A Phase 3 Trial to Evaluate the Safety, Immunogenicity, and Non-Interference With Concomitant Routine Vaccines, of a Meningococcal Serogroup ACYWX Conjugate Vaccine (NmCV-5) in Comparison With MenACWY-TT Conjugate Vaccine in Healthy Malian Infants

Infants aged 9 months will be randomized to receive a meningococcal vaccine at 9 months or 15 months. Infants randomized to the 9-month age group will be further randomized in a 2:1 ratio to receive a single dose of the experimental meningococcal vaccine (NmCV-5) or a single dose of the comparator meningococcal vaccine (MenACWY-TT). Prospectively identified and consented infants randomized to the 15-month age group will return when aged 15 months and will be randomized in a 2:1 ratio to receive a single dose of NmCV-5 or a single dose of MenACWY-TT.

开始日期2022-03-24

申办/合作机构

Emory University

[+1]

CTRI/2019/12/022436 / Active, not recruiting临床2/3期

A Phase 2/3, Randomized, Observer-blind, Controlled, Multi-Center Study to Evaluate the Lot to Lot Consistency of SIIPL Meningococcal ACYWX Conjugate Vaccine (NmCV-5) and to Compare its Safety and Immunogenicity with that of Licensed Meningococcal ACWY Vaccine MenactraÂ® in Healthy Individuals 18-85 Years of Age

开始日期2019-12-27

申办/合作机构

Serum Institute of India Pvt Ltd.

NCT04358731 / Completed临床2/3期

A Phase 2/3, Randomized, Observer-blind, Controlled, Multi-Center Study to Evaluate the Lot to Lot Consistency of SIIPL Meningococcal ACYWX Conjugate Vaccine (NmCV-5) and to Compare Its Safety and Immunogenicity With That of Licensed Meningococcal ACWY Vaccine Menactra® in Healthy Individuals 18-85 Years of Age

This is a Phase 2/3, randomized, observer blind, multi-centre, controlled study to evaluate the safety, immune response and consistency of immune response of three consecutively manufactured lots of NmCV-5 in healthy individuals between the ages of 18 to 85 years (both inclusive). The immune response of NmCV-5 will also be statistically compared against a licensed conjugate vaccine against ACYW (Menactra).
A total of 1640 subjects 18 to 85 years of age will be accrued contemporaneously across three age groups - 18 to 29 years, 30 to 60 years, and 61 to 85 years. Within each age group subjects will be randomly assigned in a 3:1 ratio to receive either NmCV-5 or Menactra. The NmCV-5 subjects in 18-29 year age group will be further randomized 1:1:1 into three different lots (Lot A, B & C) of NmCV-5.
All the randomized subjects will receive a single dose of 0.5 ml of NmCV-5 or Menactra on Day 1. Post vaccination site visits are planned on Days 8, 29 and 180 and a telephonic call at Day 85.

开始日期2019-12-27

申办/合作机构

Serum Institute of India Pvt Ltd.

100 项与 Pentavalent meningococcal conjugate vaccine(PATH) 相关的临床结果

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100 项与 Pentavalent meningococcal conjugate vaccine(PATH) 相关的转化医学

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100 项与 Pentavalent meningococcal conjugate vaccine(PATH) 相关的专利（医药）

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150

项与 Pentavalent meningococcal conjugate vaccine(PATH) 相关的文献（医药）

2024-07-01·European journal of internal medicine

Polyvalent immunoglobulin use: Issues between good use, economic constraints and shortages over 25 years

