IRCT20150303021315N23
Recruiting
Phase 2
A phase II, Randomized, Two-armed, Double-blind, Placebo controlled trial to evaluate efficacy and safety of an adjuvanted recombinant SARS-CoV-2 spike (S) protein subunit vaccine (SpikoGen®) produced by CinnaGen Co. (Two doses of 25µg with dosing interval of 21 days)
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- COVID-19.
- Sponsor
- CinnaGen Company
- Enrollment
- 400
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Men or women \=18 years
- •Participants who are willing and able to comply with study requirements, including all scheduled visits, vaccinations and tests
- •Healthy adults or adults with stable medical conditions.
- •Women eligible to participate in the study who are not pregnant or breastfeeding.
Exclusion Criteria
- •Subjects with active infection with SARS\-COV\-2 signs at the screening visit.
- •Subjects with body temperature equal or more than 38 degrees centigrade, during 72 hours before screening visit or at the visit.
- •Subjects with any progressive or severe neurological disorder, seizures, or a history of Guillain\-Barre syndrome.
- •Subjects who receive immunosuppressive or cytotoxic medications.
- •Pregnant women, or breastfeeding mothers, or women who plan to become pregnant during the study.
- •Subjects who have a history of severe allergic reactions (e.g. anaphylaxis) to the study vaccine or any components of the vaccine or any other drugs.
- •Subjects who have received any other investigational product within 30 days prior to the screening visit or intend to participate in other clinical studies during this trial.
- •Subjects who have been vaccinated with other vaccines against the SARS\-CoV\-2 virus.
- •Subjects who received other authorized vaccines within 28 days prior to the screening visit in this study or intend to receive any vaccines up to 14 days after the second vaccination.
- •Subjects who have any known bleeding disorder or may have problems with the intramuscular injection according to the researcher's opinion.
Outcomes
Primary Outcomes
Not specified
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