scholarly journals 1501. Pragmatic Assessment of Influenza Vaccine Effectiveness in the DoD (PAIVED): Updates from Year 2 of multi-site trial

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S752-S753
Author(s):  
Stephanie A Richard ◽  
Timothy Burgess ◽  
Timothy Burgess ◽  
Limone Collins ◽  
Rhonda Colombo ◽  
...  
Keyword(s):  
Influenza Vaccine ◽  
Clinic Visit ◽  
Vaccine Effectiveness ◽  
Symptom Duration ◽  
Blood Draw ◽  
Duration Of Symptoms ◽  
Nasal Swabs ◽  
Second Year ◽  
Military Facilities ◽  
Pragmatic Assessment

Abstract Background Despite nearly universal influenza vaccination for active duty military personnel, breakthrough influenza infections occur. We are reporting on the second year of the Pragmatic Assessment of Influenza Vaccine Effectiveness in the DoD (PAIVED), comparing three FDA-licensed influenza vaccine types (egg-based, cell -based, and recombinant) to assess differences in immunogenicity and effectiveness. Methods Participants in the second year of PAIVED were enrolled from Oct 2019 through Jan 2020 at 9 military facilities. Participants received weekly inquiries about influenza-like-illnesses (ILI) experienced in the past week, and if the participant reported having a cough or sore throat and a) muscle/body aches or fatigue and/or b) being feverish or having chills, they were scheduled for a clinic visit. During this visit, a blood sample and a nasal swab were collected, as well as information about symptom duration and severity. A second (convalescent) visit was conducted approximately 4 weeks later, which involved collecting additional information about the duration of symptoms and illness burden, as well as a second blood draw. Due to the COVID-19 pandemic, acute and convalescent visits were disrupted at most sites in March and April due to COVID-19 precautions. Results PAIVED year 2 enrolled 5,892 participants who completed demographic forms (Table 1). Among those who reported any ILIs, most reported one ILI (1,345), while 264 reported two ILIs, and 42 reported three ILIs. Nasal swabs were processed from 273 ILIs at four sites (Fig 1), and 14 cases of influenza were identified thus far. The median duration of ILIs was ten days, with a median of three days of limited activity, and two days with fever. Nine individuals were hospitalized. Table 1. Demographic characteristics of individuals enrolled in PAIVED 2019/20 Figure 1. Lab results as of 5/15 (N=273 samples) Conclusion Over 25% of participants reported an ILI, and 5% of the nasal swabs that have been tested thus far have been positive for influenza. While most samples have not yet been analyzed, we have identified some breakthrough cases of influenza among vaccinated participants. Planned analyses include comparative vaccine effectiveness in order to inform future vaccine purchasing decisions. Disclaimer Disclosures All Authors: No reported disclosures

scholarly journals 05. Pragmatic Assessment of Influenza Vaccine Effectiveness in the DoD (PAIVED): Updates from Year 3 of Multi-Site Trial

2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S126-S127
Author(s):  
Timothy Burgess ◽  
Stephanie A Richard ◽  
Limone Collins ◽  
Rhonda E Colombo ◽  
Anuradha Ganesan ◽  
...  
Keyword(s):  
Influenza Vaccine ◽  
Blood Sample ◽  
Respiratory Infections ◽  
Panel Member ◽  
Vaccine Effectiveness ◽  
Symptom Duration ◽  
Serological Response ◽  
Review Panel ◽  
Military Populations ◽  
Pragmatic Assessment

Abstract Background 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)

scholarly journals 2756. Pragmatic Assessment of Influenza Vaccine Effectiveness in the DoD (PAIVED), Influenza-Like-Illnesses (ILIs) Sub-Study at the Marine Corps Recruit Depot-San Diego, CA (MCRD-SD) During the 2018–2019 Influenza Season

2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S970-S971
Author(s):  
Ryan Maves ◽  
Gregory Utz ◽  
Stephanie Richard ◽  
Melissa Smith ◽  
Limone Collins ◽  
...  
Keyword(s):  
Influenza Vaccine ◽  
San Diego ◽  
Diagnostic Testing ◽  
Prospective Trial ◽  
Marine Corps ◽  
Vaccine Effectiveness ◽  
Training Time ◽  
Military Recruits ◽  
Nasal Swabs ◽  
Pragmatic Assessment

Abstract Background 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.

scholarly journals 2757. Pragmatic Assessment of Influenza Vaccine Effectiveness in the DoD (PAIVED): Immunogenicity Sub-Study

2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S971-S972
Author(s):  
Rhonda Colombo ◽  
Stephanie Richard ◽  
Christina Schofield ◽  
Limone Collins ◽  
Anuradha Ganesan ◽  
...  
Keyword(s):  
Influenza Vaccine ◽  
Vaccine Effectiveness ◽  
Vaccine Uptake ◽  
Buccal Swab ◽  
Study Cohort ◽  
Blood Draw ◽  
Physically Active ◽  
Vaccine Type ◽  
Study Participants ◽  
Pragmatic Assessment

Abstract Background 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.

scholarly journals 2800. Pragmatic Assessment of Influenza Vaccine Effectiveness in the DoD (PAIVED): Influenza-Like-Illness Rates in Year 1

2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S990-S990
Author(s):  
Christina Schofield ◽  
Stephanie Richard ◽  
Rhonda Colombo ◽  
Limone Collins ◽  
Anuradha Ganesan ◽  
...  
Keyword(s):  
Influenza Vaccine ◽  
Influenza Season ◽  
Physical Exertion ◽  
Active Duty ◽  
Case Definition ◽  
Surveillance Period ◽  
Effective Prevention ◽  
Nasal Swabs ◽  
Military Facilities ◽  
Reduced Activity

Abstract Background 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.

