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hepatitis A vaccine (Havisure)

✓ Approved

Indian Immunologicals · 疫苗 · 疫苗

什么是 hepatitis A vaccine？

hepatitis A vaccine 是一种疫苗，由Indian Immunologicals研发。该药已获批，用于治疗相关适应症，给药途径：Injectable (Others)、Intramuscular (IM) Injection。

药物档案

商品名Havisure
公司Indian Immunologicals
药物类别疫苗, 大分子
给药途径Injectable (Others), Intramuscular (IM) Injection
状态Approved
来源： ClinicalTrials.gov, Indian Immunologicals

治疗适应症

hepatitis A vaccine 针对 1 个适应症，涉及 1 个治疗领域。

治疗领域疾病/病症分期
Surgical and medical proceduresAntiviral prophylaxis✓ Approved

相关研究文献

PubMedHepatology international2026-08-04

National guideline for hepatitis B elimination in Thailand: a decentralized health system model for expanding diagnosis and treatment.

Charatcharoenwitthaya Phunchai P, Tanwandee Tawesak T, Tangkijvanich Pisit P, Piratvisuth Teerha T et al.

Despite sustained universal infant hepatitis B vaccination, chronic hepatitis B (CHB) remains an important cause of cirrhosis and hepatocellular carcinoma in Thailand, particularly among adults born before vaccine implementation. This article summarizes the 2026 National Guideline on Elimination of Viral Hepatitis B in Thailand and presents a health-system framework for addressing the remaining disease burden. The guideline was developed by a multidisciplinary expert panel using evidence from international recommendations, peer-reviewed literature, national epidemiological data, implementation studies, and health economic analyses. The recommendations were formulated using the GRADE framework and adapted for implementation within Thailand's Universal Health Coverage system. The national strategy prioritizes birth-cohort HBsAg screening for adults born before 1992, simplified evidence-based treatment eligibility incorporating non-invasive fibrosis assessment and virological criteria, and first-line use of high genetic-barrier nucleos(t)ide analogs. Prevention of mother-to-child transmission prioritizes HBV DNA-guided antiviral prophylaxis, with simplified implementation pathways reserved for settings with substantial diagnostic constraints. Long-term care emphasizes structured monitoring, appropriate specialist referral, conservative treatment discontinuation criteria, defined retreatment thresholds, and risk-based semiannual ultrasound surveillance for hepatocellular carcinoma. Integration with antenatal services, HIV programs, and primary care facilities supports decentralized delivery and continuity of care. Thailand's 2026 hepatitis B guideline operationalizes evidence-based CHB management within a publicly financed decentralized health system and provides a scalable model for expanding hepatitis B diagnosis and treatment in endemic settings.

PMID 42547747
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PubMedThe Lancet. Infectious diseases2026-08-04

Efficacy, immunogenicity, and safety of the 9-valent human papillomavirus vaccine in males aged 16-26 years in Japan: a randomised, double-blind, placebo-controlled trial.

Hisamoto Koji K, Yamanaka Masaki M, Nomura Masayasu M, Kanno Nobufumi N et al.

