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.
Details
State: Public
Version: Final published version
License: CC BY-NC-ND 4.0
Serval ID
serval:BIB_B952B5300090
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
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.
Journal
Clinical infectious diseases
Working group(s)
Swiss HIV Cohort Study and the Swiss Transplant Cohort Study
Contributor(s)
Aebi-Popp I.A., Anagnostopoulos K., Battegay A., Bernasconi M., Braun E., Bucher D.L., Calmy H.C., Cavassini A., Ciuffi M., Dollenmaier A., Egger G., Elzi M., Fehr L., Fellay J., Furrer J., Fux H., Günthard C.A., Haerry A., Hirsch B., Hoffmann H.H., Hösli M., Huber I., Kahlert M., Keiser L., Klimkait O., Kouyos T., Kovari R.D., Kusejko H., Martinez de Tejada G., Marzolini B., Metzner C., Müller K.J., Nemeth N., Nicca J., Paioni D., Pantaleo P., Perreau G., Rauch M., Speck P., Stöckle R., Trkola P., Wandeler A., Yerly G., Amico P., Axel A., Aubert J.D., Banz V., Sonja B., Beldi G., Berger C., Berishvili E., Binet I., Bochud P.Y., Branca S., Bucher H.C., Carrel T., Catana E., Chalandon Y., De Geest S., De Rougemont O., Dickenmann M., Dreifuss J.L., Duchosal M., Fehr T., Ferrari-Lacraz S., Franscini N., Garzoni C., Soccal P.G., Gaudet C., Golshayan D., Goossens N., Hadaya K., Halter J., Heim D., Hess C., Hillinger S., Hirsch H., Hirt P., Hofbauer G., Huynh-Do U., Immer F., Koller M., Laager M., Laesser B., Lehmann R., Leichtle A., Lovis C., Manuel O., Marti H.P., Martin P.Y., Martinelli M., McLin V., Mellac K., Merçay A., Mettler K., Mueller N., Müller A., Müller-Arndt U., Müllhaupt B., Nägeli M., Oldani G., Pascual M., Posfay-Barbe K., Rick J., Rosselet A., Rossi S., Rothlin S., Ruschitzka F., Schachtner T., Schanz U., Schaub S., Schnyder A., Schuurmans M., Sengstag T., Simonetta F., Stampf S., Steiger J., Stirniman G., Stürzinger U., Van Delden C., Venetz J.P., Villard J., Vionnet J., Wick M., Wilhlem M., Yerly P.
ISSN
1537-6591 (Electronic)
ISSN-L
1058-4838
Publication state
Published
Issued date
24/08/2022
Peer-reviewed
Oui
Volume
75
Number
1
Pages
e585-e593
Language
english
Notes
Publication types: Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
Publication Status: ppublish
Publication Status: ppublish
Abstract
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.
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).
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.
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.
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).
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.
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.
Keywords
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, Viral Envelope Proteins/metabolism, Viral Vaccines, HIV, organ transplant, platform trial, randomized controlled trial, vaccine
Pubmed
Web of science
Open Access
Yes
Create date
26/01/2024 14:02
Last modification date
26/03/2024 8:10
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