scholarly journals POS1120 PRESENCE OF TOPHI IS ASSOCIATED WITH A RAPID DECLINE IN THE RENAL FUNCTION IN PATIENTS WITH GOUT

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 839.1-839
Author(s):  
Y. J. Oh ◽  
K. W. Moon
Keyword(s):  
Renal Function ◽  
Renal Dysfunction ◽  
Clinical Characteristics ◽  
Multivariate Logistic Regression Analysis ◽  
Joint Involvement ◽  
Rapid Decline ◽  
Symptom Duration ◽  
Tophaceous Gout ◽  
Duration Of Symptoms ◽  
Increased Risk

Background:Gout is the most common inflammatory arthritis resulting from a chronic deposition of MSU crystals in the joints and other soft tissues. After the process of repeated tissue damage and repair due to gout, tophi could be formed around the affected joints. Intra-articular tophi may sometimes result in bone destruction, joint deformities, and dysfunction which can adversely affect the patient’s quality of life. Furthermore, early-onset tophaceous gout patients are more likely to develop renal dysfunction, however, few studies have investigated if the presence of tophi is related with the progression of renal dysfunction in gout patients.Objectives:We aimed to compare clinical characteristics of patients with and without tophi at the time of the diagnosis of gout and investigate the effect of tophi on the renal function in gout patients.Methods:Data of 257 patients who were first diagnosed with gout at the Kangwon National University Hospital from January 2012 to December 2018 were retrospectively studied. Patients were divided into 2 groups according to the presence of tophi at the diagnosis. We compared clinical characteristics and the progression of renal dysfunction between the two groups.Results:Of all patients, 66 (25.5%) initially presented with tophi. Patients with tophi were older, had a longer duration of symptoms, and had a higher prevalence of multiple joint involvement than those without tophi. The decline in the eGFR was more prominent in patients with tophi than in those without (-4.8±14.5 ml/min/1.73m2vs. -0.7±11.9 ml/min/1.73m2, respectively; P=0.039). In multivariate logistic regression analysis, a prolonged symptom duration (odds ratio [OR], 1.010; 95% confidence interval [CI], 1.004–1.017; P=0.001) and multiple joint involvement (OR, 3.027; 95% CI, 1.831–5.004; P<0.001) were significantly associated with increased risk of formation of tophi. The presence of tophi was significantly associated with a rapid decline in the eGFR (β=-0.141; P=0.035).Conclusion:A prolonged symptom duration and multiple joint involvement were independent risk factors for tophi as the presenting symptom in gout patients. The presence of tophi was associated with a declining renal function. Therefore, an early diagnosis and active treatment are important in tophaceous gout.References:[1]Bardin T, Richette P. Definition of hyperuricemia and gouty conditions. Curr Opin Rheumatol 2014;26:186-91.[2]Liu F, Du GL, Song N, Ma YT, Li XM, Gao XM, et al. Hyperuricemia and its association with adiposity and dyslipidemia in Northwest China: results from cardiovascular risk survey in Xinjiang (CRS 2008-2012). Lipids Health Dis 2020;19:58.[3]Dalbeth N, Merriman TR, Stamp LK. Gout. Lancet 2016;388:2039-52.[4]Ruoff G, Edwards NL. Overview of Serum Uric Acid Treatment Targets in Gout: Why Less Than 6 mg/dL? Postgrad Med 2016;128:706-15.[5]Bieber A, Schlesinger N, Fawaz A, Mader R. Chronic tophaceous gout as the first manifestation of gout in two cases and a review of the literature. Semin Arthritis Rheum 2018;47:843-8.Disclosure of Interests:None declared.

scholarly journals Influenza Vaccine Effectiveness and Waning Effect in Hospitalized Older Adults. Valencia Region, Spain, 2018/2019 Season

2021 ◽  
Vol 18 (3) ◽  
pp. 1129
Author(s):  
Ainara Mira-Iglesias ◽  
F. Xavier López-Labrador ◽  
Javier García-Rubio ◽  
Beatriz Mengual-Chuliá ◽  
Miguel Tortajada-Girbés ◽  
...  
Keyword(s):  
Older Adults ◽  
Influenza Vaccine ◽  
Influenza A ◽  
Vaccine Effectiveness ◽  
Surveillance Network ◽  
Adjuvanted Vaccine ◽  
Clinical Registries ◽  
Populations At Risk ◽  
Influenza A H1n1 ◽  
Hospitalized Older Adults

Influenza vaccination is annually recommended for specific populations at risk, such as older adults. We estimated the 2018/2019 influenza vaccine effectiveness (IVE) overall, by influenza subtype, type of vaccine, and by time elapsed since vaccination among subjects 65 years old or over in a multicenter prospective study in the Valencia Hospital Surveillance Network for the Study of Influenza and other Respiratory Viruses (VAHNSI, Spain). Information about potential confounders was obtained from clinical registries and/or by interviewing patients and vaccination details were only ascertained by registries. A test-negative design was performed in order to estimate IVE. As a result, IVE was estimated at 46% (95% confidence interval (CI): (16%, 66%)), 41% (95% CI: (−34%, 74%)), and 45% (95% CI: (7%, 67%)) against overall influenza, A(H1N1)pdm09 and A(H3N2), respectively. An intra-seasonal not relevant waning effect was detected. The IVE for the adjuvanted vaccine in ≥75 years old was 45% (2%, 69%) and for the non-adjuvanted vaccine in 65–74 years old was 59% (−16%, 86%). Thus, our data revealed moderate vaccine effectiveness against influenza A(H3N2) and not significant against A(H1N1)pdm09. Significant protection was conferred by the adjuvanted vaccine to patients ≥75 years old. Moreover, an intra-seasonal not relevant waning effect was detected, and a not significant IVE decreasing trend was observed over time.

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