bluuebunny/crossref_metadata_2025_split huggingface dataset:
7. Two-Dose 4CMenB Vaccination in Adolescents Elicits a Bactericidal Activity against 15 Outbreak-Representative Meningococcal Strains
Authors: Biolchi Alessia , Tomei Sara , Santini Laura , Gaetana Rita La , Mori Elena , Novy Patricia , Rappuoli Rino , Bekkat-Berkani Rafik , Giuliani Marzia Monica , Pizza Mariagrazia , Sciences Biological 
Published: January 2021

Abstract

Background
Meningococcal outbreaks have often been associated with N. meningitidis serogroup B (MenB) in high-income countries. We examined whether antibodies elicited by the 4-component MenB vaccine (4CMenB) in adolescents could induce complement-mediated bacterial killing of a panel of 14 genetically diverse MenB strains representative of outbreaks that occurred from 2001 to 2016 (11 from the US, 2 from the UK, and 1 from France). One N. meningitidis serogroup W (MenW) hyperendemic strain (UK, 2011) was also included in the analysis.

Methods
In a previous multicenter study (NCT02212457), adolescents aged 10-18y received 2 4CMenB doses 2 months apart. We tested individual sera collected from a subgroup of 20 US participants at pre-vaccination and 1 month post-second dose in a serum bactericidal assay with human complement (hSBA) against the meningococcal strain panel. Similarly, sera collected from 23 Chilean adolescents aged 11-17y (NCT00661713) were tested in a hSBA against a subset of 4 strains (3 from the US, 1 from the UK).

Results
At baseline, the percentage of US subjects with seroprotective titers (hSBA ≥ 1:4) ranged from 5% to 35%. One month after 4CMenB series completion, 65% to 100% had seroprotective titers (hSBA ≥ 1:4) against 11 out of the 14 MenB tested strains. The seroprotection rate was 45%, 25%, and 15% against the 3 remaining MenB strains. Against MenW, the percentage of adolescents with hSBA titers ≥ 1:4 was 15% at baseline and 95% one month after series completion. No significant changes in the percentage of subjects were observed when analysing hSBA titers ≥ 1:8. Moreover, the subset analysis indicated similar results for US and Chilean subjects for 3 out of 4 strains: the percentage of US vs Chilean subjects with hSBA titers ≥ 1:4 was 100% vs 100%; 80% vs 74%; 45% vs 52%. For the 4th strain, 65% of US subjects vs 91% of Chilean subjects showed a hSBA ≥ 1:4.

Conclusion
4CMenB elicited bactericidal antibodies against a panel of 14 outbreak-representative MenB strains and 1 MenW hyperendemic strain in US adolescents. No major differences were detected in the bactericidal activity of Chilean subjects vaccinated with 4CMenB when tested against a subset of 4 MenB outbreak strains, suggesting that the immune response to 4CMenB is comparable in adolescents from different geographic areas.

Disclosures
Alessia Biolchi, n/a, GSK (Employee) Sara Tomei, n/a, GSK (Employee) Laura Santini, n/a, GSK (Employee) Rita La Gaetana, n/a, GSK Vaccines (Employee, Shareholder) Elena Mori, n/a, GSK (Employee) Patricia Novy, PhD, GSK (Employee, Shareholder) Rino Rappuoli, PhD, GSK (Employee) Rafik Bekkat-Berkani, M.D, GSK (Employee, Shareholder) Marzia Monica Giuliani, n/a, GSK (Employee, Shareholder) Mariagrazia Pizza, Biological Sciences, PhD, GSK Vaccines (Employee)
9. Influenza Vaccine Rates Amongst Patients With Limited English Proficiency In A Primary Health Care Clinic; Our 3 Years Experience
Authors: Ajayi Eloho , kpehor Atsoufui , Khanal Shristi , Munir Samavia , Estepa Adrian 
Published: January 2021

Abstract

Background
Influenza has been recognized to be a significant cause of morbidity and mortality. It was the cause of 10.1% of all deaths recorded on death certificates during the week ending January 20, 2018.In order to reduce the risk of influenza, Centers for Disease Control recommends that every person six months and older who have no contraindications be vaccinated with the influenza vaccine.
Limited English Proficiency (LEP) describes individuals who have limited ability to speak, read, write or understand English language. Sadly, there is an increasing body of data that suggest that patients with LEP are less likely to seek out medical attention in a timely manner, are less adherent to medically recommended preventive and therapeutic measures. The purpose of this study was to determine the rate of acceptance of the Influenza vaccine amongst patients with LEP in our resident ran out-patient clinic.

Methods
This study was retrospective, data was obtained through chart review of the electronical medical records (EMR). Patients had to be at least 18 years old and registered patients at our primary health care clinic to be enrolled in this study. Data was gathered for the 2015–2016, 2016–2017 and 2017–2018 influenza seasons. The months of October to May were designated as the Influenza season as these months have been identified as the time frame that the influenza virus has the most activity.

Results
109 of 499 the randomly selected participants were not included in the final analysis due to reasons like: no visit to the primary health care clinic during specified periods, ability to communicate in English, insufficient data in to the EMR. Data from 390 patients were analyzed. 43.3% spoke Spanish, 36.2% were Portuguese speaking and 20.5% spoke other languages. A large majority of patients across all language groups did not receive the influenza vaccine each season.
Table 1

Figure 1

Figure 2

Conclusion
Results from this study indicate that there was an alarmingly low rate of influenza vaccination among patients with LEP in our primary care clinic in during the 2015–2016, 2016–2017 and 2017–2018 influenza seasons. This highlights the need for implementing interventions aimed at both understanding why this vaccination gap exist and improving the vaccine acceptance rate amongst this venerable population.

Disclosures
All Authors: No reported disclosures
14. A Comprehensive Real-World Analysis to Compare Adjuvanted Trivalent Influenza Vaccine and Trivalent High Dose Influenza Vaccine by Age and Period of High Influenza Activity for the 2018–19 Season among U.S. Elderly
Authors: Postma Maarten , Pelton Stephen I , Divino Victoria , Mould-Quevedo Joaquin F , Shah Drishti , DeKoven Mitchell 
Published: January 2021

Abstract

Background
Influenza vaccine effectiveness decreases with increasing age due to the senescence of immune function and a reduced immune response to antigens. There is also considerable vaccine effectiveness heterogeneity depending on the influenza activity time period, especially in seasons where two different circulating strains predominated, such as the 2018–19 season. This research aimed to assess the effect of age and high influenza activity period (HIAP) on the relative vaccine effectiveness (rVE) of adjuvanted trivalent influenza vaccine (aTIV) vs. trivalent high-dose influenza vaccine (HD-TIV) among elderly (≥65y) recipients in the U.S.

Methods
During the 2018–19 influenza season, a retrospective cohort analysis was conducted using professional fee, prescription claims and hospital charge master data in the U.S. The first sub-analysis evaluated rVE for different age groups (65–74 years, 75–84 years, ≥85 years). The second sub-analysis evaluated rVE overall, restricting the observation period from to HAIP: Dec 2018-Mar 2019 (August 2018-July 2019 in the main analysis). Adjusted analyses were conducted through inverse probability of treatment weighting (IPTW) to control for selection bias. Poisson regression was used to estimate the adjusted pairwise rVE for influenza-related hospitalizations/emergency room (ER) visits and office visits.

Results
Following IPTW, 561,315 recipients of aTIV and 1,672,779 of TIV-HD were identified. Following IPTW adjustment and Poisson regression, aTIV was more effective in reducing influenza-related office visits compared to TIV-HD (7.0%; 95% CI: 2.6%-11.2%) in the HIAP sub-analysis. In the age sub-analysis, the rVE favoring aTIV ranged from 5.1% (95% CI: -0.17%-10.1%) for the youngest group (65–74) up to 11.4% (95% CI: 0.6%-21.1%) for the eldest group (≥85y) for influenza-related office visits. No statistically significant differences were found for aTIV compared to TIV-HD for prevention of influenza-related hospitalizations/ER visits in the sub-analyses evaluated.

Conclusion
In adjusted analyses, aTIV reduced influenza-related office visits compared to TIV-HD within the two older age groups and HIAP sub-analysis. aTIV and TIV-HD demonstrated comparable reductions in influenza-related hospitalizations/ER visits.

