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hepatitis-B vaccine

✓ Approved

Merck & Co. · · Vaccine

What is hepatitis-B vaccine?

hepatitis-B vaccine is a vaccine developed by Merck & Co.. It is approved for therapeutic indications via injectable (others) or intradermal injection.

Drug Profile

CompanyMerck & Co.
Drug ClassVaccine
RouteInjectable (Others), Intradermal Injection
StatusApproved
Sources: ClinicalTrials.gov, Merck & Co.

Mechanism of Action

Molecular Targets

hepatitis-B vaccine acts on 1 molecular target:

(S)
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Related Research Articles

PubMedSouthern African journal of HIV medicine2026-11-11

A retrospective study of HIV and hepatitis B co-infection at a tertiary hospital in the Western Cape province of South Africa.

Hugo Alida M AM, Lovelock Tamsin T, Taljaard Jantjie J JJ

HIV and hepatitis B virus (HBV) coinfection is a clinical concern because of shared transmission routes and accelerated liver disease progression. Data from sub-Saharan Africa (SSA) remain limited. To describe the clinical, laboratory, radiological, and outcome characteristics of adults with chronic HIV/HBV coinfection attending a tertiary hospital in South Africa. A retrospective observational study of adults with HIV and chronic HBV infection attending an infectious diseases clinic between 01 January 2019 and 31 October 2024. Chronic HBV was defined as hepatitis B surface antigen positivity for at least 6 months. Eligible patients had at least two clinic visits. Data were extracted from clinical, laboratory, imaging, and pharmacy records. Of the 179 patients screened, 140 met inclusion criteria. The cohort had a female predominance of 51.4% and a median age of 42 years; most were diagnosed through routine HIV care. The median CD4 count was 214 cells/μL, and many had advanced immunosuppression. Most were receiving antiretroviral therapy (ART), with 78.8% on tenofovir (TDF)-based regimens. HIV and HBV viral load (VL) was low, and the median HBV VL was 81 IU/mL. Liver assessment showed that 36.3% had an abnormal Aspartate Aminotransferase to Platelet Ratio Index score and 40.2% had an elevated liver stiffness measurement (> 7 kPa) suggestive either of significant fibrosis or cirrhosis. Fifteen patients died, 3 of whom died from HBV-related causes. Retention in care was poor, with only one-third remaining in follow-up. Chronic HBV remains an important comorbidity among people living with HIV in South Africa, particularly in those born before widespread vaccination. Despite high ART coverage, important gaps remain in fibrosis assessment and retention in care. Strengthening prevention, vaccination, diagnostic access, and continuity of care is essential to reduce HBV-related morbidity and mortality.

PMID 43011457
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PubMedMedicine2026-11-11

Syphilitic proctitis with profuse rectal bleeding in an HIV-infected patient with preserved CD4 count (case report).

Mosi Mohamad H MH, Alfarra Hisham H, Davi Chandni C, Saaki Shaila S et al.

Syphilitic proctitis is an uncommon and frequently under-recognized manifestation of Treponema pallidum infection that can closely mimic inflammatory, infectious, or neoplastic rectal disease. We report an unusually severe, hemorrhagic presentation in a patient with human immunodeficiency virus (HIV) and a preserved cluster of differentiation 4 (CD4) count, a setting in which overlapping etiologies often delay the diagnosis. A heterosexual man in his early 50s with untreated HIV infection and chronic hepatitis B-related cirrhosis (Child-Pugh class B) presented with sudden onset of profuse hematochezia, watery diarrhea, abdominal cramping, and fatigue. Computed tomography angiography revealed pronounced rectal wall thickening with deep ulceration. Colonoscopy demonstrated an indurated, ulcerated rectal lesion, and biopsy showed dense lymphoplasmacytic inflammation, with spirochetes confirmed by T pallidum immunohistochemistry. Negative cytomegalovirus (CMV) immunohistochemistry, undetectable CMV DNA in plasma and rectal tissue, and a preserved CD4 count (445 cells/µL) made CMV proctitis unlikely. The overall clinical, endoscopic, and histologic findings supported a diagnosis of syphilitic proctitis. Management included doxycycline 100 mg twice daily for 2 weeks, selected because of the patient's documented penicillin allergy. Antiretroviral therapy with bictegravir/tenofovir alafenamide/emtricitabine was initiated to treat HIV and provide concurrent hepatitis B coverage. Within 2 weeks, the patient experienced complete resolution of hematochezia and diarrhea. At 3-month follow-up, the CD4 count had risen to 570 cells/µL, HIV RNA was undetectable (<20 copies/mL), and the rapid plasma reagin titer had declined from 1:512 to 1:32. This case underscores that syphilitic proctitis may manifest with severe ulcerative disease even in patients with relatively preserved immune function. Clinicians should maintain vigilance for syphilis in individuals with HIV who present with rectal bleeding or proctitis to prevent diagnostic delays and ensure timely therapy.

