scholarly journals Anti-SARS-CoV-2 antibody levels are concordant across multiple platforms but are not fully predictive of sterilizing immunity

2021 ◽  
Author(s):  
Benjamin T. Bradley ◽  
Andrew Bryan ◽  
Susan L. Fink ◽  
Erin A. Goecker ◽  
Pavitra Roychoudhury ◽  
...  
Keyword(s):  
Symptom Onset ◽  
Vaccine Dose ◽  
Humoral Response ◽  
Pcr Detection ◽  
Clinical Sensitivity ◽  
Significant Difference ◽  
Antibody Assays ◽  
Unit Conversion ◽  
Antibody Levels

AbstractWith the availability of widespread SARS-CoV-2 vaccination, high-throughput quantitative anti-spike serological testing will likely become increasingly important. Here, we investigated the performance characteristics of the recently FDA authorized semi-quantitative anti-spike AdviseDx SARS-CoV-2 IgG II assay compared to the FDA authorized anti-nucleocapsid Abbott Architect SARS-CoV-2 IgG, Roche elecsys Anti-SARS-CoV-2-S, EuroImmun Anti-SARS-CoV-2 ELISA, and GenScript surrogate virus neutralization assays and examined the humoral response associated with vaccination, natural protection, and breakthrough infection. The AdviseDx assay had a clinical sensitivity at 14 days post-symptom onset or 10 days post PCR detection of 95.6% (65/68, 95% CI: 87.8-98.8%) with two discrepant individuals seroconverting shortly thereafter. The AdviseDx assay demonstrated 100% positive percent agreement with the four other assays examined using the same symptom onset or PCR detection cutoffs. Using a recently available WHO International Standard for anti-SARS-CoV-2 antibody, we provide assay unit conversion factors to international units for each of the assays examined. We performed a longitudinal survey of healthy vaccinated individuals, finding median AdviseDx immunoglobulin levels peaked seven weeks post-first vaccine dose at approximately 4,000 IU/mL. Intriguingly, among the five assays examined, there was no significant difference in antigen binding level or neutralizing activity between two seropositive patients protected against SARS-CoV-2 infection in a previously described fishing vessel outbreak and five healthcare workers who experienced vaccine breakthrough of SARS-CoV-2 infection – all with variants of concern. These findings suggest that protection against SARS-CoV-2 infection cannot currently be predicted exclusively using in vitro antibody assays against wildtype SARS-CoV-2 spike. Further work is required to establish protective correlates of protection for SARS-CoV-2 infection.

scholarly journals Anti-SARS-CoV-2 antibody levels measured by the Advise Dx SARS-CoV-2 assay are concordant with previously available serologic assays but are not fully predictive of sterilizing immunity

2021 ◽  
Author(s):  
Benjamin T. Bradley ◽  
Andrew Bryan ◽  
Susan L. Fink ◽  
Erin A. Goecker ◽  
Pavitra Roychoudhury ◽  
...  
Keyword(s):  
Symptom Onset ◽  
Vaccine Dose ◽  
Humoral Response ◽  
Pcr Detection ◽  
Clinical Sensitivity ◽  
Significant Difference ◽  
Antibody Assays ◽  
Unit Conversion ◽  
Antibody Levels

With the availability of widespread SARS-CoV-2 vaccination, high-throughput quantitative anti-spike serological testing will likely become increasingly important. Here, we investigated the performance characteristics of the recently FDA authorized semi-quantitative anti-spike AdviseDx SARS-CoV-2 IgG II assay compared to the FDA authorized anti-nucleocapsid Abbott Architect SARS-CoV-2 IgG, Roche elecsys Anti-SARS-CoV-2-S, EuroImmun Anti-SARS-CoV-2 ELISA, and GenScript surrogate virus neutralization assays and examined the humoral response associated with vaccination, natural protection, and breakthrough infection. The AdviseDx assay had a clinical sensitivity at 14 days post-symptom onset or 10 days post PCR detection of 95.6% (65/68, 95% CI: 87.8-98.8%) with two discrepant individuals seroconverting shortly thereafter. The AdviseDx assay demonstrated 100% positive percent agreement with the four other assays examined using the same symptom onset or PCR detection cutoffs. Using a recently available WHO International Standard for anti-SARS-CoV-2 antibody, we provide assay unit conversion factors to international units for each of the assays examined. We performed a longitudinal survey of healthy vaccinated individuals, finding median AdviseDx immunoglobulin levels peaked seven weeks post-first vaccine dose at approximately 4,000 IU/mL. Intriguingly, among the five assays examined, there was no significant difference in antigen binding level or neutralizing activity between two seropositive patients protected against SARS-CoV-2 infection in a previously described fishing vessel outbreak and five healthcare workers who experienced vaccine breakthrough of SARS-CoV-2 infection – all with variants of concern. These findings suggest that protection against SARS-CoV-2 infection cannot currently be predicted exclusively using in vitro antibody assays against wildtype SARS-CoV-2 spike. Further work is required to establish protective correlates for SARS-CoV-2 infection.

scholarly journals Waning Humoral Response 3 to 6 Months after Vaccination with the SARS-COV-2 BNT162b2 mRNA Vaccine in Dialysis Patients

2021 ◽  
Vol 11 (1) ◽  
pp. 64
Author(s):  
Noa Berar-Yanay ◽  
Sarit Freiman ◽  
Maʹanit Shapira ◽  
Amer Saffoury ◽  
Ameer Elemy ◽  
...  
Keyword(s):  
Response Rate ◽  
Vaccine Dose ◽  
Humoral Response ◽  
Albumin Level ◽  
High Response Rate ◽  
Control Group ◽  
Dialysis Patients ◽  
Serious Adverse Events ◽  
Antibody Levels

Background and objectives: The short-term reported antibody response to SARS-COV-2 vaccination in dialysis patients is high, with a seroconversion response rate up to 97%. Data on the long-term durability of this response are scarce. Our objective was to characterize the long-term anti-spike antibody level in dialysis patients. Design, setting, participants, and measurements: In an observational study, we measured SARS-COV-2 anti-spike antibody levels in dialysis patients who completed 2 doses of the BNT162b2 mRNA SAR S-COV-2 vaccine at 1, 3 and 6 months after the second vaccine dose. We compared the response to dialysis patients who were infected with COVD-19 and to a control group of healthcare-employees. Results: One hundred and forty-two dialysis patients who had been vaccinated (ages 64 ± 11.9 years, 61% male), 33 dialysis patients who had COVID-19 infection (ages 54 ± 14.3 years, 55% male) and 104 individuals in the control group (ages 50 ± 12.2 years, 44% male) were included. The response rate in the vaccinated dialysis patients was 94%, 78% and 73% at 1, 3 and 6 months after the second vaccine dose. In the COVID-19 infected dialysis group and in the control group, the response rate remained at 100% over 6 months. The percentage of change in antibody levels between one and 6 months was −66% in the vaccinated dialysis group, −28% in the control group (p < 0.001) and +48% in dialysis patients who had been infected with COVID-19 (p < 0.001). A non-responder status at 6 months was associated with a lower albumin level. No serious adverse events following vaccination were reported. In conclusion: the initially high response rate to the BNT162b2 vaccine in dialysis patients decreases rapidly. Our results indicate that an early booster (3rd) dose, at three months after the second dose, may be advised for this population to preserve the humoral immunity.

scholarly journals Impact of Age and Sex on Antibody Response Following the Second Dose of COVID-19 BNT162b2 mRNA Vaccine in Greek Healthcare Workers

2021 ◽  
Vol 9 (8) ◽  
pp. 1725
Author(s):  
Niki Vassilaki ◽  
Antonios N. Gargalionis ◽  
Anastasia Bletsa ◽  
Nikolaos Papamichalopoulos ◽  
Elisavet Kontou ◽  
...  
Keyword(s):  
Healthcare Workers ◽  
Venous Blood ◽  
Age Groups ◽  
Vaccine Dose ◽  
Humoral Response ◽  
Continuous Variables ◽  
Igg Antibody ◽  
Female Population ◽  
Significant Difference ◽  
Antibody Titers

Anti-SARS-CoV-2 spike RBD (receptor-binding domain) IgG antibody levels were monitored in 1643 volunteer healthcare workers of Eginition, Evangelismos, and Konstantopoulio General Hospitals (Athens, Greece), who underwent vaccination with two doses of COVID-19 BNT162b2 mRNA vaccine (Pfizer) and had no history of SARS-CoV-2 infection. Venous blood was collected 20–30 days after the second vaccine dose and anti-RBD IgG levels were determined using CMIA SARS-CoV-2 IgG II Quant (Abbott) on ARCHITECT i System or ADVIA Centaur SARS-CoV-2 IgG (Siemens) on Centaur XP platform. From the total population of 1643 vaccinees (533 M/1110 F; median age = 49; interquartile range-IQR = 40–56), 1636 (99.6%) had anti-SARS-CoV-2 IgG titers above the positivity threshold of the assay used. One-Way ANOVA Kruskal-Wallis H test showed a statistically significant difference in the median of antibody titers between the different age groups (p < 0.0001). Consistently, Spearman’s correlation coefficient (r) for IgGs and age as continuous variables was −0.2380 (p = 1.98 × 10−17). Moreover, antibody titers were slightly higher by 1.2-mean fold (p = 3 × 10−6) in the total female population of the three hospitals (median = 1594; IQR = 875–2584) as compared to males (median = 1292; IQR = 671.9–2188). The present study supports that BNT162b2 vaccine is particularly effective in producing high anti-SARS-CoV-2 IgG levels in healthy individuals, and this humoral response is age- and gender-dependent.

scholarly journals ANTIBODY RESPONSE OF HUMAN BEINGS FOLLOWING VACCINATION WITH INFLUENZA VIRUSES

1942 ◽  
Vol 75 (5) ◽  
pp. 495-511 ◽  
Author(s):  
G. K. Hirst ◽  
E. R. Rickard ◽  
Loring Whitman ◽  
F. L. Horsfall
Keyword(s):  
Influenza Virus ◽  
Antibody Response ◽  
Influenza A ◽  
Geometric Mean ◽  
Allantoic Fluid ◽  
Influenza Viruses ◽  
Human Beings ◽  
Significant Difference ◽  
Antibody Levels

Eleven different preparations of influenza virus were used to vaccinate large groups of human beings. The antibody response to these vaccines was measured by means of the in vitro agglutination inhibition test, and the geometric mean titers of sera taken 2 weeks after vaccination were compared. From these comparisons the following conclusions were drawn: 1. There was a wide individual variation in the antibody response of human beings to the same preparation of influenza virus administrated subcutaneously. The amount of antibody produced by a group with a low prevaccination antibody level was very nearly the same as the amount produced by groups that had higher initial levels. 2. The use of the X strain of distemper virus in the preparation of an influenza vaccine did not enhance the antigenicity of the influenza virus present. 3. Within certain limits the mean antibody response of human beings increased as the amount of virus injected was increased. When large amounts of influenza A virus were given, the antibody response was of the same order of magnitude as that which occurred following actual infection by this virus. 4. When the vaccine was prepared from allantoic fluid, there was no significant difference in the antibody response of human beings given active virus, formalin-inactivated virus, heat-inactivated virus, or virus inactivated by the drying process. 5. Ground infected chick embryos, when diluted with infected allantoic fluid, gave a greater antibody response than allantoic fluid alone (when the virus remained active). The antigenicity of such a preparation was diminished when the virus was inactivated by formalin. 6. Antibody levels 6 and 9 weeks after vaccination showed a marked drop from the 2-week postvaccination levels. In a small group the antibody levels at 5 months were still further reduced. Those individuals who possessed the higher titers tended to lose their antibodies faster than did those at a lower level.

scholarly journals Humoral Immune Response in IBD Patients Three and Six Months after Vaccination with the SARS-CoV-2 mRNA Vaccines mRNA-1273 and BNT162b2

