NCT04944368

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

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 400 (actual)
• Sponsor: Cinnagen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

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 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 non-dominant arm

Timeline

• Start date: 2021-05-30
• Primary completion: 2021-07-19
• Completion: 2021-12-30
• First posted: 2021-06-29
• Last updated: 2022-10-13

Locations

1 site across 1 country: Iran