A single immunogenicity assay for testing potency of combination DTaP vaccines: Simultaneous quantitation of anti-DT, anti-TT, anti-PTxd and anti-FHA antibodies in Guinea-pig serum with a Luminex®-xMAP® bead-based serological assay

Publication date: Available online 23 August 2019Source: BiologicalsAuthor(s): Silvio Bandiera, Annabelle Lebas, Livia Canizares-Martinello, Fabien Guinchard, Corinne Lyonnais, Sophie Perrin, Marine Nicolas, Sylvie Uhlrich, Martine Chabaud-RiouAbstractThe diphtheria toxoid (DT), tetanus toxoid (TT), and acellular pertussis (aP) single immunogenicity assay (DTaP SIA) is a Luminex®-xMAP®-bead-based multiplex immunoassay for estimating the potency of DTaP pediatric combination vaccines in guinea pigs. This manuscript describes the validation of this assay for the simultaneous quantitation of anti-diphtheria toxoid (anti-DT), anti-tetanus toxoid (anti-TT), anti-pertussis toxoid (anti-PTxd), and anti-filamentous hemagglutinin (anti-FHA) antibodies in guinea pig serum following injection of a DTaP vaccine formulation. The results were expressed in arbitrary units/mL (AU/mL) using reference serum for comparison. Specificity was demonstrated by ≥ 75% homologous and ≤25% heterologous inhibition for all the antigens. The results were linear for anti-DT, anti-TT, anti-PTxd and anti-FHA antibodies. Accuracy was demonstrated with recovery of between 80% and 120% for all four antibodies. The relative standard deviation of repeatability was ≤20%. The results demonstrate that this SIA can be used for the linear, accurate, and precise simultaneous detection of all four antibodies, based on both the ICH Q2 and the EMA guidelines on bioanalytical method validation.
Source: Biologicals - Category: Biology Source Type: research

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Rajat Garg, Shyam S MoudgilNeurology India 2019 67(4):1122-1123
Source: Neurology India - Category: Neurology Authors: Source Type: research
Vaccinations before and during pregnancy are important to protect both mother and baby. Three vaccinations are recommended: flu, Tdap (tetanus, diphtheria, and acellular pertussis), and MMR (measles, mumps, and rubella).
Source: TMA News Room - Category: Consumer Health News Source Type: news
CONCLUSIONS: Despite high overall DTP3 coverage observed in two communities, many vaccinations were delayed. Vulnerable groups identified in this study should be targeted with improved vaccination services to enhance uptake and timeliness of vaccination. PMID: 31456549 [PubMed - in process]
Source: South African Medical Journal - Category: African Health Tags: S Afr Med J Source Type: research
Conditions:   Diphtheria;   Tetanus;   Pertussis;   Hepatitis B;   Poliomyelitis;   Haemophilus Influenzae Type b Infection Interventions:   Biological: DTwP-HepB-Sabin IPV-Hib;   Biological: Pentavalent vaccine and Salk IPV Sponsor:   LG Chem Not yet recruiting
Source: ClinicalTrials.gov - Category: Research Source Type: clinical trials
Conditions:   Diphtheria;   Tetanus;   Pertussis;   Hepatitis B;   Poliomyelitis;   Haemophilus Influenzae Type b Infection Interventions:   Biological: DTwP-HepB-Sabin IPV-Hib;   Biological: Pentavalent vaccine and Salk IPV Sponsor:   LG Chem Not yet recruiting
Source: ClinicalTrials.gov - Category: Research Source Type: clinical trials
Conditions:   Diphtheria;   Tetanus;   Pertussis;   Hepatitis B;   Poliomyelitis;   Haemophilus Influenzae Type b Infection Interventions:   Biological: DTwP-HepB-Sabin IPV-Hib;   Biological: Pentavalent vaccine and Salk IPV Sponsor:   LG Chem Not yet recruiting
Source: ClinicalTrials.gov - Category: Research Source Type: clinical trials
Conditions:   Diphtheria;   Tetanus;   Pertussis;   Hepatitis B;   Poliomyelitis;   Haemophilus Influenzae Type b Infection Interventions:   Biological: DTwP-HepB-Sabin IPV-Hib;   Biological: Pentavalent vaccine and Salk IPV Sponsor:   LG Chem Not yet recruiting
Source: ClinicalTrials.gov - Category: Research Source Type: clinical trials
Conditions:   Diphtheria;   Tetanus;   Pertussis;   Hepatitis B;   Poliomyelitis;   Haemophilus Influenzae Type b Infection Interventions:   Biological: DTwP-HepB-Sabin IPV-Hib;   Biological: Pentavalent vaccine and Salk IPV Sponsor:   LG Chem Not yet recruiting
Source: ClinicalTrials.gov - Category: Research Source Type: clinical trials
Conditions:   Diphtheria;   Tetanus;   Pertussis;   Hepatitis B;   Poliomyelitis;   Haemophilus Influenzae Type b Infection Interventions:   Biological: DTwP-HepB-Sabin IPV-Hib;   Biological: Pentavalent vaccine and Salk IPV Sponsor:   LG Chem Not yet recruiting
Source: ClinicalTrials.gov - Category: Research Source Type: clinical trials
Conditions:   Diphtheria;   Tetanus;   Pertussis;   Hepatitis B;   Poliomyelitis;   Haemophilus Influenzae Type b Infection Interventions:   Biological: DTwP-HepB-Sabin IPV-Hib;   Biological: Pentavalent vaccine and Salk IPV Sponsor:   LG Chem Not yet recruiting
Source: ClinicalTrials.gov - Category: Research Source Type: clinical trials
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