Biomedicines ◽  
2022 ◽  
Vol 10 (1) ◽  
pp. 171
Author(s):  
Richard Vollenberg ◽  
Phil-Robin Tepasse ◽  
Joachim Ewald Kühn ◽  
Marc Hennies ◽  
Markus Strauss ◽  
...  
Keyword(s):  
Neutralization Test ◽  
Humoral Response ◽  
Igg Antibody ◽  
Humoral Immune ◽  
The Core ◽  
Neutralizing Capacity ◽  
Significant Difference ◽  
Inflammatory Bowel ◽  
Antibody Levels ◽  
Necrosis Factor

Severe acute respiratory syndrome coronovirus-2 (SARS-CoV-2) is the cause of the coronavirus disease 2019 (COVID-19) pandemic. Vaccination is considered the core approach to containing the pandemic. There is currently insufficient evidence on the efficacy of these vaccines in immunosuppressed inflammatory bowel disease (IBD) patients. The aim of this study was to investigate the humoral response in immunosuppressed IBD patients after COVID-19 mRNA vaccination. In this prospective study, IgG antibody levels (AB) against the SARS-CoV-2 receptor-binding domain (spike-protein) were quantitatively determined. For assessing the potential neutralizing capacity, a SARS-CoV-2 surrogate neutralization test (sVNT) was employed in IBD patients (n = 95) and healthy controls (n = 38). Sera were examined prior to the first/second vaccination and 3/6 months after second vaccination. Patients showed lower sVNT (%) and IgG-S (AU/mL) AB both before the second vaccination (sVNT p < 0.001; AB p < 0.001) and 3 (sVNT p = 0.002; AB p = 0.001) and 6 months (sVNT p = 0.062; AB p = 0.061) after the second vaccination. Although seroconversion rates (sVNT, IgG-S) did not differ between the two groups 3 months after second vaccination, a significant difference was seen 6 months after second vaccination (sVNT p = 0.045). Before and three months after the second vaccination, patients treated with anti-tumor necrosis factor (TNF) agents showed significantly lower AB than healthy subjects. In conclusion, an early booster shot vaccination should be discussed for IBD patients on anti-TNF therapy.

scholarly journals Function Is More Reliable than Quantity to Follow Up the Humoral Response to the Receptor-Binding Domain of SARS-CoV-2-Spike Protein after Natural Infection or COVID-19 Vaccination

Viruses ◽  
2021 ◽  
Vol 13 (10) ◽  
pp. 1972
Author(s):  
Carlos A. Sariol ◽  
Petraleigh Pantoja ◽  
Crisanta Serrano-Collazo ◽  
Tiffany Rosa-Arocho ◽  
Albersy Armina-Rodríguez ◽  
...  
Keyword(s):  
Immune Response ◽  
Natural Infection ◽  
Vaccine Dose ◽  
Humoral Response ◽  
Neutralizing Antibody ◽  
Viral Neutralization ◽  
Neutralizing Activity ◽  
Humoral Immune ◽  
Antibody Assays ◽  
Novel Coronavirus

Both the SARS-CoV-2 pandemic and emergence of variants of concern have highlighted the need for functional antibody assays to monitor the humoral response over time. Antibodies directed against the spike (S) protein of SARS-CoV-2 are an important component of the neutralizing antibody response. In this work, we report that in a subset of patients—despite a decline in total S-specific antibodies—neutralizing antibody titers remain at a similar level for an average of 98 days in longitudinal sampling of a cohort of 59 Hispanic/Latino patients exposed to SARS-CoV-2. Our data suggest that 100% of seroconverting patients make detectable neutralizing antibody responses which can be quantified by a surrogate viral neutralization test. Examination of sera from ten out of the 59 subjects which received mRNA-based vaccination revealed that both IgG titers and neutralizing activity of sera were higher after vaccination compared to a cohort of 21 SARS-CoV-2 naïve subjects. One dose was sufficient for the induction of a neutralizing antibody, but two doses were necessary to reach 100% surrogate virus neutralization in subjects irrespective of previous SARS-CoV-2 natural infection status. Like the pattern observed after natural infection, the total anti-S antibodies titers declined after the second vaccine dose; however, neutralizing activity remained relatively constant for more than 80 days after the first vaccine dose. Furthermore, our data indicates that—compared with mRNA vaccination—natural infection induces a more robust humoral immune response in unexposed subjects. This work is an important contribution to understanding the natural immune response to the novel coronavirus in a population severely impacted by SARS-CoV-2. Furthermore, by comparing the dynamics of the immune response after the natural infection vs. the vaccination, these findings suggest that functional neutralizing antibody tests are more relevant indicators than the presence or absence of binding antibodies.

