bluuebunny/crossref_metadata_2025_split huggingface dataset:
567. Reasons for Deferral of COVID-19 Vaccines Among Arab American Healthcare Professionals Living in the United States
Authors: Shallal Anita , Abada Evi , Musallam Rami , Fehmi Omar , Kaljee Linda , Fehmi Ziad , Alzouhayli Suma , Ujayli Deema , Dankerlui Doreen , Kim Seongho , Kumar Vijaya Arun , Zervos Marcus , Ali Rouba 
Published: December 2021

Abstract

Background
The WHO identified the three most common reasons for worldwide vaccine hesitancy to be safety concerns, lack of knowledge and awareness, and religion and cultural issues. There is limited information on this topic among Arab Americans, a rapidly growing demographic in the US. We sought to determine the reasons for deferral of the coronavirus disease 2019 (COVID-19) vaccine amongst Arab American health professionals living in the US.

Methods
This was a cross-sectional study utilizing an anonymous online survey. The survey was distributed via e-mail to National Arab American Medical Association members and Arab-American Center for Economic and Social Services healthcare employees. Respondents were considered vaccine hesitant if they selected responses other than a willingness to receive the COVID-19 vaccine.

Results
A total of 4,000 surveys were sent via e-mail from December 28 2020 to January 31 2021. The highest group of respondents were between the ages of 18-29 years and physicians constituted 48% of the respondents. Among 515 respondents, 41.9% (n=216) would receive the vaccine within one month of it becoming available to them, and 30.2% (n=156) had already received a vaccine. Among those who would defer the vaccine, 9.3% (n=48) would receive it within 1-3 months, 5.6% (n=29) within 3-6 months and 6.6% (n=34) after over 6 months or longer. 6.2% (n=32) would not receive the vaccine. The three most commonly reported reasons for deferral of vaccine among 75 vaccine hesitant respondents were: “I am worried about the side effects” (65.3%), “I am worried the vaccine moved through clinical trials too fast (54.7%), and “There is no information about long term side effects of the vaccine” (52%). Data indicate that about a quarter of respondents also expressed distrust of the government and the pharmaceutical industry. The results are summarized in table 1.

Conclusion
Reasons cited by this sample of Arab Americans for deferring the COVID-19 vaccine mirror more general concerns about vaccine side effects and need for information. Concerns about clinical trial procedures and distrust have become more prevalent with COVID-19. This data can help inform COVID-19 vaccine advocacy efforts among health care providers, and thus could have substantial impact on vaccine attitudes of the general population.

Disclosures
Marcus Zervos, MD, contrafect (Advisor or Review Panel member)janssen (Grant/Research Support)merck (Grant/Research Support)moderna (Grant/Research Support)pfizer (Grant/Research Support)serono (Grant/Research Support)
577. COVI-VAC™, a Live Attenuated COVID-19 Vaccine, Provides Single Dose Protection Against Heterologous Challenge with SARS-CoV-2 Beta (B.1.351) in the Syrian Golden Hamster Model
Authors: Kushnir Anna , Mueller Steffen , Tasker Sybil , Robert Coleman J 
Published: December 2021

Abstract

Background
Although multiple COVID-19 vaccines are currently in use, emergence of novel SARS-CoV-2 variants with reduced neutralization raises concern of future vaccine escape. COVI-VAC™ is a live attenuated SARS-CoV-2 strain based on WA/1 being developed as an intranasal COVID-19 vaccine. COVI-VAC is attenuated through removal of the furin cleavage site and introduction of 283 silent, deoptimizing mutations that maintain viral amino acid sequence but slow viral replication in vivo by up to 5 logs. Notably, COVI-VAC presents all viral antigens in their native conformation and is not limited to spike. COVI-VAC demonstrated attenuation, immunogenicity and single dose protection in both the Syrian golden hamster and non-human primate models and currently in Phase 1 clinical trials. In this study, we evaluated efficacy of COVI-VAC against challenge with the Beta/B.1.351 variant in Syrian golden hamsters.

Methods
Syrian golden hamsters, 7-10 weeks of age were, vaccinated intranasally with 8.25x104 PFU COVI-VAC (n=28) or vehicle control (n=16). Twenty seven days post-vaccination, animals were challenged intranasally with 3x104 PFU of wildtype (WT) SARS-CoV-2 Beta. Animals were weighed daily. Further analysis is being conducted with serum and key tissues from pre and post challenge timepoints to include neutralizing antibody, biodistribution (subgenomic qPCR) and histopathology.

