Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2025-12-25 @ 8:16 PM
Study NCT ID:
NCT04866069
Status:
TERMINATED
Last Update Posted:
2023-04-18
First Post:
2021-04-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of a Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) Adjuvanted Inactivated Vaccine in Healthy Adults
Sponsor:
Osman ERGANIS, PhD, Prof
Organization:
Study Overview
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
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Although cellular responses to virus were satisfactory, neutralizing titres against virus were lower then expected levels
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COVID-19
Brief 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.
Detailed 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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: