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

NCT05175625 | Completed Phase 3

• 2 other identifiers: VAC.CIN.PT.BOOSTERIRCT20150303021315N26
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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

Conditions

COVID-19

Keywords

COVID-19; SARS-CoV-2; Recombinant protein; Spike; Advax-SM; Advax; Vaccine; Adjuvant

Outcome Measures

Primary Outcomes (1)

• Percentage of participants with seroconversion for SARS-CoV-2 neutralizing antibodies

  As measured by ELISA

  14 days after the booster dose

Secondary Outcomes (12)

• Incidence of solicited adverse events

  For 7 days after the booster dose

• Incidence of unsolicited adverse events

  For 14 days after the booster dose

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

  For 6 months after the booster dose

• Geometric mean concentration (GMC) for S1 binding IgG antibodies

  Days 0, 14, 90, and 180

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

  14 days after the booster dose

Study Arms (2)

SpikoGen COVID-19 Vaccine

EXPERIMENTAL

Biological: SARS-CoV-2 recombinant spike protein + Advax-SM adjuvant

Saline Placebo

PLACEBO COMPARATOR

Biological: Saline placebo

Interventions

SARS-CoV-2 recombinant spike protein + Advax-SM adjuvant BIOLOGICAL

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

Also known as: COVAX-19

SpikoGen COVID-19 Vaccine

Saline placebo BIOLOGICAL

0.9% sodium chloride (1 mL); a single intramuscular injection into the deltoid muscle of the non-dominant arm

Saline Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cinnagen: lead
• Vaxine Pty Ltd: collaborator

Study Sites (1)

Orchid Life Department, Orchid Pharmed Company

Tehran, Iran

Location

Related Publications (1)

• 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.

  PMID: 35758850 RESULT

MeSH Terms

Conditions

COVID-19

Interventions

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

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory 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: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2022
• First Posted: January 4, 2022
• Study Start: December 15, 2021
• Primary Completion: December 30, 2021
• Study Completion: June 20, 2022
• Last Updated: October 14, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)