COVID-19Phase 3NCT05231590

Immunogenicity and Safety of the SpikoGen COVID-19 Vaccine in Children Aged 5 to <12 Years and 12 to <18 Years Compared With Adults Aged 18 to 40 Years

A Phase 3 study testing Low-dose SARS-CoV-2 recombinant spike protein + Advax-SM adjuvant and 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

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Trial summary

Who is it for?: Ages 5 to 40 yearsHealthy volunteers can take part
Conditions the study is for: COVID-19
What is being tested?: Low-dose SARS-CoV-2 recombinant spike protein + Advax-SM adjuvant and SARS-CoV-2 recombinant spike protein + Advax-SM adjuvant
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 581 participants
Where: 1 siteIran
Study dates: 23 Feb 2022to 30 Sep 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 5 to 40 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

Male or female between 5 and 40 years of age inclusive
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
Children with a body mass index equal to or greater than the 3rd percentile for age and sex as per the World Health Organization child growth standards

Who cannot join

Subjects with signs of active SARS-CoV-2 infection at the screening visit.
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.
Subjects who have been vaccinated with any vaccine or vaccine candidate against SARS-CoV-2.

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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.
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 Non-Randomized, Three-Armed, Open-Label, Parallel-Group, Non-Inferiority Trial to Compare the Immunogenicity and Safety of an Adjuvanted Recombinant Spike Protein COVID-19 Vaccine (SpikoGen) in Children Aged 5 to <12 Years and 12 to <18 Years With Adults Aged 18 to 40 Years

This was a non-randomized, three-armed, open-label, parallel-group, non-inferiority trial designed to compare the immunogenicity and safety of the SpikoGen COVID-19 vaccine in children aged 5 to <12 years and 12 to <18 years with adults aged 18 to 40 years. Children aged 12 to <18 years and adults received 25 µg of the recombinant protein together with 15 mg of Advax-SM. Children aged 5 to <12 years received a half-dose of the adjuvanted vaccine. The injection was given in two doses with a 21-day interval in the deltoid muscle of the non-dominant arm. The vaccine immunogenicity was evaluated at 14 days after the second dose. Solicited adverse events were recorded for 7 days after each vaccination. Unsolicited adverse events were collected through one month after the second dose. Safety monitoring was continued through six months after the second dose in children aged 5 to <12 years and 12 to <18 years.

Conditions: COVID-19
Being tested: Low-dose SARS-CoV-2 recombinant spike protein + Advax-SM adjuvant, SARS-CoV-2 recombinant spike protein + Advax-SM adjuvant
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.

Low-dose SARS-CoV-2 recombinant spike protein + Advax-SM adjuvantBiological
SARS-CoV-2 recombinant spike protein (12.5 µg) with Advax-SM adjuvant (7.5 mg) in two doses with a 21-day interval administered with intramuscular injections in the non-dominant arm
SARS-CoV-2 recombinant spike protein + Advax-SM adjuvantBiological
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 non-dominant arm

Study groups in NCT05231590
Study group	Role	What they receive
Children Aged 5 to <12 Years	Other	Not described Receives: Biological: Low-dose SARS-CoV-2 recombinant spike protein + Advax-SM adjuvant
Children Aged 12 to <18 Years	Other	Not described Receives: Biological: SARS-CoV-2 recombinant spike protein + Advax-SM adjuvant
Adults Aged 18 to 40 Years	Other	Not described Receives: Biological: SARS-CoV-2 recombinant spike protein + Advax-SM adjuvant

What is being measured

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

Percentage of participants with seroconversion for SARS-CoV-2 neutralizing antibodies
As measured by virus neutralization test; the primary aim of this study was to establish non-inferiority of the immunogenicity of SpikoGen COVID-19 vaccine in children aged 5 to <12 to that in adults
Measured: 14 days after the second dose

Secondary outcomes (10)

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
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: Up to 1 month after the second dose
Incidence of serious adverse events (SAEs) and suspected unexpected serious adverse reaction (SUSARs) in children
As defined using system organ classes and preferred terms of the Medical Dictionary for Regulatory Activities (MedDRA)
Measured: Up to 6 months after the second dose
Geometric mean fold rise (GMFR) for S1 binding IgG antibodies
As measured by ELISA
Measured: 14 days after the second dose
Percentage of participants with seroconversion for S1 binding IgG antibodies
As measured by ELISA
Measured: 14 days after the second dose
Geometric mean ratio (GMR) for S1 binding IgG antibodies
As measured by ELISA
Measured: 14 days after the second dose
Geometric mean titer (GMT) for SARS-CoV-2 neutralizing antibodies
As measured by virus neutralization test
Measured: 14 days after the second dose
Geometric mean fold rise (GMFR) for SARS-CoV-2 neutralizing antibodies
As measured by virus neutralization test
Measured: 14 days after the second dose
Geometric mean ratio (GMR) for SARS-CoV-2 neutralizing antibodies
As measured by virus neutralization test
Measured: 14 days after the second dose
Geometric mean concentration (GMC) for S1 binding IgG antibodies
As measured by ELISA
Measured: 14 days after the second dose

