ABSTRACT
Introduction: In this study we aimed to monitor the risk of breakthrough COVID-19 infection in pwMS on different Disease Modifying Therapies (DMT) included in RELACOEM, a LATAM registry of MS and NMOSD patients infected with and vaccinated against COVID-19. Method(s): retrospective cohort study conducted between May 2021 and December 2021. The primary outcome was the appearance of infection during the follow-up time (at least three months after complete vaccination (second dose)). Specific information was requested (vaccine received, dose, date, symptoms, COVID- 19 infection, need for hospitalization, ventilatory assistance, treatment, and evolution). The primary objective of the analysis was to compare the incidence of breakthrough SARS-CoV-2 infections among the vaccinated pwMS in each DMT group. These conditions entail a PCR-confirmed test, and a time lag of at least 14 days from a full vaccination cycle (after the second vaccination dose). Cumulative incidence was reported by Kaplan Meier survival curves as well as incidence density. Result(s): A total of 857 pwMS patients from eight countries in LATAM were included. Mean age was 44.3 +/-12 years. The most frequent treatment used was fingolimod in 171 (19.9%). Most frequent first and second dose received was Astra-Zeneca (33%). During follow-up, a total of 28 COVID-19 cases were observed for a total exposure time of 150.965 days. The overall cumulative incidence was 3.2% (SE 0.22%) with an overall incidence density (ID) of 1.8 x 10.000 patients/day (95%CI 0.2-3.2). Compared to other DMTs, the incidence rate of breakthrough infections was significantly higher on ocrelizumab (6.02 (95%CI=5.65-7.16, RR=5.17 95%CI 3.27-7.12) and rituximab (6.94 (95%CI=6.15-9.12, RR= 5.93 95%CI 3.55-7.32) compared with other DMTs. No significant differences in the risk of breakthrough were observed for vaccine subtypes. Conclusion(s): An increased risk of breakthrough COVID-19 infections was observed in patients treated with ocrelizumab and rituximab.
ABSTRACT
Objective: The objective of the study was to evaluate the incidence of COVID-19 infections after vaccination in NMOSD patients included in RELACOEM, a LATAM registry of MS and NMOSD patients infected and vaccinated for COVID-19. Method(s): Retrospective cohort study developed between May 2021 to December 2021. The primary outcome was the appearance of infection during the follow up time (at least three months after complete vaccination (second dose)). Data was collected through the contact between the treating physician and the patient. Specific information was requested (vaccine received, dose, date, symptoms, COVID-19 infection, need for hospitalization, ventilatory assistance, treatment, and evolution). The primary objective of the analysis was to compare the incidence of breakthrough SARS-CoV-2 19 infections among the vaccinated pwMS in each DMT group. These conditions entail a PCR-confirmed test, and a time lag of at least 14 days from a full vaccination cycle (after the second vaccination dose). Cumulative incidence was reported by Kaplan Meier survival curves as well as incidence density. Result(s): A total of 49 NMOSD patients from eight countries in LATAM were included. Mean age was 43.8 +/-13 years. The most frequent treatment use was rituximab in 29 (59.2%). The mean follow up after the second dose was 149 +/- 32 days. Most frequent first and second dose received was Pfizer (28.6%), followed by Sinopharm (24.5%). During follow up a total of 2 COVID-19 cases were observed for a total exposure time of 8627 days. Cumulative incidence was 4.1% (SE 0.87%) with an overall incidence density of 2.31 x 10.000 patients/day (95%CI 1.13-3.71). Both cases occurred in patients under rituximab (2/29, exposure time 4208, IR 4.7 x 10,000 patients/day 95%CI 3.5-5.1). No hospitalizations were reported for both cases. Conclusion(s): We observed an ID of COVID-19 infection after vaccination of 2.31 x 10.000 patients/day in NMOSD patients.
ABSTRACT
Objectives: In a context of COVID-19 vaccine shortages, this study sought to evaluate the safety and efficacy of receiving one dose of Gam-COVID-Vac rAd26 followed by a second COVID-19 vaccine dose of either Gam-COVID-Vac rAd5, ChAdOx1 nCoV-19 or BBIBP-CorV in a cohort of older adults. Study design: Single-centre, randomised, open label, non-inferiority trial. Methods: Adults aged ≥65 years who had received one dose of Gam-COVID-Vac rAd26 were randomised in a 1:1:1 ratio to receive a second-dose COVID-19 vaccination of either Gam-COVID-Vac rAd5, ChAdOx1 nCoV-19 or BBIBP-CorV. The primary outcome was the assessment of the humoral immune response to vaccination (i.e. antibody titres of SARS-CoV-2 spike protein at 28 days after second-dose vaccination). In addition, neutralising antibody titres at day 28 for the three schedules were measured. Results: Of 85 participants who were enrolled in the study between 26 and July 30, 2021, 31 individuals were randomised to receive Gam-COVID-Vac rAd5, 27 to ChAdOx1 nCoV-19 and 27 to BBIBP-CorV. The mean age of participants was 68.2 years (SD 2.9) and 49 (57.6%) were female. Participants who received Gam-COVID-Vac rAd5 and ChAdOx1 nCoV1-19 showed significantly increased anti-S titres at 28 days after second-dose vaccination, but this magnitude of difference was not observed for those who received BBIBP-CorV. The ratio between the geometric mean at day 28 and baseline within each group was 11.8 (6.98-19.89) among patients assigned to Gam-COVID-Vac rAd26/rAd5, 4.81 (2.14-10.81) for the rAd26/ChAdOx1 nCoV-19 group and 1.53 (0.74-3.20) for the rAd26/BBIBP-CorV group. All of the schedules were shown to be safe. Conclusions: The findings in this study contribute to the scarce information published on the safety and immunogenicity of Gam-COVID-Vac heterologous regimens and will help the development of guidelines and vaccine programme management.