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PO

polio vaccine (OPV, Bio Farma / tOPV, Bio Farma)

✓ Approved

Bio Farma · 疫苗 · 疫苗

什么是 polio vaccine？

polio vaccine 是一种疫苗，由Bio Farma研发。该药已获批，用于治疗相关适应症，给药途径：Oral (PO)。

药物档案

商品名OPV, Bio Farma, tOPV, Bio Farma
公司Bio Farma
药物类别疫苗, 大分子
给药途径Oral (PO)
状态Approved
来源： ClinicalTrials.gov, Bio Farma

治疗适应症

polio 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 proceduresPolio immunisation✓ Approved

相关研究文献

PubMedVaccines2026-07-27

Oral HPV Dynamics in MSM Living with HIV in the Nine-Valent HPV Vaccination Era.

Zulian Verdiana V, Sanctis Martina De M, Pauciullo Silvia S, Sciamanna Roberta R et al.

Background/Objectives: Oral human papillomavirus (HPV) infection is emerging as a key driver of HPV-associated oropharyngeal cancer, especially in high-risk groups such as men who have sex with men (MSM) living with HIV (PLWH). However, evidence on oral HPV persistence and the impact of nine-valent HPV vaccination in adults remains limited. We conducted a prospective longitudinal study including 76 MSM PLWH, of whom 64 were nine-valent HPV-vaccinated and 12 unvaccinated. Methods: Oral rinse samples were collected at baseline (T0) and after 6 months (T6). HPV DNA detection and genotyping were performed using the Allplex™ HPV28 assay. Oral HPV dynamics (persistence, clearance, and incidence) were assessed for high-risk (HR) HPV, low-risk (LR) HPV, and vaccine-type HPV genotypes. Results: Baseline oral HPV prevalence was high (59.2%), with HR HPV detected in 43.4% of participants. HPV16 was the most frequent genotype at both T0 and T6. Among participants HPV-positive at baseline, persistence of HPV DNA was high and similar regardless of vaccination status (77.8%). However, incident vaccine-type oral HPV infection was significantly lower among vaccinated individuals than unvaccinated participants (6.3% vs. 33.3%; OR 0.13, 95% CI: 0.03-0.71; p = 0.0441). Finally, reporting ≥10 sexual partners in the previous year was significantly associated with baseline oral HPV positivity (p = 0.0298). Conclusions: In MSM PLWH, oral HPV infection is highly prevalent and persistent, underscoring that it may represent a reservoir for HPV-related oropharyngeal disease. In our small observational cohort, nine-valent HPV vaccination was associated with lower incident detection of vaccine-type oral HPV, supporting targeted vaccination and oral HPV surveillance in high-risk adult populations, while highlighting the need for larger longitudinal studies to confirm these findings and better define the magnitude and durability of vaccine-associated protection at the oral site.

PMID 42506626
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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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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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PubMedVaccines2026-07-27

Evaluation of Safety, Immunogenicity, and Protective Efficacy of an Orally Administered African Swine Fever Vaccine Candidate ASFV-G-∆I177L/∆LVR.

Kim Yeonji Y, Choi Sun A SA, Kim Wonjun W, Shin Yongwoo Y et al.

Background/Objective: African swine fever (ASF), caused by African swine fever virus (ASFV), is a highly contagious viral disease affecting domestic pigs and wild boars, causing severe economic losses. Although commercial ASF vaccines have recently been approved in Vietnam, controlling ASF transmission remains challenging. Since injection-based vaccination is impractical for wild boars, oral vaccination is considered essential. This study aimed to evaluate the safety, immunogenicity, protective efficacy, and dose-related outcomes of ASFV-G-ΔI177L/ΔLVR, a live attenuated ASFV vaccine candidate with deletion in the I177L gene and left variable region (LVR), administered orally to convention pigs. Methods: The ASFV-G-ΔI177L/ΔLVR vaccine candidate was orally administered to conventional pigs at three dose levels (102.25, 105.0, and 106.0 TCID50/dose). At 28 days post-vaccination, pigs were challenged intramuscularly with a virulent ASFV field strain at 102.0 HAD50/mL and monitored clinically. Protection was assessed by ASFV-specific antibody responses (p32) and survival following challenge. Results: Oral immunization was well tolerated, with no vaccine-associated clinical signs observed before challenge. Following challenge, vaccinated pigs showed different protective outcomes among the tested dose groups, with survival rates of 1/4 (102.25 TCID50/dose), 4/4 (105.0 TCID50/dose), and 3/4 (106.0 TCID50/dose), respectively. Pigs that succumbed to infection showed neither detectable viremia nor ASFV-specific antibodies before challenge, suggesting incomplete vaccine uptake may have resulted in insufficient immune induction rather than an adverse effect associated with vaccination. In contrast, pigs that seroconverted prior to challenge were fully protected and exhibited lower viral loads than the control animals. Conclusions: ASFV-G-ΔI177L/ΔLVR was well tolerated as an oral live attenuated vaccine candidate and induced protective immunity against virulent ASFV challenge under the present experimental conditions. Notably, complete protection was observed in the 105.0 TCID50/dose group, supporting the potential of this vaccine candidate for oral immunization strategies against ASF. However, the present data do not allow a definitive conclusion regarding the dose-response relationship, and further studies with larger group sizes and field-relevant models are needed to refine dose selection and practical applicability, particularly for wild boar vaccination.