scholarly journals A betacoronavirus multiplex microsphere immunoassay detects early SARS-CoV-2 seroconversion and antibody cross reactions

2020 ◽  
Author(s):  
Eric Laing ◽  
Spencer Sterling ◽  
Stephanie Richard ◽  
Nusrat Epsi ◽  
Shreshta Phogat ◽  
...  
Keyword(s):  
Symptom Onset ◽  
Human Subject ◽  
Spike Protein ◽  
Igg Antibody ◽  
Memory Response ◽  
Cross Reactions ◽  
Antibody Assays ◽  
Antibody Levels ◽  
Simultaneous Identification ◽  
Microsphere Immunoassay

Abstract Sensitive and specific SARS-CoV-2 antibody assays remain critical for community and hospital-based SARS-CoV-2 surveillance. Here, we developed and applied a multiplex microsphere-based immunoassay (MMIA) for COVD-19 antibody studies that incorporates spike protein trimers of SARS-CoV-2, SARS-CoV-1, MERS-CoV, and the seasonal human betacoronaviruses, HCoV-HKU1 and HCoV-OC43, that enables measurement of off-target pre-existing cross-reactive antibodies. The MMIA performances characteristics are: 98% sensitive and 100% specific for human subject samples collected as early as 10 days from symptom onset. The MMIA permitted the simultaneous identification of SARS-CoV-2 seroconversion and the induction of SARS-CoV-2 IgG antibody cross reactions to SARS-CoV-1 and MERS-CoV. Further, synchronous increases of HCoV-OC43 IgG antibody levels was detected with SARS-CoV-2 seroconversion in a subset of subjects for whom early infection sera were available prior to their SARS-CoV-2 seroconversion, suggestive of an HCoV-OC43 memory response triggered by SARS-CoV-2 infection.

scholarly journals Immunoprophylactic strategies against enterotoxemia caused by Clostridium perfringens type D in goats

2006 ◽  
Vol 26 (1) ◽  
pp. 51-54 ◽  
Author(s):  
Josir Laine A. Veschi ◽  
Iveraldo S. Dutra ◽  
Mariano E. Fernandez Miyakawa ◽  
Silvia Helena V. Perri ◽  
Francisco A. Uzal
Keyword(s):  
Clostridium Perfringens ◽  
Booster Dose ◽  
Serum Antibody ◽  
Passive Immunization ◽  
Vaccine Dose ◽  
Serological Response ◽  
Type D ◽  
Group 4 ◽  
Significant Difference ◽  
Antibody Levels

The serological response to an experimental vaccine against Clostridium perfringens type D enterotoxemia was evaluated in four groups of goats. Group 1 received colostrum from unvaccinated cows and no vaccine. Groups 2, 3 and 4 received colostrum from vaccinated cows. In addition, Groups 3 and 4 received a vaccine dose at 80 days of age, and Group 4 received a second vaccine dose at 120 days of age. Serum antibody levels were determined by ELISA in cows before and after calving, and in goats at 3, 80, 120 and 160 days of age. No significant difference in serum antibody levels was observed between vaccinated and unvaccinated cows, or between the four groups of goats evaluated at 3 days of life. Groups 3 and 4 presented mean antibody titers of 0.6 and 1.1 IU/ml, respectively, 40 days after first vaccination. The vaccine response of Group 4 was 1.8 IU/ml 40 days after the booster dose and was higher than that observed for Group 3 (0.2 IU/ml). Thus, in the proposed regimen the use of heterologous colostrum did not induce passive immunization in goat kids. However, first vaccination and a booster dose after 40 days triggered satisfactory antibody levels.

