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trivalent rotavirus gene reassortment oral vaccine

✓ Approved

Lanzhou Institute · Vaccine · Vaccine

What is trivalent rotavirus gene reassortment oral vaccine?

trivalent rotavirus gene reassortment oral vaccine is a vaccine developed by Lanzhou Institute. It is approved for therapeutic indications via oral (po).

Drug Profile

CompanyLanzhou Institute
Drug ClassVaccine
RouteOral (PO)
StatusApproved
Sources: ClinicalTrials.gov, Lanzhou Institute

Therapeutic Indications

trivalent rotavirus gene reassortment oral vaccine is developed for 2 unique indications across 1 therapeutic area.

Therapeutic AreaConditionPhase
Infections and infestationsGastroenteritis✓ Approved
Infections and infestationsRotavirus infection✓ Approved

Related Research Articles

PubMedNPJ vaccines2026-11-11

A structure-guided trivalent subunit vaccine confers maternal protection to neonatal piglets against PEDV and PDCoV.

Liu Jia J, Chen Longping L, Li Dan D, Wang Zhuo Z et al.

Antigenic divergence among porcine epidemic diarrhea virus (PEDV) genotypes and porcine deltacoronavirus (PDCoV) limits the cross-protection provided by current commercial vaccines. Here, employing a structure-guided antigen design strategy, we developed a trivalent subunit vaccine concurrently targeting PEDV G2a, PEDV G2b, and PDCoV. The vaccine antigen set comprises optimized spike ectodomain antigens, featuring stabilizing mutations, a heptad repeat 2 (HR2) deletion, a fused neutralizing epitope, and a flagellin adjuvant fused to the N-terminus. Formulated with MF59+CpG adjuvants, this trivalent vaccine elicited robust PEDV- and PDCoV-specific neutralizing antibody responses and Th1/Th2-associated cellular immune responses characterized by IFN-γ, IL-2, and IL-4 production in mice. Immunization of pregnant sows with 300 μg dose induced high-titer IgG, IgA, and colostral secretory IgA (SIgA) against all three target viruses. Although neutralizing antibody titers were comparable between the 100 μg and 300 μg dose groups, the 300 μg group showed higher and more persistent levels of colostral binding IgG and SIgA. Following maternal immunization, piglets that acquired maternal antibodies through colostrum exhibited reduced clinical diarrhea, lower fecal viral RNA shedding, and less severe intestinal lesions after challenge with PEDV G2a, PEDV G2b, or PDCoV. These findings support this structure-guided trivalent subunit vaccine as a promising candidate for maternal immunization against co-circulating porcine enteric coronaviruses.

PMID 43009510
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PubMedBMC microbiology2026-11-11

Accounting for the silent threat: using QMRA to quantify downstream infection risks from oral poliovirus vaccination.

Boroujeni Negin Iranpour NI, S Lewis Madeline M, Weir Mark H MH

The global effort to eradicate poliovirus relies heavily on the oral poliovirus vaccine (OPV), yet the environmental shedding of vaccine-derived poliovirus (VDPV) into surface waters remains a critical, often overlooked, secondary hazard. In regions with poor sanitation and limited infrastructure, downstream communities may be unknowingly exposed to infectious viruses shed by upstream vaccinated populations. This study aimed to develop a quantitative microbial risk assessment (QMRA) framework to characterize these downstream infection risks and evaluate the efficacy of water treatment as a mitigation strategy. We utilized an in-silico model to simulate viral transport between two hypothetical under-vaccinated rural communities of varying sizes. Infection risks were estimated using two distinct approaches for calculating viral loading: a traditional mechanistic method based on individual shedding rates and a novel regression approach integrated with wastewater-based epidemiology (WBE) data. A Monte Carlo simulation (10,000 iterations) was employed to characterize uncertainties in pathogen occurrence, environmental decay, and within-host dose-response. Our results indicate that classical mechanistic models tend to overestimate viral loading and subsequent community risk, particularly in smaller populations. The QMRA estimated mean probabilities of infection as high as [Formula: see text] for large communities consuming untreated source water. However, sensitivity analysis identified water treatment as the most critical factor in risk reduction; standard filtration processes were shown to decrease the mean probability of infection by up to 99%. This research demonstrates that watershed dynamics and community placement are essential considerations for poliovirus risk management during vaccination campaigns. By transitioning toward WBE-based regression for risk estimation, public health officials can achieve more accurate environmental surveillance. Ultimately, our findings highlight the urgent need for accessible water filtration and integrated watershed modeling to protect vulnerable populations from silent viral circulation.

