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 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.

Determinants of antibody response to severe acute respiratory syndrome coronavirus 2 mRNA vaccines in people with HIV

“…Hence, nuanced assessment of antibody development to SARS-CoV-2 vaccines is critical for understanding the most important determinants of humoral immune response and for protecting patients at risk of not developing adequate vaccine response. In this post hoc analysis of our trial data [3], we investigated factors that influence the antibody response to both mRNA vaccines in people with HIV (PWH).…”

“…Following the approval of Pfizer-BioNTech (BNT162b2; Comirnaty) and Moderna (mRNA-1273; Spikewax) vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by Swiss health authorities, the Swiss HIV Cohort Study (SHCS) [1] and the Swiss Transplant Cohort Study (STCS) rapidly joined forces and built a trial platform embedded in the two cohorts [2,3] that monitors vaccine efficacy and investigates the antibody response in immuno-compromised patients. The continuous emergence of divergent variants requires increased antibody titers to establish vaccine efficacy [4][5][6].…”

Developing and testing a Corona VaccinE tRiAL pLatform (COVERALL) to study Covid-19 vaccine response in immunocompromised patients

“…Of the 430 patients, 412 could be included into the intention-to-treat dataset for the main analysis, i.e., comparing the two vaccines. The results of this pilot study, including detailed characteristics of the study population, were published on March 2nd 2022 [ 26 ]. In addition, data collected in the COVERALL pilot trial were merged back to data collected in the SHCS.…”

Advances in Research on COVID-19 Vaccination for People Living with HIV

“…[ 47 ] However, several studies have shown that PLWH receiving two doses of mRNA-1273 have a greater neutralizing humoral response than PLWH receiving two doses of BNT162b2. [ 38 , 48 , 49 ] Moreover, a recent study described a higher risk of SARS-CoV-2 breakthrough in PLWH with BNT162b2 (Pfizer-BioNTech), with an increased risk of breakthroughs of 2.6% and 1.7% for mRNA BNT162b2 and mRNA-1273 vaccines, respectively, in PLWH than in HIV-uninfected individuals. [ 50 ] Among PLWH, the cumulative incidence and relative risks of breakthroughs were not significantly different based on CD4 + T cell count or HIV viral load suppression.…”