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

PHASE3CompletedINTERVENTIONAL
Enrollment

300

Participants

Timeline

Start Date

December 15, 2021

Primary Completion Date

December 30, 2021

Study Completion Date

June 20, 2022

Conditions
COVID-19
Interventions
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

BIOLOGICAL

Saline placebo

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

Trial Locations (1)

Unknown

Orchid Life Department, Orchid Pharmed Company, Tehran

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Vaxine Pty Ltd

INDUSTRY

lead

Cinnagen

INDUSTRY