Disclosures
Maarten Postma, Dr., IQVIA (Consultant) Stephen I. Pelton, MD, Merck vaccine (Consultant, Grant/Research Support)Pfizer (Consultant, Grant/Research Support)Sanofi Pasteur (Consultant, Other Financial or Material Support, DSMB)Seqirus Vaccine Ltd. (Consultant) Victoria Divino, PhD, Seiqrus Vaccines Ltd. (Consultant) Joaquin F. Mould-Quevedo, PhD, Seqirus Vaccines Ltd. (Employee, Shareholder) Drishti Shah, PhD, Seqirus Vaccines Ltd. (Consultant) Mitchell DeKoven, PhD, Seqirus Vaccines Ltd. (Consultant)
15. A Novel Approach to Bacterial Vaccines: Haemophilus influenzae as a Paradigm
Authors: Stull Terrence , Whitby Paul , Morton Daniel , Mussa Huda , Mirea Lucia 
Published: January 2021

Abstract

Background
The H. influenzae type b vaccines target the type b capsule and therefore have no impact on the nontypable (unencapsulated) H. influenzae (NTHi). NTHi has become the most common cause of otitis media and is the most common isolate from patients with exacerbations of Chronic Obstructive Pulmonary Disease (COPD). Therefore, NTHi is an appropriate target for vaccine development.

Methods
To characterize potential vaccine targets, the core outer proteins of NTHi present in the available sequenced genomes were identified through genomic bioinformatics. The structures of the outer proteins were analyzed through comparison with the available structures of homologues characterized by X-ray crystallography. Sequenced conserved outer regions of these proteins were analyzed for their protective capacity in the infant rat model of H. influenzae infection.

Results
Nine peptides that were protective in the infant rat model were used in a novel vaccine to immunize chinchillas, the most established animal model of otitis media. Chinchillas (40 vaccinated and 41 controls) were infected with NTHi 86-028NP. The vaccinated group cleared infection more quickly than the control group as indicated by significantly decreased positive findings on video-otoscopy (p&lt; 0.0001) and tympanometry (p=0.0002) on day 7, and presence of middle ear fluid obtained by aspiration (p=0.0001) on day 10 post infection. Similarly, in the mouse model of NTHi pulmonary clearance, the vaccinated group (n=5) reduced infection more rapidly than the control group (n= 5), p=0.008.

Conclusion
These data demonstrate the effectiveness of the Bacterial Vaccine Polypeptide methodology in development of a vaccine against NTHi with protection in relevant preclinical models of both otitis media and pulmonary clearance. The methods are applicable to other bacteria, and this approach to a Bacterial Vaccine Polypeptide against NTHi serves as a paradigm for development of similar vaccines to protect against other bacterial infections.

Disclosures
All Authors: No reported disclosures
16. A Randomized Phase 1 Study of a Novel Pneumococcal Conjugate Vaccine in Healthy Japanese Adults in the United States
Authors: Fitz-Patrick David , Young Jr. Mariano , Scott Daniel , Scully Ingrid L , Baugher Gary , Peng Yahong , Jansen Kathrin U , Gruber William C , Watson Wendy 
Published: January 2021

Abstract

Background
Because of the number and variability of serotypes causing pneumococcal disease among different geographic regions, age groups, and environmental backgrounds, expanding serotype coverage with pneumococcal conjugate vaccines (PCVs) is a continued unmet need.

Methods
This phase 1, randomized, double-blind study included healthy Japanese adults aged 18–49 years residing in the United States. Subjects were randomized 1:1:1 to receive a single dose of a 20-valent PCV (containing 13-valent PCV [PCV13] serotypes plus 8, 10A, 11A, 12F, 15B, 22F, 33F), a novel pneumococcal polysaccharide conjugate vaccine with extended coverage, or PCV13 (control). Safety was the primary endpoint and included reactogenicity events occurring ≤ 14 days after vaccination, adverse events (AEs) ≤ 1 month after vaccination, and serious AEs (SAEs) ≤ 6 months after vaccination. The secondary endpoint was pneumococcal serotype-specific immunogenicity as determined by opsonophagocytic activity (OPA) titers on sera collected before and 1 month after vaccination.

Results
Overall, 35 subjects received PCV20 and 35 subjects received PCV13. One subject withdrew before the 1-month follow-up. Local reactions and systemic events across groups were generally mild or moderate (Figure 1). Two vaccine-related AEs occurred (injection site erythema and swelling in the PCV20 group); no severe AEs, SAEs, or safety-related withdrawals were reported. OPA geometric mean titers increased for all 20 serotypes in the PCV20 group and all 13 serotypes in the PCV13 group 1 month after vaccination; corresponding OPA geometric mean fold rises from baseline to 1 month after vaccination are reported (Figure 2; Figure 3).
Figure 1

Figure 2

Figure 3

Conclusion
PCV20 was well tolerated and induced serotype-specific functional OPA immune responses that are anticipated to be associated with protection in Japanese adults. ClinicalTrials.gov: NCT03642847. Funding: Pfizer Inc.

