Status:
COMPLETED
Safety Study Comparing a Vaccine Transcutaneous Administration to the Intramuscular Route
Lead Sponsor:
Objectif Recherche Vaccins SIDA
Conditions:
Healthy Volunteers
HIV Infection
Eligibility:
MALE
18-45 years
Phase:
PHASE1
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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 Investigational Product (egg products, neomycin),
- Medical history of allergy or hypersensitization to any ingredient of colorant used in the transcutaneous mode of administration,
- Medical history of skin cancer,
- Any acute or chronic illness which may expose the subject or interfere with results of the trial,
- Use of any topical treatment on the injection site within the last four weeks,
- Use, within the past 3 months, of any topical and systemic treatment that would interfere with assessment and/or investigational treatment (anti-inflammatory drugs, immunosuppressors or any immune modulator agent),
- Prevision of UV sessions or sun exposure 6 weeks prior to the study or during the study period,
- Subjects with current alcohol or illicit drug use which, in the opinion of the investigator, may interfere with the subject's ability to comply with the dosing schedule and protocol evaluations.
- Subject being in the exclusion period of a previous clinical trial (1 month.
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00261001
Start Date
October 1 2005
End Date
September 1 2009
Last Update
November 25 2009
Active Locations (2)
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1
Hospital of the Johann Wolfgang Goethe-University Frankfurt am Main
Frankfurt, Frankfurt Am Main, Germany, 60590
2
Charité - Universitätsmedizin Berlin
Berlin, State of Berlin, Germany, 10117