Unknown

Dataset Information

0

Dose Selection for an Adjuvanted Respiratory Syncytial Virus F Protein Vaccine for Older Adults Based on Humoral and Cellular Immune Responses.


ABSTRACT: This is the second phase 1 study of a respiratory syncytial virus (RSV) vaccine containing RSV fusion protein (sF) adjuvanted with glucopyranosyl lipid A (GLA) in a squalene-based 2% stable emulsion (GLA-SE). In this randomized, double-blind study, 261 subjects aged ?60 years received inactivated influenza vaccine (IIV), a vaccine containing 120 ?g sF with escalating doses of GLA (1, 2.5, or 5 ?g) in SE, or a vaccine containing 80 ?g sF with 2.5 ?g GLA in SE. Subjects receiving 120 ?g sF with 2.5 or 5 ?g GLA were also randomized to receive IIV or placebo. Immunity to RSV was assessed by detection of microneutralizing, anti-F immunoglobulin G, and palivizumab-competitive antibodies and F-specific gamma interferon enzyme-linked immunosorbent spot assay T-cell responses. Higher adjuvant doses increased injection site discomfort, but at the highest dose, the reactogenicity was similar to that of IIV. Significant humoral and cellular immune responses were observed. The 120 ?g sF plus 5.0 ?g GLA formulation resulted in the highest responses in all subjects and in older subjects. These results confirm previous observations of vaccine tolerability, safety, and immunogenicity and were used to select the 120 ?g sF plus 5.0 ?g GLA formulation for phase 2 evaluation. (This study has been registered at ClinicalTrials.gov under registration no. NCT02289820.).

SUBMITTER: Falloon J 

PROVIDER: S-EPMC5585697 | BioStudies | 2017-01-01

REPOSITORIES: biostudies

Similar Datasets

2015-01-01 | S-EPMC4368639 | BioStudies
2017-01-01 | S-EPMC5705161 | BioStudies
2020-01-01 | S-EPMC7076177 | BioStudies
2019-01-01 | S-EPMC6820558 | BioStudies
1000-01-01 | S-EPMC6162314 | BioStudies
2012-01-01 | S-EPMC3532059 | BioStudies
2020-01-01 | S-EPMC7190115 | BioStudies
| S-EPMC5123812 | BioStudies
2017-01-01 | S-EPMC5853767 | BioStudies
2014-01-01 | S-EPMC4208815 | BioStudies