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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
Sources: ClinicalTrials.gov, Bharat Biotech Ltd.

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

PubMedJournal of the International AIDS Society2026-07-25

Vaccination Coverage and Prevention Counselling for Vaccine-Preventable STIs Among HIV PrEP Users in São Paulo, Brazil: A Retrospective Cohort Study.

Rapozo Marjorie Marini MM, Lara Amanda Nazareth AN, Passarelli Victor Cabelho VC, Ramos Laísa Rivas Dapousa LRD et al.

HIV pre-exposure prophylaxis (PrEP) users may be disproportionately vulnerable to sexually transmitted infections (STIs) in general, including several that are vaccine-preventable. Understanding immunization patterns in this population is, therefore, crucial. However, data on vaccination coverage among Brazilian PrEP users remains limited. We conducted a retrospective single-centre study of adults using HIV PrEP at an STI clinic in São Paulo, Brazil, between 2017 and 2024, to assess vaccination adequacy for vaccine-preventable STIs among PrEP users, as well as other STI prevention measures during follow-up. Demographic characteristics, substance use, STI history and vaccination status for hepatitis A (HAV), hepatitis B (HBV), human papillomavirus (HPV) and MPox were extracted from medical records, immunization registries and laboratory results, and descriptive analyses were performed. Among 190 participants (median age: 36 years), 89.5% were gay or other men who have sex with men (MSM). Over a mean follow-up period of 45 months, complete vaccination coverage was observed in 97.7% for HBV, 49.5% for HAV, 24.2% for HPV and 1.6% for MPox. Despite documented prior vaccination, a proportion of participants remained susceptible to HAV (16.3%) and HBV (2.3%). Furthermore, a substantial proportion of participants (32.1% for HAV, 53.7% for HPV and 81.0% for MPox) had neither a documented vaccination status nor a provider recommendation for vaccination recorded in their medical charts. HPV- and MPox-related clinical lesions were documented in 17.9% and 2.1% of participants, respectively. Notable gaps in immunization against preventable STIs were observed in this PrEP cohort in São Paulo, Brazil. While HBV coverage was high, uptake of HAV, HPV and MPox vaccines was low. Addressing these gaps in our cohort requires transitioning from mere provider recommendations to structural public health policies. Implementing on-site vaccine administration within PrEP services, integrating immunization into STI screening, expanding free access and addressing key vulnerabilities are critical steps to eliminate structural barriers and reduce the STI burden.

PMID 42499158
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PubMedOpen forum infectious diseases2026-07-25

Prevalence of Hepatitis B Coinfection in People With HIV by Birth-Year Cohort.

Lee So Jeong SJ, Verinumbe Tarfa T, Lesko Catherine R CR, Fojo Anthony A et al.

Availability of the hepatitis B virus (HBV) vaccine in the United States since 1982 and recommendations for universal/catch-up vaccination of infants and children since the 1990s may be associated with lower HBV prevalence among people with human immunodeficiency virus (HIV; PWH) born after 1980. Active HBV infection prevalence, defined as the proportion of patients with a positive hepatitis B surface antigen result, was assessed among PWH at entry into a clinical cohort. Patients were categorized into birth-year cohorts of 1940-1959, 1960-1979, or 1980-1999 and then further dichotomized into pre- and post-1980 birth-year cohorts. Log binomial regression was used to assess the association of birth-year cohort with hepatitis B surface antigen positivity, adjusting for race/ethnicity, HIV infection risk factor, baseline HIV viral load and CD4+ cell count, HBV active therapy, and year of/age at cohort entry. Among 5598 PWH, most were male (67%) and Black (77%), with a mean age (SD) of 39.7 (9.6) years at cohort entry. Approximately a third of the participants (30%) identified as men who have sex with men, and 39% reported a history of injection drug use. At cohort entry, the majority had a CD4+ cell count <350/µL and a viral load >1000 copies/mL. The HBV prevalence was 6.7% overall but varied by birth-year cohort: 6.2% for 1940-1959, 7.9% for 1960-1979, and 2.6% for 1980-1999. The risk of HBV infection was lower in the post-1980 than in the pre-1980 cohort (adjusted prevalence ratio, 0.19 [95% confidence interval, .09- .42]). PWH born after 1980 had a lower prevalence of HBV coinfection than those born before 1980, supporting the potential impact of universal childhood HBV vaccination.

PMID 42500124
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PubMedCureus2026-07-25

Fatal Acute Liver Failure Associated With Presumed Hepatitis B Virus Reactivation During Rituximab Maintenance Therapy: A Case Report.

Tran James J, Zhou Calvin C, Babun Asis A AA, Leung Whinkie W et al.

We report a woman in her 60s with follicular non-Hodgkin lymphoma receiving maintenance rituximab therapy, last administered one month prior to presentation, who developed progressive malaise, jaundice, and acute liver failure. Laboratory evaluation demonstrated severe hepatocellular injury with marked transaminase elevations (alanine aminotransferase: 2,500 U/L; aspartate aminotransferase: 2,400 U/L), hyperbilirubinemia (total bilirubin: 20 mg/dL), and coagulopathy. Hepatitis B virus (HBV) serology demonstrated active infection with elevated hepatitis B surface antigen (HBsAg) and detectable HBV DNA. Baseline HBV screening and antiviral prophylaxis records prior to rituximab initiation were unavailable from the treating institution, limiting the definitive confirmation of pre-existing HBV status. Given the patient's recent rituximab exposure, clinical presentation, and exclusion of alternative etiologies, HBV reactivation was considered the most likely diagnosis. The patient was diagnosed with HBV reactivation associated with rituximab therapy. Despite the initiation of antiviral treatment and aggressive supportive care, her clinical course rapidly deteriorated, complicated by hepatic encephalopathy, acute kidney injury requiring hemodialysis, and hypoxic respiratory failure. She was evaluated for liver transplantation but deemed ineligible due to multiorgan failure and ultimately transitioned to end-of-life care. This case highlights the potentially fatal consequences of HBV reactivation during rituximab therapy and underscores the importance of appropriate screening, prophylaxis, and vigilance in high-risk patients.

