Ignite Creation Date:
2025-12-24 @ 5:26 PM
Ignite Modification Date:
2026-01-01 @ 7:01 AM
Study NCT ID:
NCT04944368
Status:
COMPLETED
Last Update Posted:
2022-10-13
First Post:
2021-06-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase II Clinical Trial of CinnaGen COVID-19 Vaccine (SpikoGen)
Sponsor:
Cinnagen
Organization:
Study Overview
Official Title:
A Phase II, Randomized, Two-armed, Double-blind, Placebo-controlled Trial to Evaluate the Safety, Tolerability, and Immunogenicity of an Adjuvanted Recombinant SARS-CoV-2 Spike (S) Protein Subunit Vaccine Candidate (SpikoGen)
Status:
COMPLETED
Status Verified Date:
2022-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a phase II, randomized, two-armed, double-blind, placebo-controlled trial designed to evaluate the safety, tolerability, and immunogenicity of a candidate adjuvanted recombinant SARS-CoV-2 spike (S) protein subunit vaccine (SpikoGen) produced by CinnaGen Co. 400 adult individuals receive either SARS-CoV-2 recombinant spike protein (25 µg) with Advax-SM adjuvant (15 mg) or saline placebo in a 3:1 ratio. The injection is given in two doses with a 21-day interval in the deltoid muscle of the non-dominant arm. The randomization was stratified by age (\<65 or ≥65) and health conditions of potential risk for severe COVID-19. Participants will be visited at two weeks and will be followed up for six months after the second dose of the study intervention.
Study hypotheses include:
1. The adjuvanted COVID-19 vaccine candidate is safe and tolerable in adult subjects.
2. The adjuvanted COVID-19 vaccine candidate induces strong immunogenicity against SARS-CoV-2 in adult subjects.
Study hypotheses include:
1. The adjuvanted COVID-19 vaccine candidate is safe and tolerable in adult subjects.
2. The adjuvanted COVID-19 vaccine candidate induces strong immunogenicity against SARS-CoV-2 in adult subjects.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| IRCT20150303021315N23 | REGISTRY | Iranian Registry of Clinical Trials | View |