Influenza Clinical Trial
Official title:
Breadth of T-cell Responses After Heterologous Route Immunological Prime-boost Using Influenza Antigens as a Model System
Verified date | January 2016 |
Source | University of Surrey |
Contact | n/a |
Is FDA regulated | No |
Health authority | United Kingdom: Research Ethics Committee |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | January 2016 |
Est. primary completion date | January 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 55 Years |
Eligibility |
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. |
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
United Kingdom | Surrey Clinical Research Centre | Guildford | Surrey |
Lead Sponsor | Collaborator |
---|---|
University of Surrey |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
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