Establishing Correlates of Protection for Vaccine Development: Considerations for the Respiratory Syncytial Virus Vaccine Field
Open accessAbstract
Correlates of protection (CoPs) can play a significant role in vaccine development by assisting the selection of vaccine candidates for clinical trials, supporting clinical trial design and implementation, and simplifying tests of vaccine modifications. Because of this important role in vaccine development, it is essential that CoPs be defined by well-designed immunogenicity and efficacy studies, with attention paid to benefits and limitations. The respiratory syncytial virus (RSV) field is unique in that a great deal of information about the humoral response is available from basic research and clinical studies. Polyclonal and monoclonal antibodies have been used routinely in the clinic to protect vulnerable infants from infection, providing a wealth of information about correlations between neutralizing antibodies and disease prevention. Considerations for the establishment of future CoPs to support RSV vaccine development in different populations are therefore discussed.
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Measurement of serum neutralizing activity has been shown to be a mechanistic correlate of protection for other respiratory viruses, such as influenza and respiratory syncytial virus, and is generally accepted as a functional biomarker of the in vivo humoral response.
“Though correlates of protection from SARS-CoV-2 infection have not yet been determined, measurement of serum neutralizing activity has been shown to be a mechanistic correlate of protection for other respiratory viruses, such as influenza14 and respiratory syncytial virus,15 and is generally accepted as a functional biomarker of the in vivo humoral response.16”
From An mRNA Vaccine against SARS-CoV-2 — Preliminary Report (2020) · cites this paper as [15]
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- Authors
- Kulkarni, P. S., Hurwitz, J. L., Simões, E. A. F., & Piedra, P. A.
- Affiliations
- Serum Institute of India (India) (IN)
- St. Jude Children's Research Hospital (US)
- Colorado School of Public Health (US)
- Baylor College of Medicine (US)
- Venue
- Viral Immunology
- Publisher
- SAGE Publications
- Published
- 2018-03
- Volume
- 31
- Issue
- 2
- Pages
- 195-203
- ISSN
- 0882-8245 (ISSN-L)
- 1557-8976
- PMC
- PMC5863081
- OpenAlex
- W2783725776
- Cited by
- 53
- References
- 120
- Citations by year
- 2025: 6 · 2024: 11 · 2023: 9 · 2022: 5 · 2021: 8 · 2020: 7 · 2019: 7
- FWCI
- 0.79
- Type
- journal article
- Language
- en
- Open access
- green
- europepmc.org
- Locations
- Viral Immunology (publishedVersion)
- Europe PMC (PubMed Central) (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- American Lebanese Syrian Associated Charities (CA 21765)
- National Institutes of Health (NCI P30-CA21765, CA21765))
- National Cancer Institute (CA21765, P 30CA 21765, P30CA021765)
- Topics
- Health Sciences › Medicine › Epidemiology › Respiratory viral infections research
- Health Sciences › Medicine › Infectious Diseases › SARS-CoV-2 and COVID-19 Research
- Life Sciences › Immunology and Microbiology › Immunology › Immune responses and vaccinations
- Keywords
- correlates of protection, RSV vaccine, vaccine development, neutralizing antibodies, humoral immune response, monoclonal antibodies, polyclonal antibodies, vaccine efficacy, immunogenicity, infants, vaccine candidate selection, clinical trial design
- MeSH terms
- Drug Evaluation, Preclinical, Humans, Biomarkers, Respiratory Syncytial Virus, Human, Respiratory Syncytial Virus Infections, Respiratory Syncytial Virus Vaccines, Drug Discovery
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