scholarly journals Predicting the protective humoral response to a SARS-CoV-2 mRNA vaccine

Author(s):  
Silvia Meschi ◽  
Giulia Matusali ◽  
Francesca Colavita ◽  
Daniele Lapa ◽  
Licia Bordi ◽  
...  

Abstract Objectives Simple and standardized methods to establish correlates to vaccine-elicited SARS-CoV-2 protection are needed. Methods An observational study on antibody response to a mRNA vaccine (Comirnaty) was performed on health care workers (V, n=120). Recovered COVID-19 patients (N, n=94) were used for comparison. Antibody response was evaluated by a quantitative anti-receptor binding domain IgG (anti-RBD) commercial assay and by virus microneutralization test (MNT), in order to establish a threshold of anti-RBD binding antibody units (BAU) able to predict a robust (≥1:80) MNT titer. Results Significant correlation between BAU and MNT titers was found in both V and N, being stronger in V (rs=0.91 and 0.57 respectively, p<0.001); a higher incremental trend starting from MNT titer 1:80 was observed in the V group. The 99% probability of high MNT titer (≥1:80) was reached at 1,814 and 3,564 BAU/mL, and the area under the receiver operating characteristic (ROC) curve was 0.99 (CI: 0.99–1.00) and 0.78 (CI: 0.67–0.86) in V and N, respectively. Conclusions A threshold of 2,000 BAU/mL is highly predictive of strong MNT response in vaccinated individuals and may represent a good surrogate marker of protective response. It remains to be established whether the present results can be extended to BAU titers obtained with other assays.

1990 ◽  
Vol 47 (3) ◽  
pp. 199-202
Author(s):  
A Cockcroft ◽  
P Soper ◽  
C Insall ◽  
Y Kennard ◽  
S Chapman ◽  
...  

2020 ◽  
Author(s):  
Diego S. Ojeda ◽  
María Mora Gonzalez Lopez Ledesma ◽  
Horacio Pallares ◽  
Guadalupe S. Costa Navarro ◽  
Lautaro Sanchez ◽  
...  

ABSTRACTWe report the emergency development and application of a robust serologic test to evaluate acute and convalescent antibody responses to SARS-CoV-2 in Argentina. The assays, COVIDAR IgG and IgM, which were produced and provided for free to health authorities, private and public health institutions and nursing homes, use a combination of a trimer stabilized spike protein and the receptor binding domain (RBD) in a single enzyme-linked immunosorbent assay (ELISA) plate. Over half million tests have already been distributed to detect and quantify antibodies for multiple purposes, including assessment of immune responses in hospitalized patients and large seroprevalence studies in neighborhoods, slums and health care workers, which resulted in a powerful tool for asymptomatic detection and policy making in the country. Analysis of antibody levels and longitudinal studies of symptomatic and asymptomatic SARS-CoV-2 infections in over one thousand patient samples provided insightful information about IgM and IgG seroconversion time and kinetics, and IgM waning profiles. At least 35% of patients showed seroconversion within 7 days, and 95% within 45 days of symptoms onset, with simultaneous or close sequential IgM and IgG detection. Longitudinal studies of asymptomatic cases showed a wide range of antibody responses with median levels below those observed in symptomatic patients. Regarding convalescent plasma applications, a protocol was standardized for the assessment of end point IgG antibody titers with COVIDAR with more than 500 plasma donors. The protocol showed a positive correlation with neutralizing antibody titers, and was used to assess antibody titers for clinical trials and therapies across the country. Here, we demonstrate the importance of providing a robust and specific serologic assay for generating new information about antibody kinetics in infected individuals and mitigation policies to cope with pandemic needs.AUTHOR SUMMARYThe development of robust and specific serologic assays to detect antibodies to SARS-CoV-2 is essential to understand the pandemic evolution and to stablish mitigation strategies. Here, we report the emergency development, production and application of a versatile ELISA test for detecting antibodies against the whole spike protein and its receptor binding domain. Over half million tests have been freely distributed in public and private health institutions of Argentina for evaluating immune responses, convalescent plasma programs and for large seroprevalence studies in neighborhoods and health care workers. We are still learning how and when to use serologic testing in different epidemiological settings. This program allowed us to produce large amount of high quality data on antibody levels in symptomatic and asymptomatic SARS-CoV-2 infections and generate relevant information about IgM and IgG seroconversion time and kinetics. We also present standardized protocols for antibody quantification as guidance for convalescent donor plasma selection in hospitals throughout the country for compassionate use and clinical trials. Here, we provide a framework for generating widely available tools, protocols and information of antibody responses for pandemic management.


