Delving into the Latest Updates on 13-valent pneumococcal conjugate vaccine(Bravovax) with Synapse

Overview

Basic Info

Drug Type

Prophylactic vaccine, Multivalent vaccine, Conjugated vaccine

Synonyms

13价肺炎球菌结合疫苗（成大生物）, Pneumococcal 13-valent Conjugate Vaccine (CDBIO)

Target-

Action

stimulants

Mechanism

Immunostimulants

Therapeutic Areas

Infectious DiseasesRespiratory Diseases

Active Indication

Pneumonia

Inactive Indication

Pneumococcal Infections

Originator Organization

Bravovax Co., Ltd.

Active Organization

Bravovax Co., Ltd.

Liaoning Chengda Biotechnology Co. Ltd.

Inactive Organization-

Drug Highest PhasePhase 1

First Approval Date-

Regulation-

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Streptococcus pneumoniae is a major cause of morbidity and mortality in children worldwide, resulting in up to 1 million pediatric deaths every year. Since the licensure of PCV7, PCV10, PCV13 and PCV15, the reported overall decline in invasive pneumococcal disease in hospitalized children younger than 5 years is approximately 60% around the world.
This is a single center, blinded, randomized, positive-controlled phase I clinical trial to evaluate the safety and explore the immunogenicity of a candidate PCV13 in healthy people aged 2 months (minimum 6 weeks) and above.

Start Date01 Nov 2022

Sponsor / Collaborator

Bravovax Co., Ltd.

[+2]

CTR20222724

/ Active, not recruitingPhase 1

评价13价肺炎球菌结合疫苗在2月龄（最小满6周龄）及以上健康人群中使用的安全性、免疫原性探索的I期临床试验方案

[Translation] Phase I clinical trial plan to evaluate the safety and immunogenicity of 13-valent pneumococcal conjugate vaccine in healthy people aged 2 months (minimum 6 weeks) and above

主要目的：评价13价肺炎球菌结合疫苗接种于2月龄（最小满6周龄）及以上人群的安全性。探索目的：探索13价肺炎球菌结合疫苗接种于2月龄（最小满6周龄）及以上人群的免疫原性。

[Translation]

Main purpose: To evaluate the safety of 13-valent pneumococcal conjugate vaccine in people aged 2 months (minimum 6 weeks) and above. Exploratory purpose: To explore the immunogenicity of 13-valent pneumococcal conjugate vaccine in people aged 2 months (minimum 6 weeks) and above.

Start Date01 Nov 2022

Sponsor / Collaborator

Liaoning Chengda Biotechnology Co. Ltd.

[+1]

100 Clinical Results associated with 13-valent pneumococcal conjugate vaccine(Bravovax)

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100 Translational Medicine associated with 13-valent pneumococcal conjugate vaccine(Bravovax)

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100 Patents (Medical) associated with 13-valent pneumococcal conjugate vaccine(Bravovax)

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104

Literatures (Medical) associated with 13-valent pneumococcal conjugate vaccine(Bravovax)

01 Aug 2024·Pediatric Emergency Care

Incidence of Bacteremia and Serious Bacterial Infections in Hyperpyrexic Infants Offered Universal Pneumococcal Conjugate Vaccine 13 and Haemophilus influenzae B Immunization

Article

Author: Segev, Or ; Glatstein, Miguel ; Scolnik, Dennis ; Huber, Adi ; Be'er, Moria ; Rimon, Ayelet

BackgroundHigh fevers, especially in young children, often alarm clinicians and prompt extensive evaluation based on perceptions of increased risk of serious bacterial infection (SBI), and even brain damage or seizure disorders.ObjectiveThe aim of this study was to determine the prevalence of SBI in infants aged 3–36 months with fever ≥40.5°C in a population of infants offered universal pneumococcal conjugate vaccine 13 and Haemophilus influenzae B immunization.MethodsThis study is a retrospective review of all infants aged 3–36 months with temperature ≥40.5°C presenting to a tertiary care pediatric emergency department over a 30-month period in an era of universal pneumococcal conjugate 13 and H. influenzae B immunization.ResultsSBI was recorded in 54 (21.8%) of 247 study infants, most commonly pneumonia 30 patients (12.1%) and urinary tract infection 16 patients (6.5%). Two patients had positive blood cultures, yielding a bacteremia rate of 0.8%. Patients with SBI had a significantly higher WBC count (P < 0.0001) and C-reactive protein levels (P < 0.0001), and were significantly more likely to be hospitalized (P < 0.0001).DiscussionAlthough SBI was common (21.8%) in our cohort of hyperpyrexic infants universally offered vaccination with pneumococcal conjugate 13 and H. influenzae B vaccines, bacteremia was a rare finding (0.8%).

01 Jul 2024·WMJ : official publication of the State Medical Society of Wisconsin

Knowledge, Attitudes, and Behaviors Regarding Pneumococcal Vaccines in Adults 65 Years and Older in Primary Care in Wisconsin.