Timeline

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

23 Feb 202230 Sep 2022

First posted9 Feb 2022
Study start23 Feb 2022
Primary completion14 Apr 2022
Study completion30 Sep 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for COVID-19Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 581 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05231590
Sponsor's protocol ID: VAC.CIN.PT.PEDS
Other IDs: IRCT20150303021315N27
Status last verified: Oct 2022
First submitted: 8 Feb 2022
Last updated: 17 Oct 2022
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 17 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Non-Randomized, Three-Armed, Open-Label, Parallel-Group, Non-Inferiority Trial to Compare the Immunogenicity and Safety of an Adjuvanted Recombinant Spike Protein COVID-19 Vaccine (SpikoGen) in Children Aged 5 to <12 Years and 12 to <18 Years With Adults Aged 18 to 40 Years
ClinicalTrials.gov ID: NCT05231590
Acronym / sponsor ID: VAC.CIN.PT.PEDS
Conditions: COVID-19
Keywords: COVID-19, SARS-CoV-2, Recombinant protein, Spike, Advax-SM, Advax, Vaccine, Adjuvant
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 581 participants (actual)
Lead sponsor: CinnagenIndustry (pharma, biotech, devices)
Collaborators: Vaxine Pty Ltd
Study start: 23 Feb 2022 (actual)
Primary completion: 14 Apr 2022 (actual)
Study completion: 30 Sep 2022 (actual)
First posted: 9 Feb 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Children Aged 5 to <12 Years	Other	Biological: Low-dose SARS-CoV-2 recombinant spike protein + Advax-SM adjuvant
Children Aged 12 to <18 Years	Other	Biological: SARS-CoV-2 recombinant spike protein + Advax-SM adjuvant
Adults Aged 18 to 40 Years	Other	Biological: SARS-CoV-2 recombinant spike protein + Advax-SM adjuvant

Who may qualify

Ages: 5 to 40 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (5 listed)

Male or female between 5 and 40 years of age inclusive
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
Children with a body mass index equal to or greater than the 3rd percentile for age and sex as per the World Health Organization child growth standards

Key exclusion criteria (11 listed)

Subjects with signs of active SARS-CoV-2 infection at the screening visit.
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Low-dose SARS-CoV-2 recombinant spike protein + Advax-SM adjuvantSARS-CoV-2 recombinant spike protein (12.5 µg) with Advax-SM adjuvant (7.5 mg) in two doses with a 21-day interval administered with intramuscular injections in the non-dominant arm	Biological	Children Aged 5 to <12 Years
SARS-CoV-2 recombinant spike protein + Advax-SM adjuvantSARS-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 non-dominant arm	Biological	Adults Aged 18 to 40 Years, Children Aged 12 to <18 Years

Primary outcome

Percentage of participants with seroconversion for SARS-CoV-2 neutralizing antibodies
Time frame: 14 days after the second dose
As measured by virus neutralization test; the primary aim of this study was to establish non-inferiority of the immunogenicity of SpikoGen COVID-19 vaccine in children aged 5 to <12 to that in adults

10 secondary outcomes

Incidence of solicited adverse events
Time frame: For 7 days after each dose
Incidence of unsolicited adverse events
Time frame: Up to 1 month after the second dose
Incidence of serious adverse events (SAEs) and suspected unexpected serious adverse reaction (SUSARs) in children
Time frame: Up to 6 months after the second dose
Geometric mean fold rise (GMFR) for S1 binding IgG antibodies
Time frame: 14 days after the second dose
Percentage of participants with seroconversion for S1 binding IgG antibodies
Time frame: 14 days after the second dose
Geometric mean ratio (GMR) for S1 binding IgG antibodies
Time frame: 14 days after the second dose
Geometric mean titer (GMT) for SARS-CoV-2 neutralizing antibodies
Time frame: 14 days after the second dose
Geometric mean fold rise (GMFR) for SARS-CoV-2 neutralizing antibodies
Time frame: 14 days after the second dose
Geometric mean ratio (GMR) for SARS-CoV-2 neutralizing antibodies
Time frame: 14 days after the second dose
Geometric mean concentration (GMC) for S1 binding IgG antibodies
Time frame: 14 days after the second dose

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2022.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Payam Tabarsi, M.D. principal investigator

Shahid Beheshti University of Medical Sciences

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 inclusion and 11 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 17 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. 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 second 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 NCT05231590.

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 17 Oct 2022.