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  • 1
    In: Vaccine, Elsevier BV, Vol. 41, No. 9 ( 2023-02), p. 1537-1540
    Materialart: Online-Ressource
    ISSN: 0264-410X
    Sprache: Englisch
    Verlag: Elsevier BV
    Publikationsdatum: 2023
    ZDB Id: 1468474-3
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  • 2
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    Southern Medical Association ; 2015
    In:  Southern Medical Journal Vol. 108, No. 3 ( 2015-3), p. 170-177
    In: Southern Medical Journal, Southern Medical Association, Vol. 108, No. 3 ( 2015-3), p. 170-177
    Materialart: Online-Ressource
    ISSN: 0038-4348
    Sprache: Englisch
    Verlag: Southern Medical Association
    Publikationsdatum: 2015
    ZDB Id: 2031166-7
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  • 3
    In: Open Forum Infectious Diseases, Oxford University Press (OUP), Vol. 6, No. Supplement_2 ( 2019-10-23), p. S971-S972
    Kurzfassung: Despite greater than 90% of US active duty (AD) military personnel receiving influenza vaccination annually, vaccine effectiveness (VE) among AD members has been substantially lower than in groups with less vaccine uptake. The substrate used in vaccine production may impact immunogenicity and thus VE. The PAIVED study is investigating VE of 3 different influenza vaccine formulations; a sub-study assesses immunogenicity. This analysis compares demographic characteristics and influenza-like illness (ILI) experience among main and sub-study participants for the first year of PAIVED. Methods During the 2018–2019 influenza season, PAIVED enrolled participants at 5 military medical centers, recruiting sub-study subjects from the main cohort excluding marine recruits. All participants were randomized (1:1:1) to receive either egg-based, cell-culture based or recombinant influenza vaccine. At enrollment, participants provided key demographic and behavioral data. Weekly surveillance for ILI symptoms was performed electronically. Sub-study volunteers underwent an additional blood draw prior to and at 21–35 days post vaccination ± an optional buccal swab. Results 200 (23.5%) of 852 non-recruit PAIVED participants enrolled in the immunogenicity sub-study. Similar to the main cohort, 46% of sub-study volunteers were female, 85% were physically active, and 6% smoked tobacco. Sub-study participants were younger (47 ± 16 years vs. 51 ± 17 years, P = 0.004) and more likely to be AD (34% vs. 22%, P = 0.001). Although 70% of both groups identified as White, the percent African American (20% sub-study; 13% main), Asian (3%; 7%), multi-racial (2%; 5%), and unknown (6%; 4%) differed (P = 0.02). More sub-study participants developed an ILI (19% vs. 12%, P = 0.02). Conclusion The convenience sampling method used for recruitment into the sub-study was effective. The younger age and higher AD status in the sub-study group may be informative for evaluation of military readiness issues. The greater incidence of ILI in the sub-study increases the chance differences in immune response by vaccine type may be interpretable in the context of circulating influenza strains. Targeted efforts to enhance recruitment of a racially diverse sub-study cohort may be warranted. Disclosures All authors: No reported disclosures.