Results
COVI-VAC prevented weight loss following challenge with the heterologous variant of SARS-CoV-2, B.1.351/Beta (Figure). Results of additional analyses will be available before the IDWeek meeting.
Change in Weight following SARS-CoV-2 Beta Challenge

Conclusion
COVI-VAC is protective against heterologous challenge with SARS-CoV-2 Beta. By presenting all viral antigens, COVI-VAC may be less affected by viral evolution than spike-based vaccines.

Disclosures
Anna Kushnir, PHD, Codagenix Inc (Employee) Steffen Mueller, PhD, Codagenix Inc (Board Member, Employee, Shareholder) Sybil Tasker, MD, MPH, FIDSA, Codagenix Inc (Employee, Shareholder) J. Robert Coleman, PhD, Codagenix Inc. (Board Member, Employee, Shareholder)
589. Oral Tablet Vaccination Induces Heightened Cross-Reactive CD8 T Cell Responses to SARS-COV-2 in Humans
Authors: Johnson Susan , Martinez Clarissa , Cortese Mario , Martinez Josefina , Garg Shaily , Peinovich Nadine , Dora Emery , Tucker Sean 
Published: December 2021

Abstract

Background
Covid-19 has accelerated global demand for easily distributed vaccines. Furthermore, as variant SARS-CoV-2 strains that circumvent antibody responses emerge, cross-protective vaccines provide substantial public health benefits. Vaxart is developing a shelf stable oral tablet vaccine that incorporates both the spike (S) and the more conserved nucleocapsid (N) proteins. Vaxart’s vaccine platform uses a non-replicating adenovirus and a TLR3 agonist as an adjuvant.

Methods
In an open-label phase 1 clinical study, 35 healthy subjects received either a single low (1x1010 IU; n=15) or high (5x1010 IU; n=15) dose of the vaccine candidate VXA-CoV2-1 with a small cohort receiving 2 low doses. PBMCs were taken at pre- and 7 days post-vaccination and restimulated with S and N peptides from SARS-CoV-2 or the 4 human endemic coronaviruses (HCoV). Cells were stained for CD4/CD8/CD107a (surface) and IFNγ/TNFα (intracellular). Subjects that received an intramuscular (i.m.) mRNA vaccine had PBMCs taken at the same timepoints and were compared in the same assay.

Results
The study’s results indicate that the VXA-CoV2-1 tablet was well tolerated. The majority of subjects had an increase in S-specific anti-viral CD8+ T cell responses. 19/26 (73%) subjects had a measurable CD8+ T cell response on day 8 above baseline, on average 1.5-4.6%. In a comparator experiment with the 2 SARS-CoV-2 i.m. mRNA vaccines, VXA-CoV2-1 outperformed other vaccine candidates with a &gt;3.5-fold increase in S specific antiviral CD8 T cell responses. T cell responses specific to the 4 endemic HCoV were increased by 0.6% in subjects given VXA-CoV2-1.

Conclusion
Here we describe a room temperature stable tablet that induces SARS-CoV-2 S specific CD8 T cells of high magnitude after one dose in humans. Overall, the level of antiviral SARS-CoV-2 specific T cells, particularly IFNg-producing CD8s, induced following oral immunization with VXA-CoV2-1 are of higher magnitude than the mRNA vaccines currently in use against COVID-19. T cell responses against 4 endemic HCoV were also induced. Because T cells may be important in protecting against death and severe infection, these results suggest that VXA-CoV2-1 could be cross-protective against a wide array of emerging pandemic coronaviruses.

Disclosures
Susan Johnson, PhD, Vaxart (Employee) Clarissa Martinez, MPH, Vaxart (Employee) Mario Cortese, PhD, Vaxart (Employee) Josefina Martinez, n/a, Vaxart (Employee) Shaily Garg, BS, Vaxart (Employee) Nadine Peinovich, MPH, Vaxart (Employee) Emery Dora, n/a, Vaxart (Employee) Sean Tucker, PhD, Vaxart (Employee)
600. The Effect of Medication-Assisted Treatment on Completion Rates of Outpatient Parenteral Antibiotic Therapy
Authors: Greco Christian S , Sobhanie Mohammad Mahdee , Coe Kelci E , Hebert Courtney , Williams Margaret 
Published: December 2021

Abstract

Background
Injection drug use is a nationwide epidemic associated with an increased risk of invasive Staphylococcus aureus (S. aureus) infections. Medication-assisted treatment (MAT) is effective in reducing substance use and increasing adherence to inpatient medical therapy in persons with injection drug use (PWID). Studies assessing the impact MAT has on completion of outpatient parenteral antibiotic therapy (OPAT) are limited.

