Clin Infect Dis . Antibody response in immunocompromised patients after the administration of SARS-CoV-2 vaccine BNT162b2 or mRNA-1273: A randomised controlled trial

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Clin Infect Dis


. 2022 Mar 2;ciac169.
doi: 10.1093/cid/ciac169. Online ahead of print.
Antibody response in immunocompromised patients after the administration of SARS-CoV-2 vaccine BNT162b2 or mRNA-1273: A randomised controlled trial


Benjamin Speich ^{1 2} , Frédérique Chammartin ¹ , Irene A Abela ^{3 4} , Patrizia Amico ⁵ , Marcel P Stoeckle ⁶ , Anna L Eichenberger ⁷ , Barbara Hasse ⁴ , Dominique L Braun ³ , Macé M Schuurmans ⁸ , Thomas F Müller ⁹ , Michael Tamm ¹⁰ , Annette Audigé ³ , Nicolas J Mueller ⁴ , Andri Rauch ⁷ , Huldrych F Günthard ^{3 4} , Michael T Koller ⁵ , Alexandra Trkola ³ , Matthias Briel ^{1 11} , Katharina Kusejko ^{3 4} , Heiner C Bucher ¹² , Swiss HIV Cohort Study and the Swiss Transplant Cohort Study



Affiliations

• PMID: 35234868
• DOI: 10.1093/cid/ciac169

Abstract

Background: BNT162b2 by Pfizer-BioNTech and mRNA-1273 by Moderna are the most commonly used vaccines to prevent SARS-CoV-2 infections. Head-to-head comparison of the efficacy of these vaccines in immunocompromised patients is lacking.
Methods: Parallel, two-arm (allocation 1:1), open-label, non-inferiority randomised clinical trial nested into the Swiss HIV Cohort Study and the Swiss Transplant Cohort Study. Patients living with HIV (PLWH) or solid organ transplant recipients (SOTR; i.e. lung and kidney) from these cohorts were randomised to mRNA-1273 or BNT162b2. The primary endpoint was antibody response to SARS-CoV-2 spike (S1) protein receptor binding domain (Elecsys Anti-SARS-CoV-2 immunoassay, Roche; cut-off ≥0.8 units/ml) 8 weeks after second vaccination. In addition, antibody response was measured with the Antibody CORonavirus Assay 2 (ABCORA 2).
Results: 430 patients were randomised and 412 were included in the intention-to-treat analysis (341 PLWH and 71 SOTR). The percentage of patients showing an immune response was 92.1% (95% confidence interval [CI] 88.4-95.8%; 186/202) for mRNA-1273 and 94.3% (95% CI 91.2-97.4; 198/210) for BNT162b2 (difference: 2.2%; 95% CI -7.1 to 2.7), fulfilling non-inferiority of mRNA-1273. With the ABCORA 2 test 89.1% had an immune response to mRNA-1273 (95% CI 84.8-93.4%; 180/202) and 89.5% to BNT162b2 (95% CI 85.4-93.7%; 188/210). Based on the Elecsys test, all PLWH had an antibody response (100.0%; 341/341), while for SOTR only 60.6% (95% CI 49.2-71.9%; 43/71) had titres above the cut-off.
Conclusions: In immunocompromised patients the antibody response of mRNA-1273 was non-inferior to BNT162b2. PLWH had in general an antibody response, while a high proportion of SOTR had no antibody response.

Keywords: HIV; Organ transplant; Platform trial; Randomised controlled trial; SARS-CoV-2; Vaccine.