search
Back to results

Immunogenicity and Safety of a Booster Dose of the SpikoGen COVID-19 Vaccine

Primary Purpose

COVID-19

Status
Completed
Phase
Phase 3
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
SARS-CoV-2 recombinant spike protein + Advax-SM adjuvant
Saline placebo
Sponsored by
Cinnagen
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Male or female ≥18 years
  • 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
  • Subjects who have received two doses of a COVID-19 vaccine of any type between 4 to 9 months before the screening visit

Exclusion Criteria:

  • Subjects with signs of active SARS-CoV-2 infection at the screening visit or within 72 hours prior to the screening visit
  • Subjects who have been diagnosed with a breakthrough infection after receiving two doses of a COVID-19 vaccine
  • 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 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.
  • Female Subjects who are pregnant or breastfeeding or have planned to become pregnant within one month after the study 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 Type

Experimental

Placebo Comparator

Arm Label

SpikoGen COVID-19 Vaccine

Saline Placebo

Arm Description

Outcomes

Primary Outcome Measures

Percentage of participants with seroconversion for SARS-CoV-2 neutralizing antibodies
As measured by ELISA

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)
As defined using system organ classes and preferred terms of the Medical Dictionary for Regulatory Activities (MedDRA)
Geometric mean concentration (GMC) for S1 binding IgG antibodies
As measured by ELISA
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
Percentage of participants with seroconversion for receptor-binding domain (RBD) binding IgG antibodies
As measured by ELISA
Geometric mean concentration (GMC) for receptor-binding domain (RBD) binding IgG antibodies
As measured by ELISA
Geometric mean fold rise (GMFR) for receptor-binding domain (RBD) binding IgG antibodies
As measured by ELISA
Geometric mean concentration (GMC) for SARS-CoV-2 neutralizing antibodies
As measured by ELISA
Geometric mean fold rise (GMFR) for SARS-CoV-2 neutralizing antibodies
As measured by ELISA
Change in T-cell IFN-γ secretion from baseline to 14 days after the booster dose
As measured by IGRA

Full Information

First Posted
January 3, 2022
Last Updated
October 11, 2022
Sponsor
Cinnagen
Collaborators
Vaxine Pty Ltd
search

1. Study Identification

Unique Protocol Identification Number
NCT05175625
Brief Title
Immunogenicity and Safety of a Booster Dose of the SpikoGen COVID-19 Vaccine
Official Title
A Randomized, Two-Armed, Placebo-Controlled, Double-Blind, Parallel-Group Clinical Trial to Evaluate the Immunogenicity and Safety of a Booster Dose of an Adjuvanted Recombinant Spike Protein COVID-19 Vaccine (SpikoGen)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
December 15, 2021 (Actual)
Primary Completion Date
December 30, 2021 (Actual)
Study Completion Date
June 20, 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
No

5. Study Description

Brief Summary
This was a randomized, two-armed, double-blind, placebo-controlled trial designed to evaluate the safety and immunogenicity of a booster dose of an adjuvanted recombinant SARS-CoV-2 spike protein subunit vaccine (SpikoGen) produced by CinnaGen Co. A total of 300 adult individuals received a single dose of either the SpikoGen vaccine or the saline placebo in a 5:1 ratio at 4 to 9 months after the second dose of a COVID-19 vaccine of any type. The injection was given in the deltoid muscle of the non-dominant arm. On day 14, the trial was unblinded, and the participants in the placebo group received a booster dose of the SpikoGen vaccine. For immunogenicity assessments, blood samples were collected on days 0 and 14 from all participants and on days 90 and 180 from those in the vaccine group only. For safety assessments, all participants were followed up for six months. Study hypotheses included: A booster dose of the SpikoGen COVID-19 vaccine is safe and tolerable in adult subjects. A booster dose of the SpikoGen COVID-19 vaccine induces strong immunogenicity against SARS-CoV-2 in adult subjects.

