bluuebunny/crossref_metadata_2025_split huggingface dataset:
2380. Menstrual changes after COVID vaccine in the Dominican Republic
Authors: Roque Yori A , De Luna David 
Published: November 2023

Abstract

Background
Women around the world began reporting menstrual disorders after receiving COVID vaccines. Numerous studies were launched evaluating a possible causal relationship between vaccines and these disorders. To date, it has not been possible to establish causality between the different vaccine compounds and these disorders. Here we identify the main self-reported menstrual disorders in vaccinated women the Dominican Republic.

Methods
We elaborated a multiple-choice self-questionnaire shared through a link on social networks. Sociodemographic factors, type of vaccine received, number of doses, and symptoms or disorders related to the menstrual cycle that occurred after its administration were addressed.

Results
200 participants completed the questionnaire. The ages were mainly between 18 to 28 years (40.5%), 29 to 38 years (39%), 39 to 49 years (18.5%). 74% defined their menstrual cycle as regular (between 21 and 29 days). Most of the vaccines reported were Coronavac (63%), Astra Zeneca (23%) and Pfizer (7%). 81.5% received two doses of the vaccine, while 13.5% had received 3 doses. Most of the disorders reported occurred after the second dose (60%), the most frequent being dysmenorrhea (33%), menorrhagia (31.5%) delayed menstrual bleeding (31%), and heavy bleeding (30.5%). 59.5% considered these symptoms as moderate and 44.5% reported that they were maintained for 2 to 3 months. 65.5% of women reported that they would get vaccinated against COVID again despite these events.

Conclusion
Dysmenorrhea, menorrhagia, delayed menstrual bleeding, and heavy bleeding were the most reported disorders in our cohort. Although causality has not been confirmed, health personnel should be aware of these findings and offer the relevant recommendations to women who are going to be vaccinated.

Disclosures
All Authors: No reported disclosures
2383. Immunogenicity and reactogenicity of a first booster with BNT162b2 or full-dose mRNA-1273: a randomised trial in adults ≥75 years (EU-COVAT-1) from the VACCELERATE consortium
Authors: Salmanton-Garcia Jon , Neuhann Julia M , Stemler Jannik , Carcas Antonio , Frías-Iniesta Jesús , Bethe Ullrich , Heringer Sarah , Tischmann Lea , Zarrouk Marouan , Cuepers Arnd , Koehler Philipp , Grothe Jan H , Singh Samir Kumar , García-León Alejandro , Loens Katherine , Lammens Christine , Koenig Franz , Yeghiazaryan Lusine , Posch Martin , Cornely Oliver A 
Published: November 2023

Abstract

Background
Vaccination remains crucial for protection against severe SARS-CoV-2 infection, especially in aged population.

Methods
We evaluated, with a randomised controlled, adaptive, multicentre phase II study, the safety and immunogenicity of a 3rd vaccination dose (1st booster) in individuals ≥75 years (ClinicalTrials.gov Identifier: NCT05160766, EudraCT Number: 2021-004526-29). Participants were randomized to either a full-dose (100µg) of mRNA-1273 (Spikevax®) or 30 µg of BNT162b2 (Comirnaty®). The primary endpoint was the rate of 2-fold antibody titre increase 14 days post-vaccination measured by quantitative enzyme-linked immunosorbent assay (Anti-RBD-ELISA). Secondary endpoints included changes in neutralising capacity (ACE2 Virus Neutralisation Assay) against wild-type and 25 variants at 14 days and up to 12 months.

Results
Fifty-three volunteers were randomised between 8 November 2021 and 4 January 2022, with 52 receiving a COVID-19 vaccine as 1st booster. Fifty subjects (BNT162b2 n=25/mRNA-1273 n=25) were included in the analyses for immunogenicity after day 14. The primary endpoint of a 2-fold anti-RBD IgG titre increase 14 days post-vaccination was reached in all subjects. A 3rd full-dose mRNA-1273 vaccination provided higher anti-RBD IgG titres (GMT D14 7090 [95% CI 5688 – 8837] BNT162b2 vs. 10711 [95% CI 8003 – 14336] mRNA-1273). A pattern showing higher neutralising capacity of full-dose mRNA-1273 against Wuhan wild-type so as for 23/25 tested variants was observed.

