Immunogenicity and safety evaluation of Pastocovac Plus as the booster dose in Iranian adults aged from 18 to 80 who received two doses of Sinopharm and Astrazeneca

Pasture Institute of Iran0 个研究点目标入组 190 人开始时间: 待定最近更新: 2022年3月8日

适应症

试验速览

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•Signed informed written consent
•Able to follow the vaccination schedules, visits and tests
•General health and controlled underlying diseases (based on the physician's recommendation)
•Iranian citizenship
•Resident in Tehran
•Both sexes (male and female)
•Aged above 18 years
•Receiving 2 doses of Sinopharm vaccine with 28±5 days interval
•Receiving 2 doses of Astrazeneca vaccine with 3 to 4 months interval
•All candidates whose second vaccination either Sinopharm or Astrazeneca was done 3 to 6 prior to enrollment.

•Having a history of vaccination against Covid-19 with other available vaccines
•History of COVID-19 based on laboratory or clinical evidence after receiving the vaccine
•History of any vaccinations except COVID-19 within 3 months prior to enrollment
•Pregnant or breastfeeding women or those who intend to become pregnant up to 3 months after the booster dose injection.
•Having uncontrolled hypertension (cytological pressure greater than 140 or diastolic pressure greater than 90 mm Hg)
•History of receiving blood or blood products such as immunoglobulin in the last three months
•Suffering from chronic kidney disease (GFR less than 30)
•Suffering from chronic liver disease (liver enzymes more than 5 times normal: 150ALT=, 100AST=)
•Suffering from uncontrolled asthma (Having had an asthma attack in the last three months)
•History of severe allergic reaction (anaphylaxis) to the vaccine during a person's lifetime
•History of treatment with immunosuppressive drugs 1 month before the booster injection (including oral and inhaled steroids (does not include topical steroids), cytostatic, interferon, immunoferon, transfer factor, Biomodulin T, any type of gammaglobin, levamisole , Heberferon, thymosin or any other immunomodulatory drug (including patients taking the above drugs due to an underlying disease).
•Having a fever or acute illness during the 7 days before the injection or on the day of the booster injection
•Suffering from an unstable heart disease

发起方

Pasture Institute of Iran