative Sequence Analysis of the Envelope Gene of Kyasanur Forest Disease Virus Vaccine Strain With Currently Circulating Field Strains.

Kaje Keerthi K, Marinaik Chandranaik B CB, Gomes Amitha Reena AR, Rizwan Apsana A et al.

The present study was undertaken with the objective of performing comparative sequence analysis of the envelope (E) gene of Kyasanur forest disease virus (KFDV) vaccine strain P9605 with the circulating field strains. The study was taken up as the currently used KFDV vaccine strain, KFDV P9605, was isolated in the 1960s. For this study, we designed two sets of primers targeting the complete amplification of the E gene of KFDV. The sequencing was performed by the Sanger method, and the deduced sequence of the vaccine virus was deposited in GenBank with accession number PX067005. This sequence obtained for the vaccine virus was aligned and compared with sequences of GenBank-deposited circulating field strains. We also performed comparative sequence analysis of the Kyasanur forest disease (KFD) vaccine seed virus having passaged twice in mouse brain with the vaccine seed virus passaged six times in mouse brain to investigate whether multiple passages in mouse brain will lead to genetic mutation in the immunologically important E gene. The phylogenetic analysis revealed seven amino acid mutations in the field strains at positions A123T, S158N, D178E, D239N, A313S, M429I, and G479A when compared with the vaccine strain. We did not find any mutations at the critical fusogenic segment (residues 98-113) in the E gene of currently circulating field strains compared to the vaccine seed virus. The study found no genetic variations in the E gene of the KFD virus passed two times and passed six times in mouse brain. We performed SWISS-MODEL homology modeling, AlphaFold protein analysis, and Ramachandran plot analysis to study the E protein structures and stability. The observations made in this study suggest slow evolutionary drift and conserved structural stability of the envelope gene of KFDV ever since its emergence 7 decades ago; however, the functional implications of these amino acid substitutions need further studies on their roles in viral infectivity, transmission, and impact on immunity.

PubMedFrontiers in medicine2026-09-19

Elevated ALT correlates with severe liver injury, monocyte infiltration, and Pro-inflammatory immune dysregulation in chronic hepatitis B virus infection.

Huang Jian J, Xu Ning N, Liang Xiuyan X, Cai Defeng D

Hepatitis B virus (HBV) infection remains a global health burden. Although alanine aminotransferase (ALT) is a well-established marker of liver injury, its relationship with immune infiltration, monocyte activation, and inflammatory immune skewing in chronic HBV infection remains incompletely understood. This study aimed to investigate the associations of ALT with liver injury, monocyte infiltration, and hepatic immune microenvironment dysregulation. A total of 192 HBV-infected patients and 37 healthy controls were enrolled. Serum ALT, AST, HBV seromarkers, HBV-DNA, alpha-fetoprotein (AFP), and serum fibrosis markers (COLIV, HA, PIIINP, LN) were measured. Univariate and multivariate regression analyses were used to adjust for confounders including age, sex, HBV-DNA, fibrosis markers, and HBeAg status. Transcriptomic data from the GSE84044 liver biopsy cohort (n = 105) were analyzed using the xCell algorithm to evaluate hepatic immune infiltration, macrophage polarization, and immune scores. Gene set enrichment analysis (GSEA) was performed to explore monocyte chemotaxis, activation, and WNT/β-catenin signaling pathway. Chronic hepatitis B (CHB) patients showed significantly elevated ALT and AST. Higher ALT levels were strongly associated with elevated fibrosis markers and AFP, indicating more severe liver injury. Peripheral monocytes count and intrahepatic monocyte infiltration were both significantly increased in high-ALT patients. However, after multivariate adjustment, ALT was no longer independently associated with monocyte infiltration, suggesting that the association was largely attributable to overall disease severity rather than a specific ALT-related association. GSEA showed that ALT was positively correlated with monocyte chemotaxis, activation, macrophage differentiation, and WNT/β-catenin signaling pathway. Immune landscape analysis revealed a pro-inflammatory immune profile in high-ALT patients, characterized by increased M1 macrophages, CD8+ T cells, and elevated immune scores, accompanied by decreased Tregs and Th1 cells. Elevated ALT in chronic HBV infection correlates with severe liver injury and a pro-inflammatory, dysregulated hepatic immune microenvironment characterized by enhanced monocyte infiltration and M1 macrophage polarization. Transcriptomic associations reveal a statistical link between WNT/β-catenin signaling activation and hepatic immune dysregulation in HBV-related liver injury; these correlative findings provide preliminary clues for developing immunomodulatory therapeutic strategies for CHB.

PubMedMedicine2026-09-19

Clinical spectrum and burden of extrahepatic manifestations in chronic hepatitis B: A multinational study from 2000 to 2025.

Khan Sajjad Ahmed SA, Subedi Anuj A, Marasini Anurag A, Shrestha Alisha A et al.

