Delving into the Latest Updates on DTP-poliovirus vaccine(Kitasato Daiichi Sankyo Vaccine Co., Ltd.) with Synapse

Overview

Basic Info

Drug Type

Combination vaccine, Prophylactic vaccine

Synonyms

4-valent combination DTP-poliovirus vaccine - Kitasato Daiichi Sankyo, DTP-IPV, DTP-IPV vaccine

+ [4]

Target-

Mechanism

Immunostimulants

Therapeutic Areas

Infectious DiseasesNervous System DiseasesRespiratory Diseases+ [1]

Active Indication

DiphtheriaPoliomyelitisTetanus+ [1]

Inactive Indication-

Originator Organization

Kitasato Daiichi Sankyo Vaccine Co., Ltd.

Active Organization

Kitasato Daiichi Sankyo Vaccine Co., Ltd.

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

JP (04 Jul 2014),

DiphtheriaPoliomyelitisTetanus+ [1]

Regulation-

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Author: Fitzgerald, Nicholas A. ; Pyles, Gage M ; Damron, F Heath ; Bitzer, Graham J. ; DeJong, Megan A. ; Barbier, Mariette ; Dublin, Spencer R. ; Damron, F. Heath ; Boehm, Dylan T ; Huckaby, Annalisa B. ; Boehm, Dylan T. ; Chapman, Joshua A. ; Warden, Matthew D. ; Pyles, Gage M. ; Bitzer, Graham J ; Dublin, Spencer R ; Huckaby, Annalisa B ; Warden, Matthew D ; Chapman, Joshua A ; Miller, Sarah J. ; Fitzgerald, Nicholas A ; Miller, Sarah J ; Cunningham, Casey ; DeJong, Megan A

ABSTRACTBordetella pertussis is a Gram-negative bacterium that is the causative agent of the respiratory disease known as pertussis. Since the switch to the acellular vaccines of DTaP and Tap, pertussis cases in the US have risen and cyclically fallen. We have observed that mRNA pertussis vaccines are immunogenic and protective in mice. Here, we further evaluated the pertussis toxoid mRNA antigen and refined the formulation based on optimal pertussis toxin neutralization in vivo . We next evaluated the mRNA pertussis vaccine in Sprague-Dawley rats using an aerosol B. pertussis challenge model paired with whole-body plethysmography to monitor coughing and respiratory function. Female Sprague-Dawley rats were primed and boosted with either commercially available vaccines (DTaP or wP-DTP), an mRNA-DTP vaccine, or mock-vaccinated. The mRNA-DTP vaccine was immunogenic in rats and induced antigen-specific IgG antibodies comparable to DTaP. Rats were then aerosol challenged with a streptomycin-resistant emerging clinical isolate D420Sm1. Bacterial burden was assessed at days 1 and 9 post-challenge, and the mRNA vaccine reduced burden equal to both DTaP and wP-DTP. Whole-body plethysmography revealed that mRNA-DTP vaccinated rats were well protected against coughing which was comparable to the non-challenged group. These data suggest that an mRNA-DTP vaccine is immunogenic in rats and provides protection against aerosolized B. pertussis challenge in Sprague-Dawley rats.

01 Dec 2023·British Journal of Clinical Pharmacology

Direct‐to‐participant investigational medicinal product supply in clinical trials in Europe: Exploring the experiences of sponsors, site staff and couriers

Article

Author: Santa-Ana-Tellez, Yared ; Grupstra, Renske J ; Zuidgeest, Mira G P ; Gardarsdottir, Helga ; de Boer, Anthonius ; de Jong, Amos J ; Jami, Fatemeh

AbstractAimsInsights into the current practice of direct‐to‐participant (DtP) supply of investigational medicinal product (IMP) in the context of clinical trials conducted in Europe are needed, as regulations are unharmonized. This study is set out to explore how DtP IMP supply has been employed in Europe and what the advantages and disadvantages and barriers and facilitators of its implementation are.MethodsWe conducted semi‐structured interviews with representatives from sponsor companies, courier services and site study staff involved in the IMP dispensing and delivery process in Europe. Interviews were conducted between May and November 2021, and data were analysed following thematic analysis.ResultsSixteen respondents participated in one of the 12 interviews. Respondents had experience with different models of DtP IMP supply including shipment from the investigative site, a central pharmacy (a depot under the control of a pharmacist) and a local pharmacy—aiming to reduce trial participation burden. The respondents indicated that investigative site‐to‐participant shipment is not affected by regulatory barriers, but could burden site staff. Shipment from central locations was considered most efficient, but possible regulatory barriers related to maintaining participants' privacy and investigator oversight were identified. The respondents indicated that the involvement of local pharmacies to dispense IMP can be considered when the IMP is authorized.ConclusionsSeveral DtP IMP supply models are implemented in clinical trials conducted in Europe. In this study, three main DtP IMP models were identified, which can be referenced when describing these approaches for regulatory approval.

20 Oct 2023·Natural product research

Preparation, structural characteristics and antioxidant activity of polysaccharide and its metal chelates from the peel of Dioscorea oppositifolia L.

Article

Author: Wang, Yi ; Li, Hui ; Liu, Yi ; Niu, Chao-Fei ; Ma, Bing-Ji ; Wang, Li ; Ruan, Yuan

Two metal chelates of Dioscorea oppositifolia L. peel polysaccharides (DTP) were prepared: iron chelate (DTP-Fe) and zinc chelate (DTP-Zn). The physicochemical properties of the polysaccharide and its metal chelates were assessed by UV-Vis absorption spectroscopy, Fourier-transform infra-red spectroscopy, scanning electron microscopy, and thermogravimetric analysis. Antioxidant activities were evaluated by DPPH, ABTS + and hydroxyl radical scavenging assays. According to ICP-MS, the iron content of DTP-Fe was 9.47%, while the zinc content of DTP-Zn was 4.02%. The antioxidant capacity of DTP-Fe increased with the increase of concentration, and its overall activity was higher than that of DTP and DTP-Zn. This polysaccharide-iron chelate can be developed and utilised as an antioxidant and multifunctional iron supplement. DTP-Zn showed the potential to be a natural antioxidant and zinc supplement food.

100 Deals associated with DTP-poliovirus vaccine(Kitasato Daiichi Sankyo Vaccine Co., Ltd.)

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