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Postdose 3 G1 serum neutralizing antibody as correlate of protection for pentavalent rotavirus vaccine.
Hum Vaccin Immunother. 2017 10 03; 13(10):2357-2363.HV

Abstract

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.

Authors+Show Affiliations

a Merck & Co., Inc. , Kenilworth , NJ , USA.a Merck & Co., Inc. , Kenilworth , NJ , USA.a Merck & Co., Inc. , Kenilworth , NJ , USA.a Merck & Co., Inc. , Kenilworth , NJ , USA.

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

28836489

Citation

Liu, G Frank, et al. "Postdose 3 G1 Serum Neutralizing Antibody as Correlate of Protection for Pentavalent Rotavirus Vaccine." Human Vaccines & Immunotherapeutics, vol. 13, no. 10, 2017, pp. 2357-2363.
Liu GF, Hille D, Kaplan SS, et al. Postdose 3 G1 serum neutralizing antibody as correlate of protection for pentavalent rotavirus vaccine. Hum Vaccin Immunother. 2017;13(10):2357-2363.
Liu, G. F., Hille, D., Kaplan, S. S., & Goveia, M. G. (2017). Postdose 3 G1 serum neutralizing antibody as correlate of protection for pentavalent rotavirus vaccine. Human Vaccines & Immunotherapeutics, 13(10), 2357-2363. https://doi.org/10.1080/21645515.2017.1356522
Liu GF, et al. Postdose 3 G1 Serum Neutralizing Antibody as Correlate of Protection for Pentavalent Rotavirus Vaccine. Hum Vaccin Immunother. 2017 10 3;13(10):2357-2363. PubMed PMID: 28836489.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Postdose 3 G1 serum neutralizing antibody as correlate of protection for pentavalent rotavirus vaccine. AU - Liu,G Frank, AU - Hille,Darcy, AU - Kaplan,Susan S, AU - Goveia,Michelle G, Y1 - 2017/08/24/ PY - 2017/8/25/pubmed PY - 2018/6/12/medline PY - 2017/8/25/entrez KW - correlation of protection KW - geometric mean titer (GMT) KW - immunogenicity KW - pentavalent rotavirus vaccine (RV5) KW - rotavirus gastroenteritis (RGE) SP - 2357 EP - 2363 JF - Human vaccines & immunotherapeutics JO - Hum Vaccin Immunother VL - 13 IS - 10 N2 - 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. SN - 2164-554X UR - https://www.unboundmedicine.com/medline/citation/28836489/Postdose_3_G1_serum_neutralizing_antibody_as_correlate_of_protection_for_pentavalent_rotavirus_vaccine_ L2 - https://www.tandfonline.com/doi/full/10.1080/21645515.2017.1356522 DB - PRIME DP - Unbound Medicine ER -