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

• ClinicalTrials.gov Identifier: NCT05175625
• Recruitment Status: Completed
• First Posted: January 4, 2022
• Last Update Posted: October 14, 2022
• Sponsor: Cinnagen
• Collaborator: Vaxine Pty Ltd
• Information provided by (Responsible Party): Cinnagen

Tracking Information

• First Submitted Date: January 3, 2022
• First Posted Date: January 4, 2022
• Last Update Posted Date: October 14, 2022
• Actual Study Start Date: December 15, 2021
• Actual Primary Completion Date: December 30, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 3, 2022)

Percentage of participants with seroconversion for SARS-CoV-2 neutralizing antibodies [ Time Frame: 14 days after the booster dose ]

As measured by ELISA

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: January 3, 2022)

• Incidence of solicited adverse events [ Time Frame: For 7 days after the booster 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)
• Incidence of unsolicited adverse events [ Time Frame: For 14 days after the booster 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)
• Incidence of serious adverse events (SAEs) and suspected unexpected serious adverse reaction (SUSARs) [ Time Frame: For 6 months after the booster dose ]
  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 [ Time Frame: Days 0, 14, 90, and 180 ]
  As measured by ELISA
• Geometric mean fold rise (GMFR) for S1 binding IgG antibodies [ Time Frame: 14 days after the booster dose ]
  As measured by ELISA
• Percentage of participants with seroconversion for S1 binding IgG antibodies [ Time Frame: 14 days after the booster dose ]
  As measured by ELISA
• Percentage of participants with seroconversion for receptor-binding domain (RBD) binding IgG antibodies [ Time Frame: 14 days after the booster dose ]
  As measured by ELISA
• Geometric mean concentration (GMC) for receptor-binding domain (RBD) binding IgG antibodies [ Time Frame: Days 0, 14, 90, and 180 ]
  As measured by ELISA
• Geometric mean fold rise (GMFR) for receptor-binding domain (RBD) binding IgG antibodies [ Time Frame: 14 days after the booster dose ]
  As measured by ELISA
• Geometric mean concentration (GMC) for SARS-CoV-2 neutralizing antibodies [ Time Frame: Days 0, 14, 90, and 180 ]
  As measured by ELISA
• Geometric mean fold rise (GMFR) for SARS-CoV-2 neutralizing antibodies [ Time Frame: 14 days after the booster dose ]
  As measured by ELISA
• Change in T-cell IFN-γ secretion from baseline to 14 days after the booster dose [ Time Frame: Days 0 and 14 ]
  As measured by IGRA

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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)

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:

1. A booster dose of the SpikoGen COVID-19 vaccine is safe and tolerable in adult subjects.
2. A booster dose of the SpikoGen COVID-19 vaccine induces strong immunogenicity against SARS-CoV-2 in adult subjects.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Prevention
• Condition: COVID-19

Intervention

• Biological: SARS-CoV-2 recombinant spike protein + Advax-SM adjuvant
  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
  Other Name: COVAX-19
• Biological: Saline placebo
  0.9% sodium chloride (1 mL); a single intramuscular injection into the deltoid muscle of the non-dominant arm

Study Arms

• Experimental: SpikoGen COVID-19 Vaccine
  Intervention: Biological: SARS-CoV-2 recombinant spike protein + Advax-SM adjuvant
• Placebo Comparator: Saline Placebo
  Intervention: Biological: Saline placebo

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 3, 2022): 300
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: June 20, 2022
• Actual Primary Completion Date: December 30, 2021 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Iran, Islamic Republic of

Administrative Information

• NCT Number: NCT05175625
• Other Study ID Numbers: VAC.CIN.PT.BOOSTER; IRCT20150303021315N26 ( Registry Identifier: Iranian Registry of Clinical Trials )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Cinnagen
• Original Responsible Party: Same as current
• Current Study Sponsor: Cinnagen
• Original Study Sponsor: Same as current
• Collaborators: Vaxine Pty Ltd

Investigators

• Principal Investigator: Payam Tabarsi, M.D.; Shahid Beheshti University of Medical Sciences

• PRS Account: Cinnagen
• Verification Date: October 2022