The Clinical Effectiveness and Safety of Vaccinations against COVID-19 in HIV-Positive Patients: Data from Observational Study in Poland.

People living with HIV (PLWH) are a heterogeneous group of immunocompromised persons, yet underrepresented in randomized clinical trials leading to vaccination registration. Detectable HIV viral load and having chronic comorbidities may increase the risk of severe COVID-19 outcomes in this group of patients. We aimed to assess the efficacy and safety of vaccinations against COVID-19 in PLWH. MATERIALS AND METHODS: We performed a retrospective analysis of medical records of HIV-positive individuals routinely followed up between 1 January 2021 and 30 April 2022 that were at the HIV Outpatient Clinic in Warsaw. The analysis included data on the type and date of administration of subsequent doses of COVID-19 vaccination, adverse vaccine reactions, and the history of SARS-CoV-2 infection. RESULTS: In total, 217 patients were included in the analysis, with a median age of 43 years (IQR: 35.5-51.5 years) and median CD4+ count of 591 cells/uL (IQR: 459.5-745.0 cells/uL). Most of the patients were male (191/217, 88.0%) and were vaccinated with the BNT162b2 vaccine (143/217, 65.9%). None of the patients diagnosed with COVID-19 required hospitalization. Vaccine adverse events (VAE) mostly occurred after the 1st dose (in 33/217 (15.2%)), and none of them were severe or required medical care. CONCLUSIONS: In our cohort of patients, vaccination against COVID-19 proved to be safe and effective against a severe course of the disease among people living with HIV. However, vaccination, to a lesser degree, protects against mild SARS-CoV-2 infection. Longer observations are required in order to assess the sustainability of protection against severe COVID-19 in this group of patients.

Higher Immunological Response after BNT162b2 Vaccination among COVID-19 Convalescents-The Data from the Study among Healthcare Workers in an Infectious Diseases Center.

Introduction: The BNT162b2 vaccination studies did not specifically focus on groups that were heavily exposed to SARS-CoV-2 infection. Therefore, we aimed to assess the safety and efficacy of the BNT162b2 vaccine among healthcare workers (HCWs). Methods: Study participants were recruited from hospital employees who received BNT162b2 vaccination at the Hospital for Infectious Diseases in Warsaw. Blood samples were collected before and after each vaccination dose. At each timepoint, the levels of anti-SARS CoV-2 IgM, anti-n SARS-CoV-2 IgG, and S-RBD antibodies were measured. Data on concomitant diseases and the vaccine's adverse events (VAE) were collected after each vaccination dose. In the statistical analyses, non-parametric tests were used. Results: In total, 170 healthcare workers were included in the analysis. Their median age was 51 years (interquartile range (IQR): 41−60 years); most of them were women (n = 137, 80.6%) working in direct contact with patients (n = 137, 73.2%); and 46 (27.0%) had concomitant diseases. More than one fifth of subjects had COVID-19 before their first dose of vaccination (n = 38, 22.6%). In terms of immunological responses, our investigations showed a high level of efficacy for the BNT162b2 mRNA vaccination as measured by S-RBD antibody concentrations: these were positive in 100% of participants 14 days after the second dose of the vaccine. It was also observed that employees with high S-RBD antibodies (>=433 BAU/mL) were more likely to be COVID-19 convalescents before receiving the first vaccine dose (p < 0.001). Conclusion: The BNT162b2 vaccine is safe and effective among HCWs. Vaccine adverse events occurred, but serious events were not observed. Moreover, the BNT162b2 vaccine is effective against symptomatic and severe COVID-19­none of the workers that acquired a SARS-CoV-2 infection after vaccination required hospitalization or medical care. We also observed higher immunological responses among COVID-19 convalescents.

The Clinical Course and Outcomes of Patients Hospitalized Due to COVID-19 during Three Pandemic Waves in Poland: A Single Center Observational Study.

Background: The first case of coronavirus disease 2019 (COVID-19) in Poland was reported on 4 March 2020. We aim to compare the clinical course and outcomes of patients hospitalized in the Hospital for Infectious Diseases in Warsaw due to COVID-19 during three pandemic waves. Materials and methods: The medical data were collected for all patients diagnosed with COVID-19 hospitalized in our hospital from 6 March 2020 till 30 November 2021. COVID-19 diagnosis was confirmed by nasopharyngeal swabs using real-time polymerase chain reaction assay (RT-PCR) or SARS-CoV-2 antigen test. COVID-19 waves were defined based on the number and dynamics of cases. Results: Altogether, 2138 patient medical records were analyzed. The majority of the cohort was male (1235/2138, 57.8%), and the median age was 65 years [IQR: 50−74 years]. Patients hospitalized during the third wave had lower oxygen saturation on admission (p < 0.001) and were more likely to receive oxygen supplementation (p < 0.001). Serious complications, including pneumothorax (p < 0.001) and thromboembolic complications (p < 0.001), intensive care unit admission (p = 0.034), and death (p = 0.003), occurred more often in patients of the third wave. Conclusions: During the third wave, patients in our cohort experienced a more severe course of the disease and poorer outcomes.

