https://orcid.org/0000-0003-1932-6345
![Sample our Bioscience journals, sign in here to start your access, Latest two full volumes FREE to you for 14 days]({"type":"image" , "src" : "/sda/5925/TOC-Subject-Sample-2021-Bioscience.jpg"})
ABSTRACT
NDV-HXP-S is a Newcastle disease virus (NDV) vectored vaccine candidate which expresses the S-antigen of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). This vaccine candidate is under evaluation in human clinical studies with and without cytosine phosphate guanine (CpG) 1018® adjuvant. Existing potency methods for NDV-HXP-S do not allow for quantification of the S-antigen when the adjuvant is present. To support evaluation of NDV-HXP-S with CpG 1018® adjuvant, an inhibition enzyme-linked immunosorbent assay (ELISA) was developed to allow for quantification and stability assessments of the vaccine. A pilot 6-month stability study was conducted on NDV-HXP-S vaccine with and without CpG 1018® adjuvant under refrigerated conditions (2°C to 8°C) and accelerated stability testing conditions (40°C). The vaccine was mixed with and without CpG 1018® adjuvant in saline and maintained S-antigen content at 2°C to 8°C for the entire 6-month period. Additionally, a pilot controlled temperature chain (CTC) stability study was conducted at the completion of the 6-month study and demonstrated the possibility for this vaccine candidate to attain CTC stability labeling.
Acknowledgments
We would like to thank Bruce Innis, Rami Schaf, and Richard Hjorth for review of data and scientific input. We would also like to thank Dynavax Technologies Corporation for suppling CpG 1018® adjuvant; The Government Pharmaceutical Organization, Thailand for supplying bulk vaccine material and glass vials for the studies; and Instituto Butantan, Brazil for supplying bulk vaccine material and glass vials for the studies.
Disclosure statement
No potential conflict of interest was reported by the author(s).
Abbreviations
| b-P | = | beta propiolactone |
| CpG | = | cytosine phosphate guanonine |
| CTC | = | controlled temperature chain |
| ELISA | = | enzyme-linked immunosorbent assay |
| GPO | = | Government Pharmaceutical Organization, Thailand |
| ICH | = | International Conference on Harmonization |
| NDV | = | Newcastle disease virus |
| OD | = | optical density |
| PBS | = | phosphate-buffered saline |
| RBD | = | receptor binding domain |
| RPM | = | revolutions per minute |
| RT | = | room temperature |
| SARS-CoV-2 | = | severe acute respiratory syndrome coronavirus 2 |
| TMB | = | tetramethylbenzidine |
Author contributions
Marcus Estrada, Changcheng Zhu, Anan Bzami, Jessica White and Manjari Lal conducted the experiments. Marcus Estrada, Jessica White, and Manjari Lal drafted the manuscript.