Postdose 3 G1 serum neutralizing antibody as correlate of protection for pentavalent rotavirus vaccine
Although clinical trials of the pentavalent rotavirus vaccine (RotaTeq®, RV5) have demonstrated efficacy against RV gastroenteritis (RGE) in low and high-income settings, a clear correlate of protection or a measure of immune response that could predict efficacy has yet to be identified. This is the...
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| Format: | Article |
| Language: | English |
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Taylor & Francis Group
2017-10-01
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| Series: | Human Vaccines & Immunotherapeutics |
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| Online Access: | http://dx.doi.org/10.1080/21645515.2017.1356522 |
| _version_ | 1797677526392242176 |
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| author | G. Frank Liu Darcy Hille Susan S. Kaplan Michelle G. Goveia |
| author_facet | G. Frank Liu Darcy Hille Susan S. Kaplan Michelle G. Goveia |
| author_sort | G. Frank Liu |
| collection | DOAJ |
| description | Although clinical trials of the pentavalent rotavirus vaccine (RotaTeq®, RV5) have demonstrated efficacy against RV gastroenteritis (RGE) in low and high-income settings, a clear correlate of protection or a measure of immune response that could predict efficacy has yet to be identified. This is the first time that immunogenicity data with both serum neutralized antibody (SNA) titers and anti-RV IgA titers from several clinical efficacy trials were pooled to provide a unique context for evaluating the correlation between immunogenicity and RGE risk or efficacy of RV5. The correlation between immunogenicity and RGE risk is evaluated with data at the individual subject level. The analyses show that higher Postdose 3 (PD3) G1 SNA titers are associated with lower odds of contracting any RGE. The correlation between immunogenicity and efficacy is assessed using aggregated population level data, which shows higher efficacy associated with higher PD3 G1 SNA geometric mean titer (GMT) ratio (between RV5 and placebo) and PD3 serum anti-RV IgA GMT ratio. Among high-income countries, efficacy plateaus over the range of PD3 G1 SNA GMT ratios and PD3 serum anti-RV IgA GMT ratios. From both individual- and population-level analyses, PD3 G1 SNA titers correlated most closely with the RGE risk or efficacy for RV5. |
| first_indexed | 2024-03-11T22:46:27Z |
| format | Article |
| id | doaj.art-1471cc6bced24320a70bf638d415e5f7 |
| institution | Directory Open Access Journal |
| issn | 2164-5515 2164-554X |
| language | English |
| last_indexed | 2024-03-11T22:46:27Z |
| publishDate | 2017-10-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Human Vaccines & Immunotherapeutics |
| spelling | doaj.art-1471cc6bced24320a70bf638d415e5f72023-09-22T08:17:51ZengTaylor & Francis GroupHuman Vaccines & Immunotherapeutics2164-55152164-554X2017-10-0113102357236310.1080/21645515.2017.13565221356522Postdose 3 G1 serum neutralizing antibody as correlate of protection for pentavalent rotavirus vaccineG. Frank Liu0Darcy Hille1Susan S. Kaplan2Michelle G. Goveia3Merck & Co., Inc.Merck & Co., Inc.Merck & Co., Inc.Merck & Co., Inc.Although clinical trials of the pentavalent rotavirus vaccine (RotaTeq®, RV5) have demonstrated efficacy against RV gastroenteritis (RGE) in low and high-income settings, a clear correlate of protection or a measure of immune response that could predict efficacy has yet to be identified. This is the first time that immunogenicity data with both serum neutralized antibody (SNA) titers and anti-RV IgA titers from several clinical efficacy trials were pooled to provide a unique context for evaluating the correlation between immunogenicity and RGE risk or efficacy of RV5. The correlation between immunogenicity and RGE risk is evaluated with data at the individual subject level. The analyses show that higher Postdose 3 (PD3) G1 SNA titers are associated with lower odds of contracting any RGE. The correlation between immunogenicity and efficacy is assessed using aggregated population level data, which shows higher efficacy associated with higher PD3 G1 SNA geometric mean titer (GMT) ratio (between RV5 and placebo) and PD3 serum anti-RV IgA GMT ratio. Among high-income countries, efficacy plateaus over the range of PD3 G1 SNA GMT ratios and PD3 serum anti-RV IgA GMT ratios. From both individual- and population-level analyses, PD3 G1 SNA titers correlated most closely with the RGE risk or efficacy for RV5.http://dx.doi.org/10.1080/21645515.2017.1356522correlation of protectiongeometric mean titer (gmt)immunogenicitypentavalent rotavirus vaccine (rv5)rotavirus gastroenteritis (rge) |
| spellingShingle | G. Frank Liu Darcy Hille Susan S. Kaplan Michelle G. Goveia Postdose 3 G1 serum neutralizing antibody as correlate of protection for pentavalent rotavirus vaccine Human Vaccines & Immunotherapeutics correlation of protection geometric mean titer (gmt) immunogenicity pentavalent rotavirus vaccine (rv5) rotavirus gastroenteritis (rge) |
| title | Postdose 3 G1 serum neutralizing antibody as correlate of protection for pentavalent rotavirus vaccine |
| title_full | Postdose 3 G1 serum neutralizing antibody as correlate of protection for pentavalent rotavirus vaccine |
| title_fullStr | Postdose 3 G1 serum neutralizing antibody as correlate of protection for pentavalent rotavirus vaccine |
| title_full_unstemmed | Postdose 3 G1 serum neutralizing antibody as correlate of protection for pentavalent rotavirus vaccine |
| title_short | Postdose 3 G1 serum neutralizing antibody as correlate of protection for pentavalent rotavirus vaccine |
| title_sort | postdose 3 g1 serum neutralizing antibody as correlate of protection for pentavalent rotavirus vaccine |
| topic | correlation of protection geometric mean titer (gmt) immunogenicity pentavalent rotavirus vaccine (rv5) rotavirus gastroenteritis (rge) |
| url | http://dx.doi.org/10.1080/21645515.2017.1356522 |
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