Methods
This was a single-center, retrospective, cohort study at The Ohio State University Wexner Medical Center in patients admitted from 12/1/2017 to 12/1/2019 with a diagnosis of S. aureus bacteremia who were identified as PWID either by ICD-9 or 10 code or chart review. A formal MAT program was established on 11/30/2018. Patients were assigned to the pre-MAT group if they were discharged prior to 11/30/2018 and to the MAT group with treatment after 11/30/2018. We evaluated a composite outcome of failure to complete OPAT, recurrence of S. aureus bacteremia during the OPAT period and readmission within 30 days. A multivariable logistic regression analysis was performed to examine the association between MAT therapy and the primary composite outcome, while adjusting for proven confounders.

Results
A total of 700 patients were identified with 644 patients omitted based on exclusion criteria. The study population included 27 in the Pre-MAT group and 17 in the MAT. Median age was 37 years (IQR 30.6 - 46.1). There was a higher number of females in the MAT therapy group compared to the pre-MAT group (82% vs. 33%, p=0.002). Patients in the pre-MAT group had a significantly longer length of stay (25 days vs. 17 days, p=0.01). The primary composite outcome was met if a patient did not complete their OPAT, if they had a recurrence of S. aureus bacteremia during their OPAT or if they were readmitted to the hospital within 30 days. In the pre-MAT group 14/27 (52%) met the composite outcome versus 6/17 (35%) of the MAT group (p=0.28).

Conclusion
Patients in the MAT group met the composite outcome 17% less than those in the pre-Mat group which is suggestive of the impact MAT has on completion of OPAT therapy; however, this study did not reach statistical significance as it was underpowered. Further longitudinal evaluation with greater sample size is needed to fully evaluate this intervention.

Disclosures
Mohammad Mahdee Sobhanie, M.D., Regeneron (Scientific Research Study Investigator)Regeneron (Scientific Research Study Investigator, Was a sub-investigator for Regeneron 2066 and 2069)
603. Misdiagnosis of Lyme Disease in Patients Referred to an Academic Lyme Center
Authors: Shere-Wolfe Kalpana D , Silk Rachel , Lynch Mia , Jones-Dove Adrian , Alexander Carla 
Published: December 2021

Abstract

Background
Confusion and controversy surround various aspects of Lyme Disease (LD) including diagnosis. Typically, the diagnosis of LD is based on tick exposure, clinical history, exam, and laboratory testing. Laboratory testing and interpretation can be confusing, difficult, and a source of misdiagnosis.

Methods
One hundred and fifteen records of patients referred to the Integrated Lyme Program at University of Maryland for evaluation of LD were analyzed. All patients underwent initial evaluation by Infectious Disease (ID) physician who made a determination regarding Lyme diagnosis based on history, exam, epidemiologic risk factors and laboratory test results. Pt were determined to have one of the following diagnoses: 1) Acute LD 2) Past LD 3) Post Treatment Lyme Disease Syndrome (PTLDS) 4) Misdiagnosed LD. Data was also collected on reasons for misdiagnosis based on record review, referral information and patient reported information.

Results
We evaluated 115 patient records from our Lyme Program Registry. There were 78 female (68%) and 37 males (32%). The mean age was 46 years (range 19 to 83). Of the 115 records analyzed, there were 8 (7%) patients with acute Lyme disease; 38 (33%) patients with past Lyme disease , 3 (2.6%) patients with PTLDS and 93 (81%) of patients who were misdiagnosed with LD. Patients were misdiagnosed for multiple reasons and by different people. Twenty three percent (21/93) were misdiagnosed based on false positive IGM Western Blot; 16% (15/93) were misdiagnosed based on misread IGG Western Blot and 14% (13/93) were misdiagnosed based on unconventional Lyme test. The remainder were misdiagnosed based on symptoms. Forty two percent (39/93) were misdiagnosed by PCP; 4.3%(3/93) were misdiagnosed by Urgent/Emergent care physician and 31% (29/93) were misdiagnosed by physicians’ self-referred as Lyme Literate Medical Doctor. The remainder were incorrectly self-diagnosed by patients based on symptoms.

