- First such clinical trial collaboration for Siemens Healthineers in Asia Pacific in the development of COVID-19 vaccine candidates
- Antibody tests play a significant role in measuring the protective immune response elicited by vaccines; Siemens Healthineers SARS-CoV-2 IgG antibody test is being used to assess this immune response
- Phase 2 study showed robust immune responses; Phase 3 study has commenced with 13,000 subjects
Siemens Healthineers announces its collaboration with Nanogen Pharmaceutical Biotechnology to utilize Siemens Healthineers SARS-CoV-2 IgG antibody test (sCOVG) in Nanogen’s Nanocovax vaccine clinical trials for COVID-19. This is a first-of-its-kind collaboration for Siemens Healthineers in Asia Pacific, which will facilitate the quantitative measurement of SARS-CoV-2 IgG antibodies in vaccinated subjects and help assess the level of potentially protective immune responses induced by the Nanocovax vaccine.
Nanocovax, researched and developed by Nanogen, consists of recombinant spike-protein subunits bound to silica nanoparticles. A Phase 2 study of Nanocovax was successfully conducted with 560 subjects and robust immune responses, including a strong IgG response as measured by the sCOVG test were observed in all vaccinated subjects. Phase 3 study has commenced with the recruitment of 13,000 subjects.
Clinical trial on vaccine
As part of the evaluation of study subjects, Nanogen required an antibody test against the spike protein that could deliver quantitative results, had good correlation to virus neutralization titer and could be deployed in a high throughput manner. Correlation between sCOVG to a virus neutralization test was previously performed and the result showed a strong relationship between the test and virus neutralizing titer. Siemens Healthineers sCOVG met Nanogen’s criteria and was subsequently selected for use. Study subjects have their anti-spike IgG antibody levels measured using this test at baseline and at multiple time points, post-vaccination. This data will allow Nanogen to assess the level of immune response elicited by Nanocovax.
Interim analysis of Phase 2 study results showed that Nanocovax elicited anti-spike IgG responses in all vaccinated subjects and these responses were well detected by the sCOVG. IgG antibodies indicate the development of a mature adaptive immune response and may be more effective than other antibody isotypes in triggering additional anti-viral pathways beyond virus neutralization1. In addition, IgG antibodies may persist longer than other antibody isotypes. Therefore, IgG-specific tests are commonly used to evaluate the immune response after vaccination or infection2.
Siemens Healthineers SARS-CoV-2 IgG test
“Siemens Healthineers values this collaboration with Nanogen”, said Philipp Breschan, General Manager, Siemens Healthineers, Vietnam. “We are pleased that the Siemens Healthineers SARS-CoV-2 IgG test met Nanogen’s stringent selection criteria. We will continue to support Nanogen in this crucial project in the fight against the pandemic.”
Mr. Philipp Breschan, General Manager, Siemens Healthineers, Vietnam
“Our decision to develop Nanovax was to extend our support to the Vietnam government’s COVID-19 fight. Nanogen appreciates Siemens Healthineers support in our clinical trials of Nanovax. The SARS-CoV-2 IgG assay on an automated platform meets the reference labs’ requirement, as well as provides the data to assess the level of immune responses elicited by our vaccine”
Dr. Do Minh Si, Director of Research and Development, Nanogen Pharmaceutical Biotechnology
Contact:
Ms. Dinh Thi Hoai Thu
Phone : +84 904 624 959
Email: dinh-thi-hoai.thu@siemens-heatlhineers.com