NCT05231590

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
581

participants targeted

Target at P50-P75 for phase_3 covid19

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 8, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 9, 2022

Completed
14 days until next milestone

Study Start

First participant enrolled

February 23, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 14, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

October 17, 2022

Status Verified

October 1, 2022

Enrollment Period

2 months

First QC Date

February 8, 2022

Last Update Submit

October 13, 2022

Conditions

COVID-19

Keywords

COVID-19SARS-CoV-2Recombinant proteinSpikeAdvax-SMAdvaxVaccineAdjuvant

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • Incidence of solicited adverse events

    For 7 days after each dose

  • Incidence of unsolicited adverse events

    Up to 1 month after the second dose

  • Incidence of serious adverse events (SAEs) and suspected unexpected serious adverse reaction (SUSARs) in children

    Up to 6 months after the second dose

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

    14 days after the second dose

  • Percentage of participants with seroconversion for S1 binding IgG antibodies

    14 days after the second dose

  • +5 more secondary outcomes

Study Arms (3)

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

Interventions

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

Children Aged 5 to <12 Years
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

Adults Aged 18 to 40 YearsChildren Aged 12 to <18 Years

Eligibility Criteria

Age5 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orchid Life Department, Orchid Pharmed Company

Tehran, Iran

Location

MeSH Terms

Conditions

COVID-19

Interventions

SARS-CoV-2 recombinant spike protein with delta inulin and CpG-ODN adjuvant vaccine

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Payam Tabarsi, M.D.

    Shahid Beheshti University of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2022

First Posted

February 9, 2022

Study Start

February 23, 2022

Primary Completion

April 14, 2022

Study Completion

September 30, 2022

Last Updated

October 17, 2022

Record last verified: 2022-10

Locations

IR(1)