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IRCT20140818018842N24 IRCT 2022-07-22 Tehran University of Medical Sciences Evaluation of the serological response to booster vaccinationin in patients receiving autologous hematopoietic stem cell transplantation Evaluation of the serological response to the heterologous versus homologous booster vaccinationin in patients receiving autologous hematopoietic stem cell transplantation 2022-07-22 anticipated 90 Complete https://irct.ir/trial/64741 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Assigning to the study groups is a parallel; group A is considered the intervention group of homologous vaccine (Pastocovac vaccine), and group B is the intervention group of heterologous vaccine (Sinopharm vaccine). The balanced block randomization list will be generated through the research institute's web-based software; after entering the sample size 90 and considering the block size of 4, according to this balanced block randomization list, a sequence of numbers is created, and this sequence of numbers is defined in the system. If the patients meet the criteria of the study after obtaining informed consent, their national code will be entered into the system, and the software will announce the code of each patient. Patients receive one of two vaccines randomly, Blinding description: Due to ethical considerations, a placebo arm will not be used. 10-dose vials of both types of vaccines are given to a person outside the research team. At pre-determined times when some patients come to inject a booster dose, each vial of 10-dose Sinopharm or Pastocococ vaccine is poured into ten insulin syringes as a single dose by the responsible person and is coded by the sequence of numbers according to a random list and considering the cold chain. The code label has already been prepared and is provided to that person. Coded vaccine syringes will be placed in a special refrigerator at a temperature of 2-4 degrees until the time of injection, which should be half an hour. Apart from the above person, all the research team members, including the Care provider, the person responsible for injecting the vaccine, the person responsible for collecting information, the analyst, and the patient, are not aware of the type of vaccine. 2-3 Condition 1: Multiple myeloma. Condition 2: Non-Hodgkin lymphoma. Condition 3: Hodgkin lymphoma. Condition 4: Myelodysplastic syndrome. Intervention 1: Intervention group 1: injection of one homologous booster dose of Pastocovac 4 weeks (±7 days) after receiving two doses of primary Pastocovac vaccine, that is injected intramuscularly 0.5 ml into the deltoid muscle. Intervention 2: Intervention group 2: injection of one heterologous booster dose of Sinopharm 4 weeks (±7 days) after receiving two doses of primary Pastocovac vaccine, that is injected intramuscularly 0.5 ml into the deltoid muscle. https://www.frontiersin.org/articles/10.3389/fimmu.2023.1237916/full Background/Purpose: Optimizing vaccine efficacy is of particular concern in patients undergoing hematopoietic stem cell transplantation (HSCT), which mainly have an inadequate immune response to primary SARS-CoV-2 vaccination. This investigation aimed to explore the potential prime-boost COVID-19 vaccination strategies following autologous (auto-) HSCT. Methods: In a randomized clinical trial, patients who had already received two primary doses of receptor-binding domain (RBD) tetanus toxoid (TT) conjugated SARS-CoV-2 vaccine during three to nine months after auto-HSCT were randomized to receive either a homologous RBD-TT conjugated or heterologous inactivated booster dose four weeks after the primary vaccination course. The primary outcome was comparing the anti-S IgG Immune status ratio (ISR) four weeks after the heterologous versus homologous booster dose. The assessment of safety and reactogenicity adverse events was considered as the secondary outcome.(IRCT Id IRCT20140818018842N24) Results: Sixty-one auto-HSCT recipients were recruited and randomly assigned to receive either homologous or heterologous booster doses four weeks after the primary vaccination course. The mean ISR was 3.40 (95% CI: 2.63- 4.16) before the booster dose with a 90.0% seropositive rate. The ISR raised to 5.12 (95% CI: 4.15- 6.08) with a 100% seropositive rate after heterologous (P= 0.0064) and to 3.42 (95% CI: 2.67- 4.17) with a 93.0% seropositivity after the homologous booster doses (P= 0.96). In addition, the heterologous group suffered more AEs following the booster dosage than the homologous group, but this difference was not statistically significant (p = 0.955). In multivariable analysis, the primeboost vaccination strategy (heterologous versus homologous), the level of ISR before the booster dose, and the length of time between auto-HSCT and booster dose were the positive predictors of serologic response to a booster dose. No serious adverse event is attributed to booster vaccination. Conclusion: In patients who were primed with two SARS-CoV-2 vaccine doses during the first year after auto-HSCT, heterologous prime-boost COVID-19 vaccination with inactivated platform resulted in considerably enhanced serologic response and non-significantly higher reactogenicity adverse events than homologous RBD-TT conjugated prime-boost COVID-19 vaccination strategy. KEYWORDS SARS-CoV-2, heterologous prime boost COVID-19 vaccination, hematopoietic stem cell transplantation, RBD subunit vaccine, inactivated vaccines, immunogenicity 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 There is no further information
public Leyla Sharifi Aliabadi
Shariati Hospital, North Kargar Ave.
Tehran Iran (Islamic Republic of) 1411713135 +98 21 8490 2635 ctu@sina.tums.ac.ir Tehran University of Medical Sciences scientific Manoochehr Karami
Shahid Beheshti university of Medical Sciences School of Public Health and Safety, Shahid Shahriari Sq, Yaman St., Shahid Chamran Highway, Tehran, Iran
Tehran Iran (Islamic Republic of) 1983535511 +98 21 2243 2040 man.karami@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Patients who have undergone autologous hematopoietic stem cell transplantation Between 6 months and 12 months after transplantation They have received two initial doses of Pastocovac vaccine At least one month after receiving the second dose 18 years 65 years Both Treatment with rituximab during last 6 months Relapse of underlying disease Positive rapid COVID-19 test before booster dose vaccination Patients who do not consent to vaccination C90 C81 C81 D46 Multiple myeloma and malignant plasma cell neoplasms Hodgkin lymphoma Hodgkin lymphoma Myelodysplastic syndromes Treatment - Other Treatment - Other Intervention group 1: injection of one homologous booster dose of Pastocovac 4 weeks (±7 days) after receiving two doses of primary Pastocovac vaccine, that is injected intramuscularly 0.5 ml into the deltoid muscle Intervention group 2: injection of one heterologous booster dose of Sinopharm 4 weeks (±7 days) after receiving two doses of primary Pastocovac vaccine, that is injected intramuscularly 0.5 ml into the deltoid muscle SARS-CoV-2 antibody titers. Timepoint: before the start of the intervention and 4 weeks (±7 days) after the injection of the booster dose vaccine. Method of measurement: ChemoBind SARS-CoV-۲ IgG Test. Probable Side effect: local pain, fever, fatigue, headache and sore throat. Timepoint: One week after vaccination. Method of measurement: Vaccine side effects checklist. Tehran University of Medical Sciences Approved 2022-07-04 Ethic committee of Hematology- Oncology and Stem Cell Transplantation Research Center, Tehran Univer Shariati hospital, Kargar shomali Ave Tehran Tehran Iran (Islamic Republic of)