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recombinant HBV vaccine (Hansenula Polymorpha)

✓ Approved

AIM Vaccine · 疫苗 · 疫苗

什么是 recombinant HBV vaccine (Hansenula Polymorpha)？

recombinant HBV vaccine (Hansenula Polymorpha) 是一种疫苗，由AIM Vaccine研发。该药已获批，用于治疗相关适应症，给药途径：Injectable (Others)。

药物档案

公司AIM Vaccine
药物类别疫苗, 大分子
给药途径Injectable (Others)
状态Approved
来源： ClinicalTrials.gov, AIM Vaccine

治疗适应症

recombinant HBV vaccine (Hansenula Polymorpha) 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
Infections and infestationsHepatitis B✓ Approved

相关研究文献

PubMedVaccines2026-07-27

Hepatitis B Vaccination in People Living with HIV: Bridging the Immunological Gap.

Radi Christelle C, Abu Faraj Jana J, Idriss Jad J, Gromer Daniel J DJ et al.

Hepatitis B virus (HBV) infection remains a major driver of liver-related morbidity and mortality among people living with HIV (PLWH), yet vaccine-induced protection is frequently suboptimal. HIV-associated immune dysfunction, including CD4+ T-cell depletion, altered antigen presentation, impaired T follicular helper cell support, and B-cell dysregulation, reduces seroprotection after standard recombinant HBV vaccines and may limit durability of antibody responses. Vaccine response is further influenced by HIV viral suppression, age, comorbidities, prior vaccine history, and baseline HBV serologic status, including isolated hepatitis B core antibody (anti-HBc) and occult HBV infection (OBI) considerations. Although antiretroviral therapy (ART) improves vaccine responsiveness, many PLWH fail to achieve protective hepatitis B surface antibody (anti-HBs) titers (≥10 mIU/mL) after conventional schedules, or experience antibody waning over time. Current guidelines recommend HBV vaccination for all susceptible PLWH with post-vaccination serologic testing and revaccination for nonresponders. Persistent implementation barriers, including incomplete series, vaccine hesitancy, stigma, and logistical constraints, continue to limit real-world impact. Emerging clinical trial data support CpG-adjuvanted HBV vaccines (HepB-CpG/Heplisav-B) and intensified dosing and schedules (double-dose or four-dose regimens) to improve seroprotection and generate higher peak anti-HBs titers, which may enhance durability. This review synthesizes guideline recommendations, immunologic mechanisms of hyporesponsiveness, predictors of vaccine response, and practical strategies to optimize HBV vaccination in PLWH.

PMID 42506660
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PubMedVaccines2026-07-27

Immunogenicity of a Candidate Hepatitis C Vaccine Based on Non-Structural DNA-Protein Sequences and a Novel Complex Adjuvant.

Masalova Olga V OV, Lesnova Ekaterina I EI, Kozlov Vyacheslav V VV, Valuev-Elliston Vladimir T VT et al.

Global elimination of hepatitis C virus (HCV) infection requires not only direct-acting antivirals (DAAs) but also the development of a highly effective prophylactic and/or therapeutic vaccine. Background/Objectives: Our aim was to optimize the composition of the candidate vaccine against HCV by combining recombinant non-structural proteins and a DNA construct with a complex adjuvant. Methods: C57BL/6 and DBA/2J mice were immunized three times at 2-week intervals using different schemes. The viral antigens consisted of a mixture of NS3, NS5A, and NS5B proteins and/or recombinant DNA expressing NS3-NS5B polyprotein. As adjuvants, a complex adjuvant, a mixture of Polymuramil® and Pyrogenalum® (NOD1/NOD2 and TLR-4 agonists), or a CpG ODN adjuvant (TLR-9 agonist) were used. Results: The most efficient regimen was three subcutaneous administrations of the combined DNA, recombinant protein components, and a new complex adjuvant. This scheme elicited a robust immune response, characterized by high antibody titers, enhanced antigen-specific lymphocyte proliferation, and significant interferon-gamma (IFN-γ) secretion in both mouse lines. Furthermore, the complex adjuvant outperformed CpG ODN in stimulating both humoral and cellular immunity against the HCV antigens. The vaccine composition stimulated the formation of CD4+ memory T cells and decreased the relative frequences of suppressive Treg and MDSCs. Conclusions: The presented candidate vaccine induces a strong immune response to HCV proteins. The next step would be to validate the protective effect in cell culture and animal models. This would one the path to preclinical studies of this vaccine composition.

PMID 42506677
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PubMedVaccines2026-07-27

Advancing Global Hepatitis B Elimination: The Case for Using Maize as a Low-Cost, Heat-Stable, and Scalable Oral Vaccine.

