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IRCT20171122037571N4 IRCT 2022-02-26 SHIFAPHARMED Industrial Group Co A Clinical trial of Omicron-Based CovIran Barkat vaccine as a third injection dose in vaccinated population over 18 years of age A Clinical trial to evaluate the immunogenicity and safety of Omicron-Based CovIran Barkat vaccine as a third injection dose in vaccinated population over 18 years of age 2022-02-26 anticipated 210 Complete https://irct.ir/trial/62022 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention. 3 COVID-19 disease. Intervention 1: Group of recipients of the third injection of CovIran Barkat vaccine of Wuhan strain, with a history of receiving two doses of CovIran Barkat vaccine. Intervention 2: Group of recipients of the third injection of CovIran Barkat vaccine of Omicron strain, with a history of receiving two doses of CovIran Barkat vaccine. Intervention 3: Group of recipients of the third injection of CovIran Barkat vaccine of Omicron strain, with a history of receiving two doses of Sinopharm vaccine. Yes - There is a plan to make this available What will be shared: De-identified, individual participant data will be made available upon requests directed to the corresponding author; after the approval of a proposal, data can be shared through a secure online platform. When: Access will be granted after publishing the results To whom: Anyone who requests Conditions: Categorization and reanalysis of data is permitted. The publication of analysis results is possible only with the permission of the corresponding author of the article. Where to obtain: Requests directed to the corresponding author How to obtain: Request from the corresponding author, granting access to anonymized data in one month Comments:
public Hasan Jalili
Soha St., Shifa St., Mapna Blv
kordan Iran (Islamic Republic of) 1417993337 +98 21 9109 0245 hjalili@ut.ac.ir SHIFAPHARMED Industrial Group Co scientific Minoo Mohraz
AIDS research center, Tehran University of Medical Sciences
Tehran Iran (Islamic Republic of) 1417993337 +98 21 6658 1583 minoomohraz@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) 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.) 18 years no limit Both 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. U07.1 COVID-19, virus identified Prevention Prevention Prevention Group of recipients of the third injection of CovIran Barkat vaccine of Wuhan strain, with a history of receiving two doses of CovIran Barkat vaccine Group of recipients of the third injection of CovIran Barkat vaccine of Omicron strain, with a history of receiving two doses of CovIran Barkat vaccine Group of recipients of the third injection of CovIran Barkat vaccine of Omicron strain, with a history of receiving two doses of Sinopharm vaccine 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). Any immediate reaction after inoculation. Timepoint: 0-30 minutes after inoculation. Method of measurement: Close observation. Percentage of local reactions (pain, redness, swelling, ....in injection site). Timepoint: Days 0 to 7 after each inoculation. Method of measurement: Examination, history, and report of the study participant based on the Vaccine Adverse Event Reporting System. Percentage of systemic events (fever, headache, chills, nausea, vomiting, diarrhoea, fatigue, muscle pain, arthralgia, ....). Timepoint: Days 0 to 7 after inoculation. Method of measurement: Examination, history, and report of the study participant based on the Vaccine Adverse Event Reporting System. Occurrence of any adverse event (serious or non-serious). Timepoint: Days 0 to 7 after inoculation. Method of measurement: Examination, history, and report of the study participant based on the Vaccine Adverse Event Reporting System. Occurrence of any systemic events. Timepoint: Days 0 to 180 after inoculation. Method of measurement: Examination, history, and report of the study participant based on the Vaccine Adverse Event Reporting System. Occurrence of any adverse event (serious or non-serious). Timepoint: Days 0 to 180 after inoculation. Method of measurement: Examination, history, and report of the study participant based on the Vaccine Adverse Event Reporting System. Occurrence and the severity of SARS-COV-2 infection. Timepoint: Till 180 days after inoculation. Method of measurement: Comparing confirmed COVID-19 cases, severity status is categorised as non-severe, severe, and critical based on the WHO diagnosis scheme. SHIFAPHARMED Industrial Group Co Approved 2022-02-22 National research ethics committee 13th floor, Block A, Ministry of health, Simaye Iran street, Shahrake ghods(qarb) Tehran Tehran Iran (Islamic Republic of)