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Anti-rotavirus antibody measurement in a rotavirus vaccine trial: Choice of vaccine antigen in immunoassays does matter.

ABSTRACT: In a clinical trial of Bangladeshi infants who received three doses of RotaTeq (ages 6, 10, and 14 weeks), we did a head-to-head assessment of two vaccine virus strains to measure rotavirus IgA in sera. Serum samples collected at pre-dose 1 (age 6 weeks) and post-dose 3 (age 22 weeks) were tested for rotavirus IgA by EIA by using the matching vaccine strain (RotaTeq) and a different vaccine strain (Rotarix) as antigens. Overall, rotavirus IgA seropositivity and titers with each antigen were compared. At age 22 weeks (N = 531), the proportion of infants who tested rotavirus IgA seropositive was similar when measured using the RotaTeq (412/531 [78%]) or the Rotarix antigen (403/531 [76%]) in the EIA. However, the IgA geometric mean titer was higher when measured using the RotaTeq antigen as compared to that measured using the Rotarix antigen [218 (95%CI: 176-270) vs. 93 (77-111), p < .0001]. We have compared two globally licensed vaccines, the human monovalent, and the pentavalent reassortant, as antigens on a RotaTeq cohort, resulting in higher estimations of IgA antibodies in the same sample when measured using the RotaTeq antigen. Our findings support matching vaccine antigens in EIA for the most desired immunogenicity testing of the RotaTeq vaccine.

SUBMITTER: Wang X

PROVIDER: S-EPMC10012887 | biostudies-literature | 2023 Dec

REPOSITORIES: biostudies-literature

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Anti-rotavirus antibody measurement in a rotavirus vaccine trial: Choice of vaccine antigen in immunoassays does matter.

Wang Xiaoqian X Velasquez Portocarrero Daniel E DE Cortese Margaret M MM Parashar Umesh U Zaman Khalequ K Jiang Baoming B

Human vaccines & immunotherapeutics 20230130 1

In a clinical trial of Bangladeshi infants who received three doses of RotaTeq (ages 6, 10, and 14 weeks), we did a head-to-head assessment of two vaccine virus strains to measure rotavirus IgA in sera. Serum samples collected at pre-dose 1 (age 6 weeks) and post-dose 3 (age 22 weeks) were tested for rotavirus IgA by EIA by using the matching vaccine strain (RotaTeq) and a different vaccine strain (Rotarix) as antigens. Overall, rotavirus IgA seropositivity and titers with each antigen were comp ...[more]

PMID: 36715015

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Project description:The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) emerged in December 2019 and caused a dramatic pandemic. Serological assays are used to check for immunization and assess herd immunity. We evaluated commercially available assays designed to quantify antibodies directed to the SARS-CoV-2 Spike (S) antigen, either total (Wantaï SARS-CoV-2 Ab ELISA) or IgG (SARS-CoV-2 IgG II Quant on Alinity, Abbott, and Liaison SARS-CoV-2 TrimericS IgG, Diasorin). The specificities of the Wantaï, Alinity, and Liaison assays were evaluated using 100 prepandemic sera and were 98, 99, and 97%, respectively. The sensitivities of all three were around 100% when tested on 35 samples taken 15 to 35 days postinfection. They were less sensitive for 150 sera from late infections (>180 days). Using the first WHO international standard (NIBSC), we showed that the Wantai results were concordant with the NIBSC values, while Liaison and Alinity showed a proportional bias of 1.3 and 7, respectively. The results of the 3 immunoassays were significantly globally pairwise correlated and for late infection sera (P < 0.001). They were correlated for recent infection sera measured with Alinity and Liaison (P < 0.001). However, the Wantai results of recent infections were not correlated with those from Alinity or Liaison. All the immunoassay results were significantly correlated with the neutralizing antibody titers obtained using a live virus neutralization assay with the B1.160 SARS-CoV-2 strain. These assays will be useful once the protective anti-SARS-CoV-2 antibody titer has been determined. IMPORTANCE Standardization and correlation with virus neutralization assays are critical points to compare the performance of serological assays designed to quantify anti-SARS-CoV-2 antibodies in order to identify their optimal use. We have evaluated three serological immunoassays based on the virus spike antigen that detect anti-SARS-CoV-2 antibodies: a microplate assay and two chemiluminescent assays performed with Alinity (Abbott) and Liaison (Diasorin) analysers. We used an in-house live virus neutralization assay and the first WHO international standard to assess the comparison. This study could be useful to determine guidelines on the use of serological results to manage vaccination and treatment with convalescent plasma or monoclonal antibodies.

Dataset Information

Anti-rotavirus antibody measurement in a rotavirus vaccine trial: Choice of vaccine antigen in immunoassays does matter.

Publications

Anti-rotavirus antibody measurement in a rotavirus vaccine trial: Choice of vaccine antigen in immunoassays does matter.

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