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A Pragmatic Assessment of Influenza Vaccine Effectiveness in the DoD (PAIVED)

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ClinicalTrials.gov Identifier: NCT03734237
Recruitment Status : Recruiting
First Posted : November 7, 2018
Last Update Posted : December 17, 2018
Sponsor:
Collaborators:
National Institute of Allergy and Infectious Diseases (NIAID)
Food and Drug Administration (FDA)
Defense Health Agency Immunization Healthcare Branch
Armed Forces Health Surveillance Branch
Naval Health Research Center
United States Air Force School of Aerospace Medicine
Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc.
Uniformed Services University of the Health Sciences
Information provided by (Responsible Party):
Henry M. Jackson Foundation for the Advancement of Military Medicine

Brief Summary:
A total of 10,650 eligible subjects (or 3,550 subject distributed evenly between the 3 study arms) will be enrolled. Eligible subjects will be randomized in 1:1:1 (cell-culture-based vaccine, the recombinant vaccine, or the egg-based vaccine) over two influenza seasons (2018-2019, 2019-2020).

Condition or disease Intervention/treatment Phase
Influenza Influenza-like Illness Biological: Egg based influenza vaccines Biological: Recombinant influenza vaccines Biological: Cell-culture based influenza vaccines Phase 4

Detailed Description:
This two-year, pragmatic, prospective study will compare the effectiveness of licensed egg-based inactivated influenza vaccines to the effectiveness of two other types of licensed vaccines, the cell-culture based inactivated influenza vaccine and the recombinant influenza vaccine, in the prevention of laboratory-confirmed influenza infection in active duty members, military retirees, and other DoD beneficiaries. Six military treatment facilities (MTFs) in the United States will participate in this protocol. Enrollment will be restricted to adults (≥18 years and older, or ≥17 years old if an active duty member) who are preparing to receive seasonal influenza vaccination at participating DoD sites. Subjects will be randomized to receive one of the three licensed influenza vaccines types for evaluation of effectiveness. There is no exclusion for pregnancy, as none of these licensed products are contraindicated in pregnant women.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10650 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A total of 10,650 eligible subjects (or 3,550 subject distributed evenly between the 3 study arms) will be enrolled. eligible subjects will be randomized in 1:1:1 (cell-culture-based vaccine, the recombinant vaccine, or the egg-based vaccine) over two influenza seasons (2019-2020, 2020-2021).
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Pragmatic Assessment of Influenza Vaccine Effectiveness in the DoD
Actual Study Start Date : November 6, 2018
Estimated Primary Completion Date : May 31, 2020
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Active Comparator: Egg based influenza vaccines
Quadrivalent egg-based vaccines, which contain an inactivated form of the virus. Vaccines will be given to the participant in accordance with standard clinical practices for those in the US military. All egg-based vaccines are FDA licensed for use in the United States.
Biological: Egg based influenza vaccines
Participants will be randomly allocated to one of three vaccine types in accordance with standard clinical practices for those in the US military. All vaccines are FDA licensed for use in the United States.

Active Comparator: Recombinant influenza vaccines
FluBlok, recombinant HA influenza vaccine. Vaccines will be given to the participant in accordance with standard clinical practices for those in the US military. Flublok Quadrivalent is a quadrivalent recombinant influenza vaccine that has been licensed by the FDA for use in the United States.
Biological: Recombinant influenza vaccines
Participants will be randomly allocated to one of three vaccine types in accordance with standard clinical practices for those in the US military. All vaccines are FDA licensed for use in the United States.

Active Comparator: Cell-culture based influenza vaccines
Flucelvax, Madin-Darby canine kidney (MDCK)-cell-culture based inactivated influenza vaccine. Vaccines will be given to the participant in accordance with standard clinical practices for those in the US military. Flucelvax quadrivalent, the only cell-based flu vaccine FDA licensed for use in the United States.
Biological: Cell-culture based influenza vaccines
Participants will be randomly allocated to one of three vaccine types in accordance with standard clinical practices for those in the US military. All vaccines are FDA licensed for use in the United States.




Primary Outcome Measures :
  1. Laboratory confirmed influenza attack rates [ Time Frame: Onset > 13 days after vaccination up to 1 year ]

Secondary Outcome Measures :
  1. Hemagglutination Inhibition (HI) titer responses to vaccine and circulating strains of influenza [ Time Frame: Baseline to 21-35 days post vaccine ]
    A subset of volunteers may participate it in this outcome.

  2. Pseudovirion neutralization (PVN) responses to vaccine and circulating strains of influenza [ Time Frame: Baseline to 21-35 days post vaccine ]
    A subset of volunteers may participate it in this outcome.

  3. Anti-Neuraminidase (Anti-NA) titer responses to vaccine and circulating strains of influenza [ Time Frame: Baseline to 21-35 days post vaccine ]
    A subset of volunteers may participate it in this outcome.