scholarly journals Neutralization of SARS-CoV-2 Variants by Serum from BNT162b2 Vaccine Recipients

Viruses ◽  
2021 ◽  
Vol 13 (10) ◽  
pp. 2011
Author(s):  
Fabrizia Valleriani ◽  
Elisa Mancuso ◽  
Giacomo Vincifori ◽  
Liana Teodori ◽  
Lisa Di Marcantonio ◽  
...  
Keyword(s):  
Reference Strain ◽  
Vaccine Dose ◽  
Humoral Response ◽  
Serum Samples ◽  
Fold Reduction ◽  
Long Term Follow Up ◽  
The Impact

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has evolved rapidly, leading to viral lineages characterized by multiple mutations in the spike protein, which could potentially confer to the virus the ability to avoid the vaccine-induced immune response, making the vaccines less effective or ineffective. Here, we initially evaluated the neutralization capabilities in vitro by serum neutralization (SN) of six serum samples collected from recipients of the BNT162b2 vaccine against 11 SARS-CoV-2 isolates belonging to the major SARS-CoV-2 lineages that had been circulating in Italy. Then, we considered 30 additional serum samples by SN assay against the dominant B.1.617.2 (Delta) variant. A B.1 lineage isolate was used as a reference. In the first analysis, significant differences when compared with the reference strain (p > 0.05) were not evidenced; instead, when the panel of 30 sera was tested against the B.1.617.2 (Delta) variant, a significant (p = 0.0015) 2.38-fold reduction in neutralizing titres compared with the reference after the first vaccine dose was demonstrated. After the second vaccine dose, the reduction was not significant (p = 0.1835). This study highlights that the BNT162b2 vaccine stimulates a humoral response able to neutralize all tested SARS-CoV-2 variants, thus suggesting a prominent role in mitigating the impact of the SARS-CoV-2 pandemic in real-world conditions. Long-term follow-up is currently ongoing.

scholarly journals IgM and IgG Profiles Reveal Peculiar Features of Humoral Immunity Response to SARS-CoV-2 Infection

2021 ◽  
Vol 18 (3) ◽  
pp. 1318
Author(s):  
Antonella De Donno ◽  
Giambattista Lobreglio ◽  
Alessandra Panico ◽  
Tiziana Grassi ◽  
Francesco Bagordo ◽  
...  
Keyword(s):  
Humoral Immunity ◽  
Symptom Onset ◽  
Half Life ◽  
Clinical Status ◽  
Humoral Response ◽  
Individual Variability ◽  
Chemiluminescence Immunoassay ◽  
Time Points ◽  
Antibody Levels ◽  
Number Of Individuals

The emergence of coronavirus disease 2019 (COVID-19) is globally a major healthcare threat. There is little information regarding the mechanisms and roles of the humoral response in SARS-CoV-2 infection. The aim of this study was to analyze the antibody levels (IgM and IgG) by chemiluminescence immunoassay in 54 subjects positive to SARS-CoV-2 swab test in relation to their clinical status (whether asymptomatic, pauci-symptomatic or with mild, sever or critical symptoms), the time from the symptom onset, sex, age, and comorbidities. Overall, the presence of comorbidities and the age of subjects were associated with their clinical status. The IgG concentrations were significantly higher in patients who developed critical and severe symptoms and seemed to be independent from age, sex and comorbidities. IgG titers peaked around day 60, and then began gradually to drop, decreasing by approximately 50% on the 180th day, while the IgM titers progressively decreased as early as the tenth day, but they could be detected even at later time points. Despite the small number of individuals, some peculiar characteristics of the humoral response in COVID-19 emerged. We observed a high inter-individual variability, an ephemeral IgG half-life in several patients, and a persistence of IgM in others.

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