Watanabe Muneaki M, Howard John A JA

Because hepatitis B virus (HBV) remains a major global health burden, innovative strategies are essential to achieve the World Health Organization's goal of eliminating viral hepatitis and closing persistent coverage gaps for injectable vaccines. While parenteral administration remains the gold standard for immunization, constraints such as cold-chain dependence and needle-associated barriers limit its reach, particularly in resource-constrained environments. This review summarizes work aimed at a plant-produced orally delivered vaccine as a transformative, scalable step towards global hepatitis B elimination. Early studies demonstrated proof of concept for the oral delivery of plant-produced hepatitis B vaccine candidates, including human trials using lettuce and potato as the host, but they were limited by low antigen yields and instability. In contrast, maize-produced antigens represent a significant advancement, achieving high levels of accumulation and utilizing the seed's natural desiccation physiology for bioencapsulation to protect the antigen from digestion in the gastrointestinal tract. Mechanistically, this platform enables timed antigen release in the duodenum, promoting M-cell uptake and CD103+ (cells expressing CD103 known as integrin alpha E) dendritic cell (DC) presentation, thus encouraging immunogenic programming over oral tolerance. In addition, defatting the grain by supercritical fluid extraction further improves antigen thermostability up to 45 °C for one month and ambient temperatures for one year, maintaining structural integrity under extreme conditions in accordance with the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) stability guidelines. Current recommendations for immunization are for three parenteral administrations using the hepatitis B surface antigen (HBsAg). The primary dose is usually given shortly after birth as a part of a multivalent vaccine. Therefore, initial studies for the oral plant-based vaccine have focused on using an oral boost after the parenteral prime. Data to support this premise are summarized along with co-administration of an oral and parental administration to elicit a stronger immune response. By overcoming past issues related to dose density and stability, this scalable, needle-free platform offers a practical way to eliminate global hepatitis B virus (HBV) transmission, especially in resource-constrained environments.

PMID 42506615
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PubMedZhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology2026-07-27

[Distribution of serum HBV RNA in the natural history of chronic HBV infection and factors influencing HBV RNA negativity: a retrospective study stratified by HBeAg status].

Li Y J YJ, Deng J H JH, Yan Z L ZL, Yang L P LP et al.

Objective: To characterize the distribution of serum hepatitis B virus (HBV) RNA in patients with HBV infection according to different HBeAg statuses and natural history stages, to analyze factors associated with HBV RNA negativity, and to observe dynamic changes in HBV RNA after six months of follow-up in patients treated with nucleos(t)ide analogues (NAs). Methods: This was a single-center, retrospective, real-world cohort study. A total of 1 184 patients with chronic HBV infection who attended the Fourth People's Hospital of Qinghai Province between October 2023 and October 2025 and underwent HBV RNA testing were enrolled. Baseline characteristics and HBV RNA levels were compared after stratification by hepatitis B e antigen (HBeAg) status. Patients were classified into five stages of the natural history of chronic HBV infection according to the Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2022 Edition), and HBV RNA levels were compared across stages. Two-way ANOVA was performed for HBV RNA levels using HBeAg status and baseline high-sensitivity HBV DNA status as grouping factors. Logistic regression was used to analyze factors associated with HBV RNA negativity, and a receiver operating characteristic (ROC) curve was plotted based on a multivariate model in the HBeAg-negative population. Among patients receiving NAs therapy who completed six months of follow-up, HBV RNA levels at baseline and at six months were compared, and ΔHBV RNA was compared after stratifying by baseline high-sensitivity HBV DNA status. Depending on data type, intergroup comparisons were performed using the χ2 test, Mann-Whitney U test, or Kruskal-Wallis H test; pre- and post-treatment comparisons were performed using the Wilcoxon signed-rank test; and ΔHBV RNA was compared between groups using the Mann-Whitney U test. Results: Among the enrolled patients, 461 were HBeAg-positive and 723 were HBeAg-negative. HBV RNA levels in the HBeAg-positive group were higher than those in the HBeAg-negative group (P<0.001). HBV RNA levels differed significantly across natural history stages (P<0.001). Two-way ANOVA showed a statistically significant main effect of HBeAg status on HBV RNA levels with a large effect size (F=923.869, P<0.001, partial η2=0.444). The main effect of baseline high-sensitivity HBV DNA status on HBV RNA levels was also statistically significant but with a small effect size (F=3.981, P=0.046, partial η2=0.003). No significant interaction was observed between the two factors (P>0.05). Multivariate logistic regression showed that HBeAg negativity (OR=16.028, 95% CI: 9.910-25.924), lower hepatitis B surface antigen (HBsAg) level (OR=0.561, 95% CI: 0.475-0.663), and lower alanine aminotransferase (ALT) level (OR=0.995, 95%CI:0.992-0.999) were associated with HBV RNA negativity. In the HBeAg-negative subgroup, HBsAg and ALT remained independently associated factors, and the model achieved an AUC of 0.658 (95%CI: 0.618-0.698), indicating modest discriminative ability. Follow-up analysis showed an overall decline in HBV RNA after six months of treatment. Stratified analysis revealed that in the group with negative baseline high-sensitivity HBV DNA, HBV RNA decreased significantly after treatment (P< 0.001); in the group with positive baseline high-sensitivity HBV DNA, HBV RNA showed a decreasing trend, but the difference was not statistically significant (P>0.05). No significant difference in ΔHBV RNA was observed between the two groups (P>0.05). Conclusion: Serum HBV RNA levels in patients with chronic HBV infection are closely associated with HBeAg status, and HBeAg was an important factor influencing HBV RNA levels. HBV RNA negativity is independently associated with HBeAg negativity, lower HBsAg levels, and lower ALT levels. In the HBeAg-negative population, conventional clinical indicators have only modest discriminative ability for identifying HBV RNA negativity. HBV RNA may serve as a complementary biomarker to assess residual viral transcriptional activity.

