Development of a monoclonal antibody sandwich ELISA for the determination of antigen content and quality in diphtheria vaccines

Abstract

the production of toxin-neutralizing antibodies. They are among the most widely employed and successful human vaccines, and their use has significantly decreased the incidence of the disease worldwide (Clarke et al., 2019), although there can still be significant outbreaks where there is insufficient vaccination coverage.Diphtheria vaccines consist of formaldehyde-inactivated preparations of DTxn (forming diphtheria toxoid, DTxd) adsorbed onto an aluminium adjuvant (aluminium hydroxide, Al(OH) 3 , aluminium phosphate, AlPO 4 , or a combination of both), and include additional non-diphtheria components such as tetanus toxoid, pertussis (acellular antigens or whole cell), inactivated poliomyelitis, hepatitis B surface antigen, and Haemophilus influenzae type b polysaccharide. The chemical inactivation of DTxn results in toxoids that consist of 1 IntroductionDiphtheria is a potentially fatal infection caused by toxigenic strains of corynebacteria, primarily Corynebacterium diphtheriae. Diphtheria is generally an acute respiratory infection, characterized by the formation of a pseudomembrane in the throat, but cutaneous infections are also possible. Diphtheria toxin (DTxn), an exotoxin that inhibits protein synthesis and causes cell death, is the most important virulence factor for disease-causing C. diphtheriae strains. As well as causing local tissue destruction, DTxn can enter the bloodstream and disseminate throughout the body causing complications such as myocarditis and neuropathy (Sharma et al., 2019