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

Primary Purpose

Covid19

Status

Completed

Phase

Phase 3

Locations

Iran, Islamic Republic of

Study Type

Interventional

Intervention

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

Saline placebo

About this trial

This is an interventional prevention trial for Covid19 focused on measuring COVID-19, SARS-COV-2, Recombinant protein, Spike, Advax-SM, Advax, Vaccine, Adjuvant

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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
Subjects with cystic fibrosis, chronic obstructive pulmonary disease, or pulmonary arterial hypertension
Subjects with uncontrolled asthma, hypertension, or diabetes mellitus
Subjects who receive cytotoxic medications or immunosuppressive drugs, including systemic corticosteroids at doses equivalent to prednisolone 10 mg or higher per day for more than 14 days.
Subjects who can get a COVID-19 vaccine within 2 months after the study enrollment date based on the national COVID-19 immunization program in Iran

Sites / Locations

Espinas Palace Hotel

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Vaccine candidate

Saline placebo

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Incidence of solicited adverse events

Injection site pain, erythema, swelling, and induration, axillary swelling or tenderness ipsilateral to the side of injection, fever (oral temperature), headache, fatigue, myalgia, arthralgia, nausea, vomiting, and chills, as reported by the study participants on electronic diaries, and as defined using system organ classes and preferred terms of the Medical Dictionary for Regulatory Activities (MedDRA)

Incidence of unsolicited adverse events

As reported by the study participants on electronic diaries, and as defined using system organ classes and preferred terms of the Medical Dictionary for Regulatory Activities (MedDRA)

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

As defined using system organ classes and preferred terms of the Medical Dictionary for Regulatory Activities (MedDRA)

Occurrence of severe COVID-19

Any symptomatic COVID-19 patient with any one or more of the following: respiratory rate of 30 per minute or more, heart rate of 125 per minute or more, oxygen saturation of 93% or less in ambient air, respiratory failure, acute respiratory distress syndrome (ARDS), need for high-flow oxygen therapy, non-invasive mechanical ventilation, invasive mechanical ventilation, or extracorporeal membrane oxygenation, any evidence of shock (systolic blood pressure of lower than 90 mmHg, diastolic blood pressure of lower than 60 mmHg, or need for vasopressors), acute renal, hepatic or neurological dysfunction, and hospitalization or death due to COVID-19.

Full Information

NCT ID

NCT05005559

First Posted

August 11, 2021

Last Updated

October 11, 2022

Sponsor

Cinnagen

Collaborators

Vaxine Pty Ltd

1. Study Identification

Unique Protocol Identification Number

NCT05005559

Brief Title

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

Official Title

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)

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Completed

Study Start Date

August 7, 2021 (Actual)

Primary Completion Date

March 10, 2022 (Actual)

Study Completion Date

March 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cinnagen

Collaborators

Vaxine Pty Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Covid19

Keywords

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

16876 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Vaccine candidate

Arm Type

Experimental

Arm Title

Saline placebo

Arm Type

Placebo Comparator

Intervention Type

Biological

Intervention Name(s)

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

Other Intervention Name(s)

SpikoGen

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

Saline placebo

Other Intervention Name(s)

Normal saline

Intervention Description

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

Primary Outcome Measure Information:

Title

Occurrence of symptomatic COVID-19

Description

Time Frame

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

Secondary Outcome Measure Information:

Title

Incidence of solicited adverse events

Description

Time Frame

For 7 days after each dose

Title

Incidence of unsolicited adverse events

Description

As reported by the study participants on electronic diaries, and as defined using system organ classes and preferred terms of the Medical Dictionary for Regulatory Activities (MedDRA)

Time Frame

For 28 days after each dose

Title

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

Description

As defined using system organ classes and preferred terms of the Medical Dictionary for Regulatory Activities (MedDRA)

Time Frame

For 6 months after the second dose

Title

Occurrence of severe COVID-19

Description

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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 Subjects with cystic fibrosis, chronic obstructive pulmonary disease, or pulmonary arterial hypertension Subjects with uncontrolled asthma, hypertension, or diabetes mellitus Subjects who receive cytotoxic medications or immunosuppressive drugs, including systemic corticosteroids at doses equivalent to prednisolone 10 mg or higher per day for more than 14 days. Subjects who can get a COVID-19 vaccine within 2 months after the study enrollment date based on the national COVID-19 immunization program in Iran

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Payam Tabarsi, M.D.

Organizational Affiliation

Shahid Beheshti University of Medical Sciences

Official's Role

Principal Investigator

Facility Information:

Facility Name

Espinas Palace Hotel

City

Tehran

ZIP/Postal Code

1981846911

Country

Iran, Islamic Republic of

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

36096430

Citation

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.

Results Reference

result

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

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