NCT02557802

Completed

T-cell Diversity Following Intranasal and Intramuscular Vacc...

University of Surrey Source

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Other study identifiers

Sponsor study identifier

CRC306C

Study Type

interventional

Estimated enrollment

30

Locations

1 country

Sites

1

Timeline

Study Start

October 2015

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

January 2016

Actual (reported)

Study Completion

January 2016

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Estimated enrollment: 30 participants
Study completion date: January 2016
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
September 22, 2015
Actual (reported)
First Posted
September 23, 2015
Actual (reported)
Study Start
October 2015
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
January 2016
Actual (reported)
Study Completion
January 2016
Actual (reported)

Last Updated: January 26, 2016
Status Verified: January 2016
Last Update Submitted: January 25, 2016

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 TetraBiological: Fluarix Tetra

Group B

EXPERIMENTAL

Intramuscular injection at day 0, nasal spray at day 28

Biological: Fluenz TetraBiological: Fluarix Tetra

Interventions

Fluenz TetraBiological

Intranasal spray, 0.2 ml dose

Group AGroup B

Fluarix TetraBiological

Intramuscular injection, 0.5 ml dose

Group AGroup B

Eligibility Criteria

Age18 Years - 55 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (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.

Sponsors & Collaborators

University of Surrey
Otherlead

Study Sites (1)

Surrey Clinical Research Centre

Guildford, Surrey, GU2 7XP, United Kingdom

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory 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 2015

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

January 2016

Actual (reported)

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GEneRating Mucosal Immunity After INfluenzA Infection and Vaccination in Lung and Lymphoid TissuE

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Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

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.

Contact the study team to confirm eligibility.

Study Completion

January 2016

Actual (reported)

Last Updated

January 26, 2016

Record last verified: 2016-01

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT02557802
Data provider: ClinicalTrials.gov
Source updated: 2016-01-26
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:26:22 UTC

Locations

GB(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

Group A

Group B

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations