Delving into the Latest Updates on PBPV with Synapse

Overview

Basic Info

Drug Type

Prophylactic vaccine

Synonyms-

Target-

Mechanism

Immunostimulants

Therapeutic Areas

Infectious DiseasesRespiratory Diseases

Active Indication

Pneumococcal InfectionsPneumonia

Inactive Indication-

Originator Organization

CanSino Biologics, Inc.

Active Organization

CanSino Biologics, Inc.

Inactive Organization-

Drug Highest PhasePhase 1

First Approval Date-

Regulation-

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Streptococcus pneumoniae infections often cause serious health problems, especially in infants and the elderly. Failure to cover all polysaccharide types of vaccines is a greater problem for adults than for children.
The purpose of this study was to preliminarily evaluate the safety and immunogenicity of a recombinant pneumococcal protein vaccine applied to adults aged 50 years and older to provide a basis for subsequent clinical trial design.

Start Date11 Mar 2023

Sponsor / Collaborator

CanSino Biologics, Inc.

CTR20191743 / CompletedPhase 1

初步评价重组肺炎球菌蛋白疫苗在18~49 岁健康成人中接种后安全性、免疫原性的随机、双盲、安慰剂对照Ⅰa 期临床试验

[Translation] A randomized, double-blind, placebo-controlled phase Ia clinical trial to preliminarily evaluate the safety and immunogenicity of a recombinant pneumococcal protein vaccine in healthy adults aged 18 to 49 years

初步评价重组肺炎球菌蛋白疫苗应用于18-49 岁健康成人的安全性，初步观察免疫原性，为后续临床试验设计提供依据。

[Translation]

To preliminarily evaluate the safety of recombinant pneumococcal protein vaccine in healthy adults aged 18-49 years, and to preliminarily observe the immunogenicity, so as to provide a basis for the design of subsequent clinical trials.

Start Date10 Apr 2020

Sponsor / Collaborator

CanSino Biologics, Inc.

100 Clinical Results associated with PBPV

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100 Translational Medicine associated with PBPV

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100 Patents (Medical) associated with PBPV

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10

Literatures (Medical) associated with PBPV

01 Jul 2024·Translational Pediatrics

Clinical outcomes of the neonates with critical pulmonary stenosis: intrauterine versus postnatal transport

Article

Author: Zhou, Lin ; Jiang, Na ; Chen, Sun ; Lin, Zhiwei ; Zhang, Jufeng ; Chen, Yan ; Xia, Hongping

BackgroundPulmonary stenosis (PS) is one rare congenital heart disease (CHD) featuring obstruction of right ventricular outflow tract. Critical pulmonary stenosis (CPS) is neonatal PS having cyanosis and evidence of patent ductus arteriosus (PDA) dependency. There is limited data on the clinical outcomes of CPS with different modes of transportation. This study aimed to investigate clinical features and outcomes of CPS through the intrauterine transport (IT) and postnatal transport (PT).MethodsSingle-center retrospective research was performed. Neonates with CPS were grouped into the IT group and PT group. Clinical characteristics and outcomes of the neonates were compared between the two groups.ResultsTotally 110 neonates with PS were included in this study, 77 with CPS and 33 with non-CPS. In the infants with CPS, there were 53 and 24 in the IT and PT group respectively. Echocardiography showed that transvalvular pulmonary gradient (TVG) stayed lower in the IT group than that in the PT group {77.0 [interquartile range (IQR), 60.5-91.5] vs. 92.0 (IQR, 73.3-125.0) mmHg, P=0.006}. Levels of serum N-terminal pro-brain natriuretic peptide (NT-proBNP) and troponin I also remained lower in the IT group than those in the PT group [2,256 (IQR, 1,054-4,527) vs. 3,708 (IQR, 2,138-6,789) pg/mL, P=0.02; 0.020 (IQR, 0.011-0.034) vs. 0.042 (IQR, 0.027-0.072) ng/mL, P<0.001, respectively]. All infants with CPS received percutaneous balloon pulmonary valvuloplasty (PBPV) therapy in neonatal period and were discharged from the hospital. Length of hospital stay remained shorter in the IT group than that in the PT group [13.0 (IQR, 11.0-15.0) vs. 15.5 (IQR, 10.8-22.8) days, P=0.03].ConclusionsIT and early management after birth could effectively reduce the severity of CPS before PBPV treatment and shorten the length of hospital stay among neonates suffering from CPS.