PMID 42500753
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PubMedArchives of virology2026-07-25

HBV PreS/S gene mutations in patients with chronic hepatitis B.

Çakal Bülent B, Çavuş Bilger B, Atasoy Alp A, Bulakçı Mesut M et al.

Variants in the hepatitis B virus (HBV) PreS/S gene have been suggested to contribute to the development of progressive liver disease. This study aimed to evaluate the association between HBV PreS/S variations and liver histopathology in patients with chronic hepatitis B. A total of 109 patients under clinical follow-up for chronic hepatitis B were included. The HBV PreS/S gene was amplified by PCR and sequenced using the Sanger method. Amino acid substitutions, nonsense mutations, and deletions were analyzed in relation to liver fibrosis stage. Overall, 58 of 389 amino acid sites (14.9%) in the HBV PreS/S gene showed substitutions, with the highest mutation rate observed in the PreS2 region (27.27%). Mutations L54P (PreS1), F130L/S (PreS2), and S207R/N/I/T and I208T (S gene) were significantly more frequent in patients with advanced fibrosis (F ≥ 3) (p < 0.05). Multivariable analysis identified S207R/N/I/T as an independent risk factor for liver fibrosis. Patients with PreS2 mutations had higher fibrosis scores (p < 0.05). The S207R/N/I/T mutation in the C-terminal region of the HBV S protein is independently associated with liver fibrosis, while PreS2 mutations may contribute to fibrosis progression in chronic hepatitis B.

PMID 42498832
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PubMedJournal of viral hepatitis2026-07-25

The Silent Burden of Hepatitis B-Related Stigma.

Smith Verity V, Asriah Menita M, Fernelius Katherine K, Das Joyeta J et al.

Individuals experiencing stigma related to chronic hepatitis B virus (HBV) infection often experience negative self-beliefs, isolation, discrimination, and reduced willingness to engage with healthcare professionals. We aimed to understand the patient perspective of HBV-related stigma and to summarize the patient experience of stigma in a patient-centric conceptual model. Eligible adult participants with a confirmed diagnosis of chronic HBV infection were recruited from the US, China, and Poland. Qualitative, semi-structured, concept elicitation interviews of approximately 60 min were conducted to explore participants' experiences of stigma. Qualitative analysis of interview data was conducted using Thematic Analysis methods with concepts categorized into domains and pre-determined stigma types. A total of 28 participants were recruited from the US (n = 11), China (n = 11), and Poland (n = 6). Internalized stigma was reported by all participants (n = 28; 100%), social stigma was reported by 79% (n = 22) of participants, and institutional stigma was reported by 57% (n = 16) of participants. Seven domains across condition-specific and health-related quality of life (HRQoL) concepts were identified to create a patient-centric conceptual model of the experience of stigma associated with HBV infection. Each domain was reported by at least half of the participants, with social functioning (n = 28; 100%), emotional wellbeing (n = 27; 96%), and HBV transmission (n = 27; 96%) most frequently reported. Experiences of stigma were highly inter-related. Experiences of HBV-related stigma were highly pervasive, with widespread impact on HRQoL. To address the burden of stigma, reducing internalized stigma would be most impactful as this was the most common and bothersome.

PMID 42499137
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PubMedArab journal of gastroenterology : the official publication of the Pan-Arab Association of Gastroenterology2026-07-25

Prevalence of HIV, HCV, HBV, and syphilis infection among Egyptian drug users: Cairo University hospitals' experience.

Cordie Ahmed A, Mohamed Rahma R, Enaba Dalia D, Mamdouh Rania R et al.

An integrated screening program with fast-track access to care for human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis B virus (HBV), and Syphilis were implemented in substance use treatment clinic at Cairo University hospitals, Egypt. This study aimed to assess seroprevalence rates of HIV, HBV, HCV, and Syphilis among drug users and evaluate their awareness and uptake of prevention and testing services. A total of 2545 drug users were screened for HIV, HCV, Treponema pallidum (TP) antibodies, and surface antigen of HBV (HBsAg) between September 2022 and January 2024. Additionally, data on knowledge related to testing and prevention services were collected from 1066 drug users. Seroprevalence rates of HIV, HCV, HBsAg, and Syphilis were 4.4%, 8%, 1.34% and 0.1%, respectively. Among the 1066 drug users interviewed regarding their awareness and uptake of prevention and testing services, only 10 (1%) participants were tested for HCV during the previous nationwide screening campaign; three of them tested positive and two received treatment. Five (0.5%) participants were previously tested for HIV and were negative. Only 3 (0.3%) participants had heard of Pre-exposure prophylaxis (PrEP), while 5 (0.5%) received an HBV vaccination. No participants have ever received free condoms, clean needles or methadone maintenance therapy. Our findings indicate the need for improved testing, treatment, and prevention services directed to drug users, coupled with focused awareness efforts to increase access to these services.

PMID 42498558
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