Comparison of anti-pertussis toxin ELISA and agglutination assays to assess immune responses to pertussis

Abstract

Based on the obtained results and the results of other authors, we summarize that anti-PT ELISA should be carefully used to assess the population immunity to pertussis. Currently, there is neither a serological test that accurately determines the protection against pertussis nor a distinctive criterion of protection that can be applied in seroepidemiological studies.

Systematic review of immunogenicity and duration of immunity of currently licensed pertussis wP vaccines in children

“…The data show that immunogenicity levels, reported as mean GMT, were low right before the fourth (first booster) with all studies reporting levels below 11 EU/mL 33,37,39 , with three reporting values reaching above 40 EU/mL one month after the fourth-dose studies 29,33 (Figure 2). Similarly, low levels of GMT were reported prior to the fifth dose 34,[37][38][39] , with the single study evaluating pre and post-fifth dose reporting levels of 8.4 EU/mL prior, and 30.2 EU/mL 30 days post booster 34 .…”

“…All the RCTs and uncontrolled prospective cohort studies had short follow-up periods 28,29,[32][33][34] , with a maximum of six weeks post-completion of the primary schedule (third wP dose). Five 30,31,[37][38][39] cross-sectional studies included children of older ages (six years of age and older), and only one of these 39 evaluated children of 72 months of age who received a second booster dose (Table 3).…”

“…Of the seven crosssectional studies, two studies reporting clinical outcomes were assessed as of moderate overall quality 35,36 . Cross-sectional studies reporting immunogenicity outcomes had heterogeneous quality assessments, with one of high risk 37 , three moderate risk 31,38,39 , and two low risk 30 based on the Joanna Briggs' Institute checklist (Supplementary Table 4, Extended data) 14 . The 3 randomized controlled trials all had an overall high risk of bias (Supplementary Table 5, Extended data) 14 .…”

“…Although the searches were done without language restriction, seven articles had to be excluded because they were written in languages not read by the authors (two Chinese 21,22 , two German 23,24 , onw Russian 25 and two in Uzbek 26,27 . After full texts were assessed (second phase), a total of 12 studies [28][29][30][31][32][33][34][35][36][37][38][39] met the inclusion criteria. We present the complete PRISMA flow diagram in Figure 1.…”

“…The majority of the included studies (n=8) presented data from vaccines manufactured by Serum Institute of India Ltd (Table 2, Supplementary Table 2, Extended data 14 ). Study designs included three RCT 28,29,32 , two uncontrolled prospective cohort 33,34 , and seven cross-sectional studies 30,31,[35][36][37][38][39] . The studies were conducted in seven countries, none of which had introduced maternal pertussis vaccination at the time of study completion (Table 2).…”