Influenza in People With Normal and Weakened Immune Systems

NCT00533182 | Completed

• 2 other identifiers: 07022907-I-0229
• Study Type: observational
• Target: 137
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate how the immune system responds to influenza infection and compare how the infection differs in patients with a weakened immune system versus those with a healthy immune system. Patients at the NIH Clinical Center who are older than 2 years of age and who are diagnosed with influenza A or B may be eligible for this study. Patients with healthy immune systems and weakened immune systems are included. Participants answer questions about how they are feeling and have a physical examination to evaluate their symptoms. Blood and nasal fluid are collected on the first day and then every other day for a total of 8 days. Nasal fluid is collected by either inserting a small tube in the nose and washing the nose with salt water and collecting the fluid obtained, or by rubbing the inside of the nose with a swab. Physical examinations are repeated on the days that blood and nasal fluid are collected.

Conditions

Viral Infections; Respiratory Infections

Keywords

Pregnant; Children; Adults; Flu; Infection; Natural History; Influenza Infection

Outcome Measures

Primary Outcomes (1)

• The purpose of this study is to evaluate immunocompromised andnon-immunocompromised individuals who become infected with influenza virus.

  To better understand the impact influenza has on the overall health of patients

  1 year

Study Arms (3)

Immunocompromised

Immunocompromised individuals

Non-Immunocompromised

Non-immunocompromised individuals

Pregnant

Pregnant women

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with known or suspected influenza infection: NIH Patients, Non-NIH Outpatients, Hospitalized Patients at the Washington Hospital Center, Non-Hospitalized Patients at the Washington Hospital Center. Healthy Pregnant Women (Control): Patients at the Washington Hospital Center

You may qualify if:

• Greater than or equal to 2 years old
• Participant or (LAR) able and willing to complete the consent/assent process and be willing to comply with study procedures
• Suspected of having influenza by clinical diagnosis or have a positive clinical diagnostic test for influenza (rapid test molecular test, or culture) within the past 2 months.
• Agrees to undergo multiple nasal mucosal sample collections by nasal wash, swab, and/or synthetic absorptive matrix (SAM)
• Willing to have blood and nasal samples stored for future use

You may not qualify if:

• Participants will not be enrolled in this study if the following criterion applies or is satisfied:
• \. Any condition that, in the judgment of the investigator is a contraindication to protocol participation.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Publications (4)

• Askonas BA, Lin YL. An influenza specific T-killer clone is restricted to H-2Ld and cross-reacts with Dk region. Immunogenetics. 1982;16(1):83-7. doi: 10.1007/BF00364444. No abstract available.

  PMID: 6981600 BACKGROUND

• Couch RB, Kasel JA, Gerin JL, Schulman JL, Kilbourne ED. Induction of partial immunity to influenza by a neuraminidase-specific vaccine. J Infect Dis. 1974 Apr;129(4):411-20. doi: 10.1093/infdis/129.4.411. No abstract available.

  PMID: 4593871 BACKGROUND

• McMichael AJ, Gotch FM, Noble GR, Beare PA. Cytotoxic T-cell immunity to influenza. N Engl J Med. 1983 Jul 7;309(1):13-7. doi: 10.1056/NEJM198307073090103.

  PMID: 6602294 BACKGROUND

• Memoli MJ, Athota R, Reed S, Czajkowski L, Bristol T, Proudfoot K, Hagey R, Voell J, Fiorentino C, Ademposi A, Shoham S, Taubenberger JK. The natural history of influenza infection in the severely immunocompromised vs nonimmunocompromised hosts. Clin Infect Dis. 2014 Jan;58(2):214-24. doi: 10.1093/cid/cit725. Epub 2013 Nov 1.

  PMID: 24186906 DERIVED

Related Links

• NIH Clinical Center Detailed Web Page

Biospecimen

Retention: SAMPLES WITHOUT DNA

whole blood, serum, nasal samples

MeSH Terms

Conditions

Virus Diseases; Respiratory Tract Infections; Influenza, Human; Infections

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Orthomyxoviridae Infections; RNA Virus Infections

Study Officials

• Matthew J Memoli, M.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2007
• First Posted: September 21, 2007
• Study Start: January 3, 2008
• Primary Completion: December 31, 2019
• Study Completion: August 25, 2022
• Last Updated: November 10, 2022

Record last verified: 2022-11

Locations

US (1)