PMID 42506646
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PubMedJournal of public health (Oxford, England)2026-07-27

Cost analysis of vaccine-preventable diseases surveillance in Ethiopia.

Mejia Nelly N, Workineh Aschalew Abayneh AA, Zeleke Eden Dagnachew ED, Beshah Senait Alemayehu SA et al.

This study evaluated the cost of the vaccine-preventable diseases (VPD) surveillance system in Ethiopia to inform budgeting for disease detection, prevention, and control, and planning for transitions from donor funding. This cross-sectional retrospective, bottom-up micro-costing study collected data on resource utilization to conduct VPD surveillance during one fiscal year (2018-2019) in Ethiopia. The study covered 16 VPDs and costs from the government and partners perspective. The estimated economic costs of VPD surveillance in Ethiopia were US$69.11 million or US$0.70 per capita, while financial costs were US$26.83 million or US$0.27 per capita. The largest economic cost was for labor (41.0%) and the largest financial cost was for supplies (36.9%). Resources were mostly allocated to integrated, general disease surveillance (economic: 54.6%; financial: 50.7%), followed by surveillance for measles and rubella (economic: 15.9%; financial: 22.5%) and polio (economic: 12.4%; financial: 15.7%). The main funder was the Ethiopian Ministry of Health (economic: 78.8%; financial 62.6%), including donor resources channeled through the ministry. Human resources were primary drivers of economic costs. Although the Ethiopian VPD surveillance system uses shared resources across multiple VPDs, resulting in scale efficiencies, and the Ethiopian government covers most of its economic costs, a substantial portion relies on direct external donor support.

PMID 42504969
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PubMedZhonghua yu fang yi xue za zhi [Chinese journal of preventive medicine]2026-07-27

[Research progress in combination vaccines containing sabin strain inactivated poliovirus vaccine].

Fu Y X YX, Cai L K LK, Liang J L JL, Zhao T T et al.

Sabin strain inactivated poliovirus vaccine (sIPV), derived from attenuated Sabin poliovirus strains, has emerged as a promising alternative to both oral poliovirus vaccine (OPV) and conventional inactivated poliovirus vaccine (cIPV). It eliminates the risk of vaccine-associated paralytic poliomyelitis (VAPP) and the emergence of vaccine-derived polioviruses (VDPVs). In addition, sIPV demonstrates superior biosafety and vaccine safety during production and administration compared with cIPV. The integration of sIPV into combination vaccines with other routine immunization antigens can reduce the number of injections and streamline immunization schedules, making sIPV-containing combination vaccines a key focus of recent research. Japan launched the world's first sIPV-containing tetravalent vaccine in 2012, followed by the introduction of an sIPV-containing pentavalent vaccine in 2024. In China, a standalone sIPV was licensed in 2015, and multiple sIPV-containing combination vaccines are currently in clinical trials or preclinical development. The primary challenges for these vaccines include antigen compatibility within combination formulations and the scalability of sIPV production. Future strategies, such as the use of innovative adjuvants and intradermal administration, may enable antigen-sparing approaches. This review provides a comprehensive summary of the development and application of sIPV-containing combination vaccines, aiming to inform and guide ongoing vaccine research and development in China.

PMID 42503940
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