Drug Database
HE

hepatitis-B vaccine (Fendrix)

✓ Approved

GSK · · Recombinant Proteins

What is hepatitis-B vaccine?

hepatitis-B vaccine is a recombinant proteins developed by GSK. It is approved for therapeutic indications via injectable (others) or intramuscular (im) injection.

Drug Profile

Brand NamesFendrix
CompanyGSK
Drug ClassRecombinant Proteins, Vaccine
RouteInjectable (Others), Intramuscular (IM) Injection
StatusApproved
Sources: ClinicalTrials.gov, GSK

Mechanism of Action

Molecular Targets

hepatitis-B vaccine acts on 1 molecular target:

(S)
Want deeper analysis?Noah AI can explain complex mechanisms and compare to similar drugs.

Therapeutic Indications

hepatitis-B vaccine is developed for 1 unique indication across 1 therapeutic area.

Therapeutic AreaConditionPhase
Infections and infestationsHepatitis B✓ Approved

Related Research Articles

PubMedFrontiers in cellular and infection microbiology2026-10-15

Immunogenicity and protective efficacy of recombinant BCG expressing a multi-epitope vaccine against mycobacterium tuberculosis.

Zhang Xuan-Ji XJ, Luo Jia-Rui JR, Tian Ting-Ting TT, Shi Juan J et al.

Mycobacterium tuberculosis (Mtb) infects approximately one-quarter of the global population, of whom 5%-10% develop active tuberculosis (TB). Although Bacillus Calmette-Guérin (BCG) remains the cornerstone vaccine against severe infant TB, its efficacy in adults is limited, underscoring the need for novel TB vaccines. This study aimed to design a multi-epitope vaccine, tMEV, and validate its protective potential through bioinformatic prediction and in vivo experiments. tMEV was constructed from dominant T- and B-cell epitopes derived from Mtb ESAT-6, PE35, PPE38, and PE4 proteins, fused with an adjuvant. Its vaccine candidacy was assessed via physicochemical and solubility profiling, secondary and tertiary structure modeling, TLR-4 molecular docking, molecular dynamics simulation, and immune simulation. The tMEV coding sequence was cloned into pMV361 and transformed into BCG to generate recombinant BCG (rBCG-tMEV). Immunogenicity, antigenicity, and protective efficacy were evaluated in mouse immunization and Mtb challenge models. tMEV exhibited favorable vaccine-like properties in silico. In mice, both tMEV and rBCG-tMEV induced Mtb-specific immune responses. Compared with PBS, tMEV significantly enhanced cellular and humoral immunity with a Th2-biased profile. Relative to conventional BCG, rBCG-tMEV elicited a superior mixed Th1-Th2 response and higher antigen-specific immunity, accompanied by increased secretion of IFN-γ, IL-2, TNF-α, granzyme B, and perforin. Moreover, rBCG-tMEV markedly reduced bacterial loads in the lungs and spleens of Mtb-infected mice, conferring partial protection. These findings demonstrate that tMEV and rBCG-tMEV possess robust immunogenicity and protective potential against Mtb, representing promising novel TB vaccine candidates and providing a rationale for future vaccine development and optimization.

PMID 42876677
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PubMedInfectious diseases and therapy2026-10-15

A Phase 2 Trial Evaluating the Immunogenicity and Safety of an mRNA-Based Seasonal Influenza Vaccine Candidate Encoding Hemagglutinin and Neuraminidase.

Moldt Brian B, Ubeda Rafael A RA, Murray Alexander V AV, Tima Giresse G et al.

Influenza vaccines targeting both hemagglutinin (HA) and neuraminidase (NA) might offer broader protection than current vaccines, which primarily target HA. This randomized phase 2 study evaluated the immunogenicity and safety of an investigational mRNA-based trivalent seasonal influenza vaccine encoding HA and NA from A/H1N1, A/H3N2, and B/Victoria (FLUm3HA-3NA). Participants aged 18-64 years (younger adults) or 65-85 years (older adults) received one of several mRNA vaccine formulations-each containing different influenza A and B HA mRNA doses-or an age-appropriate licensed seasonal influenza vaccine as a comparator. Four formulations per age cohort were tested in part 1 of the study, and one formulation per age cohort in part 2. Day-29 hemagglutination inhibition (HI) and NA inhibition (NI) responses were assessed as primary and secondary endpoints, respectively, safety/reactogenicity as the secondary, and virus neutralization as the tertiary endpoint. A total of 250 younger and 260 older adults were vaccinated in part 1; 161 and 162, respectively, in part 2. All FLUm3HA-3NA formulations induced HI, NI, and neutralizing responses above baseline. In part 1, HI responses against A/H1N1 and A/H3N2 were similar or higher after FLUm3HA-3NA than after comparator vaccination in both age groups. For B/Victoria, HI responses were lower or similar versus comparator vaccination in younger adults and similar or higher in older adults. In part 2, HI responses were similar or higher with FLUm3HA-3NA versus comparators for A/H1N1 and A/H3N2, and lower for B/Victoria in both age groups. In both study parts and both age groups, NI titers were higher for all three strains with FLUm3HA-3NA versus comparators, and neutralizing titers were similar or higher for A/H1N1 and A/H3N2 and similar for B/Victoria. No safety concerns were identified. FLUm3HA-3NA induced HI, NI, and neutralizing responses, with an acceptable safety profile. The results support further development, including optimization of the influenza B HI response. ClinicalTrials.gov: NCT06431607.

