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

NCT05005559 | Completed Phase 3

• 2 other identifiers: VAC.CIN.PT.IIIIRCT20150303021315N24
• Study Type: interventional
• Target: 16,876
• Locations: 1 country
• Sites: 1

Brief 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. 1.The adjuvanted COVID-19 vaccine candidate significantly reduces the risk of symptomatic COVID-19 in adult subjects.
2. 2.The adjuvanted COVID-19 vaccine candidate significantly reduces the risk of severe COVID-19 in adult subjects.
3. 3.The adjuvanted COVID-19 vaccine candidate is safe and tolerable in adult subjects.

Conditions

Covid19

Keywords

COVID-19; SARS-COV-2; Recombinant protein; Spike; Advax-SM; Advax; Vaccine; Adjuvant

Outcome Measures

Primary Outcomes (1)

• Occurrence of symptomatic COVID-19

  Participants with at least one positive SARS-CoV-2 PCR test and either any two or more of the following systemic signs or symptoms: fever, chills, myalgia, headache, sore throat, nausea, vomiting, diarrhea, rhinorrhea, new-onset anosmia, and new-onset ageusia - or any one or more of the following respiratory signs and symptoms - cough, shortness of breath, and clinical or radiographic evidence of pneumonia

  2 weeks after the second dose (day 35) up to 6 months after the second dose (day 201)

Secondary Outcomes (4)

• Incidence of solicited adverse events

  For 7 days after each dose

• Incidence of unsolicited adverse events

  For 28 days after each dose

• Incidence of serious adverse events (SAEs) and suspected unexpected serious adverse reaction (SUSARs)

  For 6 months after the second dose

• Occurrence of severe COVID-19

  2 weeks after the second dose (day 35) up to 6 months after the second dose (day 201)

Study Arms (2)

Vaccine candidate

EXPERIMENTAL

Biological: SARS-CoV-2 recombinant spike protein + Advax-SM adjuvant

Saline placebo

PLACEBO COMPARATOR

Biological: Saline placebo

Interventions

SARS-CoV-2 recombinant spike protein + Advax-SM adjuvant BIOLOGICAL

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

Also known as: SpikoGen

Vaccine candidate

Saline placebo BIOLOGICAL

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

Also known as: Normal saline

Saline placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female between 18 years of age and less than 50 years
• Willing and able to comply with all study requirements, including scheduled visits, interventions, and laboratory tests
• Healthy adults or adults in a stable medical condition, defined as not being hospitalized within 3 months prior to the screening visit
• Females must not be pregnant or breastfeeding

You may not qualify if:

• Subjects with signs of active SARS-COV-2 infection at the screening visit.
• Subjects with body temperature of 38 degrees Celsius or greater at the screening visit or within 72 hours prior to the screening visit.
• Subjects with a history of any progressive or severe neurological disorders, including dementia, stroke, seizure, and Guillain-Barre syndrome.
• Female Subjects who are pregnant or breastfeeding or have planned to become pregnant during the study period.
• Subjects who have a history of severe allergic reactions (e.g., anaphylaxis) to the study vaccine, any components of the study interventions, or any pharmaceutical products.
• Subjects who have received any other investigational products within 30 days prior to the screening visit or intend to participate in any other clinical studies during the period of this study.
• Subjects who have been vaccinated with any vaccine or vaccine candidate against SARS-CoV-2.
• Subjects who have received any vaccines within 28 days prior to the screening visit or intend to receive any vaccines up to 14 days after the second dose of the study injection.
• Subjects who have any known bleeding disorders or, in the investigator's opinion, have any contraindications for an intramuscular injection.
• Subjects who have received any blood, plasma, or immunoglobulin products from 90 days prior to the screening visit or intend to receive during the study period.
• Subjects with any condition that may increase the risk of participating in the study or may interfere with the evaluation of the primary endpoints of the study in the investigator's opinion.
• Subjects who have donated ≥450 mL of blood or blood products within 28 days prior to the screening visit.
• Subjects with end-stage renal disease
• Subjects with Down syndrome
• Subjects with a body mass index of 40 kg/m2 or more

Sponsors & Collaborators

• Cinnagen: lead
• Vaxine Pty Ltd: collaborator

Study Sites (1)

Espinas Palace Hotel

Tehran, 1981846911, Iran

Location

Related Publications (2)

• Tabarsi P, Anjidani N, Shahpari R, Mardani M, Sabzvari A, Yazdani B, Kafi H, Fallah N, Ebrahimi A, Taheri A, Petrovsky N, Barati S. Evaluating the efficacy and safety of SpikoGen(R), an Advax-CpG55.2-adjuvanted severe acute respiratory syndrome coronavirus 2 spike protein vaccine: a phase 3 randomized placebo-controlled trial. Clin Microbiol Infect. 2023 Feb;29(2):215-220. doi: 10.1016/j.cmi.2022.09.001. Epub 2022 Sep 10.

  PMID: 36096430 RESULT

• Honda-Okubo Y, Sajkov D, Wauchope B, Turner JV, Vote B, Antipov A, Andre G, Lebedin Y, Petrovsky N. Immunogenicity and safety study of a single dose of SpikoGen(R) vaccine as a heterologous or homologous intramuscular booster following a primary course of mRNA, adenoviral vector or recombinant protein COVID-19 vaccine in ambulatory adults. Vaccine. 2025 Mar 7;49:126744. doi: 10.1016/j.vaccine.2025.126744. Epub 2025 Feb 5.

  PMID: 39914274 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

SARS-CoV-2 recombinant spike protein with delta inulin and CpG-ODN adjuvant vaccine; Saline Solution

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Payam Tabarsi, M.D.

  Shahid Beheshti University of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2021
• First Posted: August 13, 2021
• Study Start: August 7, 2021
• Primary Completion: March 10, 2022
• Study Completion: March 10, 2022
• Last Updated: October 13, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)