Complementary dose of COVID-19 vaccination may prevent SARS-CoV-2 breakthrough infection among previously vaccinated HIV positive persons.

People living with HIV (PLWH) are a heterogeneous group of immunocompromised persons. Detectable HIV viral load and chronic comorbidities are independently increasing the risk of severe outcomes from COVID-19 among PLWH. We aimed to assess the efficacy and safety of the COVID-19 vaccines in PLWH. A significant increase in S-RBD antibody titers >100 AU/mL was observed when compared the titers measured one week after the 1st dose to titers performed after the 2nd vaccine dose.

The Presence of Either Typical or Atypical Radiological Changes Predicts Poor COVID-19 Outcomes in HIV-Positive Patients from a Multinational Observational Study: Data from Euroguidelines in Central and Eastern Europe Network Group.

HIV-positive patients may present lungs with multiple infections, which may hinder differential diagnoses and the choice of treatment in the course of COVID-19, especially in countries with limited access to high-standard healthcare. Here, we aim to investigate the association between radiological changes and poor COVID-19 outcomes among HIV-positive patients from Central and Eastern Europe. Between November 2020 and May 2021, the Euroguidelines in Central and Eastern Europe Network Group started collecting observational data on HIV and COVID-19 co-infections. In total, 16 countries from Central and Eastern European submitted data (eCRF) on 557 HIV-positive patients. The current analyses included patients who had a radiological examination performed. Logistic regression models were used to identify the factors associated with death, ICU admission, and partial recovery (poor COVID-19 outcomes). Factors that were significant in the univariate models (p < 0.1) were included in the multivariate model. Radiological data were available for 224 (40.2%) patients, 108 (48.2%) had computed tomography, and 116 (51.8%) had a chest X-ray. Of these, 211 (94.2%) were diagnosed using RT-PCR tests, 212 (94.6%) were symptomatic, 123 (55.6%) were hospitalized, 37 (16.6%) required oxygen therapy, and 28 (13.1%) either died, were admitted to ICU, or only partially recovered. From the radiologist's description, 138 (61.6%) patients had typical radiological changes, 18 (8.0%) atypical changes, and 68 (30.4%) no changes. In the univariate models, CD4 count (OR = 0.86 [95% CI: 0.76-0.98]), having a comorbidity (2.33 [1.43-3.80]), HCV and/or HBV co-infection (3.17 [1.32-7.60]), being currently employed (0.31 [0.13-0.70]), being on antiretroviral therapy (0.22 [0.08-0.63]), and having typical (3.90 [1.12-13.65]) or atypical (10.8 [2.23-52.5]) radiological changes were all significantly associated with poor COVID-19 outcomes. In the multivariate model, being on antiretroviral therapy (OR = 0.20 [95% CI:0.05-0.80]) decreased the odds of poor COVID-19 outcomes, while having a comorbidity (2.12 [1.20-3.72]) or either typical (4.23 [1.05-17.0]) or atypical (6.39 [1.03-39.7]) radiological changes (vs. no changes) increased the odds of poor COVID-19 outcomes. Among HIV patients diagnosed with symptomatic SARS-CoV-2 infection, the presence of either typical or atypical radiological COVID-19 changes independently predicted poorer outcomes.

The Beneficial Effect of the COVID-19 Vaccine Booster Dose among Healthcare Workers in an Infectious Diseases Center.

INTRODUCTION: Healthcare workers in Poland received a booster dose of the BNT162b2 mRNA vaccine (Pfizer-BioNTech, Manufacturer: Pfizer, Inc., and BioNTech; Moguncja, Germany) at the beginning of October 2021. Here, we report on the preliminary results of an ongoing clinical study into the antibody response to SARS-CoV-2 of healthcare workers previously exposed to the virus, with or without evidence of past infection, in the Hospital for Infectious Diseases in Warsaw before and after the vaccine booster dose. METHODS: Blood samples were collected on the day the vaccine booster dose was administered and again 14 days later. The levels of SARS-CoV-2 IgG antibodies (against the n-protein, indicative of disease) and S-RBD (indicative of a response to vaccination) were measured. RESULTS: One hundred and ten health care workers from the Hospital for Infectious Diseases were included in the study. The percentage of subjects with a positive test for anti-n-protein IgG antibodies at both time points remained unchanged (16, 14%), while a statistically significant increase in the percentage of subjects producing high levels of S-RBD antibodies (i.e., >433 BAU/mL) was observed (from 23, 21% to 109, 99%; p = 0.00001). CONCLUSIONS: The results of the study indicate that the booster dose of the vaccine significantly increases the percentage of people with high levels of S-RBD antibodies, regardless of previous contact with the virus, which may indicate greater protection against both the disease and a severe course of COVID-19.