PMID 42875682
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PubMedInfectious diseases and therapy2026-10-15

A Phase 1/2 Trial Evaluating the Safety and Immunogenicity of an mRNA-based Seasonal Influenza Vaccine Candidate Encoding Hemagglutinin and Neuraminidase.

De Coster Ilse I, Cardona Jose F JF, Ferguson Murdo M, Leroux-Roels Isabel I et al.

Hemagglutinin (HA) is the principal immunologic target of most licensed seasonal influenza vaccines. Targeting both HA and neuraminidase (NA) might improve vaccine effectiveness. This randomized phase 1/2 study evaluated an investigational mRNA-based quadrivalent seasonal influenza vaccine, encoding HA and NA of A/H1N1, A/H3N2, B/Victoria, and B/Yamagata (FLUm4HA-4NA). In phase 1, adults aged 18-50 years received either one of twelve mRNA vaccine formulations of varying HA-only or HA and NA mRNA doses, or a licensed quadrivalent seasonal influenza comparator. In phase 2, participants aged 18-64 years (younger adults) and 65-85 years (older adults) received FLUm4HA-4NA (three groups per age category, with different HA/NA mRNA doses) or age-appropriate licensed quadrivalent comparator. Primary endpoints were safety/reactogenicity, and hemagglutination inhibition [HI] and NA inhibition [NI] responses against the four seasonal strains at day 29. Cross-reactive HI/NI responses against drifted strains, virus neutralization, and HA-/NA-specific cell-mediated immunity were evaluated in phase 2 as tertiary objectives. A total of 293 participants (21-25 per group) were vaccinated in phase 1, 480 younger (108-137 per group) and 483 older adults (117-125 per group) in phase 2. Solicited events were more frequent with FLUm4HA-4NA than comparators and were mostly short-lived and mild or moderate. No deaths or vaccine-related serious adverse events were reported. Post-vaccination HI and neutralizing titers in the FLUm4HA-4NA groups were similar or higher for the A strains and lower for the B strains versus comparators. NI responses exceeded those of comparators for all four strains. HI and NI titers against evaluated drifted A strains were similar or higher after FLUm4HA-4NA than after comparator vaccination. HA-specific CD4+ and CD8+ T-cell responses were generally higher after FLUm4HA-4NA than comparator vaccination. FLUm4HA-4NA showed an acceptable safety profile and humoral and cellular immunogenicity in the study population, supporting further development and formulation optimization to improve influenza B HI responses. ClinicalTrials.gov: NCT05823974; euclinicaltrials.eu: 2022-502308-66-00.

PMID 42875683
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PubMedJournal of digestive diseases2026-10-15

Single Jaundice in Cirrhosis: A Neglected Acute Decompensation of Acute-on-Chronic Liver Failure and Mortality.

Zhang Xin X, Wang Xian Bo XB, Zheng Xin X, Tan Wen Ting WT et al.

To compare the risk of acute-on-chronic liver failure (ACLF) and short-term outcomes among cirrhotic patients with single jaundice, acute decompensation (AD) (including ascites, variceal bleeding, hepatic encephalopathy, and/or bacterial infection), and non-AD non-jaundice. We analyzed cirrhotic inpatients without obstructive jaundice enrolled from two large multicenter prospective cohorts. Patients were divided at admission into classical AD, single jaundice, or non-AD non-jaundice groups. Baseline characteristics, ACLF development, and short-term outcomes were compared between groups. Among 2645 cirrhotic patients, classical AD, single jaundice, and non-AD non-jaundice were observed in 2163 (81.78%), 267 (10.09%), and 215 (8.13%), respectively. The 90-day liver transplant (LT)-free mortality was comparable between single jaundice patients and classical AD patients (15.09% vs. 17.81%, p = 0.266), but significantly higher than non-AD non-jaundice patients (2.45%; p < 0.01). The prevalence of ACLF (16.10% vs. 16.09%, p = 1.000) and pre-ACLF (9.36% vs. 6.43%, p = 0.094) were comparable between the single jaundice and classical AD groups. Intrahepatic precipitants, particularly hepatitis B flare with hepatitis B virus (HBV) reactivation (odds ratio [OR] 2.69; p = 0.002), spontaneous hepatitis B flare with high HBV-DNA load (OR 23.75; p < 0.001), superimposed hepatitis A/E virus infection on HBV infection (OR 13.40; p < 0.001) and hepatotoxic drug usage (OR 3.64; p < 0.001) were associated with single jaundice. Cirrhotic inpatients with single jaundice show comparably high short-term mortality and ACLF risk to those with classical AD. Single jaundice shall be considered as an AD event and is predominantly triggered by intrahepatic insults, warranting surveillance equivalent to classical AD and prioritized management of the precipitants.

