Recruiting
Phase 2

Influenza Vaccine

Sponsor:

University of Arkansas, Fayetteville

Code:

NCT07842367

Conditions

Decision-Making

Patient Care

Treatment Decisions

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Influenza vaccine

Placebo

Study Details

Brief summary:

This is a randomized, double-blind clinical trial involving emergency medicine and internal medicine healthcare providers as participants. The intervention involves the administration of the seasonal influenza vaccine or a saline placebo; this protocol is used in psychoneuro-immunology to simulate a state of mild illness. The primary aim is to examine whether acute inflammation induced by receiving the vaccine affects decision-making on standardized psychological reaction time tasks and questionnaires. Participants attend two laboratory sessions on consecutive days, receive either a seasonal influenza vaccine or a saline placebo at the first session, provide blood samples to measure inflammatory cytokines, and complete a series of standardized assessments of medical decision-making and social attitudes. Participants who received the placebo during the first session will receive the vaccine during the second session.

Overall, the study is designed to examine how adverse provider conditions particularly acute inflammation, burnout, and concerns about one's own health affect provider judgments and healthcare-related decision-making. The primary hypothesis is that providers experiencing greater adverse conditions at the time of research participation would have altered decision-making compared to those experiencing fewer adverse conditions.

Conditions

Decision-Making

Patient Care

Treatment Decisions

Study ID

NCT07842367

Start date

Sep, 2026

Status verified date

Sep, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Oct, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Healthcare providers currently employed in emergency medicine or internal medicine
  • Must be one of the following: Resident, fellow, attending, or advanced practice provider (NP, PA)
  • Individual is able to travel to the research site for sessions
  • Has not had an acute viral or bacterial infection within the previous 14 days
  • Has not taken an antiviral medication such as Tamiflu in the previous 48 hours
  • Has not taken corticosteroids or immunosuppressants in the previous 30 days

Exclusion Criteria:

  • Does not want to receive a flu vaccine as part of the study
  • Has received a flu vaccine this season already (after August of current year)
  • Has had a prior allergic reaction or bad side effect, including Guillain-Barre, due to a flu vaccine or another vaccine
  • Is allergic to eggs or have had an adverse reaction to egg-derived vaccine
  • Is pregnant or suspects a possible pregnancy
  • Has congenital or acquired immunodeficiency such as common variable immunodeficiency (CVID) or HIV/AIDS
  • Has an active hematologic malignancy (like leukemia, lymphoma, myeloma)
  • Has Type 1 diabetes
  • Has Graft vs. Host Disease
  • Uses aspirin, ibuprofen (i.e., NSAIDs), acetaminophen, or naproxen daily
  • Uses corticosteroids or immunosuppressants daily
  • Is currently receiving systemic chemotherapy and/or immunotherapy
  • Has had changes in daily prescription medication in the last 3 months (starting, stopping, changing dose)

Study Design

Enrollment

210 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Influenza Vaccine Injection

Receives the influenza vaccine at the end of Session 1

placebo comparator: Placebo Injection

Receives a saline placebo injection at the end of Session 1

Interventions

Influenza vaccine

A single administration of a seasonal trivalent cell-based influenza vaccine delivered by injection into the arm at the end of the first study session.

Placebo

Control group will receive a saline placebo injection at the end of Session 1

Primary outcome measure

  • Testing Automatic Judgments: "Implicit Association Test" [ Time Frame: 2 days ]
  • Testing Deliberate Judgments: "Feeling Thermometers" [ Time Frame: 2 days ]

Central Contacts and Locations

Central contacts

Anastasia Makhanova, PhD

479-575-8798ammakhan@uark.edu

Locations

University of Arkansas for Medical Sciences

Recruiting

Fayetteville, Arkansas, United States, 72703

Contacts

Principal Investigator:

Roy Kamoga, MD

University of New Mexico Health Sciences Center

Recruiting

Albuquerque, New Mexico, United States, 87106

Contacts

Principal Investigator:

Joe Alcock, MD

Carilion Medical Center

Recruiting

Roanoke, Virginia, United States, 24016

Contacts

Principal Investigator:

Michael Wilson, MD

More Information

Sponsor

University of Arkansas, Fayetteville

Last update posted

Sep 30, 2026

Last verified

Sep, 2026

Keywords

  • Decision making
  • Patient Care

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-01. This information was provided to ClinicalTrials.gov by University of Arkansas, Fayetteville on 2026-09-30. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.