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Covid19Phase 3NCT05005559

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

A Phase 3 study testing SARS-CoV-2 recombinant spike protein + Advax-SM adjuvant in people with Covid19, run by Cinnagen at 1 site in Iran.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Covid19
What is being tested?
SARS-CoV-2 recombinant spike protein + Advax-SM adjuvant
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
16,876 participants
Where
1 siteIran
Study dates
7 Aug 2021to 10 Mar 2022
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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.
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  • 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

Trial locations and contacts

1 site in 1 country.

Iran1 site

  • Espinas Palace Hotel

    Tehran, 1981846911

Other trials in Iran

About this study

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)

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
Being tested
SARS-CoV-2 recombinant spike protein + Advax-SM adjuvant, Saline placebo
Keywords
COVID-19, SARS-COV-2, Recombinant protein, Spike, Advax-SM, Advax, Vaccine, Adjuvant
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SARS-CoV-2 recombinant spike protein + Advax-SM adjuvantBiological

    Also called SpikoGen

    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

  • Saline placeboBiological

    Also called Normal saline

    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

Study groups in NCT05005559
Study groupRoleWhat they receive
Vaccine candidateExperimentalNot described
Receives: Biological: SARS-CoV-2 recombinant spike protein + Advax-SM adjuvant
Saline placeboPlacebo comparatorNot described
Receives: Biological: Saline placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

Secondary outcomes (4)

  1. 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)

    Measured: For 7 days after each dose

  2. 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)

    Measured: For 28 days after each dose

  3. 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)

    Measured: For 6 months after the second dose

  4. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Aug 2021
  2. Study start7 Aug 2021
  3. Primary completion10 Mar 2022
  4. Study completion10 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
16,876 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05005559
Sponsor's protocol ID
VAC.CIN.PT.III
Other IDs
IRCT20150303021315N24
Status last verified
Mar 2022
First submitted
11 Aug 2021
Last updated
13 Oct 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 36096430

  • 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.

    PubMed 39914274

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SARS-CoV-2 recombinant spike protein + Advax-SM adjuvant in people with Covid19, run by Cinnagen at 1 site in Iran.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of symptomatic COVID-19 (time frame: 2 weeks after the second dose (day 35) up to 6 months after the second dose (day 201)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05005559, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2022.

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