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T-cell Diversity Following Intranasal and Intramuscular Vaccines

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. Read our disclaimer for details. Identifier: NCT02557802
Recruitment Status : Completed
First Posted : September 23, 2015
Last Update Posted : January 26, 2016
Information provided by (Responsible Party):
University of Surrey

Brief Summary:

The investigators will explore in an experimental medicine healthy human model of immunisation, whether switching the route of sequential administration of licensed influenza vaccines can result in an immune response that is broader in its ability to recognise different substrains of influenza viruses. The investigators will do this by initially giving an immunisation with a nasal or an injected vaccine, and then switching subjects over to receive a second dose one month later (when the cellular component of immunity will have matured) via the opposite route (nasal->injected or injected->nasal). The investigators will use research assays that can map the different parts of the influenza virus that the vaccinated person's immune cells recognise at baseline, after the first immunisation, and then again after the second, to see if the breadth of the recognition has broadened to include new strains or virus components. Should this pilot study give an indication that the breadth has widened (rather than just a further boost to the same responses seen after the first immunisation) it will provide justification for a larger study in which statistical significance may be powered for observed changes.

The study is funded by ADITEC, which is a collaborative research programme that aims to accelerate the development of novel and powerful immunisation technologies for the next generation of human vaccines.

Condition or disease Intervention/treatment Phase
Influenza Biological: Fluenz Tetra Biological: Fluarix Tetra Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Breadth of T-cell Responses After Heterologous Route Immunological Prime-boost Using Influenza Antigens as a Model System
Study Start Date : October 2015
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: Group A
Nasal spray at day 0, intramuscular injection at day 28
Biological: Fluenz Tetra
Intranasal spray, 0.2 ml dose

Biological: Fluarix Tetra
Intramuscular injection, 0.5 ml dose

Experimental: Group B
Intramuscular injection at day 0, nasal spray at day 28
Biological: Fluenz Tetra
Intranasal spray, 0.2 ml dose

Biological: Fluarix Tetra
Intramuscular injection, 0.5 ml dose

Primary Outcome Measures :
  1. Breadth of T-cell responses [ Time Frame: 8 months ]
    Breadth of T-cell responses to influenza antigens measured by increases in frequency and phenotype of T cells synthesising or secreting cytokines, or proliferating in response to in vitro stimulation with influenza antigens.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Healthy male or female participants aged 18-55 years inclusive at visit
  2. Available for follow-up for the duration of the study.
  3. If fertile female, willing to undergo urine pregnancy tests prior to immunisations.
  4. Able to read and understand the Informed Consent Form (ICF), and understand study procedures and has signed the ICF.
  5. Has not received any influenza vaccine in the 2015/16 influenza season.

Exclusion Criteria:

  1. Any contraindication to receiving the study vaccines as detailed in the Summary of Product Characteristics.
  2. Clinically significant medical condition that would interfere with study endpoints as determined by the study physician at screening.
  3. Use of immunosuppressive/immunomodulating drugs orally or parenterally within 6 months of visit 1 or during the study follow-up period. Topical, inhaled and intranasal preparations are not excluded.
  4. Currently participating in another clinical study with an investigational or non-investigational drug or device, or has participated in another clinical study within the 3 months preceding Visit 1.
  5. Any condition that, in the investigator's opinion, compromises the participant's ability to meet protocol requirements or to complete the study.
  6. Unable to read and speak English to a fluency level adequate for the full comprehension of procedures required in participation and consent.
  7. Positive pregnancy test on the day of immunisation.

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 identifier (NCT number): NCT02557802

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United Kingdom
Surrey Clinical Research Centre
Guildford, Surrey, United Kingdom, GU2 7XP
Sponsors and Collaborators
University of Surrey
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Principal Investigator: David Lewis University of Surrey
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Responsible Party: University of Surrey Identifier: NCT02557802    
Other Study ID Numbers: CRC306C
First Posted: September 23, 2015    Key Record Dates
Last Update Posted: January 26, 2016
Last Verified: January 2016
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases