Ignite Creation Date:
2024-05-05 @ 4:34 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00261001
Status:
COMPLETED
Last Update Posted:
2009-11-25
First Post:
2005-12-01
Brief Title:
Safety Study Comparing a Vaccine Transcutaneous Administration to the Intramuscular Route
Sponsor:
Objectif Recherche Vaccins SIDA
Organization:
Objectif Recherche Vaccins SIDA
Study Overview
Official Title:
A Randomized Comparative Phase I Study to Evaluate and to Compare the Safety and Immunogenicity of a Transcutaneous Mode of Administration of a Licensed TetanusInfluenza Vaccine to the Conventional Intramuscular Route of Vaccine Administration in Healthy Volunteers and HIV-infected Patients
Status:
COMPLETED
Status Verified Date:
2009-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MANON-05
Brief 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 eg 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 ie Tetagrip vaccine which is licensed for subcutaneous sc and intra-muscular routes im and to compare the induced vaccine-specific immune responses to those induced with the conventional im injection We hypothesize that the transcutaneous application of Tetagrip in the commercially available standard preparation of 05 ml should be capable to induce at least similar antibody and CD4 andor 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 im 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
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 ie Tetagrip vaccine which is licensed for subcutaneous sc and intra-muscular routes im and to compare the induced vaccine-specific immune responses to those induced with the conventional im injection We hypothesize that the transcutaneous application of Tetagrip in the commercially available standard preparation of 05 ml should be capable to induce at least similar antibody and CD4 andor 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 im 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
Detailed Description:
The proposed study aims to translate our current knowledge about vaccinology immunology of the skin and on transcutaneous penetration of epicutaneously applied active compounds into the development of more efficient and well tolerated vaccines and to progress toward an easy-to-apply patch system for transcutaneous application of vaccines
To that purpose we aim at testing the safety and immunogenicity of a new transcutaneous route of vaccine administration We propose to test this new route first with a well-known safe and highly immunogenic vaccine ie anti-influenza and tetanus vaccine which is licensed for sub-cutaneous and intra-muscular routes and to compare the vaccine-specific immune responses induced after transcutaneous administration to the conventional intramuscular im injection Seasonal vaccination against influenza is recommended for all individuals at risk for severe flu including persons above 60 years of age or suffering from chronic diseases and for medical personal It is also highly recommended at any age to prevent influenza In addition vaccination against tetanus is mandatory in childhood and requires recall injections every 5 years to protect against the lethal disease caused by the tetanus toxin
We hypothesize that the transcutaneous application of a licensed anti-influenza-tetanus vaccine in the commercially available standard preparation of 05 ml should be capable to induce at least similar antibody and CD4 andor CD8 T cell responses to both the tetanus and the flu vaccinal antigens
Tetagrip vaccine is an approved and commercially available vaccine manufactured by Sanofi-Pasteur administered in one injection for preventive vaccination of adults against tetanus and influenza The Tetagrip vaccine therefore represents a safe and approved test vaccine to evaluate safety and immunogenicity of the mode of administration under investigation
The long term goal of this strategy is to improve the efficacy of vaccines that are currently encountering major obstacles such as the HIV vaccines and to develop a non invasive mode of vaccine administration Results from this study will help establish a standardized study protocol for the application of HIV-vaccines in future clinical trials
STUDY DESIGN This Phase I open label randomized on the vaccine administration route study is designed to evaluate and to compare the safety and immunogenicity of a transcutaneous mode of Tetanus Influenza vaccination to the conventional im 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
This is a multisite trial and is being conducted in Germany in two clinical centers
Cohort I
Charité - Universitätsmedizin Berlin Clinical Research Center for Hair and Skin Physiology Department of Dermatology and Allergy Schumannstr 2021 10117 Berlin Germany
Cohort II
Hospital of the Johann Wolfgang Goethe-University Frankfurt am Main HIV Treatment Research Unit Department of Internal Medicine II Theodor-Stern-Kai 7 60590 Frankfurt am Main -Germany
To that purpose we aim at testing the safety and immunogenicity of a new transcutaneous route of vaccine administration We propose to test this new route first with a well-known safe and highly immunogenic vaccine ie anti-influenza and tetanus vaccine which is licensed for sub-cutaneous and intra-muscular routes and to compare the vaccine-specific immune responses induced after transcutaneous administration to the conventional intramuscular im injection Seasonal vaccination against influenza is recommended for all individuals at risk for severe flu including persons above 60 years of age or suffering from chronic diseases and for medical personal It is also highly recommended at any age to prevent influenza In addition vaccination against tetanus is mandatory in childhood and requires recall injections every 5 years to protect against the lethal disease caused by the tetanus toxin
We hypothesize that the transcutaneous application of a licensed anti-influenza-tetanus vaccine in the commercially available standard preparation of 05 ml should be capable to induce at least similar antibody and CD4 andor CD8 T cell responses to both the tetanus and the flu vaccinal antigens
Tetagrip vaccine is an approved and commercially available vaccine manufactured by Sanofi-Pasteur administered in one injection for preventive vaccination of adults against tetanus and influenza The Tetagrip vaccine therefore represents a safe and approved test vaccine to evaluate safety and immunogenicity of the mode of administration under investigation
The long term goal of this strategy is to improve the efficacy of vaccines that are currently encountering major obstacles such as the HIV vaccines and to develop a non invasive mode of vaccine administration Results from this study will help establish a standardized study protocol for the application of HIV-vaccines in future clinical trials
STUDY DESIGN This Phase I open label randomized on the vaccine administration route study is designed to evaluate and to compare the safety and immunogenicity of a transcutaneous mode of Tetanus Influenza vaccination to the conventional im 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
This is a multisite trial and is being conducted in Germany in two clinical centers
Cohort I
Charité - Universitätsmedizin Berlin Clinical Research Center for Hair and Skin Physiology Department of Dermatology and Allergy Schumannstr 2021 10117 Berlin Germany
Cohort II
Hospital of the Johann Wolfgang Goethe-University Frankfurt am Main HIV Treatment Research Unit Department of Internal Medicine II Theodor-Stern-Kai 7 60590 Frankfurt am Main -Germany
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None