Efficacy of the nine-valent human papillomavirus (9vHPV; HPV6, 11, 16, 18, 31, 33, 45, 52, and 58) vaccine was shown in females and inferred for males through immunobridging. We evaluated the efficacy of the 9vHPV vaccine in males aged 16-26 years. This randomised, double-blind, placebo-controlled, efficacy, immunogenicity, and safety phase 3 trial was conducted at 22 clinical research, hospital, medical, or treatment sites in Japan, with masking of investigators, sponsor personnel, and participants. Healthy males aged 16-26 years with no history of human papillomavirus (HPV)-related lesions and no previous HPV vaccination were randomly assigned (1:1) centrally, using permutated blocks (block sizes of four), to receive three intramuscular injections of the 9vHPV vaccine or placebo (saline) at day 1, month 2, and month 6. The primary and secondary efficacy endpoints were the combined incidences of 6-month anogenital persistent infection related to HPV6, 11, 16, and 18 and HPV31, 33, 45, 52, and 58. Anogenital swabs and external genital tissue samples were tested for the presence of HPV DNA. Tissue samples were adjudicated for histopathology diagnosis. The primary and secondary efficacy evaluations were tested for superiority with a margin of 0% in the per-protocol population. Another secondary endpoint was antibody responses to each vaccine-targeted HPV type at month 7; immunogenicity analyses were conducted in the per-protocol immunogenicity population. Safety was assessed in participants who received at least one dose of vaccine or placebo. This study is registered with ClinicalTrials.gov (NCT04635423) and is completed. Between Nov 30, 2020, and Dec 25, 2021, 1059 participants were enrolled and randomly assigned to receive the 9vHPV vaccine (n=529) or placebo (n=530). Vaccine efficacy for the primary and secondary endpoints was 89·3% (95% CI 55·4-98·2; p=0·0002) and 63·5% (2·7-86·0; p=0·023), respectively, in the initial efficacy analysis based on a visit cutoff date of Dec 29, 2023, and 91·6% (67·7-98·6) and 72·9% (38·7-89·3) in the end-of-study efficacy analysis based on a visit cutoff date of July 16, 2024. Seroconversion rates were greater than 98% for each vaccine-targeted HPV type. Injection-site adverse events were reported in 370 (70%) of 529 9vHPV vaccine recipients and 162 (31%) of 530 placebo recipients, and vaccine-related systemic adverse events in 58 (11%) vaccine recipients and 52 (10%) placebo recipients; most cases were mild or moderate. No deaths, vaccine-related serious adverse events, or discontinuations due to adverse events were reported. The 9vHPV vaccine prevents anogenital persistent infection related to vaccine-targeted HPV types in males and has an acceptable safety profile. These findings support the use of the 9vHPV vaccine in males to prevent HPV-related anogenital diseases. Merck Sharp & Dohme. For the Japanese translation of the abstract see Supplementary Material section.

PMID 42546724
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PubMedExperimental and clinical transplantation : official journal of the Middle East Society for Organ Transplantation2026-08-04

Kidney Transplantation from Hepatitis C-Positive Donors in the Direct-Acting Antiviral Era.

Rawashdeh Badi B, Al-Abdallat Haneen H, Mohammad Noor Haj NH, Asassfeh Ayham A et al.

The introduction of direct -acting antivirals has transformed kidney transplantation with hepatitis C virus -positive donors from a high -risk practice to a safe strategy for expanding the donor pool. This study aimed to highlight global research trends, collaborations, and shifts in hepatitis C virus -positive donor kidney transplant before and after the direct -acting antiviral era. We conducted a thorough search of the Web of Science database, focusing on research output with relevant key words related to the hepatitis C virus and kidney transplant, resulting in 414 pertinent research items. We analyzed these items using bibliometric parameters. Over the past 2 decades, notable shifts have occurred in the research trajectory, with a peak in publications observed in 2018 and 2019 following the introduction of direct -acting antivirals, followed by a decline in subsequent years. The United States generated the highest research output, followed by France and Spain. The journals Transplantation and American Journal of Transplantation dominated in terms of citations. The University of Toulouse, the University of Pennsylvania, and the University of Miami were the leading institutional contributors. The introduction of direct -acting anti -virals coincided with a rapid rise in research activity and global collaboration, reflecting the transition of hepatitis C virus -positive donor kidney transplant from a high -risk practice to routine clinical adoption.

PMID 42549788
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PubMedClinics in geriatric medicine2026-08-04

Vaccine-Preventable Diseases in Older Adults.

Al-Jabri Maha M, Rosero Christian C, Saade Elie A EA

Older adults are at an increased risk of vaccine-preventable diseases partly because of physiologic changes in the immune and other body systems related to age and/or accumulating comorbidities that increase the vulnerability to infections and decrease the response to vaccines. Strategies to improve the response to vaccines include using a higher antigenic dose (such as in the high-dose inactivated influenza vaccines) as well as adding adjuvants (such as MF59 in the adjuvanted inactivated influenza vaccine).