Letter

作者: Bedouch, P ; Chanoine, S ; Perrier, Q ; Tuloup, V ; Chevallier-Brilloit, C

Human normal polyvalent Igs (HNIg) have been widely used for the treatment of primary and secondary immune deficiencies.The objective of this study was to describe the 25-yr evolution of HNIg use in our university hospital.The data were expressed as the number of patients treated with HNIg and the consumption of HNIg in kilograms for each year.This study was conducted in accordance with the French Reference Methodol. MR-004, as per the 2016-41 law (Jan. 26, 2016)The utilization of HNIg between 1999 and 2023 involved two major disease categories: immune deficiency and neurol. diseases.Immune deficiency is a longstanding reason for prescribing HNIg, with a progressively expanding patient cohort requiring ongoing monitoring.There has been particular focus on the pos. effects of HNIg in SID, demonstrating reduced infection rates and improved patient quality of life.Neurol. diseases have experienced a significant increase in the consumption of HNIg over years.This study identified several emerging indications for the use of HNIg in recent yearsFirst, new indications arise from the emergence of new pathologies, such as in the case of COVID-IMS (immune-mediated syndrome) with inconsistent recommendation between the United Kingdom and the result of SWISS-RECOVERY trial.Second, new indications resulted from changes in treatment practices and trial results, as observed in the case of BK infection.Third, the evolution of treatment expertise has led to increased patient referrals.This increased expertise likely contributed to the growing number of patients and prescriptions for neurol. diseases such as CIDP and autoimmune encephalitis.Fourth, there are new indications related to the improvement of diagnosis.The identification of specific antibodies targeting the cell membrane and intracellular components has facilitated the etiol. assessment of encephalitis syndromes, allowing for more accurate diagnosis and targeted treatment in autoimmune encephalitis.The analyzed period highlighted two important trends: the emergence of new indications that have now been validated by regulatory (e. g., CIDP) and recognized by the scientific community (e.g., autoimmune encephalitis and BK virus.

2024-04-01·Journal of chromatography. B, Analytical technologies in the biomedical and life sciences

Molecular size distribution in pentavalent (A, C, Y, W, X) meningococcal polysaccharide conjugate vaccine by HPSEC-UV-MALS-RI method- a conceivable stability indicating parameter

Article

作者: Shinde, Prasad ; Pendharkar, Sumeet ; Kale, Sameer ; Goel, Sunil Kumar ; Gairola, Sunil ; Phugare, Swapnil ; Mandhan, Aarushi ; Sharma, Pankaj

Molecular size distribution (MSD) of polysaccharides serves as a key parameter that directly correlates to the immunogenicity of vaccine. MSD at meningococcal polysaccharide (A, C, Y and W) or conjugate bulk level is well established under detailed pharmacopeial and WHO guidelines. We report here, a newly developed method for determination of molecular size distribution of pentavalent Meningococcal conjugate vaccine comprising of A, C, Y, W and X (MenFive). Although serogroup specific molecular size could not be estimated here; lot to lot consistency monitoring, molecular aggregates distribution in final lot, are key takeaways of this method. Determination of MSD in pentavalent fill finished product was quite challenging. Various columns/detectors combination, buffers, physico-chemical conditions (temperature, 2-8 °C, 25 °C, 40 °C and 60 °C; flow rate, 0.3 mL to 0.8 mL), liquid/lyophilized formulations, were explored. Polymer-based packed columns were explored for estimation for MSD by aqueous size exclusion chromatography, using combinations of- Shodex OHPAK SB 807 HQ, Shodex OHPAK SB 806 HQ, G6000 PWXL, coupled with guard Shodex OHPAK SB-G-6B. MenFive showed heterogenous distribution of molecules ranging from 200 to 19000 kDa, indicating its complex nature. However, 1000-8000 kDa was dominant range, comprising of ≥ 50 % distribution of molecules, in both liquid as well as lyophilized formulations, with average molecular weight around 6000-6500 kDa. The molar mass distribution after slicing would provide an insight to the conformation of molecules through its presentation as HMW, LMW, aggregates and subsequently, the presence of dominant population of molecules of a particular molecular weight and its total contribution in the sample.