PMID 43012798
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PubMedmSphere2026-11-11

Genetic detoxification of an unencapsulated Neisseria meningitidis strain enhances potency of outer membrane vesicle vaccines and cross-reactivity of vaccine-specific antibodies.

Matthias Kathryn A KA, Kumova Ogan K OK, Reveille Alexandra A, Bizzell Erica E et al.

Meningococcal serogroup B (MenB) detergent-detoxified outer membrane vesicle (dOMV) vaccines demonstrate high effectiveness against the homologous production strain but confer limited cross-protection to heterologous strains. We previously reported that dOMVs isolated from a MenB strain deleted for the proteins PorA, PorB, and RmpM (ΔABR) elicited bactericidal antibodies with a greater breadth of coverage, but of lower overall titer, compared to wild-type (WT) dOMV-induced antibodies. Low ΔABR dOMV potency was associated with pronounced vesicular deterioration and lower levels of lipooligosaccharide (LOS) and capsular polysaccharide (Cps) relative to WT dOMVs, phenotypes resulting from detergent detoxification procedures required to limit LOS-induced toxicity. In this study, we engineered genetically detoxified ΔABR strains that were deleted singly for the lauroyl acyltransferase LpxL1 (ΔABRL) or in tandem for the Cps polysialyltransferase SiaD (ΔABRSL). Genetically detoxified, detergent-extracted OMVs (eOMVs) from ΔABRL and ΔABRSL retained vesicular structure and elicited functional antibodies with increased cross-reactivity compared to ΔABR and ΔABRL dOMVs when administered to rabbits. Antibody seropositivity and cross-reactivity were similarly increased in mice vaccinated with ΔABRL eOMVs vs ΔABRL dOMVs. ΔABRSL eOMV potency was higher than that of ΔABRL eOMVs, suggesting a role for Cps in suppressing antibody responses. Immunization with eOMVs was associated with trends toward improved murine T helper cell responses and elicitation of higher proportions of conformational antibodies that may have contributed to improved bactericidal activity. ΔABRSL eOMVs additionally showed decreased toxicity compared to WT and ΔABR dOMVs when tested in vitro, supporting further study as a vaccine candidate. The ability to target multiple serogroup B Neisseria meningitidis strains with a single vesicle vaccine is complicated by the diversity of antigens that span the bacterial surface. We previously reported that vesicles isolated from meningococcal strains deleted for the major antigenically diverse surface proteins elicited functional antibodies that could kill a large number of N. meningitidis strains though at relatively low titers. Low potency of the mutant vaccines was associated with a breakdown of the vesicular membrane upon detergent treatment, a process necessary to diminish endogenous endotoxin levels and ensure vaccine safety. In this study, we demonstrate that we can retain high cross-reactivity of anti-vesicle antibodies without decreasing the potency of the host immune response through genetic detoxification of the meningococcal vaccine strain. By preventing the formation of the complete endotoxin structure, we are able to isolate vesicles that are safe and immunogenic without the requirement for detergent detoxification.

PMID 43012508
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PubMedMicrobiology spectrum2026-11-11

Evaluation of point-of-care testing (POCT) for blood-borne infections in forensic autopsy specimens.

Kim Ga Eun GE, Lee Dong Yeon DY, Jung Eun-Byoul E-B, Lim Sojung S et al.

Lateral flow immunoassay (LFIA)-based point-of-care testing (POCT) for viral antigen and antibody detection enables rapid screening for blood-borne viral infections and may be particularly valuable in forensic autopsy settings, where incomplete antemortem medical histories and invasive procedures increase the risk of occupational exposure. However, its performance in postmortem specimens remains unclear. We evaluated the applicability of LFIA-based POCT for detecting human immunodeficiency virus (HIV), hepatitis C virus (HCV), and hepatitis B virus (HBV) in autopsy specimens, focusing on postmortem decomposition and the use of solid organ tissues as alternatives to blood. A total of 309 cases were analyzed using LFIA and quantitative polymerase chain reaction (qPCR) across blood, liver, and spleen specimens. Agreement was assessed using overall, positive, and negative percent agreement and Cohen's kappa coefficient (κ). Positivity rates were compared by specimen type and decomposition status. LFIA agreement with qPCR varied by marker and specimen type, with substantial agreement for HIV and HCV antibody detection in blood and lower agreement in liver and spleen. Fresh specimens generally demonstrated higher LFIA positivity rates than decomposed specimens. Among specimens meeting predefined qPCR positivity criteria, LFIA-positive specimens tended to exhibit higher viral loads than LFIA-negative specimens, reaching statistical significance for HBV in liver, with similar but non-significant trends for blood HBV and liver HCV. LFIA-based POCT may serve as a preliminary screening tool in postmortem settings, particularly when blood is available. Nevertheless, negative results do not exclude infection-especially with low viral loads or advanced decomposition-and should be confirmed by molecular testing.IMPORTANCEForensic personnel performing autopsies face significant occupational risks from exposure to blood-borne viruses, including human immunodeficiency virus, hepatitis B virus, and hepatitis C virus. Unlike clinical settings, forensic autopsies frequently involve bodies with unknown infection histories, making rapid infection screening essential for personnel safety. Lateral flow immunoassay (LFIA)-based point-of-care testing (POCT) for viral antigen and antibody detection offers a rapid, infrastructure-free screening option; however, its performance in postmortem specimens has not been systematically evaluated. This study suggests that rapid immunochromatographic POCT may serve as a preliminary screening tool in forensic autopsy settings, particularly when blood specimens are available. However, a negative result does not exclude infection, especially in cases with low viral load or advanced decomposition, and confirmatory molecular testing remains necessary. These findings provide practical guidance for forensic professionals on appropriate specimen selection and interpretation of LFIA results, ultimately supporting safer autopsy practices.

