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Randomized Controlled Trial
. 2023 Aug 1:14:1237916.
doi: 10.3389/fimmu.2023.1237916. eCollection 2023.

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

Leyla Sharifi Aliabadi  1 , Manoochehr Karami  1   2 , Maryam Barkhordar  3 , Seyed Saeed Hashemi Nazari  1 , Amir Kavousi  1 , Mohammad Ahmadvand  3 , Mohammad Vaezi  3   4
Affiliations
Randomized Controlled Trial

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

Leyla Sharifi Aliabadi et al. Front Immunol. .

Abstract

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.

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 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.

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: RBD subunit vaccine; SARS-CoV-2; hematopoietic stem cell transplantation; heterologous prime boost COVID-19 vaccination; immunogenicity; inactivated vaccines.

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Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

Figure 1
Figure 1
Flowchart of the randomized controlled trial. The chart depicts the subjects screened before the study, those recruited for Vaccination, and the processes for selecting or excluding patients.
Figure 2
Figure 2
Scatter plot of the SARS-CoV-2 IgG immune status ratio in homologous and heterologous prime-boost arms before and after the booster dose in autologous hematopoietic stem cell transplant recipients.
Figure 3
Figure 3
Reactogenicity adverse events up to 7 days after homologous and heterologous boosting in autologous hematopoietic stem cell transplant recipients.
Figure 4
Figure 4
Graphical display of immunity predictors after a SARS-CoV-2 booster dose in autologous hematopoietic stem cell transplant recipients.
See this image and copyright information in PMC

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