Preferential amplification of CD8 effector-T cells after transcutaneous application of an inactivated influenza vaccine: a randomized phase I trial.

摘要: BACKGROUND: Current conventional vaccination approaches do not induce potent CD8 T-cell responses for fighting mostly variable viral diseases such as influenza, avian influenza viruses or HIV. Following our recent study on vaccine penetration by targeting of to human hair follicular ducts surrounded Langerhans cells, we tested in the first randomized Phase-Ia trial based follicle (namely transcutaneous route) induction virus-specific T cell responses. METHODS AND FINDINGS: We chose inactivated - a licensed tetanus/influenza (TETAGRIP) compare safety and immunogenicity (TC) versus IM immunization two controlled, multi-center Phase I trials including 24 healthy-volunteers 12 HIV-infected patients. Vaccination was performed application according standard protocol allowing opening duct TC route needle-injection route. demonstrated that routes similar. showed superiority application, but route, significant increase influenza-specific cytokine-producing cells However, these did differ significantly CD4 responses, neutralizing antibodies were induced only The response is thus major immune observed after vaccination. CONCLUSIONS: This Ia clinical (Manon05) testing an anti-influenza vaccines designed antibody generate vaccine-specific when administered transcutaneously. These results underline necessity adapting strategies control complex infectious cellular are crucial. Our work opens up key area development preventive therapeutic which play crucial role. TRIAL REGISTRATION: Clinicaltrials.gov NCT00261001.