Conclusion
Third doses of either BNT162b2 or mRNA-1273 provide substantial antibody increase 14 days post-vaccination, with full-dose mRNA providing higher antibody levels and an overall similar safety profile for ≥75 subjects. Additional booster doses should be prioritised, particularly in aged people and others at high-risk. In-depth data on waning of immune response is needed to assess duration of protection, and evaluation of vaccine-dosage for individuals at risk may be reconsidered. With the data on full-dose (100µg) mRNA-1273evaluation of vaccine-dosage for individuals at risk may be reconsidered, despite the small sample size.

Disclosures
Jannik Stemler, -, Ministry of Education and Research (BMBF): Grant/Research Support Oliver A. Cornely, MD PhD, DZIF: Advisor/Consultant|DZIF: Board Member|DZIF: Grant/Research Support|DZIF: Honoraria|DZIF: Stocks/Bonds
2386. Examining Ways to Increase COVID-19 Vaccine Uptake through Motivational Interviewing
Authors: Reyes Summer M , Reyes Sydney A , Walsh Tyler , SHELLEY Jamee T , Agha Humza , Torres Ana V , Prater Jasmine , Smith Gabrielle D , Barksdale Nicholas , Lindsay Ryan R , Malone Sara , Newland Jason 
Published: November 2023

Abstract

Background
COVID-19 vaccine uptake in the U.S. has been poor especially among children. We are conducting a study evaluating 2 theoretically informed strategies to increase COVID-19 vaccine uptake.

Methods
A sequential multiple assignment randomized trail (SMART) design is being conducted where participants are randomized into receiving a text message with a link to COVID-19 vaccine resources or a motivational interview (MI). After 2 weeks, if the person is still not vaccinated, they are re-randomized to one of the same two strategies. Participants were eligible if they were completely unvaccinated or not up to date with their COVID-19 vaccines AND were a resident of St. Louis City or St. Louis County OR a school community member in one of our partnering school districts.

Results
171 individuals have participated in the trial. The median age was 28 (IQR 12-42) Of these, 107 were Black (63%), 44 White (26%), and 114 (67%) female (Table 1). 130 (76%) participants had received the flu vaccination before while only 42 (25%) had received at least one COVID-19 vaccine. A majority (65%) had private insurance; however, 3% had no insurance. Of those who received MI, the average response for importance (1= least, 10=most) of general vaccines and COVID-19 vaccines to one’s health was 7.86 and 4.06, respectively (Table 2). Ten was the most common response of participants for importance of general vaccines and 0 for importance of COVID-19 vaccines and readiness overall. Compared to COVID-19 vaccines, general vaccines had a higher importance overall and at intervention 1 and 2 time points (Figure 1a, b, & c). The four individuals received a COVID-19 vaccine during the study all received a MI call (3 had call as their only intervention while 1 had call then text).Table 1:Participant DemographicsTable 2:Motivational Interviewing Calls-Overall NumbersFigure 1:Average Numbers for MI Calls-Overall, First Intervention Only, and Second Intervention Only

Conclusion
General vaccines were regarded more highly than COVID-19 vaccines. With the continuation of this study as well as further analysis in participants’ reasons for their numerical responses, we can further understand why participants view these vaccines differently, what can be done to improve thoughts on COVID-19 vaccines, and increase COVID-19 vaccine uptake.

Disclosures
Jason Newland, MD, Moderna: Grant/Research Support|Pfizer: Grant/Research Support
2391. Evaluation and Adjudication of Case Reports of Myocarditis After mRNA-1273 Vaccination
Authors: Urdaneta Veronica , Dharia Priyadarshani , Akangbe Oketoun , Laurent Samantha St , Esposito Daina , Emile-Backer Magalie , Straus Walter 
Published: November 2023

Abstract

Background
Myocarditis and/or pericarditis have been identified as very rare adverse events (AEs) associated with administration of COVID-19 vaccines, particularly mRNA vaccines. Cases were disproportionately reported in young men aged 18-24 years, within a few days after vaccination, mostly following a second dose. This analysis describes findings of the evaluation and adjudication of myocarditis/pericarditis AE reports (18 Dec 2020 – 17 Dec 2022) in the Moderna Global Safety Database (GSDB) following mRNA-1273 vaccination.

Methods
Two different case definitions were used to characterize level of diagnostic certainty and identify strength of evidence supporting a diagnosis of myocarditis/pericarditis: the Brighton Collaboration (BC) Case Definition (1-5 categories) and the Centers for Disease Control and Prevention (CDC) definition (probable/confirmed). Causality assessment was conducted using the standard WHO-UMC criteria. Based on epidemiological criteria, analysis was concentrated on reported cases involving individuals aged &lt;40 years, including &lt; 18 years, after &gt;2 doses of mRNA-1273 and bivalent vaccines, regardless of the time-to-onset of AEs after vaccination.