2021 ◽  
Vol 28 (3) ◽  
pp. 307-313
Author(s):  
Felice FAIZAL ◽  
◽  
Rajneesh JOSHI ◽  
R CHATTRJEE ◽  
Ankur AHUJA ◽  
...  

BACKGROUND: The ChAdOx1 nCoV-19 vaccine against COVID-19 is a two-dose vaccine spread 3 to 4 weeks apart. This study aims to ascertain the antibody response to each dose with respect to age, previous infection status etc. METHODS: Baseline total COVID-19 antibody level was ascertained using Siemens SARS‑CoV‑2 Total Antibody assay in consenting health care workers before the first dose of vaccination. Adverse effects were noted in each individual and were monitored weekly for the total antibody titre following both doses. Descriptive statistical tests were used to analyse the changes in antibodies levels weekly after both doses. Association of previous COVID infection and age with antibody levels was assessed. RESULTS: Median (range) of age of the 30 study participants was 31.5 years.23% of the participants had a history of previous COVID-19 infection. Mild adverse events following immunisation were reported by 87% participants after first dose whereas only in 7% after second dose. Median baseline antibody titres were significantly higher among those with previous COVID infection as compared to previously uninfected individuals. Antibody titres increased consistently after first dose and showed a declining trend following the second dose in all participants and showed no significant association with previous COVID-19 infection or age. CONCLUSIONS: Antibody titre response was similar amongst the various age groups. Higher response in the previously infected individuals following first dose may make them ideal candidates for a single dose vaccine regimen. Individuals showing lower levels of neutralising antibodies can be ideal candidates for a booster dose.


2021 ◽  
Author(s):  
Shuchi Anand ◽  
Maria E Montez-Rath ◽  
Jialin Han ◽  
Pablo Garcia ◽  
LinaCel Cadden ◽  
...  

Background: Patients receiving dialysis may mount impaired responses to COVID19 vaccination. Methods: We report antibody response to vaccination from 1140 patients without, and 493 patients with pre-vaccination SARS-CoV-2 RBD antibody. We used commercially available assays (Siemens) to test remainder plasma monthly in association with vaccination date and type, and assess prevalence of absent total receptor binding antibody, and absent or attenuated (index value < 10) semiquantitative receptor binding domain IgG index values. We used Poisson regression to evaluate risk factors for absent or attenuated response to vaccination. Results: Among patients who were seronegative versus seropositive before vaccination, 62% and 56% were ≥65 years old, 20% and 24% were Hispanic, and 22% and 23% were Black. Median IgG index values rose steadily over time, and were higher among the seropositive than in the seronegative patients after completing vaccination (150 [25th, 75th percentile 23.2, 150.0] versus 41.6 [11.3, 150.0]). Among 610 patients who completed vaccination (assessed ≥14 days later, median 29 days later), the prevalence of absent total RBD response, and absent and attenuated semiquantitative IgG response was 4.4% (95% CI 3.1, 6.4%), 3.4% (2.4, 5.2%), and 14.3% (11.7, 17.3%) respectively. Risk factors for absent or attenuated response included longer vintage of end-stage kidney disease, and lower pre-vaccination serum albumin. Conclusions: More than one in five patients receiving dialysis had evidence of an attenuated immune response to COVID19 vaccination.


2021 ◽  
Author(s):  
Masahiro Kitabatake ◽  
Noriko Ouji-Sageshima ◽  
Shota Sonobe ◽  
Ryutaro Furukawa ◽  
Makiko Konda ◽  
...  

AbstractSince February 2021, health care workers in Japan have been preferentially vaccinated with a messenger RNA vaccine (BNT162b2/Pfizer) against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). While many studies have confirmed that this vaccine is highly effective in reducing hospitalizations and deaths from coronavirus disease 2019 (COVID-19), antibody titers tend to decline at 3 months, leading to a risk of breakthrough infections. Thus, information is needed to support decision making regarding the third vaccination. In this study, we investigated transition of the anti-SARS-CoV-2 receptor-binding domain (RBD) IgG and neutralizing antibody titers of 41 vaccinated Japanese healthcare workers. Samples were collected seven times starting 1 week before vaccination until 6 months post-vaccination. Anti-SARS-CoV-2 RBD IgG levels peaked at 7 days after the booster, then declined over time and decreased to <10% at 6 months after the booster. Workers with low anti-SARS-CoV-2 RBD IgG levels also had low neutralizing antibody titers. These data support the active use of boosters for healthcare workers, especially for those with low anti-SARS-CoV-2 RBD IgG levels.


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