    Materialart: Online-Ressource
    ISSN: 2328-8957
    Sprache: Englisch
    Verlag: Oxford University Press (OUP)
    Publikationsdatum: 2019
    ZDB Id: 2757767-3
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  • 4
    In: Open Forum Infectious Diseases, Oxford University Press (OUP), Vol. 8, No. Supplement_1 ( 2021-12-04), p. S440-S441
    Kurzfassung: Self-collection of mid-nasal swabs (SCNS) at home is a convenient alternative to health-care worker-collected nasal swabs (HCWC) for determining the pathogen-specific epidemiology of influenza-like illness (ILI). We evaluated the compliance and performance characteristics of SCNS vs. HCWC for respiratory pathogens during 2019-2020 flu season. Methods Adult Military Health System (MHS) beneficiaries were enrolled in an influenza vaccine effectiveness trial (PAIVED). Following vaccination, subjects were instructed on SCNS and completion of a symptom diary and were contacted weekly to ascertain ILI symptoms (fever, sore throat, and/or cough). In the event of an ILI, subjects completed the symptom diary and SCNS and were scheduled a clinic visit for HCWC. Swabs were tested with the Luminex NxTAG® Respiratory Pathogen Panel. We evaluated compliance with swab collection, positive percent agreement (PPA) of SCNS using PCR detection from either HCWC or SCNS as the reference standard, and agreement between paired swabs using the Cohen Kappa coefficient (Κ). Results 1808 ILI were reported by 972 participants enrolled during the study period. Compliance with HCWC was higher than SCNS (58% [1042] vs. 42% [766] ; p & lt; 0.001). SCNS were associated with a shorter interval from symptom onset (median: 4 days [IQR:2-6 days] vs. clinic collect: 7 days [IQR:4-9 days] ; p & lt; 0.001). 663 paired swabs were available for 609 participants (Table 1). The overall detection rate was higher in SCNS (36%) than HCWC (26%; p & lt; 0.001) (Figure 1). The overall PPA was 85.7% and a PPA of approximately 80% of greater was observed for influenza, rhino/enterovirus, parainfluenza and respiratory syncytial virus. Agreement between paired swabs was poor due to the lower detection rates in HCWC. Table 1. Demographics and swab collection data for 609 participants who provided 663 paired swabs Figure 1. Detection by pathogen in 663 paired swabs Conclusion SCNS were associated with higher detection rates compared to HCWC, likely due to the shorter interval between symptom onset and swab collection. Strategies to improve compliance with SCNS and minimize the interval between symptom onset and swab collection are needed to optimize detection of respiratory pathogens in this MHS cohort. Disclosures Ryan C. Maves, MD, EMD Serono (Advisor or Review Panel member)Heron Therapeutics (Advisor or Review Panel member) Jitu Modi, MD, GSK (Speaker's Bureau)
    Materialart: Online-Ressource
    ISSN: 2328-8957
    Sprache: Englisch
    Verlag: Oxford University Press (OUP)
    Publikationsdatum: 2021
    ZDB Id: 2757767-3
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  • 5
    In: Open Forum Infectious Diseases, Oxford University Press (OUP), Vol. 8, No. Supplement_1 ( 2021-12-04), p. S126-S127
    Kurzfassung: The SARS-CoV-2 pandemic has spotlighted respiratory infections and the value of effective vaccines. The SARS-CoV-2 vaccine has been remarkably effective; however, influenza vaccine effectiveness has been reported to be lower among active duty military populations than in the general public (18% vs 36%). The Pragmatic Assessment of Influenza Vaccine Effectiveness in the DoD (PAIVED) study compares 3 FDA-licensed influenza vaccine types (egg-based, cell-based, and recombinant) to assess differences in immunogenicity and effectiveness in adults. Methods Participants in the 3rd year of PAIVED (2020/21 influenza season) were enrolled from October 2020 through January 2021. Participants received weekly surveys about influenza-like-illnesses (ILI) experienced in the past week; if they reported an ILI, they were queried about symptom duration and severity, and asked to self-collect a nasal swab and dried blood sample. Four weeks later, more information about symptom duration and illness burden was obtained via telephone interview, and the participant collected a second blood sample. Results PAIVED year 3 enrolled 3,269 participants (Table 1). 278 participants reported 1 ILI , while 60 reported 2 ILIs, and 18 reported 3 ILIs. No pathogen was identified for most processed ILI samples (78%); the most common viruses were SARS-CoV-2 (25, 12%), rhinovirus (24, 12%), and seasonal coronaviruses (4, 2%). No influenza has been identified thus far. Among those participants who had convalescent ILI visits (275), the median duration of the reported ILIs was 9 days (IQR 5, 15), with a median of 4 days (IQR 2, 7) of limited activity, and 2 days (IQR 0, 3) with fever. Three individuals were hospitalized. Conclusion There have been relatively low rates of ILI identified in this study during this season, with only 11% of the participants reporting an ILI so far, consistent with low rates of non-COVID-19 ILI reported elsewhere during the current pandemic. We anticipate some influenza cases may be identified as more samples are processed. Planned analyses include calculating comparative influenza vaccine effectiveness to inform future vaccine purchasing decisions, as well as comparing serological response to the different vaccines. Disclosures Ryan C. Maves, MD, EMD Serono (Advisor or Review Panel member)Heron Therapeutics (Advisor or Review Panel member) Jitu Modi, MD, GSK (Speaker’s Bureau)