Chronic hepatitis B virus (HBV) infection is associated with both hepatic and extrahepatic complications. While liver-related outcomes are well characterized, the burden, demographic patterns, and survival associated with extrahepatic manifestations (EHMs) remain incompletely defined. This study aimed to evaluate the spectrum, incidence, and survival impact of EHMs in a large, geographically diverse cohort of patients with chronic HBV infection. We conducted a retrospective cohort study using the TriNetX Global Research Network, including 2,32,820 patients aged 0 to 90 years with chronic HBV infection. Demographic variables included age, sex, race, ethnicity, and geographic region. EHMs assessed comprised renal (glomerulonephritis), vasculitic (polyarteritis nodosa), musculoskeletal (arthralgia), hematologic (aplastic anemia), immunologic (cryoglobulinemia), and neurologic (polyneuropathy) conditions. Incidence proportions and incidence rates per person-day were calculated and stratified by demographic characteristics. Survival probabilities were estimated for each manifestation. The mean age of the cohort was 60 ± 14 years, and 56.9% were male. Racial distribution included Asian (34.4%), White (15.4%), Black or African American (12.1%), and unknown race (34.4%). Most patients were non-Hispanic (53.6%), with 44.1% reporting unknown ethnicity. Patients were represented across all US regions and internationally. Glomerulonephritis occurred in 1.26% of patients, with higher incidence in older adults, males, and Native Hawaiian/Other Pacific Islander and Hispanic/Latino populations. Polyarteritis nodosa was rare (0.04%) and predominated in older individuals, American Indian/Alaska Native, and Hispanic/Latino patients. Arthralgia was the most frequent EHM (13.76%), increasing with age and more common among females and Black or African American individuals. Cryoglobulinemia (0.10%) and aplastic anemia (0.12%) were uncommon. Polyneuropathy affected 3.27% of patients, with higher prevalence among older adults and males. Chronic HBV infection is associated with a wide spectrum of extrahepatic manifestations, with substantial variation by demographic factors. These findings underscore the need for comprehensive multisystem surveillance and targeted risk stratification in patients with chronic HBV infection.

PubMedDiagnostic microbiology and infectious disease2026-09-19

Analytical comparison of hepatitis B core total antibody serological immunoassays on Atellica and Cobas analyzers using reliable long-term frozen archived samples.

Donald Sarah S, Gee Matthew F W MFW, Pagano Maria E ME, Abou-Diwan Charbel C et al.

Serological detection of total antibodies (IgM and IgG) against hepatitis B core antigen (HBc) is essential for diagnosing and assessing infection status of Hepatitis B virus (HBV). Despite multiple commercialized anti‑HBc total automated assays, comparative assay performance remains limited. A subset of long-term frozen serum aliquots (n = 1021) from a previously reported clinical population representative of adults at risk or symptomatic for HBV infection was re-tested using the HBcT2 Atellica IM assay designed without the need for a retest zone. HBcT2 Index values obtained in 2020 and 2025 were compared by regression analysis and qualitative reactive/nonreactive interpretation agreement. The subset was also tested using the Roche Elecsys anti-HBcII assay on Cobas analyzer, and positive/negative percent agreements (PPA/NPA) were calculated to assess the methods agreement. Strong linear relationships (slope, 0.98; Pearson's r, 0.993), and PPA/NPA > 99.5% between 2020 and 2025 HBcT2 Index values showed excellent agreement confirming the reliability of the archived clinical samples. Qualitative agreement (PPA/NPA) between the Atellica IM HBcT2 and Roche Elecsys anti-HBcII was high in the population overall (PPA/NPA's >96%) and among HBV categories (PPA/NPA's >90%). The Atellica IM HBcT2 assay on the Atellica IM analyzer demonstrated high qualitative agreement with an established comparator assay for detecting total anti-HBc antibodies, thus expanding the range of valuable diagnostic methods available for HBV laboratory testing. The results were comparable to the Roche Elecsys anti-HBcII assay in a high-risk/symptomatic population.

PubMedTransfusion2026-09-19

Long-term stability and reproducibility of frozen plasma control samples for hepatitis B virus, hepatitis C virus, and human immunodeficiency virus by quantitative PCR: Implications for retrospective testing in hemovigilance.

Marx Benjamin B, Berger Annemarie A, Kohmer Niko N, Kortenbusch Marhild M et al.

Data on the long-term stability and reproducibility of nucleic acid amplification testing (NAT) results in frozen stored positive samples (≤-20°C) remain limited. This study evaluated the long-term performance of frozen virus-positive samples in quantitative PCR assays and aimed to provide evidence for their analytical reliability in retrospective NAT and quality assurance. Because blood transfusions, despite their high safety, still carry a residual risk of transmission of blood-borne viruses, these data may also be relevant for look-back investigations in hemovigilance. Diluted and aliquoted internal run controls from positive patient samples were retrospectively analyzed using routine quantitative PCR assays. Long-term stability was assessed over 37 months for HIV, 25 and 29 months for HBV-A and HBV-B, and 49 and 38 months for HCV-A and HCV-B. Descriptive statistics and linear regression were used to assess variability and temporal trends. Compliance with the German Medical Association's guidelines for quality assurance in medical laboratory testing (Rili-BAEK) was evaluated using an acceptance range of ±0.5 log10. All internal run controls demonstrated stable long-term performance during frozen storage and routine use. Across the datasets, 99.2%-100% of measurements remained within the acceptance range. Results outside mean ± 3 SD were rare, and no statistically significant temporal trend was observed for any internal run control. Frozen HBV-, HCV-, and HIV-positive samples showed robust long-term stability and reproducibility in routine quantitative PCR assays for up to 4 years. These findings support the suitability of long-term stored specimens for retrospective NAT.

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