Conclusion
Misdiagnosis of patients referred to Lyme Center is common and due to various reasons including misinterpretation of laboratory Lyme testing by healthcare providers and misinterpretation of symptoms by patients.

Disclosures
All Authors: No reported disclosures
608. Continuous Infusion Vancomycin Is Not Associated with Improved Safety in an Outpatient Parenteral Antimicrobial Therapy Program
Authors: Tagare Rosemarie D , McDonald Joshua A , Tritle Brandon , Fong Karen , Newman Michael G , Certain Laura , Benefield Russell J 
Published: December 2021

Abstract

Background
Continuous infusion (CI) vancomycin has been reported to be associated with improved safety outcomes compared to intermittent infusion (II) in the outpatient parenteral antimicrobial therapy (OPAT) setting. Based on this our institution implemented a quality improvement intervention to discharge more patients on CI vancomycin aiming to improve vancomycin safety in our OPAT program.

Methods
This single-center, pre-/post-intervention, quasi-experimental study evaluated adult patients who received vancomycin for a minimum 7-day intended duration of therapy after discharge, were discharged to home health or a skilled nursing facility, and had a follow-up visit with an infectious diseases provider. Outcomes included discontinuation due to acute kidney injury (AKI) or due to any adverse drug event (ADE), time to AKI or ADE, and unplanned 30-day readmissions and were compared between the pre-intervention (11/25/2018 to 7/5/2020) and post-intervention (7/6/2020 to 3/31/2021) periods. Adverse events were defined as premature discontinuation of vancomycin with documentation of a suspected adverse event.

Results
Of the 445 patients included, 102 patients received CI vancomycin. Demographic characteristics were generally similar between time periods, although more patients discharged to home health were included during the post-intervention period. CI vancomycin use was higher after the intervention (42% vs 11%, P &lt; 0.0001). Discontinuation due to AKI (7% vs 8%, P = 0.68) or any ADE (16% vs 18%, P = 0.65) occurred just as frequently post-implementation. Unplanned 30-day readmission was higher post-intervention (21% vs 12%, P = 0.02). When comparing patients receiving CI and II vancomycin, discontinuation rates due to AKI (10% with CI vs 7% with II, P = 0.35) and any ADE (17% with CI vs 17% with II, P = 0.85) were similar. Time to AKI (median 21 days with CI vs 16 days with II, P = 0.26) and any ADE (median 22 days vs 22 days, P = 0.55) were also similar. There was a trend toward a significantly higher unplanned 30-day readmission rate with use of CI compared to II (22% vs 14%, P = 0.07).
Control Charts

These control charts show the variation over time of the proportion of patients A. utilizing CI vancomycin, B. experiencing any adverse drug reaction, C. experiencing acute kidney injury, and D. being readmitted within 30 days. Upper and lower control limits are depicted by red lines, and the mean is depicted by a green line.

Conclusion
We found no safety advantages when using CI instead of II vancomycin in the outpatient setting. The potentially higher readmission rate observed with CI vancomycin will be investigated further.

Disclosures
Russell J. Benefield, PharmD, Paratek Pharmaceuticals (Grant/Research Support)
614. Evaluating the Use of Dalbavancin for Off-Label Indications
Authors: Taylor Katherine , Williamson John , Stone Tyler , Johnson James , Gruss Zachary , Luther Vera , Luther Vera , Russ-Friedman Courtney , Ohl Chris , Beardsley James 
Published: December 2021

Abstract

Background
Dalbavancin (dalba) is a long-acting antibiotic (ABX) approved for skin and soft tissue infections. Post-marketing data suggests dalba is being used for off-label indications that require long term IV ABX; however, data assessing this off-label usage is limited. The purpose of this study was to evaluate the real-world efficacy, safety, and financial impact of off-label dalba use.

