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
Primary Purpose
COVID-19
Status
Completed
Phase
Phase 3
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Low-dose SARS-CoV-2 recombinant spike protein + Advax-SM adjuvant
SARS-CoV-2 recombinant spike protein + Advax-SM adjuvant
Sponsored by
About this trial
This is an interventional prevention trial for COVID-19 focused on measuring COVID-19, SARS-CoV-2, Recombinant protein, Spike, Advax-SM, Advax, Vaccine, Adjuvant
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
- 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.
Sites / Locations
- Orchid Life Department, Orchid Pharmed Company
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
Children Aged 5 to <12 Years
Children Aged 12 to <18 Years
Adults Aged 18 to 40 Years
Arm Description
Outcomes
Primary Outcome Measures
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
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) in children
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
As measured by ELISA
Percentage of participants with seroconversion for S1 binding IgG antibodies
As measured by ELISA
Geometric mean ratio (GMR) for S1 binding IgG antibodies
As measured by ELISA
Geometric mean titer (GMT) for SARS-CoV-2 neutralizing antibodies
As measured by virus neutralization test
Geometric mean fold rise (GMFR) for SARS-CoV-2 neutralizing antibodies
As measured by virus neutralization test
Geometric mean ratio (GMR) for SARS-CoV-2 neutralizing antibodies
As measured by virus neutralization test
Geometric mean concentration (GMC) for S1 binding IgG antibodies
As measured by ELISA
Full Information
NCT ID
NCT05231590
First Posted
February 8, 2022
Last Updated
October 13, 2022
Sponsor
Cinnagen
Collaborators
Vaxine Pty Ltd
1. Study Identification
Unique Protocol Identification Number
NCT05231590
Brief Title
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
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
February 23, 2022 (Actual)
Primary Completion Date
April 14, 2022 (Actual)
Study Completion Date
September 30, 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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
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
None (Open Label)
Allocation
Non-Randomized
Enrollment
581 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Children Aged 5 to <12 Years
Arm Type
Other
Arm Title
Children Aged 12 to <18 Years
Arm Type
Other
Arm Title
Adults Aged 18 to 40 Years
Arm Type
Other
Intervention Type
Biological
Intervention Name(s)
Low-dose SARS-CoV-2 recombinant spike protein + Advax-SM adjuvant
Intervention Description
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
Intervention Type
Biological
Intervention Name(s)
SARS-CoV-2 recombinant spike protein + Advax-SM adjuvant
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 non-dominant arm
Primary Outcome Measure Information:
Title
Percentage of participants with seroconversion for SARS-CoV-2 neutralizing antibodies
Description
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
Time Frame
14 days after the second dose
Secondary Outcome Measure Information:
Title
Incidence of solicited adverse events
Description
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)
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
Up to 1 month after the second dose
Title
Incidence of serious adverse events (SAEs) and suspected unexpected serious adverse reaction (SUSARs) in children
Description
As defined using system organ classes and preferred terms of the Medical Dictionary for Regulatory Activities (MedDRA)
Time Frame
Up to 6 months after the second dose
Title
Geometric mean fold rise (GMFR) for S1 binding IgG antibodies
Description
As measured by ELISA
Time Frame
14 days after the second dose
Title
Percentage of participants with seroconversion for S1 binding IgG antibodies
Description
As measured by ELISA
Time Frame
14 days after the second dose
Title
Geometric mean ratio (GMR) for S1 binding IgG antibodies
Description
As measured by ELISA
Time Frame
14 days after the second dose
Title
Geometric mean titer (GMT) for SARS-CoV-2 neutralizing antibodies
Description
As measured by virus neutralization test
Time Frame
14 days after the second dose
Title
Geometric mean fold rise (GMFR) for SARS-CoV-2 neutralizing antibodies
Description
As measured by virus neutralization test
Time Frame
14 days after the second dose
Title
Geometric mean ratio (GMR) for SARS-CoV-2 neutralizing antibodies
Description
As measured by virus neutralization test
Time Frame
14 days after the second dose
Title
Geometric mean concentration (GMC) for S1 binding IgG antibodies
Description
As measured by ELISA
Time Frame
14 days after the second dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
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.
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
Orchid Life Department, Orchid Pharmed Company
City
Tehran
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Learn more about this trial
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
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