Influenza Clinical Trial
Official title:
Impact of Immunization Routes on the Immune Response to Influenza Vaccine
The project aims to evaluate the impact of skin routes of immunization (transcutaneous and intradermal vs intramuscular) on cellular and humoral responses to seasonal influenza vaccination in adults (18-45 years old).
New approaches addressing intradermal (ID) and transcutaneous (TC) routes of immunization
have been developed over the past few years and have brought novel insight in quality and
efficacy of the immune response. Indeed, compared to the muscular tissue widely used for
vaccination, the skin is particularly rich in antigen presenting cells. Our recent works
show that penetration of vaccine compounds into the hair follicular ducts surrounded by
Langerhans cells induces potent cellular immunity in contrast to the intra-muscular
immunization. Our results also suggest that differential targeting of epidermal Langerhans
cells (by TC route) or dermal dendritic cells (by ID route) could modulate the intensity and
quality of the immune response to vaccine.
The aim of this study is to evaluate the immune response to a seasonal influenza vaccine
when administrated byTC (hair follicular targeting needle-free method), ID (micro-needle
injection) and IM (conventional intramuscular injection) routes of immunization. Along with
our previous pre-clinical and clinical studies, here we hypothesize that differential
targeting of epidermis or dermis antigen-presenting cells will have a differential impact on
the cellular and humoral immune responses to Influenza vaccine.
Objectives:
We will conduct a phase I/II clinical trials on 60 healthy volunteers to compare TC and ID
routes of immunization to the conventional intramuscular (IM) vaccination. The impact of
these routes on cellular and humoral immune responses to seasonal influenza vaccine will be
assessed at baseline, day 21 (effector phase) and month 5 (memory phase) after vaccination.
Outcomes:
Using the seasonal Influenza vaccine as an example of conventional vaccine, this study will
evaluate and compare the efficacy ofTC, ID and IMroutes of immunization to induce cellular
responses at day 21 and memory responses at month 5 phases. The generation and maintenance
of Flu specific and neutralizing antibodies will be measured by Haemagglutination Inhibition
and microneutralization assays.Moreover, safety and tolerance to each vaccination methods
will be evaluated as well as inflammation and innate immune response induced at day 1 after
vaccination.
Addressing innovative skin routes of immunization, this study represents an essential step
to move forward in the development of new vaccination strategies. These results will have an
important impact on the amelioration of vaccine efficacy and less invasive method of
immunization.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
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