  4. Cellular Responses: Frequency of antigen specific CD4 and CD8 cells, B cells [ Time Frame: Baseline to 21-35 days post vaccine ]
    A subset of volunteers may participate it in this outcome.

  5. Rate of Influenza-like Illness [ Time Frame: Onset > 13 days after vaccination up to 1 year ]
  6. Frequency of influenza confirmed hospitalization [ Time Frame: Onset > 13 days after vaccination up to 1 year ]
  7. Number of duty (work) days lost due to Influenza-like Illness [ Time Frame: Onset > 13 days after vaccination up to 1 year ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Eligible for care in Department of Defence medical facilities (Defense Enrollment Eligibility Reporting System eligible)
  2. ≥17 years of age and above for active duty members and ≥18 years of age for other beneficiaries.
  3. At a participating Military Treatment Facility site for the purpose of receiving a seasonal (2018-19 and 2019-2020) influenza vaccination.
  4. Speak English and able to provide informed consent

Exclusion Criteria:

  1. Adults intending to receive or who have received the 2018-2019 and 2019-2020 FluMist vaccine (LAIV).
  2. Individual who cannot receive a flu vaccine or standard dosing due to another medical condition
  3. Allergic to gentamicin, polymyxin and/or neomycin
  4. Individuals who fail to meet the inclusion criteria

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03734237


Contacts
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Contact: Marianne Spevak, BSHS 240-694-2067 mspevak@hjf.org
Contact: Nicole Moreno 1-877-328-4258 nmoreno@idcrp.org

Locations
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United States, California
Naval Medical Center San Diego Recruiting
San Diego, California, United States, 34800
Contact: Stephanie Cammarata    619-532-7483    stephanie.m.cammarata.ctr@mail.mil   
Contact: Gregory Utz, MD    619.532.8288    gregory.utz.ctr@mail.mil   
Principal Investigator: Ryan Maves, MD         
United States, Maryland
Walter Reed National Military Medical Center Recruiting
Bethesda, Maryland, United States, 20814
Contact: Irma Barahona    301-319-8673    irma.l.barahona.ctr@mail.mil   
Contact: Anuradha Ganesan    301.295.2972    anuradha.ganesan.ctr@mail.mil   
Principal Investigator: Casey Geaney, MD         
United States, North Carolina
Womack Army Medical Center Recruiting
Fort Bragg, North Carolina, United States, 28310
Contact: Christina Spooner    858-361-4706    christina.e.spooner.civ@mail.mil   
Principal Investigator: Bruce McClenathan, MD         
United States, Texas
Brooke Army Medical Center Recruiting
Sam Houston, Texas, United States, 78234
Contact: Sanjuanita Medina    210-916-7913    sanjuanita.s.medina.ctr@mail.mil   
Contact: Katrin Mende, PhD    210.916.3859    katrin.mende.ctr@mail.mil   
Principal Investigator: Ana E Markelz, MD         
United States, Virginia
Naval Medical Center Portsmouth Recruiting
Portsmouth, Virginia, United States, 23704
Contact: Rezalina Tant    757-953-5603    rezalina.g.tant.ctr@mail.mil   
Contact: Tahaniyat Lalani    301.816.8437    tlalani@idcrp.org   
Principal Investigator: Tyler Warkentien, MD         
United States, Washington
Madigan Army Medical Center Recruiting
Tacoma, Washington, United States, 98431
Contact: Susan Chambers    253-968-1643    susan.e.chambers4.ctr@mail.mil   
Contact: Rhonda Colombo    253-968-4596    rhonda.e.colombo.ctr@mail.mil   
Principal Investigator: Christina Schofield, MD         
Sponsors and Collaborators
Henry M. Jackson Foundation for the Advancement of Military Medicine
National Institute of Allergy and Infectious Diseases (NIAID)
Food and Drug Administration (FDA)
Defense Health Agency Immunization Healthcare Branch
Armed Forces Health Surveillance Branch
Naval Health Research Center
United States Air Force School of Aerospace Medicine
Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc.
Uniformed Services University of the Health Sciences
Investigators
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Principal Investigator: Timothy Burgess, MD Uniformed Services University of the Health Sciences
Study Director: Christian Coles, PhD Infectious Diseases Clinical Research Program

Additional Information:
Publications:

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Responsible Party: Henry M. Jackson Foundation for the Advancement of Military Medicine
ClinicalTrials.gov Identifier: NCT03734237     History of Changes
Other Study ID Numbers: IDCRP-120
AAI1201200007000 ( Other Grant/Funding Number: NIAID )
First Posted: November 7, 2018    Key Record Dates
Last Update Posted: December 17, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Investigative team members with knowledge and experience with statistical and scientific procedures will de-identify PHI and prepare the data set to be shared.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Henry M. Jackson Foundation for the Advancement of Military Medicine:
Influenza vaccine
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs