Purpose: There is no standard method for confirming the immunogenicity of acellular pertussis vaccines. We tried to develop a local standard method for evaluating the immunogenicity of the three-component of acellular pertussis vaccines which was developed by a Korean local company.

Materials And Methods: The developed pertussis antigens (pertussis toxin, filamentous hemagglutinin, pertactin) were evaluated by in-house enzyme-linked immunosorbent assay (ELISA) using 189 negative sera, 25 positive sera, and 73 paired sera (pre- and post-Tdap [tetanus, diphtheria, and acellular pertussis] vaccinated sera). ELISA units were calculated by the reference line method, compared with World Health Organization reference sera, and the cut-off value was calculated using negative sera.

Results: When compared to National Institute for Biological Standards and Control control antigen (NIBSC) control antigens, the developed pertussis toxin (PT) and filamentous haemagglutinin (FHA) antigens were 203.48 and 61.60 IU/µg, respectively. Each in-house ELISA was established by validating the coefficients of variation % (PT, 11.53%; FHA, 8.60%; pertactin [PRN], 9.86%) obtained from the results of inter- and intra-assay variation. Also, the cut-off values of PT, FHA, and PRN were 11.65, 38.95, and 5.66 EU/mL, respectively. The distributions of antibody levels in paired showed that 93.15% (68/73) in anti-PT IgG, 97.26% (72/73) in anti-FHA IgG, and 100% in anti-PRN IgG were higher than a 100% increase after vaccination. Additionally, the values of 89.04% (65/73) in anti-PT IgG, 97.26% (72/73) in anti-FHA IgG, and 100% in anti-PRN IgG were below each cut-off point.

Conclusion: We established an in-house ELISA method using self-developed antigens, and these immunoassays have provided a way to standardize measuring the immunogenicity of newly developed vaccines, through single- and dual-serology.

Download full-text PDF

Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6369126PMC
http://dx.doi.org/10.7774/cevr.2019.8.1.35DOI Listing

Publication Analysis

Top Keywords

acellular pertussis
12
pertussis vaccines
12
immunogenicity acellular
8
standard method
8
developed pertussis
8
pertussis toxin
8
toxin filamentous
8
in-house elisa
8
anti-pt igg
8
igg 9726%
8

Similar Publications

Pertussis (or whooping cough) has experienced a global resurgence despite widespread vaccine efforts. In China, the incidence of pertussis has rapidly increased, particularly following the COVID-19 pandemic. Whole-genome sequencing analysis was performed on 60 strains isolated in Beijing from 2020 to 2023, and the sequences were compared with those of 635 strains from China and 943 strains from other countries.

View Article and Find Full Text PDF

Background: Immunisation in pregnancy against pertussis can reduce severe disease in infancy. There are few data on the safety and immunogenicity of vaccines given to pregnant women living with HIV and their infants. We aimed to describe the safety and immunogenicity of a tetanus-diphtheria-acellular pertussis (TdaP) vaccine containing genetically detoxified pertussis toxin given to pregnant women living with HIV and the effect of the vaccine on infant whole-cell pertussis vaccine responses.

View Article and Find Full Text PDF

Importance: Childhood vaccination rates have declined in recent years; there is also concern that resistance to COVID-19 vaccines could spill over to childhood vaccines.

Objectives: To use local-level data to study trends in childhood vaccination rates and heterogeneity in local rates; including how many areas are below herd-immunity thresholds, and assess the association between COVID-19 vaccine hesitancy and childhood vaccination.

Design: We report, for 11 states with available data, vaccination rates for measles, mumps, rubella (MMR), and diphtheria, tetanus, acellular pertussis (DTaP) vaccines, including percentage of schools/counties with rates ≥95 %, 90-95 %, 80-90 %, and < 80 %.

View Article and Find Full Text PDF

Background: Pertussis continues to pose a significant threat despite the availability of effective vaccines. The challenge lies in the vulnerability of infants who have not yet completed their vaccination schedule and in adolescents and adults becoming potential disease carriers.

Methods: We evaluated the seroprevalence of pertussis immunity in a cohort of 1,500 healthy Brazilian volunteers.

View Article and Find Full Text PDF

Pertussis resurgence has been documented even in countries with high pediatric vaccine coverage. The proportion of isolates not expressing pertactin (PRN) has increased in several countries where acellular pertussis (aP) vaccines are used. We systematically reviewed published literature up to July 2023 on PRN-negative isolates in MEDLINE and Embase with no geographical limitations, complemented with a gray literature search.

View Article and Find Full Text PDF

Want AI Summaries of new PubMed Abstracts delivered to your In-box?

Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!