AzTrials
AzTrials

COVID-19Phase 3NCT05175625

Immunogenicity and Safety of a Booster Dose of the SpikoGen COVID-19 Vaccine

A Phase 3 study testing SARS-CoV-2 recombinant spike protein + Advax-SM adjuvant in people with COVID-19, 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
Search all trials

Trial summary

This was a randomized, two-armed, double-blind, placebo-controlled trial designed to evaluate the safety and immunogenicity of a booster dose of an adjuvanted recombinant SARS-CoV-2 spike protein subunit vaccine (SpikoGen) produced by CinnaGen Co. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
COVID-19
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
300 participants
Where
1 siteIran
Study dates
15 Dec 2021to 20 Jun 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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Male or female ≥18 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
  • Subjects who have received two doses of a COVID-19 vaccine of any type between 4 to 9 months before the screening visit

Who cannot join

  • Subjects with signs of active SARS-CoV-2 infection at the screening visit or within 72 hours prior to the screening visit
  • Subjects who have been diagnosed with a breakthrough infection after receiving two doses of a COVID-19 vaccine
  • Subjects with epilepsy or a history of febrile seizures
  • Subjects who receive immunosuppressive or cytotoxic medications.
  • 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.
Show all 12Show fewer
  • Subjects who have received any vaccines within 28 days prior to the screening visit or intend to receive any vaccines up to day 14 of the study.
  • Subjects who have any known bleeding disorders or, in the investigator's opinion, have any contraindications for an intramuscular injection.
  • Female Subjects who are pregnant or breastfeeding or have planned to become pregnant within one month after the study 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.

Trial locations and contacts

1 site in 1 country.

Iran1 site

  • Orchid Life Department, Orchid Pharmed Company

    Tehran

Other trials in Iran

About this study

Official title: A Randomized, Two-Armed, Placebo-Controlled, Double-Blind, Parallel-Group Clinical Trial to Evaluate the Immunogenicity and Safety of a Booster Dose of an Adjuvanted Recombinant Spike Protein COVID-19 Vaccine (SpikoGen)

This was a randomized, two-armed, double-blind, placebo-controlled trial designed to evaluate the safety and immunogenicity of a booster dose of an adjuvanted recombinant SARS-CoV-2 spike protein subunit vaccine (SpikoGen) produced by CinnaGen Co. A total of 300 adult individuals received a single dose of either the SpikoGen vaccine or the saline placebo in a 5:1 ratio at 4 to 9 months after the second dose of a COVID-19 vaccine of any type. The injection was given in the deltoid muscle of the non-dominant arm. On day 14, the trial was unblinded, and the participants in the placebo group received a booster dose of the SpikoGen vaccine. For immunogenicity assessments, blood samples were collected on days 0 and 14 from all participants and on days 90 and 180 from those in the vaccine group only. For safety assessments, all participants were followed up for six months.

Study hypotheses included:

  1. A booster dose of the SpikoGen COVID-19 vaccine is safe and tolerable in adult subjects.
  2. A booster dose of the SpikoGen COVID-19 vaccine induces strong immunogenicity against SARS-CoV-2 in adult subjects.
Conditions
COVID-19
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 COVAX-19

    SARS-CoV-2 recombinant spike protein (25 µg) with Advax-SM adjuvant (15 mg); a single intramuscular injection into the deltoid muscle of the non-dominant arm

  • Saline placeboBiological

    0.9% sodium chloride (1 mL); a single intramuscular injection into the deltoid muscle of the non-dominant arm

Study groups in NCT05175625
Study groupRoleWhat they receive
SpikoGen COVID-19 VaccineExperimentalNot 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. Percentage of participants with seroconversion for SARS-CoV-2 neutralizing antibodies

    As measured by ELISA

    Measured: 14 days after the booster dose

Secondary outcomes (12)

  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 the booster 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 14 days after the booster 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 booster dose

  4. Geometric mean concentration (GMC) for S1 binding IgG antibodies

    As measured by ELISA

    Measured: Days 0, 14, 90, and 180

  5. Geometric mean fold rise (GMFR) for S1 binding IgG antibodies

    As measured by ELISA

    Measured: 14 days after the booster dose

  6. Percentage of participants with seroconversion for S1 binding IgG antibodies

    As measured by ELISA

    Measured: 14 days after the booster dose

  7. Percentage of participants with seroconversion for receptor-binding domain (RBD) binding IgG antibodies

    As measured by ELISA

    Measured: 14 days after the booster dose

  8. Geometric mean concentration (GMC) for receptor-binding domain (RBD) binding IgG antibodies

    As measured by ELISA

    Measured: Days 0, 14, 90, and 180

  9. Geometric mean fold rise (GMFR) for receptor-binding domain (RBD) binding IgG antibodies

    As measured by ELISA

    Measured: 14 days after the booster dose

  10. Geometric mean concentration (GMC) for SARS-CoV-2 neutralizing antibodies

    As measured by ELISA

    Measured: Days 0, 14, 90, and 180

  11. Geometric mean fold rise (GMFR) for SARS-CoV-2 neutralizing antibodies

    As measured by ELISA

    Measured: 14 days after the booster dose

  12. Change in T-cell IFN-γ secretion from baseline to 14 days after the booster dose

    As measured by IGRA

    Measured: Days 0 and 14

Timeline

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

  1. First posted4 Jan 2022
  2. Study start15 Dec 2021
  3. Primary completion30 Dec 2021
  4. Study completion20 Jun 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
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05175625
Sponsor's protocol ID
VAC.CIN.PT.BOOSTER
Other IDs
IRCT20150303021315N26
Status last verified
Oct 2022
First submitted
3 Jan 2022
Last updated
14 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, Roshanzamir K, Fallah N, Andre G, Petrovsky N, Barati S. Immunogenicity and safety of SpikoGen(R), an adjuvanted recombinant SARS-CoV-2 spike protein vaccine as a homologous and heterologous booster vaccination: A randomized placebo-controlled trial. Immunology. 2022 Nov;167(3):340-353. doi: 10.1111/imm.13540. Epub 2022 Jul 13.

    PubMed 35758850

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 COVID-19, 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 12 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 14 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?

Percentage of participants with seroconversion for SARS-CoV-2 neutralizing antibodies (time frame: 14 days after the booster dose). 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 NCT05175625, which also lists 1 linked publication.

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 14 Oct 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in