Suchergebnisse

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 ...

BACKGROUND: Most influenza vaccines come from inactivated virus grown in egg culture, and studies suggest that egg-adapted virus may have decreased immunogenicity in humans for certain influenza A strains. Cell culture-based and recombinant vaccines may be more immunogenic, but comparative studies are lacking. We are conducting a randomized, controlled trial of 3 FDA-licensed influenza vaccines (cell culture, recombinant, and egg culture) to assess differences in immunogenicity and effectiveness in adults. METHODS: A total of 10,650 eligible adults will be individually randomized 1:1:1 (cell culture, recombinant, or egg-based vaccine) over 2 influenza seasons (2018–2019 and 2019–2020) at military facilities in geographically diverse locations in the US Participants who are not military recruits will report the presence or absence of ILI symptoms on a weekly basis through an automated electronic (text message or email) survey; those who experience ILI symptoms will be scheduled for two in-person visits. Military recruits who experience an ILI report will report directly to clinic and will not receive weekly surveillance reminders (Figure 1). RESULTS: Enrollment for year 1 of PAIVED occurred November 7 to December 31, 2018 at 5 military bases. During this season, 1,623 participants were enrolled, among whom 34% were randomized to receive cell culture vaccine, 33% to recombinant vaccine, and 33% to egg-based vaccine. The participants were 61% active military, 19% retired military, and 20% military dependents. One quarter of the participants were women, and the participants were 18–88 years old, median 26 years of age. Among the 1,559 participants with complete data, 324 (21%) experienced ILI at least once. Blood and swab samples were successfully collected at visit 1 from 93% of the participants with case-defined ILIs. CONCLUSION: The initial phase of PAIVED successfully enrolled and randomized 1,623 participants during the 2018/2019 influenza season. Follow-up of this season's participants is on-going. PAIVED will ...

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 ...

BACKGROUND: 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 ...

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 ...

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 [Image: see text] Figure 1. Lab results as of 5/15 (N=273 samples) [Image: see text] CONCLUSION: Over 25% of participants reported an ILI, and 5% of the nasal swabs that have been tested thus far ...

BACKGROUND: Healthcare workers (HCWs) are at heightened risk of exposure to respiratory pathogens. There are limited published data on influenza-like illness (ILI) experience among HCWs, and the few available studies were hampered by incomplete vaccination histories. PAIVED, a multicenter, multiservice study assessing influenza vaccine effectiveness in the Department of Defense, provides a unique opportunity to describe ILI experience among vaccinated HCWs compared to vaccinated non-HCWs. METHODS: PAIVED participants were randomized to receive either egg-based, cell-based, or recombinant-derived influenza vaccine then surveyed weekly for ILI. At enrollment, participants provided key demographic data including whether they were HCWs with direct patient contact. ILI was defined a priori as 1) having cough or sore throat plus 2) feeling feverish/having chills or having body aches/fatigue. Participants with ILI completed a daily symptom diary for seven days and submitted a nasal swab for pathogen detection. RESULTS: Of 4433 eligible participants enrolled during the 2019-20 influenza season, 1551 (35%) were HCWs. A higher percentage of HCWs experienced an ILI than non-HCWs (34% vs 26%, p< 0.001). Overall, HCWs were more likely to be female (42% vs 32%), age 25-34 years (39% vs 28%), active-duty military (81% vs 62%), non-smokers (88% vs 75%), and physically active (92% vs 85%). Self-reported race differed between HCWs and non-HCWs; a higher proportion of HCWs identified as White (63% vs 56%) or Asian (8% vs 5%). Similar demographic differences existed among HCWs and non-HCWs with ILI. HCWs were more likely to respond to at least 50% of weekly surveillance messages, irrespective of ILI status. HCWs with ILI had less severe lower respiratory symptoms (p< 0.001) and a shorter duration of illness (12.4±8.1 days vs 13.7±9.0, p=0.005) than non-HCWs. Pathogen data is pending. CONCLUSION: HCWs in PAIVED were more likely to report ILI than their non-HCW counterparts yet tended to have lower illness severity, possibly ...