Prevalent levels of RSV serum neutralizing antibodies in healthy adults outside the RSV-season
One of the main challenges in early clinical research with respiratory syncytial virus (RSV) live-attenuated vaccines (LAVs) is to assess immunogenicity in healthy adults. Healthy adults will have preexisting levels of serum neutralizing antibodies that could prematurely neutralize the LAV and under...
| Main Authors: | , , , , , , |
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| Format: | Article |
| Language: | English |
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Taylor & Francis Group
2020-06-01
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| Series: | Human Vaccines & Immunotherapeutics |
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| Online Access: | http://dx.doi.org/10.1080/21645515.2019.1688040 |
| _version_ | 1797677340151513088 |
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| author | Johan L. Van Der Plas Pauline Verdijk Emilie M. J. Van Brummelen Rienk E. Jeeninga Meta Roestenberg Jacobus Burggraaf Ingrid M.C. Kamerling |
| author_facet | Johan L. Van Der Plas Pauline Verdijk Emilie M. J. Van Brummelen Rienk E. Jeeninga Meta Roestenberg Jacobus Burggraaf Ingrid M.C. Kamerling |
| author_sort | Johan L. Van Der Plas |
| collection | DOAJ |
| description | One of the main challenges in early clinical research with respiratory syncytial virus (RSV) live-attenuated vaccines (LAVs) is to assess immunogenicity in healthy adults. Healthy adults will have preexisting levels of serum neutralizing antibodies that could prematurely neutralize the LAV and underestimate the potential effect of the vaccine on the immune system. Data on prevalence and distribution of virus neutralizing titers (VNTs) in healthy adults is limited and there is no absolute threshold for protection against RSV-infection that can serve as an eligibility criterion in early phase trials. We assessed the RSV-specific serum VNT in healthy adults outside the Dutch RSV-Season in two clinical studies performed in 2017 (exploratory study, n = 100) and 2018 (first-in-human LAV-study, n = 190) using the same neutralizing assay. Our findings show that the prevalence and distribution of serum VNT was overall consistent in the two clinical studies. Log2 VNTs were normally distributed, distributions of VNTs were similar and there was no statistical difference in mean log2 VNT for both studies (p = .3). Serum VNTs were comparable during the 6 months of screening in the FIH LAV-study. Our findings will help to determine a cutoff serum VNT to be used as an eligibility criterion in future early phase clinical trials. |
| first_indexed | 2024-03-11T22:43:39Z |
| format | Article |
| id | doaj.art-5b502c9fc390473da186d46f3123535f |
| institution | Directory Open Access Journal |
| issn | 2164-5515 2164-554X |
| language | English |
| last_indexed | 2024-03-11T22:43:39Z |
| publishDate | 2020-06-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Human Vaccines & Immunotherapeutics |
| spelling | doaj.art-5b502c9fc390473da186d46f3123535f2023-09-22T08:45:34ZengTaylor & Francis GroupHuman Vaccines & Immunotherapeutics2164-55152164-554X2020-06-011661322132610.1080/21645515.2019.16880401688040Prevalent levels of RSV serum neutralizing antibodies in healthy adults outside the RSV-seasonJohan L. Van Der Plas0Pauline Verdijk1Emilie M. J. Van Brummelen2Rienk E. Jeeninga3Meta Roestenberg4Jacobus Burggraaf5Ingrid M.C. Kamerling6Centre for Human Drug ResearchInstitute for Translational Vaccinology (Intravacc)Centre for Human Drug ResearchViroclinics Biosciences B.VLeiden University Medical CenterCentre for Human Drug ResearchCentre for Human Drug ResearchOne of the main challenges in early clinical research with respiratory syncytial virus (RSV) live-attenuated vaccines (LAVs) is to assess immunogenicity in healthy adults. Healthy adults will have preexisting levels of serum neutralizing antibodies that could prematurely neutralize the LAV and underestimate the potential effect of the vaccine on the immune system. Data on prevalence and distribution of virus neutralizing titers (VNTs) in healthy adults is limited and there is no absolute threshold for protection against RSV-infection that can serve as an eligibility criterion in early phase trials. We assessed the RSV-specific serum VNT in healthy adults outside the Dutch RSV-Season in two clinical studies performed in 2017 (exploratory study, n = 100) and 2018 (first-in-human LAV-study, n = 190) using the same neutralizing assay. Our findings show that the prevalence and distribution of serum VNT was overall consistent in the two clinical studies. Log2 VNTs were normally distributed, distributions of VNTs were similar and there was no statistical difference in mean log2 VNT for both studies (p = .3). Serum VNTs were comparable during the 6 months of screening in the FIH LAV-study. Our findings will help to determine a cutoff serum VNT to be used as an eligibility criterion in future early phase clinical trials.http://dx.doi.org/10.1080/21645515.2019.1688040respiratory syncytial virusneutralizing antibodiesvaccineslive-attenuatedcontrolled human infection modelhealthy volunteers |
| spellingShingle | Johan L. Van Der Plas Pauline Verdijk Emilie M. J. Van Brummelen Rienk E. Jeeninga Meta Roestenberg Jacobus Burggraaf Ingrid M.C. Kamerling Prevalent levels of RSV serum neutralizing antibodies in healthy adults outside the RSV-season Human Vaccines & Immunotherapeutics respiratory syncytial virus neutralizing antibodies vaccines live-attenuated controlled human infection model healthy volunteers |
| title | Prevalent levels of RSV serum neutralizing antibodies in healthy adults outside the RSV-season |
| title_full | Prevalent levels of RSV serum neutralizing antibodies in healthy adults outside the RSV-season |
| title_fullStr | Prevalent levels of RSV serum neutralizing antibodies in healthy adults outside the RSV-season |
| title_full_unstemmed | Prevalent levels of RSV serum neutralizing antibodies in healthy adults outside the RSV-season |
| title_short | Prevalent levels of RSV serum neutralizing antibodies in healthy adults outside the RSV-season |
| title_sort | prevalent levels of rsv serum neutralizing antibodies in healthy adults outside the rsv season |
| topic | respiratory syncytial virus neutralizing antibodies vaccines live-attenuated controlled human infection model healthy volunteers |
| url | http://dx.doi.org/10.1080/21645515.2019.1688040 |
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