PMID 42547175
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PubMedInfection and immunity2026-08-04

A multivalent subunit vaccine augments pre-existing immunity to protect against T3SS-positive Pseudomonas aeruginosa but reveals immunological interference against ExlA-positive strains.

Howlader Debaki R DR, Das Sayan S, Biswas Satabdi S, Dietz Zackary K ZK et al.

Pseudomonas aeruginosa (Pa) is a ubiquitous, opportunistic nosocomial pathogen that poses a significant threat due to its innate and acquired multidrug resistance. Novel vaccine strategies are urgently needed for vulnerable populations, many of which harbor pre-existing immunity from prior encounters with Pa. Here, we evaluated a multivalent subunit vaccine combining type III secretion system (T3SS) antigens and exolysin A (ExlA) in a nanoemulsion formulation using a clinically relevant murine pulmonary pre-exposure model. This approach allowed us to determine whether vaccination could overcome the limitations of the host's initial, ineffective immune response. Vaccination fundamentally transforms suboptimal baseline memory into a potent, multi-faceted Th1/Th17-polarized response. This globally transformed signature was characterized by significantly enhanced antigen-specific IFN-γ and IL-17A production, both locally and systematically in the lung, with exceptionally large biological effect sizes (Cohen's d values reaching 21.35). By utilizing log10 transformation to accurately reflect pathogen growth kinetics, we demonstrated that this vaccine-augmented immunity conferred statistically significant protection following heterologous challenge. In the twice-exposed cohort, vaccination promoted superior bacterial clearance of the T3SS-positive strain, though clearance of the ExlA-positive strain was not enhanced, potentially due to immunological interference from pre-existing T3SS memory. In the thrice-exposed cohort, a functional protective threshold was observed, where high levels of natural immunity matched the vaccine-induced clearance levels. Our findings established that our vaccine formulation can effectively boost and redirect pre-existing immunity, offering a promising approach to overcome the limitations of natural exposure and protect at-risk individuals from diverse Pa infections.

PMID 42550059
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PubMedMicrobial pathogenesis2026-08-04

Development and evaluation of a virus like particle based vaccine candidate against Indian Isolate of porcine circovirus 2d in pig.

Deb Rajib R, Maity Hemanta Kumar HK, Samanta Kartik K, Madhanmohan M M et al.

Porcine circovirus type 2d (PCV2d) is the predominant genotype etiological agent of porcine circovirus-associated disease (PCVAD), causes substantial economic losses to the swine industry worldwide, including in India. Since currently available vaccines are mainly based on the PCV2a genotype, which is unable to offer cross protective immunity against emerging PCV2d strains, development of PCV2d specific vaccine is necessary. In this study, an indigenous virus-like particle (VLP)-based vaccine candidate was developed using the capsid coding gene (orf2) of an Indian PCV2d isolate expressed in a baculovirus-insect cell system. Recombinant capsid protein expression and self-assembly into VLPs were confirmed by Western blotting and transmission electron microscopy. The purified VLPs showed favourable thermostability as well as pH stability and elicited strong humoral and cellular immune responses in in vivo porcine model. A delayed booster immunization strategy resulted in prolonged antibody persistence. In further, in vivo challenge study with virulent homologous PCV2d virus vaccinated animals were protected against PCV2 clinical signs. Further, absence of detectable viral DNA in swab and tissue samples, and markedly alleviated histopathological lesions compared with unvaccinated controls animals. Overall, these findings suggest that the indigenous PCV2d VLP vaccine candidate is highly immunogenic and provides protective immunity against homologous PCV2d challenge, highlighting its potential indigenous vaccine candidate for controlling PCVAD against PCV2d.

PMID 42546908
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