Homologous versus Heterologous prime-boost COVID-19 Vaccination in autologous hematopoietic stem cell transplantation recipients: a blinded randomized controlled trial

Background/PurposeOptimizing 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 vacc...

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Main Authors: Leyla Sharifi Aliabadi, Manoochehr Karami, Maryam Barkhordar, Seyed Saeed Hashemi Nazari, Amir Kavousi, Mohammad Ahmadvand, Mohammad Vaezi
Format: Article
Language:English
Published: Frontiers Media S.A. 2023-08-01
Series:Frontiers in Immunology
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Online Access:https://www.frontiersin.org/articles/10.3389/fimmu.2023.1237916/full
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author Leyla Sharifi Aliabadi
Manoochehr Karami
Manoochehr Karami
Maryam Barkhordar
Seyed Saeed Hashemi Nazari
Amir Kavousi
Mohammad Ahmadvand
Mohammad Vaezi
Mohammad Vaezi
author_facet Leyla Sharifi Aliabadi
Manoochehr Karami
Manoochehr Karami
Maryam Barkhordar
Seyed Saeed Hashemi Nazari
Amir Kavousi
Mohammad Ahmadvand
Mohammad Vaezi
Mohammad Vaezi
author_sort Leyla Sharifi Aliabadi
collection DOAJ
description Background/PurposeOptimizing 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.MethodsIn 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.ResultsSixty-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 prime-boost 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.ConclusionIn 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.
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spelling doaj.art-c4d580ed5ea7477ca3d3f356d5f6a89e2023-08-01T12:31:55ZengFrontiers Media S.A.Frontiers in Immunology1664-32242023-08-011410.3389/fimmu.2023.12379161237916Homologous versus Heterologous prime-boost COVID-19 Vaccination in autologous hematopoietic stem cell transplantation recipients: a blinded randomized controlled trialLeyla Sharifi Aliabadi0Manoochehr Karami1Manoochehr Karami2Maryam Barkhordar3Seyed Saeed Hashemi Nazari4Amir Kavousi5Mohammad Ahmadvand6Mohammad Vaezi7Mohammad Vaezi8Department of Epidemiology, School of Public Health and Safety, Shahid Beheshti University of Medical Sciences, Tehran, IranDepartment of Epidemiology, School of Public Health and Safety, Shahid Beheshti University of Medical Sciences, Tehran, IranEnvironmental and Occupational Hazards Control Research Center, Shahid Beheshti University of Medical Sciences, Tehran, IranCell Therapy and Hematopotic Stem Cell Transplantation Research Center, Research Institute for Oncology, Hematology and Cell Therapy, Tehran University of Medical Sciences, Tehran, IranDepartment of Epidemiology, School of Public Health and Safety, Shahid Beheshti University of Medical Sciences, Tehran, IranDepartment of Epidemiology, School of Public Health and Safety, Shahid Beheshti University of Medical Sciences, Tehran, IranCell Therapy and Hematopotic Stem Cell Transplantation Research Center, Research Institute for Oncology, Hematology and Cell Therapy, Tehran University of Medical Sciences, Tehran, IranCell Therapy and Hematopotic Stem Cell Transplantation Research Center, Research Institute for Oncology, Hematology and Cell Therapy, Tehran University of Medical Sciences, Tehran, IranHematology, Oncology and Stem Cell Transplantation Research Center, Tehran University of Medical Sciences, Tehran, IranBackground/PurposeOptimizing 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.MethodsIn 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.ResultsSixty-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 prime-boost 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.ConclusionIn 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.https://www.frontiersin.org/articles/10.3389/fimmu.2023.1237916/fullSARS-CoV-2heterologous prime boost COVID-19 vaccinationhematopoietic stem cell transplantationRBD subunit vaccineinactivated vaccinesimmunogenicity
spellingShingle Leyla Sharifi Aliabadi
Manoochehr Karami
Manoochehr Karami
Maryam Barkhordar
Seyed Saeed Hashemi Nazari
Amir Kavousi
Mohammad Ahmadvand
Mohammad Vaezi
Mohammad Vaezi
Homologous versus Heterologous prime-boost COVID-19 Vaccination in autologous hematopoietic stem cell transplantation recipients: a blinded randomized controlled trial
Frontiers in Immunology
SARS-CoV-2
heterologous prime boost COVID-19 vaccination
hematopoietic stem cell transplantation
RBD subunit vaccine
inactivated vaccines
immunogenicity
title Homologous versus Heterologous prime-boost COVID-19 Vaccination in autologous hematopoietic stem cell transplantation recipients: a blinded randomized controlled trial
title_full Homologous versus Heterologous prime-boost COVID-19 Vaccination in autologous hematopoietic stem cell transplantation recipients: a blinded randomized controlled trial
title_fullStr Homologous versus Heterologous prime-boost COVID-19 Vaccination in autologous hematopoietic stem cell transplantation recipients: a blinded randomized controlled trial
title_full_unstemmed Homologous versus Heterologous prime-boost COVID-19 Vaccination in autologous hematopoietic stem cell transplantation recipients: a blinded randomized controlled trial
title_short Homologous versus Heterologous prime-boost COVID-19 Vaccination in autologous hematopoietic stem cell transplantation recipients: a blinded randomized controlled trial
title_sort homologous versus heterologous prime boost covid 19 vaccination in autologous hematopoietic stem cell transplantation recipients a blinded randomized controlled trial
topic SARS-CoV-2
heterologous prime boost COVID-19 vaccination
hematopoietic stem cell transplantation
RBD subunit vaccine
inactivated vaccines
immunogenicity
url https://www.frontiersin.org/articles/10.3389/fimmu.2023.1237916/full
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