Study of a Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) Adjuvanted Inactivated Vaccine in Healthy Adults — COVID-19  

Covid19 Clinical Trial

Official title: Phase I Study Evaluating the Safety and Efficacy of the Protective Adjuvanted Inactivated Vaccine Developed Against SARS-CoV-2 in Healthy Participants, Administered as Two Injections Subcutaneously in Two Different Dosages.

Status Terminated

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. ;

Related Conditions & MeSH terms

• Covid19

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