evaluate efficacy and safety of SpikoGen® vaccine on healthy adults to prevent COVID-19 disease

Phase 2

Recruiting

• Conditions: COVID-19.; COVID-19, virus identified; U07.1

• Registration Number: IRCT20150303021315N23
• Lead Sponsor: CinnaGen Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 12 July 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 400

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.
Subjects who have received or intend to receive any blood / plasma or immunoglobulin products 90 days prior to the screening visit.
Subjects with special circumstances who, may increase the risk of participating in the study or interfering with the evaluation of the primary endpoints of the study according to researcher's opinion.
Subjects who have donated =450 ml of blood or blood products 28 days prior to the screening visit.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Occurrence of solicited adverse events. Timepoint: Up to 7 days after each dose. Method of measurement: Checkup, history checking and participants reports based on adverse event reporting system.;Occurrence of unsolicited adverse events. Timepoint: Up to 28 days after each dose. Method of measurement: Checkup, history checking and participants reports based on adverse event reporting system.;Evaluation of seroconversion for IgG against S protein. Timepoint: On days 21 and 35. Method of measurement: ELISA and statistical analysis.;GMC measurement for IgG-binding antibody (bAb) against protein S. Timepoint: On days 0, 21 and 35. Method of measurement: ELISA and statistical analysis.