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Completed

NCT Number: NCT05231590

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

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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

5 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Orchid Life Department, Orchid Pharmed Company

Tehran, Iran

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Low-dose SARS-CoV-2 recombinant spike protein + Advax-SM adjuvant

Biological

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 adjuvant

Biological

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 outcomes

  1. 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

Secondary outcomes

  1. Incidence of solicited adverse events

    Time frame: 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)

  2. Incidence of unsolicited adverse events

    Time frame: 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)

  3. 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

    As defined using system organ classes and preferred terms of the Medical Dictionary for Regulatory Activities (MedDRA)

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

    Time frame: 14 days after the second dose

    As measured by ELISA

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

    Time frame: 14 days after the second dose

    As measured by ELISA

  6. Geometric mean ratio (GMR) for S1 binding IgG antibodies

    Time frame: 14 days after the second dose

    As measured by ELISA

  7. Geometric mean titer (GMT) for SARS-CoV-2 neutralizing antibodies

    Time frame: 14 days after the second dose

    As measured by virus neutralization test

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

    Time frame: 14 days after the second dose

    As measured by virus neutralization test

  9. Geometric mean ratio (GMR) for SARS-CoV-2 neutralizing antibodies

    Time frame: 14 days after the second dose

    As measured by virus neutralization test

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

    Time frame: 14 days after the second dose

    As measured by ELISA

Sponsors and collaborators

Lead sponsor

Cinnagen

Industry

Collaborators

  • Vaxine Pty Ltd

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 9, 2022
Registry last updated
Oct 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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