CompletedPhase 1

Safety Study Comparing a Vaccine Transcutaneous Administration to the Intramuscular Route

Germany38 participantsStarted 2005-10

Plain-language summary

The rationale for transcutaneous vaccination is based on the unique ability of cutaneous immune cells, especially Langerhans cells (LCs), to present antigens to the immune system. DCs can be found at high densities in the epidermis and the dermis of human skin, a fraction of which are the epidermal LCs. It is known that strong and efficient immune responses can be induced by targeting vaccines to skin APCs (Glenn 2003, Partidos 2003), e.g. by epicutaneous application of smallpox vaccine on scarified skin. Several obstacles however prevent vaccines from attaining sufficiently high and free concentrations in these target skin DCs. In this clinical trial we aim at testing the safety and immunogenicity of this new transcutaneous route of vaccine administration, first with a licensed, well-known, safe and highly immunogenic vaccine i.e. Tetagrip® vaccine, which is licensed for subcutaneous (s.c.) and intra-muscular routes (i.m), and to compare the induced vaccine-specific immune responses to those induced with the conventional (i.m) injection. We hypothesize that the transcutaneous application of Tetagrip® in the commercially available standard preparation of 0.5 ml should be capable to induce at least similar antibody and CD4 and/or CD8 T cell responses to both the tetanus and the flu vaccinal antigens. This Phase I, open label, randomized study is designed to evaluate and to compare the safety and immunogenicity of a transcutaneous mode of Tetanus / Influenza vaccination to the conventional i.m. route of vaccine administration in two cohorts: The cohort I constituted of healthy volunteers and the cohort II of HIV-infected patients in whom the virus is stably controlled by antiretroviral therapy, ensuring an immune competence and a capacity to respond to vaccines.

Who can participate

Age range18 Years – 45 Years

SexMALE

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Inclusion Criteria: Cohort I * Healthy male volunteers * Negative HIV test within the last 3 months Cohort II * HIV infected males * Positive HIV-serology * CD4+ counts \> 350 cells/mm3 over the last year * CD4 cells nadir \>200/mm3 * Plasma HIV RNA \< 400cp/ml over the last 6 months * Efficient antiretroviral treatment with a minimum of three drugs since at least one year In addition Patients from both cohorts must meet the following criteria to be eligible for the study: * Age between 18 and 45 years, * BMI between 21 - 26, * Phototype I to IV * Clinical examination and an interview on their medical history and possible current therapies * Subjects able to receive vaccine administration by any of the two administration routes, * Absence of tetanus vaccination within last 4 years, * Absence of influenza vaccination in the last year, * Absence of any psychological, familiar, sociological or geographical condition potentially hampering compliance with the study protocol schedule. * Written informed consent Exclusion Criteria: In both cohorts, if any of the following apply, the subject cannot enter the study: * Excessive terminal hair growth on the two investigational skin areas used for the transcutaneous mode of vaccination. * Phototype V-VI * Acute illness, e.g. fever, infection at screening and/or D0 * Any acute skin affection which may interfere with the trial assessment on the injection site, * Any allergy or hypersensibility to one of the components of the Investi…

What they're measuring

Clinical local and systemic tolerance to Tetagrip® vaccine administration for both transcutaneous (TC) and intramuscular (i.m) routes of administration .

Trial details

NCT IDNCT00261001

SponsorObjectif Recherche Vaccins SIDA

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2006-02