Pilot Influenza Challenge Study (NCT07063849)
A Pilot Study of the Effects of Pre-Existing Immunity on Influenza A/Texas/71/2017 (H3N2) Virus Shedding After Human Challenge in Healthy Participants
๐ฉบ Plain-English Summary (8th-Grade Level)
This is a research study to understand what happens when a person is infected with influenza ("flu") and how the body controls the infection. Healthy participants (challenge) will be infected with a strain of flu (H3N2), and followed to see what symptoms occur and when they occur. Blood will be drawn and nasopharyngeal (NP) swabs will be collected before participants are infected to understand if having antibodies can protect participants from flu infection or lead to a milder flu illness. Blood will also be drawn and NP swabs collected after participants are infected to understand how and when the body's immune response to flu occurs. Participants will also breathe through a device for virus collection every other day. Participants will be screened during one or more visits and will stay in the inpatient challenge unit for at least 10 days, maybe longer. Participants will complete a FLU PRO Diary Card daily. Blood will be drawn before the challenge and on Days 2, 4, and 8 while in the inpatient unit. NP samples will be taken every day to check for viruses and on certain days, immune responses such as antibodies. If on Day 8 (7 days after the challenge) the participant still has flu virus, medicine will be offered to treat the flu and the participant will be asked to stay in the challenge unit until NP swabs are negative for 2 consecutive days. Once the participant is discharged from the challenge unit, they will be asked to return to the clinic for 3 more visits. At the end of the study will be a final phone call.
Who can join: Review the eligibility criteria below.
Location: Saint Louis University Center for Vaccine Development โ St Louis, Missouri
Age range: 18 Years to 45 Years
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (1 Sites)
- Saint Louis University Center for Vaccine Development โ St Louis, Missouri
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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- B Cell and Antibody Response to Seasonal Influenza Vaccines in Younger and Older Adults โ Birmingham, Alabama
- A Study to Evaluate the Safety and Efficacy of CD388 for Prevention of Influenza โ Anniston, Alabama
- Influenza IMPRINT Cohort: Defining the Impact of Initial Influenza Exposure on Immunity in Infants โ Cincinnati, Ohio
- A Study of mRNA-1018-H5 Pandemic Influenza Vaccine in Healthy Adults โ San Bernardino, California
Explore by condition: All Influenza clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.