Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Long-term Observation of Hemagglutinin and Neuraminidase Inhibition Antibody Titers After Influenza Challenge

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02511002
Recruitment Status : Recruiting
First Posted : July 29, 2015
Last Update Posted : November 21, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )

Brief Summary:

Background:

- Influenza is a common viral infection. But it can be deadly for some people. Researchers want to learn more about how the body fights this virus. They want to study this in people who have recently been infected with influenza. They hope this can help them create more effective influenza vaccines.

Objective:

- To learn about long-term changes in the body s immune system after influenza infection.

Eligibility:

- People who have completed a previous LID Clinical Studies Unit influenza challenge study and are willing to have samples stored for future research.

Design:

  • Eligible participants will be asked to visit the clinic every 3 months for 2 years.
  • During each visit, participants will have blood drawn from an arm vein using a needle and a syringe.
  • Participants will have a medical history and physical exam and vital signs performed. This will include blood pressure, heart rate, breathing rate, temperature, weight, and finger-measured blood oxygen. They will answer questions about any medicines taken and possible recent illnesses.
  • If participants have symptoms of influenza, they may have a sample taken from the nose. A small <TAB>amount of salt water will be sprayed into the nostril with a squeezable container. The salt water will then run out of the nose and into the container. Or the inside of the nose will be wiped with a swab that is

similar to a Q-tip.

- Participants will complete a health questionnaire once a month on a secure website. Participants may also give their responses over the telephone.


Condition or disease
Post Influenza

Detailed Description:

Circulating anti-influenza antibodies are an important factor in predicting clinical illness and severity in those infected with influenza. Specific antibodies against influenza include proteins targeting hemagglutinin (HA) and neuraminidase (NA). Lifelong immunity does not occur with influenza, either from natural infection or from vaccination. Due to the antigenic variation of Influenza A, individuals may become infected multiple times with the same subtype of influenza and even with the same strain. In the setting of natural infection and vaccination, antibody titer levels can persist initially, but then wane over time.

In our previous challenge studies, measurements of antibody responses have been focused solely on the acute infection period up to 2 months after initial infection. Long-term changes in immunity have not been investigated. The challenge setting gives us the unique ability to follow individuals from a specific, known and well-characterized exposure/illness to measure long-term changes in antibody titers from a pre-exposure baseline. This study could offer unique insight into how anti-influenza antibody titers change over time naturally and in response to other infections and life events. This type of controlled study has never been done and we believe monitoring titers long-term will help us better understand protective correlates of influenza.

In this natural history study, we will follow individuals who have undergone influenza challenge or have been naturally infected with influenza to evaluate changes in anti-influenza antibody titers over a 2-year period. Subjects will be followed for symptoms of influenza-like illness (ILI) and other changes in clinical status through quarterly clinical evaluations with blood draws. Monthly questionnaires will be used to follow subjects in between visits.


Layout table for study information
Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Long-Term Observation of Hemagglutinin and Neuraminidase Inhibition Antibody Titers After Influenza Challenge
Actual Study Start Date : July 17, 2015
Estimated Primary Completion Date : May 27, 2027
Estimated Study Completion Date : May 27, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Group/Cohort
1
Post influenza infection



Primary Outcome Measures :
  1. To characterize the timing of peak antibody response to hemagglutinin (HA) and neuraminidase (NA) post influenza challenge or after natural infection [ Time Frame: 2 years ]
    Trend of HAI titer over multiple time points. Trend of NAI titer over multiple time points.

  2. To evaluate the long-term variability of hemagglutinin inhibition (HAI) and neuraminidase inhibition (NAI) antibody titers after an influenzachallenge or after natural infection [ Time Frame: 2 years ]
    Trend of HAI titer over multiple time points. Trend of NAI titer over multiple time points.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy volunteers after influenza challenge or natural infection.
Criteria
  • INCLUSION CRITERIA:

    1. Completion of participation in an LID Clinical Studies Unit influenza challenge study or current or prior participation in an LID natural history study.
    2. Willing to have samples stored for future research.

CO-ENROLLMENT GUIDELINES:

Participants may be co-enrolled in other research studies. This will be addressed on a case-by-case basis with the approval of the principal investigator (PI) or associate investigator.

If a participant enrolls in another influenza challenge study, the participant will be removed from this study. The participant can re-enroll in this study after completion of the influenza challenge study and will be followed for two years following completion of the most recent influenza challenge study.

EXCLUSION CRITERIA:

Any condition or event that, in the PI s opinion, may substantially increase the risk associated with study participation or compromise the study s scientific objectives. Conditions that exclude a subject are considered to be unlikely, but an example would include a newly diagnosed medical condition that may alter a participant s immune system and make it unsafe to obtain scheduled blood samples for research purposes.


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): NCT02511002


Contacts
Layout table for location contacts
Contact: Holly A Baus, R.N. (301) 761-6800 holly.baus@nih.gov

Locations
Layout table for location information
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY8664111010    prpl@cc.nih.gov   
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Layout table for investigator information
Principal Investigator: Alison Han, M.D. National Institute of Allergy and Infectious Diseases (NIAID)

Additional Information:
Publications:
Layout table for additonal information
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT02511002     History of Changes
Other Study ID Numbers: 150154
15-I-0154
First Posted: July 29, 2015    Key Record Dates
Last Update Posted: November 21, 2019
Last Verified: March 7, 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) ):
Influenza Like Infection (ILI)
Longitudinal Observation
Flu
Immunity
Natural History
Additional relevant MeSH terms:
Layout table for MeSH terms
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Antibodies
Hemagglutinins
Immunologic Factors
Physiological Effects of Drugs
Agglutinins