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

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Co-Author(s)

SR

Stephanie A. Richard

Epidemiologist
Infectious Disease Clinical Research Program, Department of Preventive Medicine and Biostatistics, Uniformed Services University of the Health Sciences, Bethesda, MD, USA
Bethesda, Maryland
Disclosure: I do not have any relevant financial / non-financial relationships with any proprietary interests.

Presenting Author(s)

Timothy Burgess

Director
Infectious Disease Clinical Research Program, Department of Preventive Medicine and Biostatistics, Uniformed Services University of the Health Sciences, Bethesda, MD, USA
Bethesda, Maryland
Disclosure: I do not have any relevant financial / non-financial relationships with any proprietary interests.

Co-Author(s)

LC

Limone Collins

Chief, Vaccine Safety and Evaluation Oversight
Immunization Healthcare Division, Defense Health Agency
Bethesda, Maryland
Disclosure: I do not have any relevant financial / non-financial relationships with any proprietary interests.
RC

Rhonda E. Colombo

Clinical Research Physician
Infectious Disease Clinical Research Program, Department of Preventive Medicine and Biostatistics, Uniformed Services University of the Health Sciences, Bethesda, MD, USA, The Henry M. Jackson Foundation for the Advancement of Military Medicine, Madigan Army Medical Center Division of Infectious Diseases
Tacoma, Washington
Disclosure: I do not have any relevant financial / non-financial relationships with any proprietary interests.
AG

Anuradha Ganesan

Infectious Disease Physician Walter Reed National Military Medical Center
Infectious Disease Clinical Research Program, Department of Preventive Medicine and Biostatistics, Uniformed Services University of the Health Sciences, Bethesda, MD, USA, Walter Reed National Military Medical Center
Bethesda, Maryland
Disclosure: I do not have any relevant financial / non-financial relationships with any proprietary interests.
CG

Casey Geaney

Research Physician, Site PI
Walter Reed National Military Medical Center
Bethesda, MD
Disclosure: I do not have any relevant financial / non-financial relationships with any proprietary interests.
DH

David Hrncir

Regional Medical Director, Immunization
Carl R. Darnall Army Medical Center/Wilford Hall Ambulatory Surgical Center
Fort Hood, Texas
Disclosure: I do not have any relevant financial / non-financial relationships with any proprietary interests.
TL

Tahaniyat Lalani

Research Physician, IDCRP Research Area Director, Associate Professor USU
Naval Medical Center Portsmouth
Portsmouth, Virginia
Disclosure: I do not have any relevant financial / non-financial relationships with any proprietary interests.
Ana E. Markelz

Medical Director, Infection Prevention and Control Chief, Infectious Disease Service
Brooke Army Medical Center
San Antonio, Texas
Disclosure: I do not have any relevant financial / non-financial relationships with any proprietary interests.
RM

Ryan C. Maves

Fellowship Program Director
Naval Medical Center San Diego, San Diego, CA and Infectious Disease Clinical Research Program, Bethesda, MD
San DIego, California
Disclosure: I do not have any relevant financial / non-financial relationships with any proprietary interests.
BM

Bruce McClenathan

Regional Medical Director
Womack Army Medical Center
Fort Bragg, North Carolina
Disclosure: I do not have any relevant financial / non-financial relationships with any proprietary interests.
KM

Katrin Mende

Deputy Research Area Director, EIDAR
Infectious Disease Clinical Research Program, Department of Preventive Medicine and Biostatistics, Uniformed Services University of the Health Sciences, Bethesda, MD, USA
San Antonio, Texas
Disclosure: I do not have any relevant financial / non-financial relationships with any proprietary interests.
JM

Jitendrakumar Modi

Director of Health Services
NHC Annapolis
Laurel, Maryland
Disclosure: I do not have any relevant financial / non-financial relationships with any proprietary interests.
JM

Jay R. Montgomery

Medical Director
Defense Health Agency
Vienna, Virginia
Disclosure: I do not have any relevant financial / non-financial relationships with any proprietary interests.
CS

Christina Schofield

Infectious Disease Physician
Madigan Army Medical Center Division of Infectious Diseases, Infectious Disease Clinical Research Program
Tacoma, Washington
Disclosure: I do not have any relevant financial / non-financial relationships with any proprietary interests.
SS

Srihari Seshadri

Team Lead, Regulatory Investigations Office
Immunization Healthcare Division, Defense Health Agency
Bethesda, Maryland
Disclosure: I do not have any relevant financial / non-financial relationships with any proprietary interests.
CS

Catherine Skerrett

Nurse Practitioner, Immunization
Lackland Air Force Base
San Antonio, Texas
Disclosure: I do not have any relevant financial / non-financial relationships with any proprietary interests.
CS

Christina Spooner

Team Lead, Clinical Investigations
Immunization Healthcare Division, Defense Health Agency
Bethesda, Maryland
Disclosure: I do not have any relevant financial / non-financial relationships with any proprietary interests.
GU

Gregory Utz

Research Physician, Site PI
Naval Medical Center San Diego, Infectious Disease Clinical Research Program, Bethesda, MD, and Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc., Bethesda, MD
San Diego, California
Disclosure: I do not have any relevant financial / non-financial relationships with any proprietary interests.
TW

Tyler Warkentien

Infectious Disease Specialist
Naval Medical Center Portsmouth
Portsmouth, Virginia
Disclosure: I do not have any relevant financial / non-financial relationships with any proprietary interests.
Mark P. Simons

Deputy Program Director
Infectious Disease Clinical Research Program, Bethesda, MD, The Henry M. Jackson Foundation, Bethesda, MD
Bethesda, Maryland
Disclosure: I do not have any relevant financial / non-financial relationships with any proprietary interests.

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