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

NCT05005559 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 16876

Last updated 2022-10-13

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Vaxine Pty Ltd

    collaborator INDUSTRY

  • Cinnagen

    lead INDUSTRY

Principal Investigators

  • Payam Tabarsi, M.D. · Shahid Beheshti University of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-08-07
Primary Completion
2022-03-10
Completion
2022-03-10

Countries

  • Iran

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05005559 on ClinicalTrials.gov