Article

Author: Yuroff, Alice ; Hunter, Paul H ; Sampson, Lisa ; Henningfield, Mary F

INTRODUCTIONAlthough shared decision-making is highly valued, its implementation in clinical practice is suboptimal. Shared decision-making was included in the Centers for Disease Control and Prevention (CDC) recommendations for the pneumococcal conjugate vaccine 13 valent for older adults. As a first step to develop and test clinician educational resources to facilitate shared decision-making for pneumococcal vaccines for older adults, we completed a needs assessment to identify knowledge gaps, attitudes, and behaviors.METHODSPrimary care clinicians, pharmacists, and patient care staff completed a questionnaire on shared decision-making and pneumococcal vaccines. After the CDC recommended new pneumococcal vaccines and eliminated the role of shared decision-making, a revised questionnaire was distributed to additional clinicians in an effort to increase the sample size.RESULTSKnowledge of pneumococcal vaccine recommendations was high among those who responded to knowledge questions (48 of 75 respondents). Although 96% of respondents believed shared decision-making for use of pneumococcal vaccines in adults 65 years or older was feasible, 25% responded that it would be "somewhat difficult" to explain potential harms and benefits of PCV13.DISCUSSIONAlthough shared decision-making was reported to be feasible, challenges implementing it are ongoing. Knowledge gaps regarding pneumococcal vaccines were observed, highlighting the need for ongoing medical education with changing vaccine recommendations.

01 Mar 2024·The Lancet Regional Health - Western Pacific

Impact of childhood 13-valent pneumococcal conjugate vaccine introduction on adult pneumonia hospitalisations in Mongolia: a time series analysis

Article

Author: de Campo, John ; Grobler, Anneke C ; Narangerel, Dorj ; Fagerli, Kirsten ; Suuri, Bujinlkham ; Nguyen, Cattram D ; von Mollendorf, Claire ; Luvsantseren, Dashtseren ; Dunne, Eileen M ; Mulholland, E Kim ; Gessner, Bradford D ; Batsaikhan, Purevsuren ; Allen, Kristen E ; de Campo, Margaret ; Mungun, Tuya ; Tsolmon, Bilegtsaikhan ; Ulziibayar, Munkhchuluun

BackgroundFew studies have assessed the potential indirect effects of childhood pneumococcal conjugate vaccine (PCV) programs on the adult pneumonia burden in resource-limited settings. We evaluated the impact of childhood PCV13 immunisation on adult all-cause pneumonia following a phased program introduction from 2016.MethodsWe conducted a time-series analysis to assess changes in pneumonia hospitalisation incidence at four district hospitals in Mongolia. Adults (≥18 years) that met the clinical case definition for all-cause pneumonia were enrolled. A negative binomial mixed-effects model was used to assess the impact of PCV13 introduction on monthly counts of pneumonia admissions from January 2015-February 2022. We also performed a restricted analysis excluding the COVID-19 pandemic period. All models were stratified by age and assessed separately. Additional analyses assessed the robustness of our findings.FindingsThe average annual incidence of all-cause pneumonia hospitalisation was highest in adults 65+ years (62.81 per 10,000 population) and declined with decreasing age. After adjusting for the COVID-19 pandemic period, we found that rates of pneumonia hospitalisation remained largely unchanged over time. We did not observe a reduction in pneumonia hospitalisation in any age group. Results from restricted and sensitivity analyses were comparable to the primary results, finding limited evidence of a reduced pneumonia burden.InterpretationWe did not find evidence of indirect protection against all-cause pneumonia in adults following childhood PCV13 introduction. Direct pneumococcal vaccination and other interventions should be considered to reduce burden of pneumonia among older adults.FundingPfizer clinical research collaboration agreement (contract number: WI236621).

100 Deals associated with 13-valent pneumococcal conjugate vaccine(Bravovax)

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Pneumonia	Phase 1	China	Bravovax Co., Ltd.	01 Nov 2022
Pneumonia	Phase 1	China	Liaoning Chengda Biotechnology Co. Ltd.	01 Nov 2022
Pneumococcal Infections	Preclinical	China	Liaoning Chengda Biotechnology Co. Ltd.	01 Nov 2022
Pneumococcal Infections	Preclinical	China	Bravovax Co., Ltd.	01 Nov 2022

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


EULAR2020	Not Applicable	Behcet Syndrome	88	Pneumococcal 13-valent vaccine (Patients with Behçet Syndrome)	qjravvpmyd(ytfauxnrzx) = guaxehaqaz kohdpxrcxc (vrnuuazkhc ) View more	-	03 Jun 2020
				Pneumococcal 13-valent vaccine (Ankylosing Spondylitis patients)	qjravvpmyd(ytfauxnrzx) = coiaagnasd kohdpxrcxc (vrnuuazkhc ) View more