PMID 42503910
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PubMedVaccines2026-07-27

Development of DuoChol, a Thermostable Inactivated Whole-Cell/B-Subunit Oral Cholera Vaccine in Enteric Capsule.

Terrinoni Manuela M, Lebens Michael R MR, Nordqvist Stefan L SL, Nilsson Frida F et al.

Background/Objectives: Cholera remains an important global health problem. Inactivated oral cholera vaccines (OCVs) are essential in the WHO/GTFCC (World Health Organization/Global Task Force on Cholera Control) strategy to end cholera by 2030; however, global supply is insufficient, they require partial cold-chain storage, and their formulation and antigen contents leave room for improvement. We describe here the development and preclinical evaluation of DuoChol OCV, a next-generation thermostable oral vaccine designed to address these gaps. Methods: DuoChol is a lyophilized dry-powder formulation in enteric capsules containing formalin-inactivated Vibrio cholerae O1 El Tor Ogawa and Inaba isogenic bacteria, recombinant cholera toxin B subunit (rCTB), and sucrose as stabilizer. Methods describe the construction of the novel vaccine strains, processes for the preparation and characterization of vaccine components, and the final dry formulation in enteric capsules, and in vitro and in vivo vaccine stability analyses. Results: The newly engineered vaccine strains, together with a high-yield mixed-mode chromatography process for rCTB purification, enabled efficient and cost-effective vaccine production. Stability studies demonstrated complete preservation of O1 LPS and rCTB antigens for at least 21 months across temperatures of 4-40 °C. Moreover, regardless of storage duration or temperature, oral immunization of mice with DuoChol elicited strong serum and mucosal antibacterial and antitoxin responses that were similar to those induced by the licensed Dukoral® OCV. Conclusions: Its heat stability, practical enteric capsule formulation, and potential for improved efficacy compared to inactivated whole-cell only OCVs support positioning DuoChol as a promising next-generation OCV, suitable for national cholera control programs and particularly advantageous for outbreak response, where rapid deployment and early, robust protection are essential.

PMID 42506611
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PubMedInfection2026-07-27

Real-world effectiveness of maternal genetically inactivated acellular pertussis vaccination in protecting infants under three months of age: a case-control study using concurrent community-based and test-negative controls.

Phiriyasart Farooq F, Chongsuvivatwong Virasakdi V, Kumwichar Ponlagrit P

Infants too young for primary vaccination face the highest risk of severe pertussis and death. While maternal vaccination is the primary protective strategy, the real-world vaccine effectiveness (VE) of acellular pertussis (aP) vaccines in Thailand (including recombinant aP (aPgen)) remains unknown. We aimed to evaluate the VE of the aP vaccine in protecting infants under 3 months of age against symptomatic pertussis. This case-control study was conducted in the Narathiwat Province, Thailand, during a pertussis outbreak between September 2023 and October 2024. Participants included 33 symptomatic, polymerase chain reaction (PCR)-confirmed cases, 330 asymptomatic, community-matched controls (for primary comparison), and 41 symptomatic, test-negative controls (for sensitivity simulation). Maternal vaccination with aP vaccine during pregnancy was evaluated against no pertussis vaccination. The main outcome measures were symptomatic PCR-confirmed pertussis. VEs were estimated using a logistic regression model with inverse probability of treatment weighting. All vaccinated mothers (98 of 404) received aPgen (94% for standalone aPgen). The VE of the maternal aPgen vaccination against symptomatic-PCR confirmed pertussis was 95.3% (95% CI: 64.7%, 99.4%; p = 0.003). A post-hoc E-value sensitivity analysis indicated that it was unlikely that any residual or unmeasured confounders could explain away the statistically significant VE suggesting a robustness of the observed VE. Maternal aPgen vaccination during pregnancy was highly likely to provide robust VE against symptomatic-PCR confirmed pertussis in infants during the first three months of life. These findings support the maternal pertussis vaccination with recombinant aP vaccines as effective strategy in Thailand and could be considered for other regions.

PMID 42507321
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