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 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.

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Biological: Low-dose SARS-CoV-2 recombinant spike protein + Advax-SM adjuvant; Biological: SARS-CoV-2 recombinant spike protein + Advax-SM adjuvant

• Study Type: Interventional
• Enrollment (Actual): 581
• Phase: Phase 3

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of
    • Orchid Life Department, Orchid Pharmed Company

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 40 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	14 days after the second dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	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)	Up to 6 months after the second dose
Geometric mean fold rise (GMFR) for S1 binding IgG antibodies	As measured by ELISA	14 days after the second dose
Percentage of participants with seroconversion for S1 binding IgG antibodies	As measured by ELISA	14 days after the second dose
Geometric mean ratio (GMR) for S1 binding IgG antibodies	As measured by ELISA	14 days after the second dose
Geometric mean titer (GMT) for SARS-CoV-2 neutralizing antibodies	As measured by virus neutralization test	14 days after the second dose
Geometric mean fold rise (GMFR) for SARS-CoV-2 neutralizing antibodies	As measured by virus neutralization test	14 days after the second dose
Geometric mean ratio (GMR) for SARS-CoV-2 neutralizing antibodies	As measured by virus neutralization test	14 days after the second dose
Geometric mean concentration (GMC) for S1 binding IgG antibodies	As measured by ELISA	14 days after the second dose

Collaborators and Investigators

• Sponsor: Cinnagen
• Collaborators: Vaxine Pty Ltd

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 23, 2022
• Primary Completion (ACTUAL): April 14, 2022
• Study Completion (ACTUAL): September 30, 2022

Study Registration Dates

• First Submitted: February 8, 2022
• First Submitted That Met QC Criteria: February 8, 2022
• First Posted (ACTUAL): February 9, 2022

Study Record Updates

• Last Update Posted (ACTUAL): October 17, 2022
• Last Update Submitted That Met QC Criteria: October 13, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: SARS-CoV-2; Vaccine; COVID-19; Advax; Adjuvant; Spike; Recombinant protein; Advax-SM
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Physiological Effects of Drugs; Immunologic Factors; Myeloma Proteins; Paraproteins
• Other Study ID Numbers: VAC.CIN.PT.PEDS; IRCT20150303021315N27 (REGISTRY: Iranian Registry of Clinical Trials)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No