Condition: Healthy Participants · Sarbecovirus · Sponsor: SK Bioscience Co., Ltd.
The purpose of this research study is to evaluate the safety of and the body's immune response to single and multiple vaccinations in healthy men and women. We want to find out what effects GBP511 has on you and your health. We are doing this study to find out: If the study drug has any side effects when given as single and multiple vaccinations. If reactogenicity, an indication that the immune systems is working and is preparing to protect the body against future infection, occurs. This is a normal physical inflammatory response that occurs after vaccination, manifesting as localised reactions that may include pain or redness at the injection site, or systemic symptoms such as headache or fever. If immunogenicity which is when GBP511 causes your body to make antibodies against the non-harmful viral proteins contained within GBP511, called 'neutralising antibodies (Nab),' occurs. And if GBP511 will cause the specialised cells of the body's immune system to mount a defence against the non-harmful viral proteins contained within GBP511, called 'cell-mediated immunity (CMI)'. In this study, GBP511 will be administered with and without adjuvant, CAS-1. An adjuvant is an ingredient used in some vaccines that help produce a stronger immune response in the people receiving the vaccine and thus helps the vaccine work better. This study will recruit approximately 368 participants in total and will be conducted in two stages: Stage 1 will look at two vaccinations with GBP511 when…
This description comes directly from the study's public registry record.
Hoon Lee · 82-2-2008-2200 · hoon.lee@sk.com
Jungeun Song · 82-2-2008-2200 · jungeun@sk.com
Always discuss trial participation with your own doctor first.
| Momentum Clinical Research Darlinghurst | Sydney, Kent Street, Australia | Not Yet Recruiting |
| Linear | Nedlands, Western Australia, Australia | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07280858