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

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.

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

Open Forum Infectious Diseases ◽

10.1093/ofid/ofaa439.1682 ◽

2020 ◽

Vol 7 (Supplement_1) ◽

pp. S752-S753

Author(s):

Stephanie A Richard ◽

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

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Influenza vaccine effectiveness against laboratory-confirmed influenza in hospitalised adults aged 60 years or older, Valencia Region, Spain, 2017/18 influenza season

Eurosurveillance ◽

10.2807/1560-7917.es.2019.24.31.1800461 ◽

2019 ◽

Vol 24 (31) ◽

Author(s):

Ainara Mira-Iglesias ◽

F Xavier López-Labrador ◽

Víctor Baselga-Moreno ◽

Miguel Tortajada-Girbés ◽

Juan Mollar-Maseres ◽

...

Keyword(s):

Influenza Vaccine ◽

Influenza A ◽

Vaccine Effectiveness ◽

Influenza Viruses ◽

Influenza B ◽

Current Season ◽

Hospitalised Patients ◽

Influenza A H1n1 ◽

Vaccine Type ◽

The Impact

Introduction Influenza immunisation is recommended for elderly people each season. The influenza vaccine effectiveness (IVE) varies annually due to influenza viruses evolving and the vaccine composition. Aim To estimate, in inpatients ≥ 60 years old, the 2017/18 trivalent IVE, overall, by vaccine type and by strain. The impact of vaccination in any of the two previous seasons (2016/17 and 2015/16) on current (2017/18) IVE was also explored. Methods This was a multicentre prospective observational study within the Valencia Hospital Surveillance Network for the Study of Influenza and Respiratory Viruses Disease (VAHNSI, Spain). The test-negative design was applied taking laboratory-confirmed influenza as outcome and vaccination status as main exposure. Information about potential confounders was obtained from clinical registries and/or by interviewing patients; vaccine information was only ascertained by registries. Results Overall, 2017/18 IVE was 9.9% (95% CI: −15.5 to 29.6%), and specifically, 48.3% (95% CI: 13.5% to 69.1%), −29.9% (95% CI: −79.1% to 5.8%) and 25.7% (95% CI: −8.8% to 49.3%) against A(H1N1)pdm09, A(H3N2) and B/Yamagata lineage, respectively. For the adjuvanted and non-adjuvanted vaccines, overall IVE was 10.0% (95% CI: −24.4% to 34.9%) and 7.8% (95% CI: −23.1% to 31.0%) respectively. Prior vaccination significantly protected against influenza B/Yamagata lineage (IVE: 50.2%; 95% CI: 2.3% to 74.6%) in patients not vaccinated in the current season. For those repeatedly vaccinated against influenza A(H1N1)pdm09, IVE was 46.4% (95% CI: 6.8% to 69.2%). Conclusion Our data revealed low vaccine effectiveness against influenza in hospitalised patients ≥60 years old in 2017/18. Prior vaccination protected against influenza A(H1N1)pdm09 and B/Yamagata-lineage.

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

Open Forum Infectious Diseases ◽

10.1093/ofid/ofab466.208 ◽

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)

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Effectiveness of influenza vaccination in preventing hospitalisation due to influenza in children: a systematic review and meta-analysis

Clinical Infectious Diseases ◽

10.1093/cid/ciab270 ◽

2021 ◽

Author(s):

Nicki L Boddington ◽

Isabelle Pearson ◽

Heather Whitaker ◽

Punam Mangtani ◽

Richard G Pebody

Keyword(s):

Systematic Review ◽

Influenza Vaccine ◽

Influenza Vaccination ◽

Random Effects ◽

Influenza A ◽

Influenza Infection ◽

Meta Analysis ◽

Vaccine Effectiveness ◽

Vaccine Type ◽

Inactivated Vaccines

Abstract This systematic review assesses the literature for estimates of influenza vaccine effectiveness (IVE) against laboratory-confirmed influenza-associated hospitalisation in children. Studies of any design to 08 June 2020 were included if the outcome was hospitalisation, participants were 17 years old or less and influenza infection was laboratory-confirmed. A random-effects meta-analysis of 37 studies that used a test-negative design gave a pooled seasonal IVE against hospitalisation of 53.3% (47.2-58.8) for any influenza. IVE was higher against influenza A/H1N1pdm09 (68.7%, 56.9-77.2) and lowest against influenza A/H3N2 (35.8%, 23.4-46.3). Estimates by vaccine type ranged from 44.3% (30.1-55.7) for LAIV to 68.9% (53.6-79.2) for inactivated vaccines. IVE estimates were higher in seasons when the circulating influenza strains were antigenically matched to vaccine strains (59.3%, 48.3-68.0). Influenza vaccination gives moderate overall protection against influenza-associated hospitalisation in children supporting annual vaccination. IVE varies by influenza subtype and vaccine type.

