Prevalent levels of RSV serum neutralizing antibodies in healthy adults outside the RSV-season

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...

Full description

Bibliographic Details
Main Authors: Johan L. Van Der Plas, Pauline Verdijk, Emilie M. J. Van Brummelen, Rienk E. Jeeninga, Meta Roestenberg, Jacobus Burggraaf, Ingrid M.C. Kamerling
Format: Article
Language:English
Published: Taylor & Francis Group 2020-06-01
Series:Human Vaccines & Immunotherapeutics
Subjects:
respiratory syncytial virus
neutralizing antibodies
vaccines
live-attenuated
controlled human infection model
healthy volunteers
Online Access:http://dx.doi.org/10.1080/21645515.2019.1688040
Description
Summary: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.
ISSN:2164-5515
2164-554X

Similar Items