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acellular pertussis + diphtheria + tetanus vaccine (Tribic / BK1301 / Torivic)

✓ Approved

Mitsubishi Tanabe Pharma Corporation · 细胞治疗 · 细胞治疗

什么是 acellular pertussis + diphtheria + tetanus vaccine？

acellular pertussis + diphtheria + tetanus vaccine 是一种细胞治疗，由Mitsubishi Tanabe Pharma Corporation研发。该药已获批，用于治疗相关适应症，给药途径：Injectable (Others)、Subcutaneous Injection。

药物档案

商品名Tribic, BK1301, Torivic
公司Mitsubishi Tanabe Pharma Corporation
药物类别细胞治疗, 疫苗
给药途径Injectable (Others), Subcutaneous Injection
状态Approved
来源： ClinicalTrials.gov, Mitsubishi Tanabe Pharma Corporation

治疗适应症

acellular pertussis + diphtheria + tetanus vaccine 针对 3 个适应症，涉及 1 个治疗领域。

治疗领域疾病/病症分期
Infections and infestationsDiphtheria✓ Approved
Infections and infestationsPertussis✓ Approved
Infections and infestationsTetanus✓ Approved

相关研究文献

PubMedVaccines2026-07-27

Adult Seroprotection Gaps Against Diphtheria and Tetanus in Urban China: Repeated Cross-Sectional Serosurveillance in Pudong, Shanghai, 2017-2025.

Cheng Wanran W, Li Juan J, Yang Tian T, Bai Yu Y et al.

Background: Adult susceptibility to diphtheria and tetanus may increase as vaccine-induced immunity wanes, yet repeated population-based serosurveillance data in China are limited. Methods: We analyzed annual serosurveys conducted in Pudong New Area, Shanghai, China, from 2017 to 2025 among healthy adults aged 20-49 years. Diphtheria and tetanus IgG concentrations were measured by ELISA. Seroprotection was defined as antibody concentration ≥0.1 IU/mL. Antibody concentrations were further categorized as <0.01, 0.01-<0.1, 0.1-<1.0, and ≥1.0 IU/mL, and geometric mean concentrations (GMCs) were calculated. Multivariable logistic regression models were fitted to assess factors associated with non-protection, including survey year, age group, and household registration. Sensitivity analyses excluding the 2018 survey year were conducted. Results: A total of 2376 serum samples were included. Overall seroprotection was 21.46% for diphtheria and 13.80% for tetanus. The proportion protected against both antigens was 9.05%, while 73.78% showed concurrent non-protection against both antigens. The overall GMC was 0.032 IU/mL (95% CI: 0.030-0.034) for diphtheria and 0.018 IU/mL (95% CI: 0.017-0.019) for tetanus. Concentrations ≥1.0 IU/mL were uncommon for both antigens. Adults aged 40-49 years had higher odds of non-protection than those aged 20-29 years for diphtheria (OR: 2.43, 95% CI: 1.85-3.21) and tetanus (OR: 2.94, 95% CI: 2.11-4.13). Non-local residents also had higher odds of non-protection than local residents for diphtheria (OR: 1.55, 95% CI: 1.24-1.93) and tetanus (OR: 2.81, 95% CI: 2.15-3.69). Seroprotection varied across survey years, with a marked nadir in 2018. Sensitivity analyses excluding 2018 attenuated most year-specific associations, whereas age- and residence-related differences persisted. Conclusions: Healthy adults aged 20-49 years in Pudong showed low seroprotection and low GMCs against both diphtheria and tetanus, with a high proportion concurrently non-protected against both antigens. These findings highlight a persistent adult immunity gap and support further evaluation of adult booster strategies and enhanced serosurveillance.

PMID 42506607
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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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PubMedVaccines2026-07-27

A Double-Edged Sword: Breast Milk-Derived Maternal Antibodies and Infant Vaccine Responses: A Narrative Review.

Mpakosi Alexandra A, Moutsopoulou Rafaela Anna RA, Cholevas Stamatios S, Lianou Alexandra A et al.