Disclosures
David Fitz-Patrick, MD, Pfizer Inc (Grant/Research Support) Mariano Young Jr., MD, Pfizer Inc (Employee, Shareholder) Daniel Scott, MD, Pfizer (Employee, Shareholder) Ingrid L. Scully, PhD, Pfizer Inc (Employee, Shareholder) Gary Baugher, PharmD, Pfizer Inc (Employee, Shareholder) Yahong Peng, PhD, Pfizer (Employee, Shareholder) Kathrin U. Jansen, PhD, Pfizer (Employee, Shareholder) William C. Gruber, MD, Pfizer (Employee, Shareholder) Wendy Watson, MD, Pfizer (Employee, Shareholder)
17. Assessment of Recombinant Zoster Vaccine Second Dose Completion in the United States
Authors: Patterson Brandon J , Chen Chi-Chang , McGuiness Catherine B , Glasser Lisa I , Sun Kainan , Buck Philip O 
Published: January 2021

Abstract

Background
Recombinant Zoster Vaccine (RZV) was licensed in the United States (US) in October 2017 for the prevention of herpes zoster in adults ≥ 50 years of age (YOA). The vaccine is administered in a two-dose sequence with a 2- to 6-month interval; however, the Center for Disease Control & Prevention has advised against restarting a series after the prescribed window. This study describes an assessment of 2nd dose completion and compliance of RZV in the US.

Methods
Primary analysis was conducted on a cohort ≥ 50 YOA who received an initial RZV dose between October 2017 and September 2018 as indicated in the IQVIA longitudinal prescription claims or medical claims databases. Subjects were required to have ≥ 1 year of observable time post initial dose. A sensitivity analysis was conducted using all eligible subjects regardless of observable time post initial dose. Endpoints of analyses were monthly and cumulative 2nd dose label-compliant proportions at 6 months and completers by 12-month intervals and time to completion from initial RZV vaccine administration with stratifications by age, sex, claim source and payer type.

Results
The primary sample included 1,225,088 subjects, while the sensitivity analysis included 7,097,441 (Table 1). Overall, 2nd RZV dose completion was 70.4% within 6 months and 81.8% within 12 months. Minimal variation for 12-month completion was demonstrated across age (77.2–84.5%), sex (81.7–81.9%), and Commercial vs. Medicare (80.9–83.0%). However, larger variations were seen across claim sources and other payer type, with medical claims (64.9%), Medicaid patients (72.8%) and Cash patients (74.7%) having lower rates at 12 months (Table 2). Overall, the average time to completion was around 4 months regardless of stratification except by claims source, with medical claims taking 5 months on average to complete. The sensitivity analysis of the variable follow-up cohort demonstrated findings consistent with that of the primary sample.

Conclusion
Assessment of RZV suggests high levels of completion across age, sex, payer type and claim sources. More effort is needed to understand barriers to completion rates in Medicaid patients and settings where vaccination claims are processed outside of the vaccine recipient’s pharmacy benefit.

Disclosures
Brandon J. Patterson, PharmD, PhD, GSK (Employee, Shareholder) Chi-Chang Chen, PhD, MSPharm, GSK (Research Grant or Support) Catherine B. McGuiness, MA, MS, GSK (Research Grant or Support)Pfizer (Shareholder) Lisa I. Glasser, MD, GSK (Employee, Shareholder) Kainan Sun, MS, PhD, GSK (Research Grant or Support) Philip O. Buck, PhD, MPH, ORCID: 0000-0002-3898-3669, GSK (Employee, Shareholder)
18. Association Between State-level Voting Patterns and Prior Receipt of the HPV Vaccine, an Analysis Using Data from the Behavioral Risk Factor Surveillance System 2016 – 2018
Authors: Corcorran Maria A , Valinetz Ethan , Hussein Abir , Littman Alyson J , Hawes Stephen E 
Published: January 2021

Abstract

Background
Human papillomavirus (HPV) is the main cause of cervical, anal and oro-pharyngeal cancer worldwide. The HPV vaccine can prevent over 90% of HPV-related malignancies but vaccination rates in the United State (US) vary significantly by region. In this study, we assessed whether state-level politics is associated with receipt of HPV vaccination in the US, and if the association is modified by sex and age.

