COVID-19 trials registries data warehouse

http://en.irct.ir/trial/62108

Dr.Alireza Biglari

biglari63@hotmail.com

2022-02-26

Completed

nonRCT

Non-randomized

Parallel

Open label

single-center

Prevention

Signed written informed consent Able to follow the vaccination schedules, visits and tests General health or having controlled underlying diseases (based on the physician's diagnosis) Iranian citizenship Residents of Tehran Both sexes (male and female) Aged 18-80 years Receiving the initial 2 doses of Sinopharm within a 28±5 days interval Completion of the 2-dose Sinopharm vaccination course within 3-6 months prior enrollment.

Having a history of vaccination against Covid-19 with other vaccines (in addition to 2 doses of Sinopharm) History of COVID-19 based on laboratory or clinical evidence after receiving 2 doses of Sinopharm 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 Lifetime history of severe allergic reactions (anaphylaxis) to the vaccine Coagulation disorders that contraindicate with intramuscular injection 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

3

Pasture Institute of Iran

18

80

Iran

Healthy volunteers

N/A

225

Increased Anti-Spike headline Increased Anti RBD headline Increased cVNT headline

Not reported

[{"arm_notes": "", "treatment_id": 2438, "treatment_name": "Pastocovac", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 2439, "treatment_name": "Pastocovac-plus", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 1923, "treatment_name": "Inactivated sars-cov-2 vaccine (vero cell)", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}]