PMID 43009779
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PubMedHealth communication2026-11-11

Spiritual Health Locus of Control and COVID-19 Booster Intentions Among Hispanic Americans: A Culturally Grounded Extension of the Extended Parallel Process Model.

Kim Joon J, Jun Jungmi J, Zambrano Rodriguez Viviana Carolina VC

Declining uptake of COVID-19 boosters poses significant public health concerns. Hispanic Americans, who have experienced disproportionate pandemic impacts, report lower uptake of updated boosters than non-Hispanic White adults, partly attributable to vaccine hesitancy. Although religiosity plays a central role in Hispanic communities, little is known about how spiritually grounded beliefs shape cognitive and emotional responses to vaccination. This study integrates the extended parallel process model (EPPM) with spiritual health locus of control (SHLOC) to examine how exposure to faith-based and governmental vaccine information influences booster intention through spiritually grounded efficacy appraisals. Using an online survey of Hispanic American adults (N = 349), we tested a structural equation model linking SHLOC, perceived threat, efficacy beliefs, fear, and vaccination intentions. Results indicated that active SHLOC, reflecting beliefs in divine partnership in health, increased response efficacy and indirectly promoted booster intention and vaccine advocacy, whereas passive SHLOC, reflecting divine determinism, reduced self-efficacy and indirectly discouraged booster intention. Perceived threat was positively associated with fear, and efficacy beliefs emerged as the strongest predictors of booster intention. Mediation analyses supported serial pathways from message exposure to SHLOC to efficacy to intention, identifying spiritually grounded control beliefs as a culturally embedded mechanism in vaccine decision making. Findings suggest that faith-based engagement can function as either a protective or risk communication channel, depending on whether messages reinforce divine partnership or determinism. The study advances EPPM by identifying SHLOC as a culturally grounded antecedent to efficacy appraisal and offers implications for culturally responsive vaccine communication in Hispanic communities.

PMID 43012739
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PubMedInternational journal for equity in health2026-11-11

Reaching zero-dose children through the Big Catch-Up initiative in the Eastern Mediterranean Region.

Elmahdy Eman E, Mere Osama O, Farrukh Saadia S, Alyousfi Mohamad Nihad MN et al.

Routine immunization (RI) is one of the most effective public health interventions for reducing childhood morbidity and mortality. However, recent disruptions to RI have created immunity gaps in the Eastern Mediterranean Region (EMR), increasing the number of zero-dose (ZD) and under-immunized children, particularly in countries affected by conflict, displacement, service disruption, and ongoing vaccine-preventable disease outbreaks. The Big Catch-Up (BCU) initiative aimed to identify and vaccinate missed children, close immunity gaps, and strengthen RI systems. In the six Gavi-supported EMR countries included in this study (Afghanistan, Pakistan, Somalia, Sudan, Syria, and Yemen), implementation targeted children aged 12-59 months. This study assessed progress in reaching ZD children during BCU implementation in these six countries. A descriptive, multi-country programmatic analysis was conducted using quantitative and qualitative data from BCU quarterly reports covering implementation from Q4 2024 to Q1 2026. Additional data sources included World health Organization (WHO and United Nations Children's Fund (UNICEF) Estimates of National Immunization Coverage (WUENIC), Gavi-approved vaccine dose data, and UNICEF vaccine shipment data. Quantitative analysis summarized administered doses, zero-dose targets, BCU coverage, vaccine consumption, and performance by country and antigen among children aged 12-59 months. Age-disaggregated analyses were conducted for children aged 12-23 months and 24-59 months. Qualitative information from country reports on implementation successes, challenges, and lessons learned was summarized by country and thematic area. During the BCU implementation period, 3.5 million zero-dose children were reached with Penta1 across the six countries, representing 53% of the estimated cumulative population of 6.6 million ZD children. Of the 57 million Gavi-approved vaccine doses, 98% were shipped to countries, and 47.7 million doses were administered, equivalent to 84% of approved doses. Implementation success was supported by targeted identification of areas with high numbers of zero-dose children, integrated outreach, integration with other health services, and recruitment of vaccinators and deployment of community health workers. Key challenges included insecurity, population movement, inaccessible districts, community refusal, and limited community engagement. Substantial progress in reaching missed children was reported during BCU implementation in high-priority EMR countries. Lessons learned highlight the importance of integrating catch-up vaccination with RI, strengthening microplanning, ensuring timely vaccine supply and financing, improving community engagement, and institutionalizing catch-up vaccination.

