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Gastroenterology ; 162(7):S-1248, 2022.
Article in English | EMBASE | ID: covidwho-1967431


commonly worldwide but their effectiveness in participants with cirrhosis is unknown. We explored the effectiveness of vaccination with the Janssen Ad.26.COV2.S compared to the mRNA Pfizer BNT162b2 or Moderna 1273-mRNA vaccine in participants with cirrhosis. Method: This was a test-negative case control study among participants with cirrhosis. This study design is widely used in evaluations of vaccine effectiveness and has the advantage of minimizing biases associated with access to vaccination or health care. Cases were those who were SARS CoV2 PCR positive, controls were those who tested negative during the study period between March 15, 2021 and October 3, 2021. Participants who did not undergo SARS CoV2 PCR testing, who had COVID-19 before the study period, or received a liver transplant, were excluded. COVID-19 was classified based on individual chart review using the National Institute of Health (NIH) COVID-19 severity scale as asymptomatic, mild, moderate, severe or critical illness. Propensity score matching was used to match test positive cases and test negative controls. The propensity score of having COVID-19 were derived from a logistic regression that adjusted for the participant's sex, age, date of testing, race/ethnicity, location, alcohol as the etiology of liver disease, body mass index (BMI), diabetes mellitus, current tobacco use, current alcohol use, co-morbidities, and the Child Turcotte Pugh score. Multinomial logistic regression models were fit for COVID-19, to assess the adjusted effect from vaccination with either the Ad.26.COV2.S or the mRNA-1273 or BNT162b2 vaccines. Results: A total of 955 cases and 955 matched controls were included in the study population. The two groups were well matched to all baseline characteristics. The Ad.26.COV2.S vaccine had an effectiveness of 64% against COVID-19 (adjusted Odds Ratio [aOR] 0.36, 95% CI 0.20-0.62, p=0.005). Effectiveness was lowest with asymptomatic illness (aOR 0.42, 0.18-0.73, p=0.03), and higher against mild (aOR 0.36, 0.15-0.63, p= 0.006), moderate (aOR 0.33, 0.14-0.49, p=0.002) and severe/critical (aOR 0.24, 0.08-0.83, p=0.04) COVID-19. In the same period, mRNA vaccines had a 73% effectiveness against overall COVID-19 (aOR 0.27, 0.19-0.37, p<0.0001), progressively higher from asymptomatic (aOR 0.38, 0.23-0.59, p=0.0004) to mild (aOR 0.29, 0.18-0.42, p<0.0001), moderate (aOR 0.27, 0.18-0.36, p<0.0001), and severe or critical illness (aOR 0.17, 0.06-0.32, p<0.0001). There were no statistically significant differences between the viral vector and mRNA vaccines. Conclusion: In participants with cirrhosis, the Ad.26.COV2.S demonstrated a 64% effectiveness against COVID-19, and a 74% effectiveness against severe or critical COVID-19, similar to that associated with mRNA vaccines. (Figure Presented)

Gastroenterology ; 162(7):S-1137, 2022.
Article in English | EMBASE | ID: covidwho-1967412


