[Translation] A randomized, blinded, positive-controlled phase Ib clinical trial to preliminarily evaluate the safety and immunogenicity of a recombinant pneumococcal protein vaccine in adults aged 50 years and above

初步评价重组肺炎球菌蛋白疫苗应用于50岁及以上成人的安全性和免疫原性，为后续临床试验设计提供依据

[Translation]

Preliminary evaluation of the safety and immunogenicity of recombinant pneumococcal protein vaccines in adults aged 50 years and above, providing a basis for the design of subsequent clinical trials

Start Date11 Mar 2023

Sponsor / Collaborator

CanSino Biologics, Inc.

NCT05622942 / Active, not recruitingPhase 1

Randomized, Blinded, Positive-controlled Phase Ib Clinical Trial for Preliminary Evaluation of Safety and Immunogenicity of Recombinant Pneumococcal Protein Vaccine in Adults Aged 50 Years and Older After Vaccination

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

100 Translational Medicine associated with PBPV

100 Patents (Medical) associated with PBPV

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 ; 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.

02 Sep 2021·Zhonghua er ke za zhi = Chinese journal of pediatrics

[Interim follow-up of fetal cardiac intervention in five fetuses with pulmonary atresia with intact ventricular septum].

Article

Author: Xu, Q ; Sun, Y ; Pan, S L ; Wan, H ; Chen, T T ; Luo, G

Objective: To summarize the interim outcome and right heart development of pulmonary atresia with intact ventricular septum (PA-IVS) in children after fetal cardiac intervention (FCI). Methods: The clinical data of 5 live births underwent FCI from October 2018 to April 2019 in Women and Children's Hospital, Qingdao University were analyzed retrospectively. The development of right ventricle (RV) and tricuspid valve (TV) in uterus after FCI, at birth, the age of 6 months, 1 year and 2 years, and the final outcome were assessed. Results: Five PA-IVS fetuses were included in this study. The first evaluation was performed at 24-26 weeks of gestational age, and the FCI was performed at 26-28 weeks of gestational age. During the follow-up of 6 weeks after FCI, the minimum diameter of tricuspid annulus increased from 0.85 cm to 0.92 cm, and the minimum Z-score of tricuspid annulus decreased from -0.03 to -1.62. The minimum values of TV/mitral valve annular diameter and RV/left ventricular length ratios of all fetuses increased from 0.57, 0.52 to 0.88, 0.82, respectively. The maximum tricuspid regurgitation velocity decreased from 4.60 m/s to 3.64 m/s. No severe hemodynamic change was found in any of the fetuses. All 5 fetuses were born alive. Three cases underwent percutaneous balloon pulmonary valvuloplasty (PBPV) and stent implantation for ductus arteriosus. Two cases received PBPV alone. At follow-up (26 to 32 months), obvious development of TV was observed 6 months to 1 year after birth in 5 cases with the growth rate ranging from 19.64% to 40.00%. Meanwhile, the RV development was relatively slow at 6 months with the growth rate ranging from 9.41% to 21.42%. There were individual differences in RV development at 2 years. The growth and development of all children were equal to healthy children of the same age with the body mass index less than 18.4 kg/m². At the last follow-up, all children had a transcutaneous oxygen saturation of greater than 0.95, three became biventricular circulation and two had circulation approximation to biventricular circulation with almost closed stent. Conclusions: The findings support the potential of development of right ventricular and tricuspid valve for fetuses with PA-IVS underwent FCI. All fetuses underwent FCI received intervention after birth, and biventricular circulation can be realized finally. The development of right ventricular and tricuspid valve is not proportional. In utero, the right ventricle develops rapidly, and the development of tricuspid valve is more advantageous after birth.

100 Deals associated with PBPV

R&D Status

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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	Preclinical	CN	CanSino Biologics, Inc.	10 Apr 2020

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