PMID 43009985
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PubMedFrontiers in oral health2026-11-11

The oral exposome and environment-related diseases of hard and soft oral tissues: a comprehensive review.

Aliberti Angelo A, Coppola Noemi N, Gasparro Roberta R, Trosino Oreste O et al.

The oral cavity is continuously exposed to environmental, lifestyle-related, microbial, and systemic influences capable of altering tissue homeostasis and contributing to chronic oral disease. Environmental exposures may interact through inflammatory, microbial, and metabolic pathways affecting both hard and soft oral tissues. This review critically synthesizes current evidence on environment-related oral diseases within the framework of the oral exposome, focusing on environmental determinants, biological mechanisms, tissue alterations, and implications for oral surgery, implantology, regenerative procedures, and precision oral medicine. A comprehensive narrative review was conducted through electronic searches of PubMed, Scopus, and Web of Science for studies published up to April 2026. English-language articles evaluating relationships between environmental exposure and oral tissue alterations were included. Evidence regarding environmental pollutants, smoking, alcohol consumption, dietary factors, occupational exposures, and other external determinants was critically analyzed together with host-related modifiers, including salivary dysfunction, microbial dysbiosis, systemic disease, and chronic inflammatory conditions. The review considered exposure-associated alterations involving dental hard tissues, periodontal and peri-implant structures, oral mucosa, salivary homeostasis, and oral microbial ecology. The strength of evidence varied substantially across exposure-outcome relationships. The most mature human evidence concerned conventional tobacco smoking and selected carcinogenic exposures, whereas associations involving air pollution, heavy metals, occupational toxicants, electronic cigarettes, endocrine-disrupting chemicals, and emerging contaminants showed greater heterogeneity and, for several outcomes, relied substantially on observational, experimental, or mechanistic evidence. Across these different levels of evidence, recurrent pathways included oxidative stress, inflammation, microbial dysbiosis, epithelial dysfunction, and altered tissue homeostasis. The oral exposome provides a useful framework for understanding the multifactorial nature of oral disease and the interaction among environmental exposure, microbial ecology, host response, and tissue homeostasis.

PMID 43011805
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PubMedTropical medicine and health2026-11-11

From outbreak response to system strengthening: preventing diphtheria in Somalia.

Abdullahi Zakaria Abdi ZA, Derow Ismail Mohamud IM, Yusuf Abdi Wahab Salad AWS, Abdi Aniso Mohamed AM et al.

Diphtheria, a vaccine-preventable disease, has re-emerged as a significant public health concern in Somalia, highlighting persistent weaknesses in immunization systems. Recent outbreaks demonstrate that transmission is driven not by limitations of available vaccines but by immunity gaps associated with low routine immunization coverage, high numbers of zero-dose children, conflict, population displacement, and barriers to accessing health services. The 2025 diphtheria outbreak, characterized by substantial morbidity and mortality among children, underscores the urgent need to move beyond reactive outbreak response toward sustainable immunization-system strengthening. This letter emphasizes the importance of improving routine immunization services, expanding catch-up vaccination, strengthening disease surveillance, enhancing vaccine supply chains and cold-chain capacity, and improving immunization data systems for identifying missed populations. Evidence from Somalia's recent vaccination initiatives demonstrates that community-centered approaches, digital tools, and locally adapted outreach strategies can successfully reach underserved groups even in fragile settings. Building resilient immunization systems requires coordinated efforts among government institutions, communities, health workers, and international partners. Strengthening equitable vaccination delivery is essential not only for preventing future diphtheria outbreaks, but also for improving Somalia's preparedness against other vaccine-preventable diseases and future public health emergencies.

PMID 43010036
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