Comparison of a glycoprotein E-based ELISA with a varicella-zoster whole-virus ELISA for the quantification of varicella vaccine immune responses in young children

Antibody response against varicella-zoster virus (VZV) is frequently assessed by whole-virus- (anti-VZV) or glycoprotein-based ELISAs. This study compared antibody concentrations measured by an assay quantifying anti-VZV glycoprotein E (anti-gE) and anti-VZV ELISA in 12–23-month-olds, receiving two...

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Bibliographic Details
Published in:	Vaccine Vol. 38; no. 17; pp. 3300 - 3304
Main Authors:	Feyssaguet, Muriel, Berthold, Valérie, Helle, Laurent, Povey, Michael, Ravault, Stéphanie, Carryn, Stéphane, Gillard, Paul, Di Paolo, Emmanuel
Format:	Journal Article
Language:	English
Published:	Netherlands Elsevier Ltd 09-04-2020 Elsevier Limited
Subjects:	Agreements Antibodies Antibodies, Viral - blood Antibody assay Antibody Formation Antibody response Antigens Chicken pox Chickenpox - prevention & control Chickenpox Vaccine - immunology Child Child, Preschool Children Clinical trials Confidence intervals ELISA Enzyme-Linked Immunosorbent Assay Glycoprotein E Glycoproteins Humans Immune response Laboratories Proteins Serology Vaccines Varicella Varicella vaccination Varicella-zoster virus Viral Envelope Proteins - immunology Viruses CI IgG GMR Glycoprotein E VZV mIU Varicella-zoster virus Children GMC gE Antibody assay ELISA Varicella vaccination
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Summary:	Antibody response against varicella-zoster virus (VZV) is frequently assessed by whole-virus- (anti-VZV) or glycoprotein-based ELISAs. This study compared antibody concentrations measured by an assay quantifying anti-VZV glycoprotein E (anti-gE) and anti-VZV ELISA in 12–23-month-olds, receiving two varicella vaccine doses in a phase III trial (NCT02570126). Samples (pre- and 42 days post-each vaccination) initially tested with anti-VZV ELISA were re-tested with anti-gE ELISA. Of 1138 samples from 397 children, 757 were positive by anti-VZV (antibody concentration ≥25 mIU/mL) and 758 by anti-gE ELISA (≥97 mIU/mL). There were 375 double-negative and only 11 discrepant samples. The overall agreement was 99.03% (95% confidence interval: 98.28–99.52; McNemar p-value = 1). The ratio between antibody geometric mean concentrations (anti-gE/anti-VZV) for the 752 double-positive samples was 3.78 overall, 4.75 post-first, and 3.01 post-second vaccination. The anti-gE ELISA is a valid alternative for trials assessing antibody response to new varicella vaccines versus established ones, used as control.
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 ObjectType-News-3 content type line 23
ISSN:	0264-410X 1873-2518
DOI:	10.1016/j.vaccine.2020.03.009