NCT05005559

Phase III Clinical Trial of CinnaGen COVID-19 Vaccine (SpikoGen)

A Phase III, Randomized, Two-armed, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of an Adjuvanted Recombinant SARS-CoV-2 Spike (S) Protein Subunit Vaccine Candidate (SpikoGen)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 16,876 (actual)
• Sponsor: Cinnagen · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This is a phase III, randomized, two-armed, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of a candidate adjuvanted recombinant SARS-CoV-2 spike (S) protein subunit vaccine (SpikoGen) produced by CinnaGen Co. 16,876 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 randomization is stratified by age (from 18 to under 40 years of age or from 40 to under 50 years of age). The injection is given in two doses with a 21-day interval in the deltoid muscle of the non-dominant arm. Participants 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 significantly reduces the risk of symptomatic COVID-19 in adult subjects. 2. The adjuvanted COVID-19 vaccine candidate significantly reduces the risk of severe COVID-19 in adult subjects. 3. The adjuvanted COVID-19 vaccine candidate is safe and tolerable in adult subjects.

Conditions

• Covid19

Interventions

Type	Name	Description
BIOLOGICAL	SARS-CoV-2 recombinant spike protein + Advax-SM adjuvant	SARS-CoV-2 recombinant spike protein (25 µg) with Advax-SM adjuvant (15 mg) in two doses with a 21-day interval administered with intramuscular injections in the deltoid muscle of the non-dominant arm
BIOLOGICAL	Saline placebo	0.9% sodium chloride (1 mL) injection in two doses with a 21-day interval administered with intramuscular injections in the deltoid muscle of the non-dominant arm

Timeline

• Start date: 2021-08-07
• Primary completion: 2022-03-10
• Completion: 2022-03-10
• First posted: 2021-08-13
• Last updated: 2022-10-13

Locations

1 site across 1 country: Iran