Delving into the Latest Updates on Hib conjugate vaccine(Bharat Biotech International Ltd.) with Synapse

Overview

Basic Info

Drug Type

Prophylactic vaccine, Conjugated vaccine

Synonyms

BioHib, Hib conjugate vaccine, Hib vaccine

Target-

Mechanism

Immunostimulants

Therapeutic Areas

Infectious Diseases

Active Indication

Haemophilus Infections

Inactive Indication-

Originator Organization

Bharat Biotech International Ltd.

Active Organization

Bharat Biotech International Ltd.

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

IN (19 Feb 2016),

Haemophilus Infections

Regulation-

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To fully understand the safety of DTaP-IPV/Hib vaccination, we evaluated the differences between DTaP-IPV/Hib co-administration and separate administration of the DTaP, IPV and Hib vaccines (DTaP+IPV+Hib) based on adverse events following immunization (AEFI). All AEFI reported in Hebei Province, China, between 2020 and 2022 were included in this study. The risk difference (RD%), relative risk (RR), and Chi-square value were used to compare the differences in reported rates of AEFI between the DTaP-IPV/Hib and DTaP+IPV+Hib groups. From 2020 to 2022, 130 AEFI cases were reported in Hebei Province after DTaP-IPV/Hib vaccination, corresponding to an AEFI reported rate of 66.9/million doses, which was significantly lower than that for DTaP+IPV+Hib (9836 AEFI with a reported rate of 637.8/million doses). The overall reported rate of non-severe AEFI for DTaP+IPV+Hib vaccines was 9.5 times that of DTaP-IPV/Hib vaccination [95% confidence interval (CI): 8.0, 11.3]. Meanwhile, the reported rate of AEFI among infants aged 0-1 y was 9.8 times higher for DTaP+IPV+Hib than for DTaP-IPV/Hib (95% CI: 8.2, 11.7). DTaP+IPV+Hib vaccination also resulted in higher risks of high fever, localized redness and swelling, localized induration, and allergic rash compared with DTaP-IPV/Hib vaccination. The risk of AEFI, which were mostly mild reaction, was higher after vaccination with DTaP+IPV+Hib than after DTaP-IPV/Hib vaccination.

31 Dec 2024·Human Vaccines & Immunotherapeutics

Development and validation of a 6-plex Luminex-based assay for measuring human serum antibodies to group B streptococcus capsular polysaccharides

Article

Author: Giardina, Peter C ; Giordano-Schmidt, Donna ; Pavliakova, Danka ; Anderson, Annaliesa S ; Larrier, Melissa ; Nguyen, Ha H ; Gaylord, Michelle A ; Tan, Charles Y ; Singh, Suddham ; Kalina, Warren V ; McKeen, Andrew ; Grube, Christopher D

Six serotypes (Ia, Ib, II, III, IV, and V) cause nearly all group B streptococcal (GBS) disease globally. Capsular polysaccharide (CPS) conjugate vaccines aim to prevent GBS disease, however, licensure of a vaccine would depend on a standardized serological assay for measuring anti-CPS IgG responses. A multiplex direct Luminex-based immunoassay (dLIA) has been developed to simultaneously measure the concentration of serum IgG specific for the six prevalent GBS CPS serotypes. Assay validation was performed using serum samples obtained from human subjects vaccinated with an investigational 6-valent GBS CPS conjugate vaccine. Results for the assay are expressed as IgG concentrations (µg/mL) using a human serum reference standard composed of pooled sera from vaccinated subjects. The lower limits of quantitation (LLOQ) for all serotypes covered in the 6-plex GBS IgG dLIA fell within the range of 0.002-0.022 µg/mL IgG. Taken together, the 6-plex GBS IgG dLIA platform is specific for the six GBS serotypes included in Pfizer's investigational vaccine, has a wide dilution adjusted assay range, and is precise (<18.5% relative standard deviation) for all serotypes, and, therefore, is suitable for quantitatively measuring vaccine-induced or naturally acquired serotype-specific anti-CPS IgG responses against GBS.

01 Dec 2024·International Journal of Infectious Diseases

Estimating the global and regional burden of lower respiratory infections attributable to leading pathogens and the protective effectiveness of immunization programs

Article

Author: Sun, Lin ; Yu, Xiaoran ; Zou, Zhiyong ; Chen, Wanning ; Ma, Sheng ; Wang, Huan

OBJECTIVESReducing mortality from infectious diseases is an urgent global public health priority. Streptococcus pneumoniae, H. influenzae, and influenza virus are the three leading causes of lower respiratory infections (LRIs) death worldwide. Our objective was to assess the global burden of LRIs attributable to S. pneumoniae, H. influenzae, and influenza virus and explore the protective effectiveness of immunization programs.METHODSData were retrieved from the Global Burden of Disease Study 2021 and World Health Organization United Nations Children's Fund Estimates of National Immunization Coverage. Locally weighted linear regression and Spearman correlation analysis were used to examine the associations between LRI mortality and vaccination coverage. Mixed-effects regression models were used to estimate the reduction in deaths that would be reduced by pneumococcal conjugate vaccine (PCV) and the H. influenzae type b (Hib) vaccine if all countries realized the Immunization Agenda 2030 (IA2030).RESULTSIn 2021, about 30.2% of the 2.18 million LRI-related deaths were attributed to three studied pathogens. From 1990 to 2021, the age-standardized mortality rate of LRIs was attributable to three pathogens decreased by more than half. In 2022, the global vaccination rates for PCV and Hib vaccines were 60.0% and 76.0%, respectively. The LRIs attributable to S. pneumoniae (r_s = -0.45, P <0.001) and H. influenzae (r_s = -0.47, P <0.001) decreased with the increasing vaccination coverage of PCV and Hib. By 2030, approximately 59.9% and 70.8% of countries worldwide will reach the IA2030 targets of 90% coverage for PCV and Hib, respectively. By that time, the number of deaths from LRIs in children attributable to S. pneumoniae and H. influenzae will decrease by 54.8% and 24.4%, respectively.CONCLUSIONSDespite the declines in LRI mortality attributed to respiratory pathogens, substantial deaths still occurred in 2021. To advance toward achieving the IA2030 targets and further mitigate mortality associated with LRIs, intensified efforts by the international community and national health systems are imperative.

100 Deals associated with Hib conjugate vaccine(Bharat Biotech International Ltd.)

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