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

NCT ID: NCT05175625

Last Updated: 2022-10-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-15
• Study Completion Date: 2022-06-20

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.

Conditions

COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

SpikoGen COVID-19 Vaccine

Group Type: EXPERIMENTAL

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

Intervention Type: 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

Saline Placebo

Group Type: PLACEBO_COMPARATOR

Saline placebo

Intervention Type: BIOLOGICAL

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

Interventions

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

Intervention Type: BIOLOGICAL

Saline placebo

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

Intervention Type: BIOLOGICAL

Other Intervention Names

COVAX-19

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vaxine Pty Ltd

INDUSTRY

Sponsor Role: collaborator

Cinnagen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Payam Tabarsi, M.D.

Role: PRINCIPAL_INVESTIGATOR

Shahid Beheshti University of Medical Sciences

Locations

Orchid Life Department, Orchid Pharmed Company

Tehran, , Iran

Countries

Iran

References

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.

Reference Type: RESULT

PMID: 35758850 (View on PubMed)

Other Identifiers

IRCT20150303021315N26

Identifier Type: REGISTRY

Identifier Source: secondary_id

VAC.CIN.PT.BOOSTER

Identifier Type: -

Identifier Source: org_study_id