Methods
Setting: 4-hospital health system. Design: retrospective, observational study. Adult patients (pts) who received dalba from Jan 2018 to Jan 2021 for an off-label indication were included. Pts who were pregnant or had an infection caused by a pathogen outside dalba’s antimicrobial spectrum were excluded. Primary outcome was clinical success at 90 days defined as no need for additional ABX (excluding suppression therapy) or surgical intervention following dalba therapy and no positive cultures post treatment associated with the dalba-targeted infection. Secondary outcomes included safety (nephrotoxicity and hepatotoxicity). A financial analysis was performed by subtracting the cost of dalba from the anticipated cost of pt stay [&427/day for hospital; &262/day for skilled nursing facility (SNF)] if standard IV therapy was given.

Results
50 pts met study criteria; 42% were IV drug users; 14% were self-pay. Indications included osteomyelitis (54%), endocarditis (22%), bacteremia (16%), and prosthetic joint infection (PJI) (8%). The predominant organism was S. aureus (60%), with 42% caused by MRSA. All but 1 pt received 1.5 g of dalba. 20 (40%) pts received 1 dose; 26 (52%) received 2. Overall, 43 (86%) pts achieved clinical success at 90 days, including 87% of osteomyelitis/PJI pts, 82% of endocarditis pts, and 100% of pts with bacteremia. There were no instances of nephrotoxicity or hepatotoxicity. Estimated cost avoidance per pt was &5210 and &1652 if traditional IV therapy was completed in the hospital and SNF, respectively. Because the alternative therapy to dalba could not be predicted, these costs were not included in analysis but likely would have increased calculated cost avoidance.

Conclusion
Dalba was associated with a relatively high success rate for the treatment of off-label indications and may have less total costs than traditional IV ABX.

Disclosures
James Johnson, PharmD, FLGT (Shareholder) Vera Luther, MD, Nothing to disclose
615. A Year with COVID19 – Experience from the Front Line in a Large Infectious Disease (ID) Clinical Practice
Authors: Nahass Ronald G , Giordano Angelo , McManus Edward J 
Published: December 2021

Abstract

Background
ID Care (IDC) is a large, 43 physician, 74 provider, practice that treats patients in 16 acute care hospitals (ACH) and 120 skilled nursing facilities (SNF) in NJ. March 4, 2021 was the first day a patient with COVID19 seen by IDC. Over the subsequent year IDC evaluated, treated, and tested over 23,000 persons for COVID19. Patients were seen in 2 distinct times - wave 1 (W1) March 5-August 31 and wave 2 (W2) September 1 to March 4. We compare the experience of these 2 waves and report on the year of COVID19 at IDC.

Methods
The administrative data base for IDC was queried for demographic, visit and testing information. A survey of providers was performed to capture incidence of COVID19 and vaccination rates. Daily census logs were used to create epi curves. Comparisons between waves were performed using student T Test or X2.

Results
Table 1 provides the comparisons between waves. More patients were seen in W2, however, the number of visits per patient was less, consistent with a shorter length of stay. Fewer patients were seen in SNF in W2 compared to W1. The age and sex distribution between the waves were the same. A total of 8741 molecular tests were performed. Test positivity peaked the week of December 31 at 6.99% and dropped to 0% by May 1 consistent with vaccination and the NJ epidemic curve. During the year of COVID19, 6/74 (8%) clinicians were infected with SARSCoV2. All recovered. Infections in providers were not clearly work-related exposures. 73/74 clinicians were vaccinated.

Table 1. Demographics For the Year in COVID19 at ID Care

Figure 1. Test Positivity Rate for ID Care

Conclusion
The year of COVID19 occurred in 2 distinct waves. W1 was short and intense. The age and gender distributions were the same between the waves. Even though wave 2 was numerically greater, the cases in SNF were statistically less than the first wave likely from improved IP practice initiated in W1. The numbers of visits per patient, a surrogate for LOS, was statistically less in W2. The decline in test positivity paralleled deployment of vaccination. Despite an intensity of exposure of 158 patients/provider or 1198 visits/provider to SARSCoV2 infected persons only 8% of the clinician staff were infected. ID clinical practice can use electronic databases to help describe regional outbreaks of transmissible disease giving additional perspective across the care continuum. A more usable standard tool would enhance this capacity.

Disclosures
Ronald G. Nahass, MD, Abbvie (Grant/Research Support, Speaker's Bureau)Alkermes (Grant/Research Support)Gilead (Grant/Research Support, Speaker's Bureau)Merck (Grant/Research Support, Speaker's Bureau)