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Clinical Trial Summary

This phase I study is designed as double-blinded, randomised, placebo controlled, three-armed study composed of two different dose arms of protective adjuvanted inactivated vaccine against SARS-CoV-2 in dose escalations (first low dose group, followed by high dose group) and placebo arm.


Clinical Trial Description

This phase I study is designed as double-blinded, randomised, placebo controlled, three-armed study composed of two different dose arms of protective adjuvanted inactivated vaccine against SARS-CoV-2 in dose escalations (first low dose group, followed by high dose group) and placebo arm. Each dose of vaccine will be defined as a cohort in itself, with vaccine administration to 20 participants and placebo administration to 5 participants. After completion of low-dose group, decision of switch to high-dose will be taken by the Independent Data Monitoring Committee and will continue accordingly. In the study, 50 healthy participants of 18-45 years of age will be recruited. All injections will be done subcutaneously. Injections will be administered at 1 and 21 days. The participants will be followed for 6 months and the study will be completed in 12 months. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04866069
Study type Interventional
Source The Scientific and Technological Research Council of Turkey
Contact
Status Terminated
Phase Phase 1
Start date April 25, 2021
Completion date September 5, 2021

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