Results
There were 6702 myocarditis/pericarditis cases after an estimated 773 million doses of mRNA-1273 (monovalent) or bivalent vaccine administered during the analysis period. There were no significant temporal changes in the demographic distribution of reported cases; 66.2% of these cases occurred in men aged 18-39 years (Figure 1) and after the second dose (28.3%). In individuals &lt; 40 years of age, according to the BC, 38.1% of the cases were confirmed/probable; according to CDC definition 37% of the cases were confirmed/probable. WHO causality assessment indicated that 39.8% of the cases were probable/possible.
Figure 1
Percentage of mRNA-1273, mRNA-1273.214 (Original/BA.1) and mRNA-1273.222 (Original/ BA.4/5) Reported Cases of Myocarditis and Pericarditis by Age and Sex (18 December 2022 to 17 December 2022)

Conclusion
Adjudication of myocarditis/pericarditis cases following mRNA-1273 indicated that where information was available, most reports were Probable Cases, for both BC and CDC case definitions. According to WHO-UMC causality assessment most cases were considered possibly related to mRNA-1273.

Disclosures
Veronica Urdaneta, MD, MPH, Moderna, Inc.: Salary|Moderna, Inc.: Stocks/Bonds Priyadarshani Dharia, PhD, MD, MPH, Moderna, Inc.: Salary|Moderna, Inc.: Stocks/Bonds Oketoun Akangbe, PharmD, Moderna, Inc.: Salary|Moderna, Inc.: Stocks/Bonds Samantha St Laurent, MPH, Moderna, Inc.: Salary|Moderna, Inc.: Stocks/Bonds Daina Esposito, PhD, MPH, Moderna, Inc.: Salary|Moderna, Inc.: Stocks/Bonds Magalie Emile-Backer, PharmD, CCRP, Moderna, Inc.: Salary|Moderna, Inc.: Stocks/Bonds Walter Straus, MD, MPH, Moderna, Inc.: Salary|Moderna, Inc.: Stocks/Bonds
2401. The Role of Quantitative Microbial Cell-free DNA (mcfDNA) Sequencing (Seq) from Plasma in the Diagnosis (Dx) of Staphylococcal Cardiac Implantable Electronic Device Infective Endocarditis (CIED IE)
Authors: Karchmer Adolf W , Jenifer Kaufman M , Azim Ahmed Abdul , van den Berg Polly , Matos Jason D , Kramer Daniel B , Degner Nicholas R , Zimetbaum Peter 
Published: November 2023

Abstract

Background
Optimal treatment (rx) of staphylococcal CIED IE requires removing the entire CIED. Difficulty of dx plus cost and potential morbidity of rx make treatment challenging. Complicated staphylococcal bacteremia is associated with prolonged detection of plasma mcfDNA during antibiotic rx. To assess for IE, we studied plasma mcfDNA kinetics in CIED patients (pts) with staphylococcal bacteremia undergoing CIED removal.

Methods
With written consent, CIED pts (no persistent confounding infection) with bacteremia in the prior ≤ 7 days (d) and planned CIED removal had serial plasma specimens collected [Figure]. Quantitative mcfDNA-Seq was done using the Karius Test® at Karius CLIA certified Laboratory (Redwood City,CA) on batched pt specimens. Clinical data were obtained from the electronic medical record. CIEDs were removed through sterile pockets or surgically except in pt 012. Definite CIED IE was defined by multiple d of bacteremia plus a definite lead / tricuspid vegetation per echocardiogram, direct inspection or lead tip culture; multiple d bacteremia or a definite vegetation defined possible CIED IE.

Results
Nine pts with definite CIED IE had bacteremia 3-13 d (median 6 d) with Staphylococcus aureus (7 pts) or S. epidermidis (2 pts: 012 who due to retained lead fragment relapsed after rx 021) [Table 1]. At consent, after 2-11 d rx (median 6 d) mcfDNA was detected in 8 of 9 pts; in all 9, on CIED extraction mcfDNA increased significantly from consent and pre-extraction levels [Table3]. Five pts with possible S.aureus CIED IE had 1-3 d (median1 d) bacteremia [Table 2]. None had plasma mcfDNA after 5 d rx and 4 of 5 had no mcfDNA detectable on device extraction [Table3]. McfDNA patterns in definite CIED IE (8 of 9 pos on consent / pre-extraction and had an increase on extraction) differed from those in possible CIED IE (4 of 5 neg at 5 d of rx and none detected on extraction) [p=0.023 Fisher Exact].

