Antibody Response in Immunocompromised Patients After the Administration of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Vaccine BNT162b2 or mRNA-1273: A Randomized Controlled Trial.

Abstract

BACKGROUND:

BNT162b2 by Pfizer-BioNTech and mRNA-1273 by Moderna are the most commonly used vaccines to prevent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections. Head-to-head comparison of the efficacy of these vaccines in immunocompromised patients is lacking.

METHODS:

Parallel, 2-arm (allocation 1:1), open-label, noninferiority randomized clinical trial nested into the Swiss HIV Cohort Study and the Swiss Transplant Cohort Study. People living with human immunodeficiency virus (PLWH) or solid organ transplant recipients (SOTR; ie, lung and kidney) from these cohorts were randomized 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; cutoff ≥0.8 units/mL) 12 weeks after first vaccination (ie, 8 weeks after second vaccination). In addition, antibody response was measured with the Antibody Coronavirus Assay 2 (ABCORA 2).

RESULTS:

A total of 430 patients were randomized 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 noninferiority 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), whereas for SOTR, only 60.6% (95% CI: 49.2-71.9; 43/71) had titers above the cutoff level.

CONCLUSIONS:

In immunocompromised patients, the antibody response of mRNA-1273 was noninferior to BNT162b2. PLWH had in general an antibody response, whereas a high proportion of SOTR had no antibody response.

• Authors: Benjamin Speich, Frédérique Chammartin, Irene A Abela, Patrizia Amico, Marcel P Stoeckle, Anna L Eichenberger, Barbara Hasse, Dominique L Braun, Macé M Schuurmans, Thomas F Müller, Michael Tamm, Annette Audigé, Nicolas J Mueller, Andri Rauch, Huldrych F Günthard, Michael T Koller, Alexandra Trkola, Matthias Briel, Katharina Kusejko, Heiner C Bucher, Swiss HIV Cohort Study and the Swiss Transplant Cohort Study
• Journal: Clinical infectious diseases : an official publication of the Infectious Diseases Society of America (Clin Infect Dis) Vol. 75 Issue 1 Pg. e585-e593 (08 24 2022) ISSN: 1537-6591 [Electronic] United States
• PMID: 35234868 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © The Author(s) 2022. Published by Oxford University Press for the Infectious Diseases Society of America.

Chemical References

• Antibodies, Viral
• Viral Envelope Proteins
• Viral Vaccines
• 2019-nCoV Vaccine mRNA-1273
• BNT162 Vaccine

Topics

• 2019-nCoV Vaccine mRNA-1273
• Antibodies, Viral
• BNT162 Vaccine
• COVID-19 (prevention & control)
• Cohort Studies
• Humans
• Immunocompromised Host
• SARS-CoV-2
• Viral Envelope Proteins (genetics, metabolism)
• Viral Vaccines