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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SpikoGen COVID-19 Vaccine
Arm Type
Experimental
Arm Title
Saline Placebo
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
SARS-CoV-2 recombinant spike protein + Advax-SM adjuvant
Other Intervention Name(s)
COVAX-19
Intervention Description
SARS-CoV-2 recombinant spike protein (25 µg) with Advax-SM adjuvant (15 mg); a single intramuscular injection into the deltoid muscle of the non-dominant arm
Intervention Type
Biological
Intervention Name(s)
Saline placebo
Intervention Description
0.9% sodium chloride (1 mL); a single intramuscular injection into the deltoid muscle of the non-dominant arm
Primary Outcome Measure Information:
Title
Percentage of participants with seroconversion for SARS-CoV-2 neutralizing antibodies
Description
As measured by ELISA
Time Frame
14 days after the booster 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 the booster 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
For 14 days after the booster dose
Title
Incidence of serious adverse events (SAEs) and suspected unexpected serious adverse reaction (SUSARs)
Description
As defined using system organ classes and preferred terms of the Medical Dictionary for Regulatory Activities (MedDRA)
Time Frame
For 6 months after the booster dose
Title
Geometric mean concentration (GMC) for S1 binding IgG antibodies
Description
As measured by ELISA
Time Frame
Days 0, 14, 90, and 180
Title
Geometric mean fold rise (GMFR) for S1 binding IgG antibodies
Description
As measured by ELISA
Time Frame
14 days after the booster dose
Title
Percentage of participants with seroconversion for S1 binding IgG antibodies
Description
As measured by ELISA
Time Frame
14 days after the booster dose
Title
Percentage of participants with seroconversion for receptor-binding domain (RBD) binding IgG antibodies
Description
As measured by ELISA
Time Frame
14 days after the booster dose
Title
Geometric mean concentration (GMC) for receptor-binding domain (RBD) binding IgG antibodies
Description
As measured by ELISA
Time Frame
Days 0, 14, 90, and 180
Title
Geometric mean fold rise (GMFR) for receptor-binding domain (RBD) binding IgG antibodies
Description
As measured by ELISA
Time Frame
14 days after the booster dose
Title
Geometric mean concentration (GMC) for SARS-CoV-2 neutralizing antibodies
Description
As measured by ELISA
Time Frame
Days 0, 14, 90, and 180
Title
Geometric mean fold rise (GMFR) for SARS-CoV-2 neutralizing antibodies
Description
As measured by ELISA
Time Frame
14 days after the booster dose
Title
Change in T-cell IFN-γ secretion from baseline to 14 days after the booster dose
Description
As measured by IGRA
Time Frame
Days 0 and 14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Male or female ≥18 years 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 Subjects who have received two doses of a COVID-19 vaccine of any type between 4 to 9 months before the screening visit Exclusion Criteria: Subjects with signs of active SARS-CoV-2 infection at the screening visit or within 72 hours prior to the screening visit Subjects who have been diagnosed with a breakthrough infection after receiving two doses of a COVID-19 vaccine 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 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. Female Subjects who are pregnant or breastfeeding or have planned to become pregnant within one month after the study 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

Plan to Share IPD
No
Citations:
PubMed Identifier
35758850
Citation
Tabarsi P, Anjidani N, Shahpari R, Roshanzamir K, Fallah N, Andre G, Petrovsky N, Barati S. Immunogenicity and safety of SpikoGen(R), an adjuvanted recombinant SARS-CoV-2 spike protein vaccine as a homologous and heterologous booster vaccination: A randomized placebo-controlled trial. Immunology. 2022 Nov;167(3):340-353. doi: 10.1111/imm.13540. Epub 2022 Jul 13.
Results Reference
result

Learn more about this trial

Immunogenicity and Safety of a Booster Dose of the SpikoGen COVID-19 Vaccine

We'll reach out to this number within 24 hrs