Background and Aims: Immunity to Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) can be either infection-induced or vaccine-induced. The duration of protective immunity following SARS-CoV-2 infection and how this compares with that from vaccination is presently unclear. Cirrhosis is associated with vaccine hyporesponsiveness to several vaccines include COVID-19 mRNA vaccines. The objective of our study was to compare infection-induced and vaccine-induced immunity against COVID-19 among patients with cirrhosis. Methods: This was a retrospective cohort study among patients with cirrhosis. Vaccine-induced immunity group was defined as participants with cirrhosis who were fully vaccinated with an mRNA vaccine and received the first dose of the mRNA vaccine between 12/18/2020 and 4/1/2021. Infection-induced immunity was defined as participants who had their first positive SARS-CoV-2 PCR in the same study period. The outcome was a positive SARS-CoV-2 PCR more than 60 days after previous infection or vaccination. Patients were followed until the outcome, death or the end of the study period (11/16/21). COVID-19 cases were classified based on individual chart review using the National Institute of Health (NIH) COVID-19 severity scale as asymptomatic, mild, moderate, severe or critical illness. The two groups were matched 1:3 using propensity score (PS) matching, with PS scores calculated based on variables associated with COVID-19 severity, including for the date of infection or first dose of vaccnation, and location, to account for variants. Cox proportional hazards models were fit from the immunity generating event to outcome (SARS-CoV-2PCR). Logistic regression models were also fit for the outcome (positive SARS-CoV-2 PCR) after the immunity generating event. Results: There were 443 participants in the infection-induced group, that were PS matched with 1,329 participants in the vaccine-induced group. The two groups were well matched after PS matching. On multivariable Cox hazard model, vaccine-induced immunity was associated with a 75% reduction in COVID-19 compared to infection-induced immunity (adjusted Hazard Ratio 0.25, 95% CI 0.15-0.43, p<0.0001). On multinomial logistic regression analysis, vaccine-induced immunity was associated with a 80% reduction in asymptomatic (adjusted Odds Ratio [aOR] 0.20, 95% CI 0.09-0.47, p-0.0002), 64% reduction in mild (aOR 0.36, 95% CI 0.13-0.97, p=0.048), and 79% reduction in severe or critical COVID-19 (aOR 0.21,95% CI 0.06-0.74, p=0.02) compared to infection-induced immunity. There were no observed differences between the two groups for moderate COVID-19 (aOR 0.31, 95% CI 0.06-1.56, p=0.16). Conclusions: In participants with cirrhosis, vaccine-induced immunity is associated with a significantly greater protection against COVID-19 compared to infection-induced immunity.[Figure Presented]

Journal of Clinical Oncology ; 39(28 SUPPL), 2021.
Article in English | EMBASE | ID: covidwho-1496265


Background: Patient-trial matching is a critical step in clinical research recruitment that requires extensive review of clinical data and trial requirements. Prescreening, defined as identifying potentially eligible patients using select eligibility criteria, may streamline the process and increase study enrollment. We describe the real-world experience of implementing a standardized, universal clinical research prescreening protocol within a VA cancer center and its impact on research enrollment. Methods: An IRB approved prescreening protocol was implemented at the VACT Cancer Center in March 2017. All patients with a suspected or confirmed diagnosis of cancer are identified through tumor boards, oncology consults, and clinic lists. Research coordinators perform chart review and manually enter patient demographics, cancer type and stage, and treatment history into a REDCap (Research Electronic Data Capture) database. All clinical trials and their eligibility criteria are also entered into REDCap and updated regularly. REDCap generates real time lists of potential research studies for each patient based on his/her recorded data. The primary oncologist is alerted to a patient's potential eligibility prior to upcoming clinic visits and thus can plan to discuss clinical research enrollment as appropriate. Results: From March 2017 to December 2020, a total of 2548 unique patients were prescreened into REDCAP. The mean age was 71.5 years, 97.5% were male, and 15.5% were African American. 32.57 % patients had genitourinary cancer, 17.15% had lung cancer, and 46.15% were undergoing malignancy workup. 1412 patients were potentially eligible after prescreening and 556 patients were ultimately enrolled in studies. The number of patients enrolled on therapeutic clinical trials increased after the implementation of the prescreening protocol (35 in 2017, 64 in 2018, 78 in 2019, and 55 in 2020 despite the COVID19 pandemic). Biorepository study enrollment increased from 8 in 2019 to 15 in 2020. The prescreening protocol also enabled 200 patients to be enrolled onto a lung nodule liquid biopsy study from 2017 to 2019. Our prescreening process captured 98.57% of lung cancer patients entered into the cancer registry during the same time period. Conclusions: Universal prescreening streamlined research recruitment operations and was associated with yearly increases in clinical research enrollment at a VA cancer center. Our protocol identified most new lung cancer patients, suggesting that, at least for this malignancy, potential study patients were not missed. The protocol was integral in our program becoming the top accruing VA site for NCI's National Clinical Trial Network (NCTN) studies since 2019.