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Effectiveness of 2 Influenza Vaccines in Nationwide Cohorts of Finnish 2-Year-Old Children in the Seasons 2015–2016 Through 2017–2018

Clinical Infectious Diseases ◽

10.1093/cid/ciaa050 ◽

2020 ◽

Vol 71 (8) ◽

pp. e255-e261

Author(s):

Ulrike Baum ◽

Sangita Kulathinal ◽

Kari Auranen ◽

Hanna Nohynek

Keyword(s):

Influenza Vaccine ◽

Virus Type ◽

Real Life ◽

Vaccine Effectiveness ◽

Influenza Vaccines ◽

Type B ◽

Live Attenuated Influenza Vaccine ◽

Vaccine Type ◽

Decision Making Processes ◽

Study Population

Abstract Background From 2015–2016 through 2017–2018, injectable, trivalent inactivated influenza vaccines (IIV3) and a nasal spray, tetravalent live-attenuated influenza vaccine (LAIV4) were used in parallel in Finland. To understand how well vaccination with each vaccine type protected children against influenza under real-life conditions, vaccine effectiveness in 2-year-olds was estimated for all 3 seasons. Methods Each season, a nationwide register-based cohort study was conducted. The study population comprised 60 088, 60 860, and 60 345 children in 2015–2016, 2016–2017, and 2017–2018, respectively. Laboratory-confirmed influenza was the study outcome. Seasonal influenza vaccination with either LAIV4 or IIV3 was the time-dependent exposure of interest. Vaccine effectiveness was defined as 1 minus the hazard ratio comparing vaccinated with unvaccinated children. Results From 2015–2016 through 2017–2018, the effectiveness of LAIV4 against influenza of any virus type was estimated at 54.2% (95% confidence interval, 32.2–69.0%), 20.3% (−12.7%, 43.6%), and 30.5% (10.9–45.9%); the corresponding effectiveness of IIV3 was 77.2% (48.9–89.8%), 24.5% (−29.8%, 56.1%), and −20.1% (−61.5%, 10.7%). Neither influenza vaccine clearly excelled in protecting children. The LAIV4 effectiveness against type B was greater than against type A and greater than the IIV3 effectiveness against type B. Conclusions To understand how influenza vaccines could be improved, vaccine effectiveness must be analyzed by vaccine and virus type. Effectiveness estimates also expressing overall protection levels are needed to guide individual and programmatic decision-making processes. Supported by this analysis, the vaccination program in Finland now recommends LAIV4 and injectable, tetravalent inactivated influenza vaccines replacing IIV3.

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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

Open Forum Infectious Diseases ◽

10.1093/ofid/ofz360.2433 ◽

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.

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2553. Individual Patient-Level Data Meta-Analysis of Live Attenuated and Inactivated Influenza Vaccine Effectiveness Among US Children, 2013–2014 Through 2015–2016

Open Forum Infectious Diseases ◽

10.1093/ofid/ofy209.161 ◽

2018 ◽

Vol 5 (suppl_1) ◽

pp. S68-S68

Author(s):

Jessie Chung ◽

Brendan Flannery ◽

Rodolfo Begue ◽

Herve Caspard ◽

Laurie Demarcus ◽

...

Keyword(s):