2023-11-01·Journal of pharmaceutical and biomedical analysis

Method development and validation of unbound saccharide content (serogroup A, C, Y, W, X) in novel pentavalent meningococcal polysaccharide conjugate vaccine with two different carrier proteins

Article

作者: Kale, Sameer ; Goel, Sunil Kumar ; Gairola, Sunil ; Phugare, Swapnil ; Sharma, Pankaj

Exclusive DOC-HCl formulations were developed for free polysaccharide content estimation in Meningococcal serogroup A, C, Y, W and X from pentavalent meningococcal vaccine (A, C, Y, W, X). The DOC precipitation method reported herein stands as an alternative to the ultra-filtration method for free polysaccharide estimation. DOC content was optimized for all the serogroups at a single concentration, where as effective acid concentration was altered as per serogroup. Briefly, two DOC-HCl formulations were developed for intended purpose, one for TT conjugated serogroups Men A & Men X where as other for CRM conjugated serogroups Men C, Men Y and Men W with effective HCl concentration of 23 mM and 193 mM for precipitation of Protein-DOC complex respectively. Furthermore, an exclusive buffer/DOC-HCl formulation for estimation of Men X free polysaccharide in fill finished product was developed. Accuracy of the method was proven at 12.5 %, 25 %, 50 % and 100 % of test specification where recoveries were found in the range of 70-130 %. In case of repeatability, intra assay variation ranged from 2 % to 7 % whereas inter assay variation was noted to be 2-14 %. Specificity studied revealed no interference of assay components such as sample excipients, DOC, acids. Critical quality and stability-indicating characteristics were measured. Monovalent polysaccharide standards of Men A, C, Y, W and X were developed and assigned the unitage concentration 1.01, 1.10, 1.09, 1.08 and 1.00 mg/mL respectively. Linearity curve was optimized from 0.17 to 27 µg/mL for Men A and C whereas from 0.33 to 27 µg/mL for Men Y and W considering free polysaccharide content estimation. The study suggests that DOC-HCl method meets all the criteria for free polysaccharide estimation in multivalent vaccines with additional advantages of high throughput and sized independent separation hence can be used for quality control testing.

项与 Pentavalent meningococcal conjugate vaccine(PATH) 相关的新闻（医药）

2023-05-12

·Pharma Manufacturing

GSK meningitis vaccine shines in phase 3 trials

GSK this week that its 5-in-1 meningitis vaccine — MenABCWY— shined in phase 3 trials. If approved, the vaccine would provide the most coverage against the infectious disease yet. The vaccine was found to be as effective and have a similar safety profile as two doses of Bexsero and one dose of Menveo for five different Neisseria meningitidis serogroups (A, B, C, W, and Y) in individuals aged 10-25 years. In a separate phase 3 trial, GSK’s MenABCWY also demonstrated its ability to provide immunological protection against a panel of 110 different meningococcal serogroup B invasive strains, which make up 95% of strains found in the US. Bexsero and Menveo — both made by GSK — are immunizations administered to protect against specific types of meningococcal ailments. Bexsero vaccine is intended to work against meningococcal group B bacteria, whereas Menveo vaccine targets meningococcal groups A, C, W-135, and Y bacteria. These two vaccines are recommended for specific age groups, particularly adolescents and young adults, who might be at greater risk of contracting meningococcal disease. In January 2013, Bexsero was approved by the European Commission for use in individuals from 2 months of age and older, making it the first broad coverage vaccine to receive a regulatory approval to help protect against meningitis B.

临床3期上市批准疫苗临床结果

100 项与 Pentavalent meningococcal conjugate vaccine(PATH) 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
脑膜炎球菌感染	临床3期	印度	Serum Institute of India Pvt Ltd.	2019-12-27
流行性脑脊髓膜炎	临床2期	马里	Serum Institute of India Pvt Ltd.	2017-11-15
流行性脑脊髓膜炎	临床2期	马里	Program for Appropriate Technology in Health	2017-11-15

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05093829 (CTgov)	临床3期	脑膜炎	1,325	NmCV-5 (Vaccination at 9 Months of Age With NmCV-5)	遞醖願繭齋鏇壓糧顧夢(鬱憲積糧艱鹽願築鹽築): Difference in proportions = 0.0 (95% CI, -1.0 ~ 2.0); Difference in proportions = -0.5 (95% CI, -2.3 ~ 1.9); Difference in proportions = -3.0 (95% CI, -6.3 ~ 0.8); Difference in proportions = -3.0 (95% CI, -5.4 ~ -0.4) 更多	-	2024-05-07
				MenACWY-TT (Vaccination at 9 Months of Age With MenACWY-TT)