Methods
This study analyzed data from the Center for Disease Control and Prevention’s (CDC) Behavioral Risk Factors Surveillance System (BRFSS) survey. Persons ages 18 to 36 years of age, who lived in 17 states that included the supplementary “Adult Human Papillomavirus (HPV)” module questionnaire in 2016, 2017 or 2018, were included. We compared self-reported receipt of HPV vaccination among persons living in Republican versus Democratic states, based on state electoral college votes in the 2016 US presidential election. Mantel-Haenszel stratified analysis was used to estimate prevalence ratios and to assess for effect modification and control for confounding.

Results
Overall, 36,334 survey respondents were included in the analysis, 22.7% of whom reported prior receipt of the HPV vaccine, 28.1% in Democratic states and 20.4% in Republican states. When adjusted for race, living in a Democratic state was associated with a higher prevalence of prior receipt of the HPV vaccine in comparison to living in a Republican state. This association was strongest for men less than 26 years of age (PR 1.77, 95% CI: 1.58, 1.98) but remained significant for men ages 26 – 36 years (PR 1.51, 95% CI: 1.24, 1.85), women less than 26 years of age (PR 1.20, 95% CI: 1.13, 1.27), and women ages 26 – 36 years (PR 1.69, 95% CI: 1.57, 1.83).

Conclusion
Overall HPV vaccine coverage was low in adults 18–36 years of age. The strong association between state-level voting patterns and prior receipt of the HPV vaccine suggests that HPV vaccine coverage is lower in Republican states when compared to Democratic states. Further public health efforts are needed to promote HPV vaccine uptake among young men and women, particularly in Republican voting states.

Disclosures
All Authors: No reported disclosures
30. Impact of Pharmacist Assertiveness Training in Recommending Pneumococcal Vaccination among High-Risk Adults
Authors: Gatwood Justin , Renfro Chelsea , Chiu Chi-Yang , Kapan Shiyar , Hagemann Tracy , Hohmeier Kenneth 
Published: January 2021

Abstract

Background
Community pharmacies have become vital access points to provide a range of vaccines to adults, including pneumococcal; however, despite growth in vaccines given at these sites, the most recent rates of adults being immunized against pneumococcal disease remain below goals set by Health People 2020. A lack of patient awareness is a leading reason for low vaccination rates, suggesting that a need exists to improve provider communication in recommending pneumococcal vaccination in high-risk adults.

Methods
A multi-phase, pharmacy-based intervention was launched in west and middle Tennessee locations of a nationwide community pharmacy chain focusing on improving evidence-based, presumptive recommendations related to pneumococcal vaccination. All locations were randomized to one of three arms based on training intensity: 1) no training; 2) online training only; and 3) online and live simulation training. The program focused on providing assertive recommendations and managing potential hesitancy guided by multiple health communication theories and community-based hesitancy data provided to each pharmacy by the study team. Primary endpoints included changes in pneumococcal vaccinations (counts over 6-month periods [July-December] in 2018 and 2019) and provider vaccine-related self-efficacy and were evaluated by generalized linear models.

Results
A total of 100 pharmacies were enrolled and 50 pharmacists completed their assigned training element. Completing the full training program (i.e., online and live) led to improvements in pharmacist self-efficacy related to being influential in vaccine-related decisions and not being helpless in managing resistance (both p&lt; 0.05). Overall counts of all pneumococcal vaccines were lower (-11.3%) across all stores in the period following training; however, a small increase (2.1%, P=0.084) was observed in the stores that underwent the full training, versus decreases of 22.0% and 9.4% in control and online-only training comparisons, respectively.

Conclusion
Results suggest that provider vaccine self-efficacy can be improved through an evidence-based communication training program but substantial improvements in specific vaccinations may need to leverage a more holistic focus on all recommended adult vaccines.

Disclosures
Justin Gatwood, PhD,MPH, AstraZeneca (Grant/Research Support)GlaxoSmithKline (Grant/Research Support)Merck & Co. (Grant/Research Support) Tracy Hagemann, PharmD, GSK (Grant/Research Support)Merck (Grant/Research Support)