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
Study Details
Study Description
Brief Summary
This is 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 (305 subjects) and adults (305 subjects) will receive 25 µg of the recombinant protein together with 15 mg of Advax-SM. Children aged 5 to <12 years (200 subjects) will receive 12.5 µg of the recombinant protein together with 7.5 mg of Advax-SM. The injection will be given in two doses with a 21-day interval in the deltoid muscle of the non-dominant arm. The vaccine immunogenicity will be evaluated at 14 days after the second dose. Solicited adverse events will be recorded for 7 days after each vaccination. Unsolicited adverse events will be collected through one month after the second dose. Safety monitoring will be continued through six months after the second dose in children aged 5 to <12 years and 12 to <18 years.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Children Aged 5 to <12 Years
|
Biological: Low-dose SARS-CoV-2 recombinant spike protein + Advax-SM adjuvant
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
|
| Other: Children Aged 12 to <18 Years
|
Biological: SARS-CoV-2 recombinant spike protein + Advax-SM adjuvant
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
|
| Other: Adults Aged 18 to 40 Years
|
Biological: SARS-CoV-2 recombinant spike protein + Advax-SM adjuvant
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
|
Outcome Measures
Primary Outcome Measures
- Percentage of participants with seroconversion for SARS-CoV-2 neutralizing antibodies [14 days after the second dose]
As measured by virus neutralization test; the primary aim of this study is to establish non-inferiority of the immunogenicity of SpikoGen COVID-19 vaccine in children Aged 12 to <18 to that in adults
Secondary Outcome Measures
- Incidence of solicited adverse events [For 7 days after each dose]
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 [Up to 1 month after the second dose]
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) in children [Up to 6 months after the second dose]
As defined using system organ classes and preferred terms of the Medical Dictionary for Regulatory Activities (MedDRA)
- Geometric mean fold rise (GMFR) for S1 binding IgG antibodies [14 days after the second dose]
As measured by ELISA
- Percentage of participants with seroconversion for S1 binding IgG antibodies [14 days after the second dose]
As measured by ELISA
- Geometric mean ratio (GMR) for S1 binding IgG antibodies [14 days after the second dose]
As measured by ELISA
- Geometric mean titer (GMT) for SARS-CoV-2 neutralizing antibodies [14 days after the second dose]
As measured by virus neutralization test
- Geometric mean fold rise (GMFR) for SARS-CoV-2 neutralizing antibodies [14 days after the second dose]
As measured by virus neutralization test
- Geometric mean ratio (GMR) for SARS-CoV-2 neutralizing antibodies [14 days after the second dose]
As measured by virus neutralization test
- Geometric mean concentration (GMC) for S1 binding IgG antibodies [14 days after the second dose]
As measured by ELISA
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male or female between 5 and 40 years of age inclusive
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Willing and able to comply with all study requirements, including scheduled visits, interventions, and laboratory tests
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Healthy adults or adults in a stable medical condition, defined as not being hospitalized within 3 months prior to the screening visit
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Females must not be pregnant or breastfeeding
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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
Exclusion Criteria:
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Subjects with signs of active SARS-CoV-2 infection at the screening visit.
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Subjects with epilepsy or a history of febrile seizures
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Subjects who receive immunosuppressive or cytotoxic medications.
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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.
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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.
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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.
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Subjects who have any known bleeding disorders or, in the investigator's opinion, have any contraindications for an intramuscular injection.
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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.
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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.
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Subjects who have donated ≥450 mL of blood or blood products within 28 days prior to the screening visit.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Orchid Life Department, Orchid Pharmed Company | Tehran | Iran, Islamic Republic of |
Sponsors and Collaborators
- Cinnagen
- Vaxine Pty Ltd
Investigators
- Principal Investigator: Payam Tabarsi, M.D., Shahid Beheshti University of Medical Sciences
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- VAC.CIN.PT.PEDS
- IRCT20150303021315N27