Association between Immunogenicity of a Monovalent Parenteral P2-VP8 Subunit Rotavirus Vaccine and Fecal Shedding of Rotavirus following Rotarix Challenge during a Randomized, Double-Blind, Placebo-Controlled Trial

doi:10.3390/v15091809

Randomized Controlled Trial

. 2023 Aug 25;15(9):1809.

doi: 10.3390/v15091809.

Association between Immunogenicity of a Monovalent Parenteral P2-VP8 Subunit Rotavirus Vaccine and Fecal Shedding of Rotavirus following Rotarix Challenge during a Randomized, Double-Blind, Placebo-Controlled Trial

Tamika Fellows¹, Nicola Page^{2

3}, Alan Fix⁴, Jorge Flores⁴, Stanley Cryz⁴, Monica McNeal^{5

6}, Miren Iturriza-Gomara⁴, Michelle J Groome⁷

Affiliations

¹ School of Public Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg 2001, South Africa.
² National Institute for Communicable Diseases, A Division of the National Health Laboratory Service, Sandringham 2192, South Africa.
³ Department of Medical Virology, Faculty of Health Sciences, University of Pretoria, Pretoria 0028, South Africa.
⁴ PATH, Seattle, WA 98121, USA.
⁵ Department of Pediatrics, University of Cincinnati Medical School, Cincinnati, OH 45229, USA.
⁶ Division of Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati, OH 45229, USA.
⁷ South African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg 2001, South Africa.

PMID: 37766217
PMCID: PMC10536230
DOI: 10.3390/v15091809

Randomized Controlled Trial

Association between Immunogenicity of a Monovalent Parenteral P2-VP8 Subunit Rotavirus Vaccine and Fecal Shedding of Rotavirus following Rotarix Challenge during a Randomized, Double-Blind, Placebo-Controlled Trial

Tamika Fellows et al. Viruses. 2023.

. 2023 Aug 25;15(9):1809.

doi: 10.3390/v15091809.

Authors

Tamika Fellows¹, Nicola Page^{2

3}, Alan Fix⁴, Jorge Flores⁴, Stanley Cryz⁴, Monica McNeal^{5

6}, Miren Iturriza-Gomara⁴, Michelle J Groome⁷

Affiliations

¹ School of Public Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg 2001, South Africa.
² National Institute for Communicable Diseases, A Division of the National Health Laboratory Service, Sandringham 2192, South Africa.
³ Department of Medical Virology, Faculty of Health Sciences, University of Pretoria, Pretoria 0028, South Africa.
⁴ PATH, Seattle, WA 98121, USA.
⁵ Department of Pediatrics, University of Cincinnati Medical School, Cincinnati, OH 45229, USA.
⁶ Division of Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati, OH 45229, USA.
⁷ South African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg 2001, South Africa.

PMID: 37766217
PMCID: PMC10536230
DOI: 10.3390/v15091809

Abstract

A correlate of protection for rotavirus (RV) has not been consistently identified. Shedding of RV following an oral rotavirus vaccine (ORV) challenge has been investigated as a potential model to assess protection of parenteral RV vaccines. We previously showed that shedding of a challenge ORV dose was significantly reduced among recipients of a parenteral monovalent RV subunit vaccine (P2-VP8-P[8]) compared to placebo recipients. This secondary data analysis assessed the association between fecal shedding of RV, as determined by ELISA one week after receipt of a Rotarix challenge dose at 18 weeks of age, and serum RV-specific antibody responses, one and six months after vaccination with the third dose of the P2-VP8-P[8] vaccine or placebo. We did not find any association between serum RV-specific immune responses measured one month post-P2-VP8-P[8] vaccination and fecal shedding of RV post-challenge. At nine months of age, six months after the third P2-VP8-P[8] or placebo injection and having received three doses of Rotarix, infants shedding RV demonstrated higher immune responses than non-shedders, showing that RV shedding is reflective of vaccine response following ORV. Further evaluation is needed in a larger sample before fecal shedding of an ORV challenge can be used as a measure of field efficacy in RV vaccine trials.

Keywords: fecal shedding; immune response; pediatric; rotavirus vaccine.

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Conflict of interest statement

The authors declare no conflict of interest. The funder had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript; or in the decision to publish the results.

