]>
IRCT20131221015878N3 IRCT 2022-01-18 Pasture Institute of Iran Immunogenicity and safety evaluation of Pastocovac Plus in Iranian adults who received two doses of Sinopharm and Astrazeneca 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 2021-12-12 anticipated 190 Complete https://irct.ir/trial/61025 observational Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: It is an observational study; which we follow the immunological response of those who receive an accepted booster vaccine (PastoCovac Plus). N/A Condition 1: Covid-19. Condition 2: Covid-19. Intervention 1: Intervention group: Intervention group: People receiving two doses of Sinopharm as Pastocovac Plus booster. Intervention 2: Intervention group: Intervention group: People receiving two doses of AstraZeneca as a Pastocovac Plus booster. Intervention 3: Intervention group: People receiving two doses of Sinopharm as a Sinopharm booster. Intervention 4: Control group: People receiving two doses of AstraZeneca as AstraZeneca booster. Intervention 5: Control group: People receiving two doses of AstraZeneca as a Pastocovac Plus (Cuba) booster. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is We are preparing our data-sharing plan.
public Sarah Dahmardeh
No. 69, Pasteur Ave., Tehran , Iran
Tehran Iran (Islamic Republic of) 1316943551 +98 21 6695 3311 sarahdahmardeh@gmail.com Pasture Institute of Iran scientific Amitis Ramezani
No.69, Ave pasteur, Tehran, Iran
Tehran Iran (Islamic Republic of) 131693551 +98 21 6411 2812 Amitisramezani@hotmail.com Pasture Institute of Iran Iran (Islamic Republic of) 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. 18 years 80 years Both 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 U11 U07 Need for immunization against COVID-19 COVID-19, virus identified & not identified Prevention Prevention Prevention Prevention Prevention Intervention group: Intervention group: People receiving two doses of Sinopharm as Pastocovac Plus booster. Intervention group: Intervention group: People receiving two doses of AstraZeneca as a Pastocovac Plus booster. Intervention group: People receiving two doses of Sinopharm as a Sinopharm booster. Control group: People receiving two doses of AstraZeneca as AstraZeneca booster. Control group: People receiving two doses of AstraZeneca as a Pastocovac Plus (Cuba) booster. Increased Anti-Spike headline. Timepoint: At the beginning of the study (before the intervention) and one month after the intervention (receiving a booster dose). Method of measurement: Antibody titer with ELISA Kit Anti-SARS-CoV-2 QuantiVac ELISA (IgG) Kit, Euroimmun co. Quadrupling the neutralizing antibody titer. Timepoint: At the beginning of the study (before the intervention) and one month after the intervention (receiving a booster dose). Method of measurement: SARS-CoV-2 Neutralizing Ab Elisa kit. Evaluating safety of Booster dose. Timepoint: During 30 mins till one month after intervention. Method of measurement: Visiting cases(days 0,30) and follow up cases every two weeks by phone call. Pasture Institute of Iran Approved 2021-12-12 Pasteur Institute of Iran (Research Ethics Committee) No. 69, Pasteur Ave., Tehran , Iran Tehran Tehran Iran (Islamic Republic of)