B Cell and Antibody Response to Seasonal Influenza Vaccines in Younger and Older Adults

  • STATUS
    Recruiting
  • End date
    May 6, 2024
  • participants needed
    50
  • sponsor
    University of Alabama at Birmingham
Updated on 6 June 2022
trivalent influenza vaccine
fluzone
antibody test
Accepts healthy volunteers

Summary

This study will examine how various FDA-approved seasonal influenza vaccine types, used in a manner consistent with their approved use, impact the characteristics of influenza specific antibodies in humans, and how these responses differ based on age and prior immunization history.

Description

This study is particularly focused on studying antibodies, a protein in blood that react with foreign substances (such as bacteria and viruses) to help eliminate them. This study will examine antibodies and the cells that they are produced by, B cells that develop in response to the influenza vaccine.

The majority of antibodies that develop following seasonal influenza vaccine are highly specific for particular influenza strain that comprises the influenza vaccine, necessitating the annual reformulation of the influenza vaccine to match strains expected to be in circulation for the upcoming season. This is problematic, and strategies to develop an influenza vaccine that can promote the robust and persistent development of antibodies that are effective against a wide range of influenza strains are needed. One potential strategy is to promote antibody responses targeting the neuraminidase (NA) protein of influenza. NA is more highly conserved across influenza viruses as compared to the hemagglutinin (HA) protein which is the major component of the influenza vaccine. Thus understanding how differences in seasonal influenza vaccines may influence the quality and breadth of HA and NA specific antibodies is of importance in the development of more effective influenza vaccines.

There are several FDA-approved seasonal inactivated influenza vaccines (IIVs) and it remains unknown the extent to which they may induce HA and NA-specific B cells and antibodies, and particularly those that may have broad protective activity against influenza. Differences in the various seasonal IIVs, such as how they were produced, their dose, and the immune stimulating components (adjuvant) they contain may influence the HA and NA-specific response. The two major types of seasonal IIV approved for adults are IIV that is comprised of inactivated influenza virus that was grown in chicken eggs (e.g. Sanofi Fluzone, IIV), and the other comprised of inactivated influenza virus that was grown in cell culture (e.g. Seqirus Flucelvax, cc-IIV). Additionally, for adults 65 years and older, High Dose Fluzone (HD-IIV3), and Sequris Fluad IIV, which includes an adjuvant (a-IIV3). This study will evaluate the relative induction of HA and NA-specific antibodies and B cells from adults immunized with these various seasonal influenza vaccines, and how these responses may change after each year, and differ in older adults who may have a different past exposure history to influenza compared to younger adults. The seasonal influenza vaccines will be given as standard of care, in populations they are approved for, and administered in approved dose and route.

Details
Condition Influenza
Treatment Fluzone, FLUAD, Fluzone High-Dose, FluCelVax
Clinical Study IdentifierNCT04101838
SponsorUniversity of Alabama at Birmingham
Last Modified on6 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Participation in ancillary clinical research study
Able to give informed consent
Age 18-50 years old for Arm 1 and Arm 2
Age 65-80 years old for Arm 3, Arm 4, and Arm 5
Weight of at least 110 lbs as determined by self-reporting

Exclusion Criteria

Inability to give informed consent
Refusal or inability to have blood drawn or participate in study procedures
Previous adverse reaction to influenza vaccine or medical history contraindicated for receiving influenza vaccine, including but not limited to
History of Guillain-Barre Syndrome
History of egg allergy
History of gelatin allergy
History of moderate to severe illness with or without fever within 6 weeks of receipt of influenza vaccine
Previous receipt of influenza vaccine outside of study within current season
Bleeding disorder diagnosed by a doctor (eg, factor deficiency, coagulopathy, or platelet disorder requiring special precautions)
Participant has any medical, psychiatric, or social condition, or occupational or other responsibility that, in the judgement of the investigator would interfere with, or serve as a contraindication to the planned procedure(s)
These following criteria are used for scientific reasons, and not safety reasons. Specifically, the criteria are used to obtain a population that is healthy and less likely to have conditions that may influence the immune system
No recent respiratory infections in the past 4 weeks at time of vaccination
Malignancy
Evidence of Inflammation: Systemic Lupus Erythematosis, Rheumatoid Arthritis, Polymyositis, Dermatomyositis, Scleroderma, Crohn's Disease, Ulcerative Colitis
Lymphoproliferative Disorder
Known Immunodeficiency
Myocardial Infarction <6 months
Cerebral Vascular Accident
Peripheral Vascular Disease- recannulation <6months
Cardiac Insufficiency - congestive heart failure
Hypertension with increased blood urea nitrogen (BUN)
Renal Failure
Dementia
Alcoholism (defined as >17 drinks/week)
Drug Abuse (excluding marijuana)
HIV positive
History of hepatitis
History of immunization within 4 weeks of study participation or plan to receive non- IIV vaccination within 4 weeks of receiving IIV
Moderate to severe illness at time of enrollment
Donations of blood in the 8 weeks prior to enrollment which, combined with expected
Current pregnancy at time of enrollment or pregnancy within last 4 months
volumes to be drawn for this study, would exceed 450 mL in an 8 week period
Active or planned breastfeeding during study participation
Psychiatric condition that precludes compliance with the protocol. Specifically excluded are persons with psychoses within the past 3 years, ongoing risk for suicide, or history of suicide attempt or gesture within the past 3 years
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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