Conclusion
Quantitative mcfDNA patterns can help distinguish definite from possible CIED IE and absence of mcfDNA in plasma of possible CIED IE on device extraction suggests that the CIED may not be infected. After 5 days of rx, plasma mcfDNA-Seq in CIED pts with staphylococcal bacteremia coupled with clinical features may identify patients that can be effectively treated without device removal - a testable hypothesis.

Disclosures
Adolf W. Karchmer, MD, DeBiopharma: Advisor/Consultant|DeBiopharma: Honoraria|Karius: Grant to Institution for this study Jason D. Matos, MD, Merck: Wife is an employee Nicholas R. Degner, MD, MPH, MS, Karius: Employer
2404. Widespread emergence of infective endocarditis due to Serratia spp.: Results of a large multicenter cohort
Authors: Madeline McCrary L , Shah Sunish , Slain Douglas , Stoner Bobbi Jo , Marx Ashley H , Schranz Asher J 
Published: November 2023

Abstract

Background
Infective endocarditis (IE) due to Serratia spp. (S-IE) has historically been considered a rare entity and limited to case series. Typically linked to injection drug use (IDU), S-IE appears to be growing amidst the opioid crisis. Guidance on therapy of non-HACEK gram negative IE remains limited. Our goal was to assess trends in S-IE and evaluate management strategies.

Methods
We retrospectively assessed adults treated for S-IE at 4 academic health systems in 4 US states from 2015-2021. Each site utilized different methods of identifying S-IE cases. Chart review was performed to assess management of cases. Multivariable logistic regression analyzed the association between antibiotic regimens and/or procedural management (defined as valve surgery or transcatheter aspiration of vegetation) with inpatient mortality (defined as inpatient death or hospice discharge) and was adjusted for select demographic and clinical factors (Table 2). Only the 3 sites with available antibiotic data were included in the adjusted model.

Results
169 cases of S-IE were identified with an overall increase from 2015 to 2021 and an apparent peak in 2019, although trends varied by site (Fig 1). 76% of cases were due to IDU, 56% involved a single left-sided valve and 40% were polymicrobial (Table 1). Inpatient mortality was 22%. 35% of patients had a procedural intervention, and 44% were treated with combination antibiotic therapy. Univariate analyses (Table 2) revealed significant associations between mortality and site of care, single left-sided valve disease, procedural management and treatment with combined beta-lactam and fluoroquinolone (BL+FQ). In the adjusted analysis, including 117 cases from 3 sites, lower inpatient mortality was associated with procedural intervention (OR 0.17, 95% CI 0.04-0.77) and BL+FQ treatment (OR 0.06, 95% CI 0.00-0.88).

Conclusion
In this large multicenter study, we found that S-IE is not infrequent, has high inpatient mortality and is treated with varying strategies. Procedural intervention and combination BL+FQ treatment were associated with lower mortality. Our study is limited by varying methods of case identification and a lack of data on clinical severity and surgical indications. Further study is urgently needed to define best management practices.

Disclosures
Asher J. Schranz, MD, MPH, WoltersKluwer: Honoraria
130. Influencing Antibiotic Prescribing for Patients with Enterobacter cloacae or Klebsiella aerogenes by Use of Templated Comments
Authors: Landolt Anna , Bennett Nicholas , Aragon Laura , Boyd Sarah E , Essmyer Cindy , Humphrey Matthew 
Published: November 2023

Abstract

Background
Antimicrobial resistance poses a significant threat in treating bacterial infections. One such concern is the treatment of AmpC beta-lactamase producing Enterobacterales. In October 2019, Saint Luke’s Health System incorporated an automated microbiology comment advising the avoidance of third generation cephalosporins in patients with cultures positive for two bacteria which most frequently express AmpC resistance: Enterobacter cloacae and Klebsiella aerogenes. We assessed the comments effect on treatment decisions and microbiologic outcomes.

Methods
This is a retrospective, pre-post, cohort study in a single health system. Patients were included if they were inpatients 18 years of age or older and had urine or blood cultures positive for E. cloacae or K. aerogenes. Patients were excluded if cultures were determined to be colonizing pathogens. Pre- (May to December 2018) and post-comment (May to December 2020) cohorts were compared to assess the influence of the comment on therapy selection and subsequent development of resistance. The primary endpoint was escalation to targeted antimicrobial therapy within the first 24 hours after culture speciation. Secondary outcomes included escalation within 72 hours of culture speciation, time to escalation, length of hospital stay, and subsequent development of multi-drug resistant organism one year following admission.

Results
Escalation of targeted antimicrobial therapy within 24 hours of culture speciation occurred in 20 patients in the pre-implementation group and 46 patients in the post-implementation group (p&lt; 0.001). Escalation within 72 hours occurred in 34 patients in the pre-implementation group and 57 patients in the post-implementation group (p=0.004). Median time to change in antimicrobial therapy was 23 hours in the pre-implementation group and 7 hours in the post-implementation group (p&lt; 0.001). There was no difference between groups in development of MDR (5 vs. 5.7%, p=0.6).

Conclusion
Implementation of templated microbiology comments increased the rate of escalation to targeted antimicrobial therapy in hospitalized patients with blood or urine cultures positive for E. cloacae or K. aerogenes. Templated comments are an effective, minimally invasive strategy to promote antimicrobial stewardship.

Disclosures
All Authors: No reported disclosures
2410. Clinical outcomes and antimicrobial management strategies of Pseudomonas endocarditis
Authors: Shah Sunish , Clarke Lloyd , Shields Ryan K 
Published: November 2023

Abstract

Background
Infective endocarditis secondary to Pseudomonas is rare. Our objective was to investigate outcomes of patients with Pseudomonas endocarditis by treatment strategy and identify factors associated with treatment failure.

Methods
Adult patients with definitive Pseudomonas endocarditis at 8 hospitals were identified between July 2010 and December 2022. Unless the cultured valve yielded a Gram-negative pathogen, patients with blood cultures growing Gram-positive bacteria or yeast for &gt;24 hours were excluded. Combination therapy was defined as receipt of ≥2 in vitro active agents for ≥72 hours. Failure was a defined as death or microbiologic failure by day 42; microbiologic failures included escalation of antimicrobial therapy following treatment-emergent resistance, increased vegetation size, or blood cultures positive for ≥14 days.

Results
34 patients met the inclusion criteria. 32% (11/34) were people who inject drugs and 12% (4/34) were organ transplant recipients. P. aeruginosa was the underlying pathogen in 97% (33/34) of patients. 65% (22/34) and 35% (12/34) received combination and monotherapy, respectively. Patients managed with combination therapy had comparable rates of prosthetic valve endocarditis (41% vs 17%, P=0.25), a vegetation size &gt; 1cm (59% vs 42%, P=0.33) and no receipt of cardiac surgical intervention despite an indication (32% vs 17%, P=0.44) compared to those who received monotherapy. There was no significant difference in 42-day failure rates (32% vs 17%, P=0.44), 90-day mortality (18% vs 25%, P=0.68) or median hospital length of stay (22 days vs. 23, P=0.914) between patients who receivedcombination therapy and monotherapy. Patients who experienced 42-day failure were more likely to have multi-drug resistant (MDR) Pseudomonas on initial blood cultures (44% vs 4%, P=0.012) and were less likely to be initially managed with piperacillin/tazobactam or cefepime (44% vs 96%, P=0.004) compared to those who experienced clinical cure.
Combination therapy versus monotherapy
Factors associated with clinical failure

Conclusion
To our knowledge, this is the largest study of Pseudomonas endocarditis to date. We did Not identify a benefit to combination therapy; however, the overall sample size was small. Endocarditis due to MDR P. aeruginosa was associated with a higher risk of clinical failure.

Disclosures
Ryan K. Shields, PharmD, MS, Allergan: Advisor/Consultant|Cidara: Advisor/Consultant|Entasis: Advisor/Consultant|GSK: Advisor/Consultant|Melinta: Advisor/Consultant|Melinta: Grant/Research Support|Menarini: Advisor/Consultant|Merck: Advisor/Consultant|Merck: Grant/Research Support|Pfizer: Advisor/Consultant|Roche: Grant/Research Support|Shionogi: Advisor/Consultant|Shionogi: Grant/Research Support|Utility: Advisor/Consultant|Venatorx: Advisor/Consultant|Venatorx: Grant/Research Support