PMID 43012444
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PubMedActa neurochirurgica2026-11-11

Bone flap resorption after autologous cranioplasty for traumatic brain injury: a case-control study in Vietnam.

Pham Huy Ngoc HN, Tien Anh Nguyen Cong NC, Nguyen Linh Khanh LK, Ha Son Hong SH et al.

Autologous bone is a commonly used material for cranioplasty following decompressive craniectomy; however, it is accompanied by the inherent risk of resorption. This study aimed to identify factors associated with bone flap resorption (BFR) in patients undergoing autologous cranioplasty after decompressive craniectomy for traumatic brain injury. A matched case-control study was conducted at Viet Duc University Hospital between January 2022 and July 2025. Cases were defined as patients who developed severe BFR requiring revision surgery. Each case was matched with two controls without BFR based on cranioplasty date and follow-up duration. The association of demographic, general health, trauma history and peri-cranioplasty characteristics with BFR was assessed using conditional logistic regression. A total of 71 cases and 142 matched controls were included in this study. BFR that required surgical revision occurred predominantly within two years after cranioplasty (90%). The mean time interval from cranioplasty to complication diagnosis was 444 ± 212 days. Large-sized bone flap (OR: 3.96, 95% CI: 1.86-8.43), fragmented bone flap (OR: 7.84, 95% CI: 1.38-44.53), and chronic viral hepatitis (either B or C) (OR: 4.32, 95% CI: 1.54-12.15) were independent associated factors of BFR. Young age (< 18), frontal sinus fracture, and ventriculoperitoneal shunt implantation showed a trend to increase risk of BFR but failed to reach statistical significance in multivariate analysis. In our study, bone fragmentation, large bone flap size, and chronic viral hepatitis were associated with increased risk of bone flap resorption after autologous cranioplasty in TBI patients. Further studies are necessary to confirm these findings, especially concerning the role of chronic viral hepatitis.

PMID 43009631
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PubMedInfectious agents and cancer2026-11-11

Evolutionary and functional landscape of HBx mutations in genotype D1 HBV: comparative insights from acute infection, chronic hepatitis, and HCC.

Jalali Kamyar Mazloum KM, Alkhawaja Ali Sameer AS, Xursandov Ilyos I, Gayratjon Elmurodov E et al.

HBV infection remains a major global health burden and a leading cause of hepatocellular carcinoma (HCC), with viral genetic variability contributing to the heterogeneity of clinical outcomes. Among HBV proteins, HBx functions as a multifunctional regulatory protein involved in viral replication, host transcriptional regulation, apoptosis, immune signaling, and oncogenic pathways. Although HBx biology has been extensively investigated, most mechanistic insights are derived from genotype B and C infections, while genotype D-particularly subgenotype D1-remains comparatively underrepresented. This narrative review provides an integrative synthesis of reported HBx mutational patterns across distinct clinical contexts of HBV infection, including acute infection, chronic hepatitis B, and HBV-related HCC, with particular emphasis on genotype D1-dominant populations from the Middle East. The review incorporates findings from previously published phase-specific studies together with relevant external literature to explore how HBx variability may relate to functional domains and disease-associated molecular patterns. Mutations are discussed in the context of major HBx functional regions, including the N-terminal regulatory region, the transactivation domain, the H-box/DDB1-binding motif, and the BH3-like region. Structural modeling, protein-protein interaction network analysis, and phylogenetic contextualization are used as conceptual and illustrative frameworks to interpret reported variants without inferring direct causality. Reported HBx variability appears to preferentially involve structurally flexible and interaction-rich regions. Recurrent substitutions, particularly involving glycine residues, are more frequently reported in acute and chronic infection settings, whereas HCC-associated variants more commonly involve C-terminal alterations and truncation events. Collectively, these observations support a hypothesis-generating framework in which HBx functional plasticity may reflect adaptive virus-host interactions under selective pressures rather than a linear oncogenic mechanism driven by individual mutations alone. Importantly, no new experimental or clinical data are presented, and all interpretations are derived from previously published studies and in silico analyses. By emphasizing genotype D1-specific evolutionary characteristics and addressing a geographical gap in HBV research, this review may provide a useful conceptual basis for future functional investigations, genotype-stratified analyses, and translational studies in HBV-associated liver disease.

PMID 43010014
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