A Clinical trial of Omicron-Based CovIran Barkat vaccine as a third injection dose in vaccinated population over 18 years of age

Phase 3

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

• Registration Number: IRCT20171122037571N4
• Lead Sponsor: SHIFAPHARMED Industrial Group Co

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

Aged over 18 years old
In the volunteer’s vaccination history, the interval between the first and second dose is between 4 to 8 weeks and at least 3 months and at most 5 months have passed since the injection of the second dose of the volunteer's vaccination.
The volunteer must be able and willing to cooperate with the researchers throughout the study period.
The volunteer must be able to fully understand the executive processes of the study and to understand the explanations of the facilitators correctly.
The volunteer would be able to understand the contents of the informed consent form and sign the informed consent before recruitment.
Access to the medical records and test results if hospitalised for any reason including due to the suspected or confirmed COVID-19 should be allowed.
The volunteer has been in a medically stable condition for the past three months (he/she has not been hospitalized, his / her chronic illness has not recurred). His / her chronic illness medication instructions have not changed due to lack of control over clinical symptoms, etc.)

Exclusion Criteria

Confirmed, suspected, or asymptomatic COVID-19 case
Candidate with a history of SARS-CoV-2 infection (documented rtPCR) after receiving the second dose of COVID-19 vaccine.
During the period of home quarantine due to Covid-19 (suspicion of exposure or suspicious symptoms).
In the 14 days prior to vaccination: fever or presence of at least two symptoms from Dry cough, severe fatigue, nasal congestion, runny nose, sore throat, myalgia, diarrhoea, dyspnea, and shortness of breath
History of severe allergic reaction, urticaria or allergic reactions to COVID-19 Inactivated vaccine ingredients (allergic to Aluminium).
Personal or family history of seizure, epilepsy, encephalopathy or psychiatric disorders
Presence of congenital malformations or any genetic disorder
Presence of any malignancy
Known case of immunodeficiency, HIV, lymphoma, leukemia, or other autoimmune diseases.
Receiving immunosuppressive drugs or corticosteroids in the last 6 months
Splenectomy or history of any organ removal
History of coagulation disorders
History of hereditary and acquired angioedema over the past year
Receiving Anti-TB treatment
Positive HBsAg/ Positive HCV antibody
Receiving immunomodulators or immunosuppressors at least for14 days in the past 3 months
Receiving live vaccine in one month or other vaccines in 14 days before inoculation
Receiving immunoglobulins or blood products in 3 months before inoculation
History of severe mental disorders affecting the participation in the study
Women with a positive pregnancy test (Beta HCG in a blood sample) or breastfeeding or those who intend to become pregnant during the study period.
Any other circumstances are other than the above-mentioned ones that the researcher deems inappropriate for a person participating in a clinical trial. These cases are recorded as the reason for not entering.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total IgG titers against Wuhan and Omicron variants (with GMT, GMI). Timepoint: Days 0,14, 90, 180. Method of measurement: ELISA assay.;The neutralization capacity of booster doses against Wuhan and Omicron variants. Timepoint: Days 0,14, 90, 180. Method of measurement: Conventional Virus Neutralization Test (cVNT).