    Materialart: Online-Ressource
    ISSN: 2328-8957
    Sprache: Englisch
    Verlag: Oxford University Press (OUP)
    Publikationsdatum: 2021
    ZDB Id: 2757767-3
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  • 6
    In: Clinical Infectious Diseases, Oxford University Press (OUP), Vol. 73, No. 11 ( 2021-12-06), p. e4312-e4320
    Kurzfassung: Low vaccine effectiveness against A(H3N2) influenza in seasons with little antigenic drift has been attributed to substitutions in hemagglutinin (HA) acquired during vaccine virus propagation in eggs. Clinical trials comparing recombinant HA vaccine (rHA) and cell-derived inactivated influenza vaccine (IIV) to egg-derived IIVs provide opportunities to assess how egg-adaptive substitutions influence HA immunogenicity. Methods Neutralization titers in pre- and postimmunization sera from 133 adults immunized with 1 of 3 types of influenza vaccines in a randomized, open-label trial during the 2018–2019 influenza season were measured against egg- and cell-derived A/Singapore/INFIMH-16-0019/2016-like and circulating A(H3N2) influenza viruses using HA pseudoviruses. Results All vaccines elicited neutralizing antibodies to all H3 vaccine antigens, but the rHA vaccine elicited the highest titers and seroconversion rates against all strains tested. Egg- and cell-derived IIVs elicited responses similar to each other. Preimmunization titers against H3 HA pseudoviruses containing egg-adaptive substitutions T160K and L194P were high, but lower against H3 HA pseudoviruses without those substitutions. All vaccines boosted neutralization titers against HA pseudoviruses with egg-adaptive substitutions, but poorly neutralized wild-type 2019–2020 A/Kansas/14/2017 (H3N2) HA pseudoviruses. Conclusion Egg- and cell-derived 2018–2019 season influenza vaccines elicited similar neutralization titers and response rates, indicating that the cell-derived vaccine did not improve immunogenicity against the A(H3N2) viruses. The higher responses after rHA vaccination may be due to its higher HA content. All vaccines boosted titers to HA with egg-adaptive substitutions, suggesting boosting from past antigens or better exposure of HA epitopes. Studies comparing immunogenicity and effectiveness of different influenza vaccines across many seasons are needed.
    Materialart: Online-Ressource
    ISSN: 1058-4838 , 1537-6591
    RVK:
    Sprache: Englisch
    Verlag: Oxford University Press (OUP)
    Publikationsdatum: 2021
    ZDB Id: 2002229-3
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  • 7
    In: International Journal of Life Science and Pharma Research, International Journal of Pharma and Bio Sciences, ( 2022-10-18)
    Kurzfassung: Verapamil Hydrochloride is indicated to control blood pressure in individuals due to postural and nocturnal–diurnal variations in the biological clock. The once-daily administration of Verapamil Hydrochloride is handy for patients to comply with the dosing regimen prescribed. This research aims to develop stable, bio-equivalent, cost-effective, and commercially feasible Verapamil Hydrochloride extended-release tablets, 120 mg, 180 mg and 240 mg. Inorder to achieve this aim, our objective was to explore a simple aqueous granulation involving conventional excipients viz. Sodium Alginate, Povidone, Microcrystalline Cellulose and Magnesium Stearate. The drug to polymer ratio of 1:1.35 was found to be optimum. Every unit operation involved in the process was completely optimized to achieve reproducibility and to avoid drug release variation. The designed process was scaled-up from a batch size of 75,000 tablets to 750,000 tablets. During scalability, no difference is observed in the physico-chemical characteristics of the blend or tablets. The blend and content uniformity results were found to comply with USP requirements. The manufactured product was found stable in bottle and strip packs at accelerated stability conditions for 6 months. The maximum level of the highest unknown impurity observed was 0.1% and is well within the ICH Q3BR3 requirements. Hence based on stability study results, shelf-life storage of 24 months at controlled room temperature was prescribed for the product. The end product was found to be more cost-effective (3.2 to 6.4 Indian rupees) than the brand product available nationally (within India) priced at 4.7 to 9 Indian rupees, and the physico-chemical characteristics, drug release, and stability of the manufactured drug product were comparable to the brand product available in the USA market. The similarity factor 'f2' was found to be more than 75. In the Pharmacokinetic study, the test to brand product ratio at 90% confidence interval was within 80.00-125.00%, exhibiting the developed product's bio-equivalence with the brand product. Novelty in this research is in the comprehensiveness of work done to demonstrate stability, bio-equivalence, cost-effectiveness and commercial ability aspects which were not reported elsewhere in the already published research work on Verapamil extended release tablets. 
