Influenza Clinical Trial
Official title:
Breadth of T-cell Responses After Heterologous Route Immunological Prime-boost Using Influenza Antigens as a Model System
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.
This study is an Open-label, randomised, exploratory, hypothesis generating study.
Each participant will participate in the study for approximately two months. Recruitment
aims to begin, on receipt of a favourable opinion from the ethics committee, in October/
November 2015, during the flu season.
There will be three outpatient visits during the study: Visit 1 will be screening and
immunisation, Visit 2 will be immunisation, and Visit 3 will be an outpatient follow-up. All
visits will take place at the Surrey Clinical Research Centre.
Written informed consent will be obtained after a participant is informed of the nature,
significance, implications and risks of the study and prior to the commencement of any study
specific procedures.
There will be two immunisations for each participant: one at Day 0 (visit 1) and the other
at Day 28 (visit 2). After screening participants will be randomised to one of two treatment
groups (n=15 in each group) and will receive a dose of the vaccine at the recommended dose
level, according to the Summary of Product Characteristics, in the following orders:
Group A: Intranasal spray at day 0 followed by intramuscular injection at day 28
Group B: Intramuscular injection at day 0 followed by intranasal spray at day 28
Visit 1 (Day 0): At this visit informed consent will be obtained, demographic data and
medical history recorded. Concomitant medications will be reviewed and a symptoms-directed
physical examination will take place. Heart rate, blood pressure and oral temperature will
also be recorded. A pregnancy test (urine) will be conducted where indicated. Participants
will be assessed for inclusion and exclusion criteria. At this point if the participant is
eligible they will be randomised to group A or B. Blood samples will be taken for serum and
PBMC and they will be given the immunisation of either the nasal spray or the intramuscular
injection depending on which group they are in.
Immunisation will be postponed if the person is suffering from an acute illness with an oral
temperature ≥38.0°C on day of immunisation until the symptoms have resolved, and oral
temperature is <38°C. Subsequent visits will be delayed by the same duration.
Visit 2 (Day 28): At visit two, medical history will be updated and there will be a review
of concomitant medications. A symptoms-directed physical examination will also take place.
Heart rate, blood pressure and oral temperature will also be recorded. A pregnancy test
(urine) will be conducted where indicated. Participants will be again be assessed for
inclusion and exclusion criteria. Blood samples will be taken for serum and PBMC and they
will be given the immunisation of either the nasal spray or the intramuscular injection
depending on which group they are in
Immunisation will be postponed if the person is suffering from an acute illness with an oral
temperature ≥38.0°C on day of immunisation until the symptoms have resolved, and oral
temperature is <38°C.
A visit window of -3 days or +7 days is acceptable for Visit 2 but should be avoided
wherever possible and used only in a situation where a sample would otherwise be lost. Visit
3 should be rescheduled to maintain 28 days between visits.
Visit 3 (Day 56): At visit 3 there will be a review on concomitant medications and blood
samples will be taken for serum and PBMC.
A visit window of -3 and +14 days is acceptable for Visit 3 but should be avoided wherever
possible and used only in a situation where a sample would otherwise be lost. If
participants cannot attend within this window then samples should be collected on the
earliest date possible AFTER the expected visit window. These samples may be tested but will
not be per protocol.
;
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label
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