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References

1. Tate J.E., Burton A.H., Boschi-Pinto C., Parashar U.D., World Health Organization–Coordinated Global Rotavirus Surveillance Network Global, Regional, and National Estimates of Rotavirus Mortality in Children <5 Years of Age, 2000–2013. Infect. Dis. 2016;62((Suppl. S2)):S96–S105. doi: 10.1093/cid/civ1013. - DOI - PubMed
1. VIEW-Hub by IVAC Rotavirus Vaccine Global Introduction Status. [(accessed on 13 July 2023)]. Available online: https://view-hub.org/vaccine/rota.
1. Burnett E., Parashar U.D., Tate J.E. Global Impact of Rotavirus Vaccination on Diarrhea Hospitalizations and Deaths among Children <5 Years Old: 2006–2019. J. Infect. Dis. 2020;222:1731–1739. - PMC - PubMed
1. Yen C., Tate J.E., Hyde T.B., Cortese M.M., Lopman B.A., Jiang B., Glass R.I., Parashar U.D. Rotavirus vaccines: Current status and future considerations. Hum. Vaccines Immunother. 2014;10:1436–1448. doi: 10.4161/hv.28857. - DOI - PMC - PubMed
1. Leshem E., Lopman B., Glass R., Gentsch J., Banyai K., Parashar U., Patel M. Distribution of rotavirus strains and strain-specific effectiveness of the rotavirus vaccine after its introduction: A systematic review and meta-analysis. Lancet Infect. Dis. 2014;14:847–856. doi: 10.1016/S1473-3099(14)70832-1. - DOI - PubMed

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This research was funded by the Bill and Melinda Gates Foundation (Grant no OPP1033438).

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[1] Tate J.E., Burton A.H., Boschi-Pinto C., Parashar U.D., World Health Organization–Coordinated Global Rotavirus Surveillance Network Global, Regional, and National Estimates of Rotavirus Mortality in Children <5 Years of Age, 2000–2013. Infect. Dis. 2016;62((Suppl. S2)):S96–S105. doi: 10.1093/cid/civ1013. - DOI - PubMed

[2] Tate J.E., Burton A.H., Boschi-Pinto C., Parashar U.D., World Health Organization–Coordinated Global Rotavirus Surveillance Network Global, Regional, and National Estimates of Rotavirus Mortality in Children <5 Years of Age, 2000–2013. Infect. Dis. 2016;62((Suppl. S2)):S96–S105. doi: 10.1093/cid/civ1013. - DOI - PubMed

[3] VIEW-Hub by IVAC Rotavirus Vaccine Global Introduction Status. [(accessed on 13 July 2023)]. Available online: https://view-hub.org/vaccine/rota.

[4] VIEW-Hub by IVAC Rotavirus Vaccine Global Introduction Status. [(accessed on 13 July 2023)]. Available online: https://view-hub.org/vaccine/rota.

[5] Burnett E., Parashar U.D., Tate J.E. Global Impact of Rotavirus Vaccination on Diarrhea Hospitalizations and Deaths among Children <5 Years Old: 2006–2019. J. Infect. Dis. 2020;222:1731–1739. - PMC - PubMed

[6] Burnett E., Parashar U.D., Tate J.E. Global Impact of Rotavirus Vaccination on Diarrhea Hospitalizations and Deaths among Children <5 Years Old: 2006–2019. J. Infect. Dis. 2020;222:1731–1739. - PMC - PubMed

[7] Yen C., Tate J.E., Hyde T.B., Cortese M.M., Lopman B.A., Jiang B., Glass R.I., Parashar U.D. Rotavirus vaccines: Current status and future considerations. Hum. Vaccines Immunother. 2014;10:1436–1448. doi: 10.4161/hv.28857. - DOI - PMC - PubMed

[8] Yen C., Tate J.E., Hyde T.B., Cortese M.M., Lopman B.A., Jiang B., Glass R.I., Parashar U.D. Rotavirus vaccines: Current status and future considerations. Hum. Vaccines Immunother. 2014;10:1436–1448. doi: 10.4161/hv.28857. - DOI - PMC - PubMed

[9] Leshem E., Lopman B., Glass R., Gentsch J., Banyai K., Parashar U., Patel M. Distribution of rotavirus strains and strain-specific effectiveness of the rotavirus vaccine after its introduction: A systematic review and meta-analysis. Lancet Infect. Dis. 2014;14:847–856. doi: 10.1016/S1473-3099(14)70832-1. - DOI - PubMed

[10] Leshem E., Lopman B., Glass R., Gentsch J., Banyai K., Parashar U., Patel M. Distribution of rotavirus strains and strain-specific effectiveness of the rotavirus vaccine after its introduction: A systematic review and meta-analysis. Lancet Infect. Dis. 2014;14:847–856. doi: 10.1016/S1473-3099(14)70832-1. - DOI - PubMed

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Association between Immunogenicity of a Monovalent Parenteral P2-VP8 Subunit Rotavirus Vaccine and Fecal Shedding of Rotavirus following Rotarix Challenge during a Randomized, Double-Blind, Placebo-Controlled Trial

Affiliations

Association between Immunogenicity of a Monovalent Parenteral P2-VP8 Subunit Rotavirus Vaccine and Fecal Shedding of Rotavirus following Rotarix Challenge during a Randomized, Double-Blind, Placebo-Controlled Trial

Authors

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Conflict of interest statement

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Abstract

Conflict of interest statement

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