Neonatal defense against pathogens relies on maternal antibodies transferred both through the placenta (IgG) and through breast milk (primarily secretory IgA). Maternal IgG antibodies are transferred across the placenta to the fetus mainly via the neonatal Fc receptor (FcRn), which is expressed at high levels in placental syncytiotrophoblasts, and results in the acquisition of maternal-fetal IgG. Transplacental transfer via the FcRn pathway can provide therapeutic proteins and protective antibodies following maternal vaccination. However, maternal IgG antibodies can bind to vaccine antigens such as measles, tetanus, and poliovirus, resulting in rapid clearance through FcgRIIB-mediated inhibition and inadequate B cell activation. In this way, they can inhibit de novo immune responses and significantly reduce vaccine response. On the other hand, the interference that breast milk-derived antibodies may have on vaccine-induced immunity is still largely unknown. Vaccination against influenza, pertussis, and COVID-19 during pregnancy or lactation has been shown to induce the production of protective, pathogen-specific, secretory IgA and IgG antibodies in breast milk. Conversely, studies found that breast milk-derived antibodies of vaccinated mothers reduced vaccine-induced immunity in breastfed infants by accelerating the clearance of vaccine antigen, resulting in reduced antigen availability and reduced plasma cell formation after vaccination. Additional factors in middle- and low-income countries, including environmental (increased microbiome diversity, environmental intestinal dysfunction, malnutrition, co-infections) and breastfeeding practices, may exacerbate the interference effect of maternal antibodies. Current evidence supports that breastfeeding is associated with a reduced immunological response exclusively to the rotavirus vaccine. However, the limited evidence base to date precludes definitive conclusions regarding the role of breast milk-derived antibodies in modulating vaccine-induced immunity. Nevertheless, the evidence suggests that although maternal antibodies may theoretically reduce vaccine immunogenicity, the overall protective benefits of breastfeeding outweigh any potential interference with vaccine responses.

PMID 42506596
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PubMedVaccines2026-07-27

Vaccination Coverage Among Mothers and Close Contacts of Neonates Hospitalized in NICU in Southern Greece: A Cocooning Strategy Approach.

Irakleous Angeliki A, Vergadi Eleni E, Gkentzi Despoina D, Hatzidaki Eleftheria E

Background: Neonates and young infants are susceptible to vaccine-preventable diseases because of immature immune responses and delayed acquisition of vaccine-induced protection. As household members and caregivers are a major source of exposure, international organizations recommend cocooning, i.e., vaccination of susceptible individuals who are in regular contact with infants, to provide complementary indirect neonatal protection. To evaluate cocooning implementation, we assessed influenza and pertussis vaccination uptake among mothers and close contacts of hospitalized neonates and identified factors associated with vaccine uptake. Methods: Mothers of neonates hospitalized in a Neonatal Intensive Care Unit (NICU) between 1 January 2022 and 31 December 2024 were invited to complete a structured questionnaire. Mothers reported their own vaccination status and that of the neonate's close contacts. Associations between maternal characteristics and vaccine uptake were examined using logistic regression. Results: In total, 405 mothers participated. Influenza vaccination uptake was 47.6% among mothers, and at least one adult close contact was vaccinated in 53.6% of families. Pertussis vaccination uptake was 40.5% among mothers, and at least one adult close contact was vaccinated in 32.3% of families. The most frequently reported reason for non-vaccination was low perceived need among unvaccinated mothers (74.1% for influenza and 83.4% for pertussis) and among families with incompletely vaccinated adult close contacts (81.8% for influenza and 89.7% for pertussis). In multivariable analyses, higher maternal education was associated with increased uptake of both influenza (OR 2.36, 95% CI: 1.47-3.80, p < 0.001) and pertussis vaccination (OR 4.25, 95% CI 2.02-8.94, p < 0.001), whereas younger maternal age (≤25 years) was associated with lower influenza vaccine acceptance (OR 0.24, 95% Cl: 0.1-0.60, p = 0.002). Conclusions: Vaccination uptake among mothers and adult close contacts of NICU-admitted neonates was suboptimal for both influenza and pertussis vaccines. Targeted counseling before delivery, reinforced during maternity or NICU hospitalization as a catch-up opportunity, and system-level implementation measures aligned with the dominant barrier of low perceived need are needed to strengthen cocooning in this high-risk population.