01 Jul 2024·Translational Pediatrics

Clinical outcomes of the neonates with critical pulmonary stenosis: intrauterine versus postnatal transport

Article

Author: Zhou, Lin ; Chen, Sun ; Lin, Zhiwei ; Chen, Yan ; Xia, Hongping ; Jiang, Na ; Zhang, Jufeng

BackgroundPulmonary stenosis (PS) is one rare congenital heart disease (CHD) featuring obstruction of right ventricular outflow tract. Critical pulmonary stenosis (CPS) is neonatal PS having cyanosis and evidence of patent ductus arteriosus (PDA) dependency. There is limited data on the clinical outcomes of CPS with different modes of transportation. This study aimed to investigate clinical features and outcomes of CPS through the intrauterine transport (IT) and postnatal transport (PT).MethodsSingle-center retrospective research was performed. Neonates with CPS were grouped into the IT group and PT group. Clinical characteristics and outcomes of the neonates were compared between the two groups.ResultsTotally 110 neonates with PS were included in this study, 77 with CPS and 33 with non-CPS. In the infants with CPS, there were 53 and 24 in the IT and PT group respectively. Echocardiography showed that transvalvular pulmonary gradient (TVG) stayed lower in the IT group than that in the PT group {77.0 [interquartile range (IQR), 60.5-91.5] vs. 92.0 (IQR, 73.3-125.0) mmHg, P=0.006}. Levels of serum N-terminal pro-brain natriuretic peptide (NT-proBNP) and troponin I also remained lower in the IT group than those in the PT group [2,256 (IQR, 1,054-4,527) vs. 3,708 (IQR, 2,138-6,789) pg/mL, P=0.02; 0.020 (IQR, 0.011-0.034) vs. 0.042 (IQR, 0.027-0.072) ng/mL, P<0.001, respectively]. All infants with CPS received percutaneous balloon pulmonary valvuloplasty (PBPV) therapy in neonatal period and were discharged from the hospital. Length of hospital stay remained shorter in the IT group than that in the PT group [13.0 (IQR, 11.0-15.0) vs. 15.5 (IQR, 10.8-22.8) days, P=0.03].ConclusionsIT and early management after birth could effectively reduce the severity of CPS before PBPV treatment and shorten the length of hospital stay among neonates suffering from CPS.

01 Oct 2023·Pediatric cardiology

Effect of Balloon Pulmonary Valvuloplasty on Growth of Pulmonary Annulus in Infants with Tetralogy of Fallot.

Article

Author: Whaidee, Khwaunrat ; Lekchuensakul, Sarin ; Namchaisiri, Jule ; Lertsapcharoen, Pornthep ; Benjacholamas, Vichai

Percutaneous balloon pulmonary valvuloplasty (PBPV) is an alternative intervention in infants with Tetralogy of Fallot (TOF). It can not only improve hypoxia but also promote pulmonary annulus (PA) growth. In this study, we evaluated the effect of PBPV on PA growth in infants with TOF. To eliminate the effect of the systemic to pulmonary shunt (SPS) that may promote PA growth, we divided TOF infants into 2 groups: group A, patients who underwent PBPV with or without other SPS, and group B, patients who attempted SPS but without PBPV. Sixty patients were included, 28 patients in group A and 32 patients in group B. Age at the time of intervention in group A (range, 0.4-5.4; median 1.4 months) was lower than that in group B (range, 2.3-7.7; median 4.8 months), p-value 0.02. The body weight in group A (range, 3-5.5; median 3.7 kg) was also lower than that in group B (range 4.1-6.4; median 5.9 kg), p-value 0.02. Echocardiographic data at the mean follow-up period of 37.2 months (3-88 months) in group A and 39.6 months (6-95 months) in group B demonstrated an increase in mean PA diameter from 5.0 ± 1.3 mm to 10.2 ± 2.9 mm, p-value < 0.001 in group A; and from 6.2 ± 2 mm to 9.5 ± 2.9 mm, p-value < 0.001 in group B. The median PA z-score increased from - 3.4SD (- 3.9 to - 2.6SD) to - 1.8SD (- 2.5 to - 0.8SD), with the p-value of 0.002 in group A; and increased from - 2.9SD (- 4.5 to - 1.3SD) to - 2.7SD (- 3.6 to - 1.4SD), with the p-value of 0.73 in group B. By using the PA z-score as the absolute value, there was a statistically significant increase in the PA z-score during follow-up in group A, but not in group B. Balloon pulmonary valvuloplasty in infants with TOF can facilitate the growth of the pulmonic annulus even after eliminating the effect of the systemic to pulmonary shunt.

100 Deals associated with PBPV

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Pneumococcal Infections	Phase 1	CN	CanSino Biologics, Inc.	11 Mar 2023
Pneumonia	Phase 1	CN	CanSino Biologics, Inc.	11 Mar 2023
Streptococcal Infections	Phase 1	CN	CanSino Biologics, Inc.	10 Apr 2020