PMID 42876334
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PubMedNature medicine2026-10-15

Personalized neoantigen-targeting cancer vaccines in ovarian cancer: a phase 1 trial.

Sellars MacLean C MC, Frank Jessica A JA, Shim Bohoon B, Vanasse Allison A et al.

Personalized neoantigen-targeting cancer vaccines in the adjuvant setting are of increasing interest across malignancies. Here we report the results of a phase 1 clinical trial testing the feasibility and safety of personalized neoantigen-targeting cancer vaccines for high-grade epithelial ovarian cancer. 'NeoVax' consisted of pools of synthetic long peptides targeting patient-specific neoantigens admixed with the immunostimulant poly-ICLC, was combined with delayed administration of anti-PD-1 antibody, and was tested in ten patients (one newly diagnosed patient (Cohort A) and nine patients at first recurrence (Cohort B)) with platinum-sensitive ovarian cancer following standard-of-care platinum doublet chemotherapy. Nine of 12 evaluable Cohort B patients were vaccinated (75%, 90% CI 47-93%) and 1 of 9 Cohort A patients (11%, 90% CI 0.6-43%). No unexpected safety signals were encountered and no patients discontinued treatment due to toxicity. Across patients, >70% selected targets remained detectable by noninvasive cell-free DNA analysis despite a median of 6.5 months from the time of diagnostic biopsy to vaccine administration, during which, patients received standard-of-care chemotherapy. Biomarker analysis was suggestive of biologic activity of the vaccine in six of ten patients and this was associated with broader tumor and vaccine-specific immune responses in blood and tumor following vaccination. Resistant tumor clones reflected diverse mechanisms affecting antigen presentation, indicative of immune-selective pressure exerted by vaccination. Overall, the interplay between the repertoire of antigens presented by the tumor and the breadth of induced immunity seemed to dictate clinical efficacy following vaccination. ClinicalTrials.gov identifier: NCT04024878 .

PMID 42875558
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PubMedFrontiers in medicine2026-10-15

Season-adjusted longitudinal changes in serum 25-hydroxyvitamin D during pegylated interferon add-on to ongoing tenofovir alafenamide therapy in chronic hepatitis B: a real-world cohort study.

Han Ning N, Liu Huan H, Zhu Xia X

To characterize serum 25-hydroxyvitamin D [25(OH)D] trajectories during peginterferon alfa-2b (Peg-IFN) add-on to ongoing tenofovir alafenamide (TAF) therapy in chronic hepatitis B and explore associations with hepatitis B surface antigen (HBsAg). This retrospective cohort identified 203 consecutive patients, of whom 190 contributed longitudinal data through week 48. The primary random-intercept mixed-effects model used categorical visit time and adjusted for seasonality, age, and sex. Continuous-time, random-slope, visit-timing, and HBsAg-censoring analyses assessed sensitivity. The primary adjusted week-48 25(OH)D difference was -7.9 nmol/L (95% CI, -9.8 to -6.0) (P < 0.001); the secondary continuous-time estimate was -8.3 nmol/L over 48 weeks. Observed concentrations declined through week 36 and partially rebounded at week 48. The proportion below 47.7 nmol/L increased from 21.1% to 34.7%. The adjusted total serum calcium trend was -0.061 mmol/L (95% CI, -0.074 to -0.049). Triglycerides increased while cholesterol fractions decreased. At week 48, 104/190 patients (54.7%) had an HBsAg decline of at least 1 log10 and 50/190 (26.3%) had visit-specific HBsAg loss. The concurrent 48-week change correlation was weak (ρ = 0.150; FDR-adjusted P = 0.117), and the magnitude of 25(OH)D decline was not independently associated with either binary endpoint. Within patients, each 10 nmol/L increase in 25(OH)D was associated with a 0.068-log10 IU/mL increase in concurrent HBsAg (95% CI, 0.020 to 0.116; P = 0.006). Serum 25(OH)D showed a non-linear decline during 48 weeks of follow-up, and the week-48 difference remained evident after adjustment for seasonality. However, without a concurrent comparator, the observed change cannot be attributed specifically to Peg-IFN, TAF, or their combination. Exploratory analyses suggested only a weak concurrent relationship between 25(OH)D and HBsAg, without evidence of prediction or causality. The clinical relevance of the observed changes in 25(OH)D and total serum calcium warrants further prospective investigation.

PMID 42876729
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