Influenza Vaccine ◽

Influenza A ◽

The United States ◽

Vaccine Effectiveness ◽

Vaccination Status ◽

Influenza B ◽

Rt Pcr ◽

Current Season ◽

Influenza A H1n1 ◽

Vaccine Type

Abstract Background Quadrivalent live attenuated influenza vaccine (LAIV4) was not recommended for use in the United States for the 2016–2017 and 2017–2018 influenza seasons based on US observational studies of vaccine effectiveness (VE) from 2013–2014 to 2015–2016. We pooled individual patient data on children aged 2–17 years enrolled in 5 US studies during these 3 influenza seasons to further investigate VE by vaccine type. Methods Analyses included 17,173 children enrolled in the US Department of Defense Global Laboratory-based Influenza Surveillance Program, US Influenza Vaccine Effectiveness Network, Influenza Incidence Surveillance Project, Influenza Clinical Investigation for Children, and a Louisiana State University study. Participants’ specimens were tested for influenza by reverse transcription-polymerase chain reaction (RT-PCR), culture, or a combination of rapid antigen testing and RT-PCR. VE was calculated by comparing odds of vaccination with either inactivated influenza vaccine (IIV) or LAIV4 among influenza-positive cases to test-negative controls and calculated as 100 × (1 − odds ratio) in logistic regression models with age, calendar time, influenza season, and study site (random effect). Patients were stratified by prior season vaccination status in a subanalysis. Results Overall, 38% of patients (N = 6,558) were vaccinated in the current season, of whom 30% (N = 1,979) received LAIV4. Pooled VE of IIV against any influenza virus was 51% (95% CI: 47, 54) versus 26% (95% CI: 15, 36) for LAIV4. Point estimates for pooled VE against any influenza by age group ranged from 45% to 58% for IIV and 19% to 34% for LAIV4 during the 3 seasons (Figures 1 and 2). Pooled VE against influenza A(H1N1)pdm09 was 67% (95% CI: 62, 72) for IIV versus 20% (95% CI: −6, 39) for LAIV4. Pooled VE against influenza A(H3N2) was 29% (95% CI: 14, 42) for IIV versus 7% (95% CI: −11, 23) for LAIV4, and VE against influenza B was 52% (95% CI: 42, 60) for IIV and 66% (95% CI: 47, 77) for LAIV4. VE against influenza A(H1N1)pdm09 was lower for LAIV4 versus IIV across all strata of prior season vaccination (Figure 3). Conclusion Consistent with individual studies, our pooled analyses found that LAIV4 effectiveness was reduced for all age groups against influenza A(H1N1)pdm09 compared with IIV. This result did not vary based on prior vaccination status. Disclosures H. Caspard, AstraZeneca: Employee, Salary.

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Influenza Vaccine Effectiveness in the 2014–2015 Season for Children 2–17 Years by Vaccine Type: US Influenza Vaccine Effectiveness Network

Open Forum Infectious Diseases ◽

10.1093/ofid/ofv131.142 ◽

2015 ◽

Vol 2 (suppl_1) ◽

Author(s):

Richard K. Zimmerman ◽

Brendan Flannery ◽

Alicia M. Fry ◽

Swathi Thaker ◽

Jessie Clippard ◽

...

Keyword(s):

Influenza Vaccine ◽

Vaccine Effectiveness ◽

Vaccine Type

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Seasonal Influenza Vaccine Effectiveness in People With Asthma: A National Test-Negative Design Case-Control Study

Clinical Infectious Diseases ◽

10.1093/cid/ciz1086 ◽

2019 ◽

Vol 71 (7) ◽

pp. e94-e104

Author(s):

Eleftheria Vasileiou ◽

Aziz Sheikh ◽

Chris C Butler ◽

Chris Robertson ◽

Kimberley Kavanagh ◽

...

Keyword(s):

Influenza Vaccine ◽

Influenza Vaccination ◽

Case Control Study ◽

Influenza Infection ◽

Age Groups ◽

Case Control ◽

Vaccine Effectiveness ◽

Vaccine Uptake ◽

Individual Patient Level ◽

Control Study

Abstract Background Influenza infection is a trigger of asthma attacks. Influenza vaccination can potentially reduce the incidence of influenza in people with asthma, but uptake remains persistently low, partially reflecting concerns about vaccine effectiveness (VE). Methods We conducted a test-negative designed case-control study to estimate the effectiveness of influenza vaccine in people with asthma in Scotland over 6 seasons (2010/2011 to 2015/2016). We used individual patient–level data from 223 practices, which yielded 1 830 772 patient-years of data that were linked with virological (n = 5910 swabs) data. Results Vaccination was associated with an overall 55.0% (95% confidence interval [CI], 45.8–62.7) risk reduction of laboratory-confirmed influenza infections in people with asthma over 6 seasons. There were substantial variations in VE between seasons, influenza strains, and age groups. The highest VE (76.1%; 95% CI, 55.6–87.1) was found in the 2010/2011 season, when the A(H1N1) strain dominated and there was a good antigenic vaccine match. High protection was observed against the A(H1N1) (eg, 2010/2011; 70.7%; 95% CI, 32.5–87.3) and B strains (eg, 2010/2011; 83.2%; 95% CI, 44.3–94.9), but there was lower protection for the A(H3N2) strain (eg, 2014/2015; 26.4%; 95% CI, −12.0 to 51.6). The highest VE against all viral strains was observed in adults aged 18–54 years (57.0%; 95% CI, 42.3–68.0). Conclusions Influenza vaccination gave meaningful protection against laboratory-confirmed influenza in people with asthma across all seasons. Strategies to boost influenza vaccine uptake have the potential to substantially reduce influenza-triggered asthma attacks.

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