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RA

rabies vaccine

✓ Approved

China National Biotec Group · Vaccine · Vaccine

What is rabies vaccine?

rabies vaccine is a vaccine developed by China National Biotec Group. It is approved for therapeutic indications via injectable (others) or intramuscular (im) injection.

Drug Profile

CompanyChina National Biotec Group
Drug ClassVaccine
RouteInjectable (Others), Intramuscular (IM) Injection
StatusApproved

Therapeutic Indications

rabies vaccine is developed for 1 unique indication across 1 therapeutic area.

Therapeutic AreaConditionPhase
Infections and infestationsRabies✓ Approved

Related Research Articles

PubMedBMC public health2026-10-15

Rabies and rabies prophylaxis in Egypt: a nationwide cross-sectional study that calls for action.

Helal Mohamed Basyouni MB, Saeda Mohamed Ahmed MA, Elshaar Ahmed Gamal AG, Zayed Mohamed Elsayed ME et al.

Rabies is a fatal but preventable viral disease that poses a global health threat, especially in developing countries. Despite the high incidence of animal bites reported annually in Egypt, limited data exist regarding the knowledge, attitudes, and practices (KAP) of the general population toward rabies and rabies prophylaxis. We conducted a nationwide cross-sectional study using a structured interview-based survey targeting individuals aged 18 years or older who attended outpatient clinics at nine university hospitals across Egypt. The survey assessed participants' KAP toward rabies and rabies prophylaxis and identified barriers to prophylaxis uptake. Among 1,777 participants who responded to the survey, only 42.8% (n = 760) had good knowledge about rabies and rabies prophylaxis, while the majority, 88.5% (n = 1,572), exhibited a positive attitude toward rabies prophylaxis. Knowledge was higher among those who reported awareness of rabies campaigns in their geographic areas (69.1% vs. 40.5%, p < 0.001) and those who had previously been bitten or attacked by animals (56.1% vs. 41.3%, p < 0.001). Overall, 9.7% (n = 173) of participants reported a history of animal bites or attacks; however, 18.5% (n = 32) of these participants did not receive post-exposure prophylaxis (PEP), and 17% (n = 24) did not complete the vaccine schedule. Pre-exposure prophylaxis (PrEP) uptake was low, with only 4.3% (n = 23) of high-risk individuals receiving it. Key barriers to rabies prophylaxis included lack of knowledge about the rabies vaccine, reported by 82.4% of participants, lack of knowledge about rabies, reported by 81.7%, and inadequate hospital facilities, reported by 43.1%. Despite a generally positive attitude toward rabies prophylaxis, knowledge and adherence to prophylactic measures, including pre-exposure and post-exposure prophylaxis, remain relatively inadequate in Egypt. Public health interventions, such as educational campaigns and improved accessibility to vaccination services, are needed to address these gaps and mitigate the public health burden of rabies.

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.

PubMedFrontiers in immunology2026-10-15

Dendritic-cell-targeting adeno-associated virus as potent cancer vaccine carriers.

Wei Xin X, Li Xiang X, Qi Lixia L, Qiu Wenxuan W et al.

The clinical efficacy of therapeutic cancer vaccines is critically limited by the inefficient in vivo delivery of tumor antigens to dendritic cells (DCs), the key regulators of T-cell immunity. To address this issue, we developed a dendritic-cell-targeting adeno-associated virus (AAV) vector through rational capsid design. This was achieved by site-specifically inserting the high-affinity Clec9a-targeting peptide CBP-12, optimizing its flanking sequences, and introducing T491V/S662V gain-of-function mutations to synergistically enhance DC transduction. The resulting vector, AAV2-mut-Peptide2, showed significantly improved tropism for and gene delivery efficiency to cross-presenting cDC1s in vivo. In murine models of hepatocellular carcinoma, vaccination with this platform, encoding either a model antigen (OVA) or the endogenous tumor-associated antigen GPC3, elicited a potent antigen-specific CD8+ T cell response. This response was characterized by a substantial increase in tumor-infiltrating lymphocytes, enhanced production of key effector cytokines, and consequently, potent suppression of tumor growth. Our study establishes this engineered AAV as a versatile and potent vaccine platform that effectively targets DCs, offering a promising approach for inducing robust and adaptable anti-tumor immunity.

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.

PubMedFrontiers in immunology2026-10-15

Case report: Maternal engraftment of T-cells in a patient with Severe Combined Immunodeficiency due to DCLRE1C pathogenic variant - diagnostic and treatment challenges.

Peiseniece Evija E, Rozevska Marija M, Arnite Viktorija V, Rascon Jelena J et al.

Severe combined immunodeficiency (SCID) is a rare but serious congenital condition caused by genetic defects that severely impair the development and function of T cells, B cells, and natural killer (NK) cells. Without early diagnosis and immune system reconstitution, SCID is usually fatal in infancy. The condition requires prompt recognition and hematopoietic stem cell transplantation (HSCT) to restore immune function. This report describes the first genetically confirmed case of SCID in Latvia - caused by a DCLRE1C gene pathogenic variant and diagnosed prior to the implementation of national newborn screening for SCID - complicated by disseminated tuberculosis following Bacillus Calmette-Guérin (BCG) vaccination. The male infant was born after an uneventful pregnancy to healthy parents with no known genetic disorders. The patient experienced recurrent bacterial respiratory infections and received the first scheduled vaccination, the BCG vaccine, at 2 months of age, later than recommended in the national immunization schedule because of parental hesitancy related to concerns about vaccine safety. Shortly after receiving the BCG vaccine, the infant developed erythroderma and a maculopapular rash, followed by pneumonia, acute bronchiolitis, and a bacterial skin infection at three months of age. Immunological evaluation revealed an atypical pattern for SCID, with CD3+ T cells at 53% (abs. 764/μL) and CD4+ T cells at 52% (abs. 748/μL), but a profound deficiency of CD8+ T cells (0.79%, abs. 11/μL). In our case, genetic analysis identified a homozygous pathogenic variant in the DCLRE1C gene. The presence of an XX cell line suggested maternal T-cell engraftment. The patient underwent HSCT; however, post-transplant disseminated tuberculosis required antituberculosis therapy and significantly affected the outcome. This case underscores the importance of early diagnosis and, specifically, early antimycobacterial prophylaxis in SCID: although the diagnosis was genetically confirmed at 4 months of age, prophylactic antimycobacterial treatment was not started until disseminated BCG disease was identified 3.5 months later, at 7.5 months of age, and this delay was followed by prolonged multidrug antimycobacterial therapy and a complicated post-transplant course. This highlights the risks of administering live vaccines before immune status is confirmed and reinforces the critical role of newborn screening programs for SCID, which Latvia began implementing on April 1, 2023.

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 .

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