    Materialart: Online-Ressource
    ISSN: 2250-0480
    Sprache: Unbekannt
    Verlag: International Journal of Pharma and Bio Sciences
    Publikationsdatum: 2022
    ZDB Id: 2894013-1
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  • 8
    In: Open Forum Infectious Diseases, Oxford University Press (OUP), Vol. 6, No. Supplement_2 ( 2019-10-23), p. S970-S971
    Kurzfassung: Military recruits suffer high rates of influenza and influenza-like illness (ILI) during training. ILIs may lead to morbidity, lost training time, and hospitalization. We evaluated the incidence and clinical outcomes of ILI among recruits at Marine Corps Recruit Depot San Diego (MCRD-SD) in a prospective trial of influenza vaccine efficacy. Methods Recruits at MCRD-SD were enrolled to compare the effectiveness of 3 types of FDA approved influenza vaccine: Afluria®, an egg-based vaccine; Flucelvax®, a cell-culture-derived vaccine; and Flublok®, a recombinant vaccine. Four companies of recruits were enrolled sequentially from 28 November 2018 to 19 December 2018, then randomized in a 1:1:1 ratio. Participants were followed for 18 weeks at MCRD-SD and Camp Pendleton. All participants who presented with ILI symptoms at medical care sites underwent viral diagnostic testing in addition to immunologic studies. Recruits were excluded from participation if 〈 18 years of age, if previously vaccinated in the 2018–2019 season, or if reporting allergy to the vaccines. Results Of 1338 recruits approached, 771 (57.6%) participants consented for enrollment. All recruits were men between 18 and 28 years. There were 182 ILIs amongst 177 recruits (23% of 771 recruits). Nasal swabs were obtained in 180/182 cases (99%). Mean duration of ILI symptoms was 7 days. Mean days of fever was 4. Subjects reported a total 168 days of reduced training (range 0–14 days; mean 0.9 days). There were 47 total days of missed training for all subjects (range of 0–4 days; mean 0.3 days/subject). There were no hospitalizations related to ILIs. Approximately 82% (148/182) of ILIs presented within the first 3 weeks of training; 44% (80/182) of ILIs occurred during the second week of training. PCR- nasal swabs results; race/ethnicity data, and frequency of ILI mapped to week of training are illustrated below. Conclusion ILIs can negatively impact training effectiveness. Days lost to training from ILIs and hospitalizations can prevent successful completion of training with impact on military readiness. PAIVED may inform the DoD on future strategies to minimize influenza and other respiratory threats in recruit military populations. Influenza vaccine effectiveness will be reported separately. Disclosures All authors: No reported disclosures.
    Materialart: Online-Ressource
    ISSN: 2328-8957
    Sprache: Englisch
    Verlag: Oxford University Press (OUP)
    Publikationsdatum: 2019
    ZDB Id: 2757767-3
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  • 9
    In: Open Forum Infectious Diseases, Oxford University Press (OUP), Vol. 6, No. Supplement_2 ( 2019-10-23), p. S968-S969
    Kurzfassung: Healthcare outcome disparities exist for underrepresented populations, which may be partially due to reduced engagement in clinical research trials. Within the military with free, open access to medical care for members and beneficiaries, some healthcare outcome disparities become less apparent. We sought to assess the impact of the open access to care within the military healthcare system on research engagement among underrepresented populations. Methods During the PAIVED study (2018–2019 influenza season) enrollees were randomized to receive an FDA approved influenza vaccine (egg-based, recombinant, or cell-culture derived) followed by weekly surveillance for influenza-like illness (ILI) symptoms throughout the influenza season. At enrollment, participants self-identified gender, race, ethnicity, and level of education. Results Overall, the non-recruit study population (n = 852) was 52% male, 18% Hispanic, 15% African American, 70% White, 24% with High School or less, 22% with Associate’s, 24% with Bachelor’s and 30% with Post-Bachelor degree at enrollment. Individuals who reported African American race (OR 2.1, 95% CI (1.4, 3.3)) or Hispanic ethnicity (OR 1.7 (1.1, 2.6)) were more likely to have missed 〉 15% of the surveys, whereas military retirees (OR 0.5 (0.3, 0.9)) and dependents (OR 0.6 (0.4, 0.95)) were less likely to have missed 〉 15%. Individuals with African American race (OR 2.2 (1.3, 3.9)) or Hispanic ethnicity (OR 1.9 (1.1, 3.0)) were more likely to have missed the past 3 survey weeks. Retirees (OR 0.4 (0.2, 0.7)), dependents (OR 0.5 (0.3, 0.9)) and those with higher levels of education were less likely to have missed the past 3 weeks. There were no gender differences for these outcomes. Conclusion Healthcare outcome disparities may be partially explained by disparities in healthcare research engagement from underrepresented populations. Our cohort provides a unique perspective where access to and affordability of care and reliable income are minimized. Despite this, there remained differences in research engagement by race, ethnicity and education level, but not by gender. Future efforts should inform research design to increase research engagement from underrepresented populations. Disclosures All authors: No reported disclosures.
    Materialart: Online-Ressource
    ISSN: 2328-8957
    Sprache: Englisch
    Verlag: Oxford University Press (OUP)
    Publikationsdatum: 2019
    ZDB Id: 2757767-3
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  • 10
    In: Open Forum Infectious Diseases, Oxford University Press (OUP), Vol. 6, No. Supplement_2 ( 2019-10-23), p. S990-S990
    Kurzfassung: Influenza-like illnesses (ILI) are common in military populations due to close living and working conditions, physical exertion, and exposure to novel viruses. The PAIVED trial aims to compare the effectiveness of 3 FDA approved influenza vaccines in active-duty military, retiree, and dependent populations, and will also provide information about the burden, impact, and severity of ILI. Methods Participants were enrolled in the 2018–2019 influenza season at 5 geographically diverse military facilities. Active duty, non-recruit military personnel, retirees, and dependents were randomized to receive influenza vaccine (egg-based, recombinant, or cell-culture derived) and then completed weekly electronic surveys throughout the influenza season. If a participant reported ILI symptoms during surveillance, 2 in-person visits with study personnel were scheduled for confirmed ILI. Nasal swabs and blood samples were collected for diagnostic and immunologic testing. Results Among the 852 non-recruit participants enrolled in PAIVED, 25% were active military, 36% retired military, and 39% dependents. Almost half (48%) were female, and 72% were white, 15% African American, 6% Asian, 4% multiple races, and 3% unknown or other race. 788 participants (92%) responded to at least one surveillance questionnaire. Participants reported 407 ILIs (Figure 1), of which 160 met the study case definition. Between 12 and 28% of the participants experienced an ILI during the surveillance period, and 12 people experienced 2 ILIs. Most sites reported a median 2–3 days of fever/feverishness or chills and 3–4 days of reduced activity associated with an ILI episode. No viruses were detected in 58% of nasal swabs, 1 virus in 40%, and 2 viruses in 1% of swabs (Figure 2 for pathogen data). Conclusion During the period under study, ILIs were common with 1 in 6 participants experiencing a confirmed ILI, many of which were 6–8 days in duration. ILIs resulted in reduced activity, although few individuals reported missing work or school, a situation that could result in greater likelihood of transmission to others. Planned analyses will provide additional information about the pathogens responsible for these illnesses and help guide effective prevention policies in these populations. Disclosures All authors: No reported disclosures.
    Materialart: Online-Ressource
    ISSN: 2328-8957
    Sprache: Englisch
    Verlag: Oxford University Press (OUP)
    Publikationsdatum: 2019
    ZDB Id: 2757767-3
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