Introduction: Several studies reported on the humoral response in subjects having received the BNT162b2 mRNA COVID-19 vaccine. However, data on the kinetics of antibodies 3 months postvaccination are currently lacking and are important to drive the future vaccination strategy. Methods:The CRO-VAX HCP study is an ongoing multicenter, prospective and interventional study designed to assess the antibody response in a population of healthcare professionals who had received two doses of the BNT162b2 mRNA COVID-19 vaccine. Two-hundred individuals underwent a blood drawn within 2 days before the first vaccine dose. One-hundred and forty-two persons (71%)were categorized as seronegative at baseline while 58 (29%) were seropositive. Samples were then collected after 14, 28, 42, 56, and 90 days. Antibodies against the SARS-CoV-2 nucleocapsid and the receptor binding domain of the S1 subunit of the spike protein were measured in all individuals at different time points.Results: Using a one-compartment kinetics model, the time to maximum concentration was estimated at 36 ± 3 days after the first dose and the estimated half-life of antibodies was 55 days (95% CI: 37-107 days) in seronegative participants. In seropositive participants, the time to maximum concentration was estimated at 24 ± 4 days and the estimated half-life was 80 days (95% CI: 46-303 days). The antibody response was higher in seropositive compared to seronegative participants. Conclusion:In both seropositive and seronegative subjects, a significant antibody decline was observed at 3 months compared to the peak response. Nevertheless, the humoral response remained robust in all participants.

Data about the long-term duration of antibodies after SARS-CoV-2 vaccination are still scarce and are important to design vaccination strategies. In this study, 231 healthcare professionals received the two-dose regimen of BNT162b2. Of these, 158 were seronegative and 73 were seropositive at baseline. Samples were collected at several time points. The neutralizing antibodies (NAbs) and antibodies against the nucleocapsid and the spike protein of SARS-CoV-2 were measured. At day 180, a significant antibody decline was observed in seronegative (−55.4% with total antibody assay; −89.6% with IgG assay) and seropositive individuals (−74.8% with total antibody assay; −79.4% with IgG assay). The estimated half-life of IgG from the peak humoral response was 21 days (95% CI: 13–65) in seronegative and 53 days (95% CI: 40–79) in seropositive individuals. The estimated half-life of total antibodies was longer and ranged from 68 days (95% CI: 54–90) to 114 days (95% CI: 87–167) in seropositive and seronegative individuals, respectively. The decline of NAbs was more pronounced (−98.6%) and around 45% of the subjects tested were negative at day 180. Whether this decrease correlates with an equivalent drop in the clinical effectiveness against the virus would require appropriate clinical studies.

Background: Little is known about potential confounding factors influencing the humoral response in individuals having received the BNT162b2 vaccine. Methods: Blood samples from 231 subjects were collected before and 14, 28, and 42 days following coronavirus disease 2019 (COVID-19) vaccination with BNT162b2. Anti-spike receptor-binding-domain protein (anti-Spike/RBD) immunoglobulin G (IgG) antibodies were measured at each time-point. Impact of age, sex, childbearing age status, hormonal therapy, blood group, body mass index and past-history of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection were assessed by multivariable analyses. Results and Conclusions: In naïve subjects, the level of anti-Spike/RBD antibodies gradually increased following administration of the first dose to reach the maximal response at day 28 and then plateauing at day 42. In vaccinated subjects with previous SARS-CoV-2 infection, the plateau was reached sooner (i.e., at day 14). In the naïve population, age had a significant negative impact on anti-Spike/RBD titers at days 14 and 28 while lower levels were observed for males at day 42, when corrected for other confounding factors. Body mass index (BMI) as well as B and AB blood groups had a significant impact in various subgroups on the early response at day 14 but no longer after. No significant confounding factors were highlighted in the previously infected group.

Objectives Data on the immune response after two doses of BNT162b2 are so far limited. Previously infected individuals were excluded from pivotal clinical trials and the optimal dose regimen in this population has not been clearly studied. The CRO-VAX HCP study aims at investigate the early antibody response in a population of healthcare professionals having received two doses of the BNT162b2 mRNA COVID-19 vaccine. Methods The CRO-VAX HCP study is a multicenter, prospective, interventional study conducted in several sites in Belgium. The study included 231 healthcare professional volunteers who received the two-dose regimen of the BNT162b2 mRNA COVID-19 vaccine. Of these, 73 were previously infected by SARS-CoV-2 and 158 were uninfected and seronegative. In the first group, blood samples were collected at baseline and after 2, 4, 7, 10, 14, 21, and 28 days. In the second group, samples were obtained at baseline and after 14 and 28 days. Antibodies against the SARS-CoV-2 nucleocapsid and the receptor binding domain of the S1 subunit of the spike protein were measured in all individuals at different time points. Results In uninfected individuals, 95.5% (95% CI 91.0-98.2%) developed anti-spike antibodies after 14 days and a 24.9-fold rise (95% CI 21.4-28.9%) in antibody titer was observed after the second dose. In previously infected individuals, peak antibody response was reached after 7 days (i.e. 6,347 U/mL) and the second dose did not lead to significantly higher antibody titers (i.e. 8,856 to 11,911 U/mL). Antibody titers were higher in previously infected individuals. Conclusions This study supports the concept that a single dose of BNT162b2 would be sufficient in previously infected individuals.

Data about the duration of humoral response following COVID-19 vaccines are mandatory to establish appropriate population vaccination strategy. This study reports on the antibody decline observed in a population of COVID-19 naïve and COVID-19 positive individuals having received the two dose regimen of the BNT162b2 vaccine. Six months after vaccination, a significant antibody decline was observed in both COVID-19 naïve and positive individuals. The estimated half-life of total and IgG antibodies differs and ranges from several months for total antibodies to only several weeks for IgG antibodies, explaining the significant proportions of participants with non-detectable levels of neutralizing antibodies at 6 months. Whether this decrease correlates with an equivalent drop in the clinical effectiveness against the virus will require appropriate clinical studies. Nevertheless, these data are already important to support the decision-making on the potential use of a booster dose.