PMID 42506674
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PubMedVaccines2026-07-27

Preventive Strategies and Determinants of Vaccination Compliance Among Older Adults in Rural Amazonian Communities.

Pasquel-Muñoz Luciana T LT, Ramírez-Béjar Ana Lucía AL, Chávez Cano Joaquín Eduardo JE, Camacho-Caballero Kiara K et al.

Respiratory infections are a major cause of morbidity and mortality among older adults. However, vaccination coverage against respiratory pathogens remains suboptimal, particularly in rural and vulnerable populations. This study aimed to identify factors associated with respiratory vaccination uptake among older adults living in rural Amazonian communities in Peru. We conducted an observational, analytical, cross-sectional study using secondary data from the Amazon Frail Project. A total of 429 adults aged ≥60 years from rural and suburban communities in San Martín, Loreto, and Ucayali were included. Vaccination coverage for influenza, pneumococcal disease, pertussis, and COVID-19, as well as vaccine combinations, was assessed. Multiple linear and Poisson regression models with robust variance were used to identify associated factors. Complete vaccination coverage was 42.89% for influenza, 23.08% for pneumococcal disease, 4.43% for pertussis, and 70.16% for COVID-19. Only 3.50% of participants had received all four respiratory vaccines. Higher educational attainment, multimorbidity, social frailty, greater muscle mass, better physical performance, and healthcare center attendance were associated with higher vaccination uptake. Depressive symptoms, cognitive impairment, functional dependency, physical frailty, dynapenia, and higher body mass index were associated with lower vaccination uptake. Respiratory vaccination coverage was suboptimal among older adults living in rural Amazonian communities. Educational, functional, physical, social, and healthcare access factors significantly influenced vaccine uptake, highlighting the need for targeted immunization strategies in vulnerable rural populations.

PMID 42506680
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PubMedVaccines2026-07-27

Immunization Gaps Among High-Risk Preterm Infants in Kazakhstan.

Tatibekova Balzhan N BN, Yakubovich Daniel D, Sagatbayeva Ademi K AK, Ismailova Aigul A AA

Advances in neonatal intensive care in Kazakhstan have improved the survival of preterm infants, including those with very low birth weight (VLBW) and extremely low birth weight (ELBW). However, after hospital discharge, these medically vulnerable children may remain insufficiently protected against vaccine-preventable infections because of prolonged temporary medical exemptions, clinical caution, parental concerns, and fragmented coordination between specialized follow-up services and primary health care. This study aimed to assess vaccination coverage in a 10-year cohort of high-risk preterm infants and to identify clinical, parental, and organizational factors associated with delayed immunization. We conducted a retrospective cohort study of 331 high-risk preterm infants followed at a specialized pediatric center in Astana, Kazakhstan, between 2015 and 2024. Vaccination status at hospital discharge and at 24 months of chronological age, documented temporary medical exemptions, reasons for delayed or missed vaccination, and confirmed cases of pertussis and measles were analyzed. A supplementary cross-sectional survey of parents, physicians, and health care managers was conducted to further explore barriers to catch-up immunization. At hospital discharge, 259 infants (78.2%) had not received the BCG or hepatitis B vaccine. By 24 months of age, 34.1% (n = 113) were fully vaccinated according to age, whereas 49.8% (n = 165) remained completely unvaccinated. During the observation period, 30 cases of measles and 17 cases of pertussis were recorded within the cohort, primarily during nationwide outbreaks. Among the 10 children with a history of measles before 12 months of age, 2 developed subacute sclerosing panencephalitis (SSPE), 1 developed profound hearing loss, and 1 required prolonged oxygen therapy following pneumonia. In addition, 2 children with periventricular leukomalacia (PVL) experienced clinical deterioration, while 1 infant with pertussis required hospitalization during the acute phase of illness. High-risk preterm infants in this cohort experienced substantial and persistent gaps in immunization after hospital discharge. These findings underscore the importance of regular reassessment of temporary medical exemptions, improved coordination between specialized follow-up services and primary health care, and strengthened catch-up immunization strategies for medically vulnerable children.

PMID 42506675
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