T-cell Diversity Following Intranasal and Intramuscular Vaccines

NCT02557802 | Completed

• 1 other identifier: CRC306C
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Influenza

Outcome Measures

Primary Outcomes (1)

• Breadth of T-cell responses

  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.

  8 months

Study Arms (2)

Group A

EXPERIMENTAL

Nasal spray at day 0, intramuscular injection at day 28

Biological: Fluenz Tetra; Biological: Fluarix Tetra

Group B

EXPERIMENTAL

Intramuscular injection at day 0, nasal spray at day 28

Biological: Fluenz Tetra; Biological: Fluarix Tetra

Interventions

Fluenz Tetra BIOLOGICAL

Intranasal spray, 0.2 ml dose

Group A; Group B

Fluarix Tetra BIOLOGICAL

Intramuscular injection, 0.5 ml dose

Group A; Group B

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Any contraindication to receiving the study vaccines as detailed in the Summary of Product Characteristics.
• Clinically significant medical condition that would interfere with study endpoints as determined by the study physician at screening.
• 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.
• 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.
• Any condition that, in the investigator's opinion, compromises the participant's ability to meet protocol requirements or to complete the study.
• Unable to read and speak English to a fluency level adequate for the full comprehension of procedures required in participation and consent.
• Positive pregnancy test on the day of immunisation.

Sponsors & Collaborators

• University of Surrey: lead

Study Sites (1)

Surrey Clinical Research Centre

Guildford, Surrey, GU2 7XP, United Kingdom

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• David Lewis

  University of Surrey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2015
• First Posted: September 23, 2015
• Study Start: October 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: January 26, 2016

Record last verified: 2016-01

Locations

GB (1)