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 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 22. Description of Hospitalized Patients with Influenza Vaccine Failure

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S35-S35
Author(s):  
Joanna Kimball ◽  
Yuwei Zhu ◽  
Dayna Wyatt ◽  
Helen Talbot
Keyword(s):  
Logistic Regression ◽  
Influenza Vaccine ◽  
Influenza Vaccination ◽  
Older Patients ◽  
Influenza A ◽  
Influenza Season ◽  
Hospitalized Patients ◽  
Vaccine Failure ◽  
Increased Risk ◽  
Immunosuppressed Patients

Abstract Background Despite influenza vaccination, some patients develop illness and require hospitalization. Many factors contribute to vaccine failure, including mismatch of the vaccine and circulating strains, waning immunity, timing of influenza season, age and patient comorbidities such as immune function. This study compared vaccinated, hospitalized patients with and without influenza. Methods This study used 2015–2019 Tennessee data from the US Hospitalized Adult Influenza Vaccine Effectiveness Network database. Enrolled patients were ≥ 18 years vaccinated for the current influenza season and admitted with an acute respiratory illness. Patient or surrogate interviews and medical chart abstractions were performed, and influenza vaccinations were confirmed by vaccine providers. Influenza PCR testing was performed in a research lab. Statistical analyses were performed with STATA and R using Pearson’s chi-squared, Kruskal-Wallis and Wilcoxon rank-sum tests and multivariate logistic regression. Results 1236 patients met study criteria, and 235 (19%) tested positive for influenza. Demographics, vaccines and comorbidities were similar between the two groups (Table 1) except for morbid obesity, which was more common in influenza negative patients (13% vs 8%, p = 0.04), and immunosuppression, which was more common in the influenza positive (63% vs 54%, p = 0.01). Logistic regression analysis demonstrated older patients (OR 1.47, 95% CI 1.03–2.10) and immunosuppressed patients (OR 1.56, 1.15–2.12) were at increased risk for influenza (Table 2 and Figure 1). Immunosuppression also increased the risk for influenza A/H3N2 (OR 1.86, 95% CI 1.25–2.75). A sensitivity analysis was performed on patients who self-reported influenza vaccination for the current season without vaccine verification and demonstrated increased risk of influenza in older adults (OR 1.66, 95% CI 1.16–2.39). Table 1: Demographics of influenza positive versus influenza negative patients in influenza vaccinated, hospitalized patients. Table 2: Logistic regression analyses of vaccinated, hospitalized influenza positive patients; vaccinated, hospitalized patients with influenza A subtypes and self-reported vaccinated, hospitalized influenza positive patients. Figure 1: Predicted Probability of Hospitalization with Influenza, Influenza A/H1N1 and Influenza A/H3N2 in Vaccinated Patients by Age. Conclusion Our study demonstrated an increased risk of influenza vaccine failure in older patients and immunosuppressed patients. These groups are also at increased risk for influenza complications. To improve protection of these patients against future influenza illnesses, more effective vaccines are needed, and more research on ring vaccination should be pursued. Disclosures All Authors: No reported disclosures

scholarly journals An Antigenic Thrift-Based Approach to Influenza Vaccine Design

Vaccines ◽  
2021 ◽  
Vol 9 (6) ◽  
pp. 657
Author(s):  
Jai S. Bolton ◽  
Hannah Klim ◽  
Judith Wellens ◽  
Matthew Edmans ◽  
Uri Obolski ◽  
...  
Keyword(s):  
Influenza Vaccine ◽  
Influenza Season ◽  
Vaccine Design ◽  
Antigenic Drift ◽  
Influenza Vaccines ◽  
Immune Protection ◽  
Immune Selection ◽  
Drift Theory ◽  
Gradual Accumulation ◽  
Additional Constraints

The antigenic drift theory states that influenza evolves via the gradual accumulation of mutations, decreasing a host’s immune protection against previous strains. Influenza vaccines are designed accordingly, under the premise of antigenic drift. However, a paradox exists at the centre of influenza research. If influenza evolved primarily through mutation in multiple epitopes, multiple influenza strains should co-circulate. Such a multitude of strains would render influenza vaccines quickly inefficacious. Instead, a single or limited number of strains dominate circulation each influenza season. Unless additional constraints are placed on the evolution of influenza, antigenic drift does not adequately explain these observations. Here, we explore the constraints placed on antigenic drift and a competing theory of influenza evolution – antigenic thrift. In contrast to antigenic drift, antigenic thrift states that immune selection targets epitopes of limited variability, which constrain the variability of the virus. We explain the implications of antigenic drift and antigenic thrift and explore their current and potential uses in the context of influenza vaccine design.

scholarly journals Depletion-of-susceptibles bias in influenza vaccine waning studies: how to ensure robust results

2019 ◽  
Author(s):  
M. Lipsitch ◽  
E. Goldstein ◽  
G.T. Ray ◽  
B. Fireman
Keyword(s):  
Observational Study ◽  
Influenza Vaccine ◽  
Randomized Trial ◽  
Study Design ◽  
Null Hypothesis ◽  
Influenza Season ◽  
Calendar Time ◽  
Future Studies ◽  
Biased Estimates ◽  
Induced Immunity

SUMMARYVaccine effectiveness (VE) studies are subject to biases due to depletion of at-risk persons or of highly susceptible persons at different rates from different groups (depletion-of-susceptibles bias), a problem that can also lead to biased estimates of waning effectiveness, including spurious inference of waning when none exists. An alternative study design to identify waning is to study only vaccinated persons, and compare for each day the incidence in persons with earlier or later dates of vaccination. Prior studies suggested under what conditions this alternative would yield correct estimates of waning. Here we define the depletion-of-susceptibles process formally and show mathematically that for influenza vaccine waning studies, a randomized trial or corresponding observational study that compares incidence at a specific calendar time among individuals vaccinated at different times before the influenza season begins will not be vulnerable depletion-of-susceptibles bias in its inference of waning under the null hypothesis that none exists, and will – if waning does actually occur – underestimate the extent of waning. Such a design is thus robust in the sense that a finding of waning in that inference framework reflects actual waning of vaccine-induced immunity. We recommend such a design for future studies of waning, whether observational or randomized.

scholarly journals Start of the influenza season 2008-9 in Europe - increasing influenza activity moving from West to East dominated by A(H3N2)

2009 ◽  
Vol 14 (3) ◽  
Author(s):  
N Goddard ◽  
P Zucs ◽  
B Ciancio ◽  
F Plata ◽  
O Hungnes ◽  
...  
Keyword(s):  
Influenza Virus ◽  
Influenza Vaccine ◽  
Northern Hemisphere ◽  
Virus Type ◽  
Influenza Season ◽  
Type A ◽  
Neuraminidase Inhibitors ◽  
Influenza Activity

The influenza season 2008-9 started in week 49 of 2008 and is so far characterised by influenza virus type A subtype H3N2. Isolates of this subtype that were tested proved susceptible to neuraminidase inhibitors, but resistant to M2 inhibitors. The circulating A(H3N2) viruses are antigenically similar to the component in the current northern hemisphere influenza vaccine.

scholarly journals The impact of the 2009 influenza A(H1N1) pandemic on attitudes of healthcare workers toward seasonal influenza vaccination 2010/11

2011 ◽  
Vol 16 (17) ◽  
Author(s):  
C Brandt ◽  
H F Rabenau ◽  
S Bornmann ◽  
R Gottschalk ◽  
S Wicker
Keyword(s):  
Medical Students ◽  
Influenza Vaccine ◽  
Influenza Vaccination ◽  
Healthcare Workers ◽  
Influenza A ◽  
Influenza Season ◽  
University Hospital ◽  
The Public ◽  
Influenza A H1n1 ◽  
The Impact

The emergence of the influenza A(H1N1)2009 virus provided a major challenge to health services around the world. However, vaccination rates for the public and for healthcare workers (HCWs) have remained low. We performed a study to review the reasons put forward by HCWs to refuse immunisation with the pandemic vaccine in 2009/10 and characterise attitudes in the influenza season 2010/11 due to the emergence of influenza A(H1N1)2009. A survey among HCWs and medical students in the clinical phase of their studies was conducted, using an anonymous questionnaire, at a German university hospital during an influenza vaccination campaign. 1,366 of 3,900 HCWs (35.0%) were vaccinated in the 2010/11 influenza season. Of the vaccinated HCWs, 1,323 (96.9%) completed the questionnaire in addition to 322 vaccinated medical students. Of the 1,645 vaccinees who completed the questionnaire, 712 had not been vaccinated against the influenza A(H1N1)2009 virus in the 2009/10 season. The main reason put forward was the objection to the AS03 adjuvants (239/712, 33.6%). Of the HCWs and students surveyed, 270 of 1,645 (16.4%) stated that the pandemic had influenced their attitude towards vaccination in general. Many German HCWs remained unconvinced of the safety of the pandemic (adjuvanted) influenza vaccine. For this reason, effective risk communication should focus on educating the public and HCWs about influenza vaccine safety and the benefits of vaccination.

Acceptability of Intanza® 15 μg intradermal influenza vaccine in Belgium during the 2010–2011 influenza season

2012 ◽  
Vol 29 (6) ◽  
pp. 562-577 ◽  
Author(s):  
Patrick A. Dhont ◽  
Adelin Albert ◽  
Patrick Brenders ◽  
Anna Podwapinska ◽  
Ann Pollet ◽  
...  
Keyword(s):  
Influenza Vaccine ◽  
Influenza Season ◽  
Intradermal Influenza Vaccine

Intraseason decline in influenza vaccine effectiveness during the 2016 southern hemisphere influenza season: A test-negative design study and phylogenetic assessment

Vaccine ◽  
2019 ◽  
Vol 37 (19) ◽  
pp. 2634-2641 ◽  
Author(s):  
Annette K. Regan ◽  
James E. Fielding ◽  
Monique B. Chilver ◽  
Kylie S. Carville ◽  
Cara A. Minney-Smith ◽  
...  
Keyword(s):  
Influenza Vaccine ◽  
Southern Hemisphere ◽  
Influenza Season ◽  
Vaccine Effectiveness ◽  
Design Study

scholarly journals Relative Effectiveness of the Cell-Cultured Quadrivalent Influenza Vaccine Compared to Standard, Egg-derived Quadrivalent Influenza Vaccines in Preventing Influenza-like Illness in 2017–2018

2020 ◽  
Vol 71 (10) ◽  
pp. e665-e671 ◽  
Author(s):  
Constantina Boikos ◽  
Gregg C Sylvester ◽  
John S Sampalis ◽  
James A Mansi
Keyword(s):  
Cell Culture ◽  
Health Status ◽  
Influenza Vaccine ◽  
Influenza Season ◽  
Relative Effectiveness ◽  
Geographic Region ◽  
Influenza Vaccines ◽  
Study Cohort ◽  
Influenza Like Illness ◽  
Adaptive Mutations

Abstract Background Influenza antigens may undergo adaptive mutations during egg-based vaccine production. In the 2017–2018 influenza season, quadrivalent, inactivated cell-derived influenza vaccine (ccIIV4) vaccine was produced using A(H3N2) seed virus propagated exclusively in cell culture, thus lacking egg adaptive changes. This United States study estimated relative vaccine effectiveness (rVE) of ccIIV4 vs egg-derived quadrivalent vaccines (egg-derived IIV4) for that season. Methods Vaccination, outcome, and covariate data were ascertained retrospectively from a electronic medical record (EMR) dataset and analyzed. The study cohort included patients ≥ 4 years of age. rVE was estimated against influenza-like illness (ILI) using diagnostic International Classification of Diseases, Ninth or Tenth Revision codes. The adjusted odds ratios used to derive rVE estimates were estimated from multivariable logistic regression models adjusted for age, sex, race/ethnicity, geographic region, and health status. Results Overall, 92 187 individuals had a primary care EMR record of ccIIV4 and 1 261 675 had a record of egg-derived IIV4. In the ccIIV4 group, 1705 narrowly defined ILI events occurred, and 25 645 occurred in the standard egg-derived IIV4 group. Crude rVE was 9.2% (95% confidence interval [CI], 4.6%–13.6%). When adjusted for age, sex, health status, comorbidities, and geographic region, the estimated rVE changed to 36.2% (95% CI, 26.1%–44.9%). Conclusions ccIIV4, derived from A(H3N2) seed virus propagated exclusively in cell culture, was more effective than egg-derived IIV4 in preventing ILI during the 2017–2018 influenza season. This result suggests that cell-derived influenza vaccines may have greater effectiveness than standard egg-derived vaccines.

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